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WO2015157437A1 - Aperture widening prosthesis including spline surface topography and methods of making the same - Google Patents

Aperture widening prosthesis including spline surface topography and methods of making the same Download PDF

Info

Publication number
WO2015157437A1
WO2015157437A1 PCT/US2015/024954 US2015024954W WO2015157437A1 WO 2015157437 A1 WO2015157437 A1 WO 2015157437A1 US 2015024954 W US2015024954 W US 2015024954W WO 2015157437 A1 WO2015157437 A1 WO 2015157437A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
thickness
zone
eye
region
Prior art date
Application number
PCT/US2015/024954
Other languages
French (fr)
Inventor
Ronald D. Blum
John Clamp
Original Assignee
BeautiEyes, LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/624,269 external-priority patent/US9995947B2/en
Priority claimed from US14/680,854 external-priority patent/US20150290034A1/en
Application filed by BeautiEyes, LLC filed Critical BeautiEyes, LLC
Publication of WO2015157437A1 publication Critical patent/WO2015157437A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04—Contact lenses for the eyes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes

Definitions

  • the present application relates to prostheses for use in the eye, and specifically, to the field of prostheses that enhance or alter the appearance of a wearer's eye.
  • Scleral coniact lenses are hard rigid and have been, designed in the past to fi snugly against the sclera of the wearer' eye, "vault the cornea" and. have a very thick edge design such to Sift the upper lid of the wearer's eye having ptosis. While scleral contact lenses have existed in the past that will lift the upper lid of the wearer's eye these hard/rigid sclera contact lenses are highly uncomfortable, cause very red eyes and irritate the eye lid margin thus presenting severe limitations for the wearer. For these reasons: the commercial success of scleral coniact lenses to correct for ptosis has bee a major failure. Thus nott-snrgical and comfortable means to widen the natural palpebral fissur of an individual's eye are of interest.
  • Some embodiments include a prosthesis capable of being worn on the eye of a wearer having a convex surface and a concave surface.
  • the prosthesis has an aperture widening zone located on the convex surface. The prosthesis widens the natural palpebral fissure f the wearer's eye by at least J mm.
  • Some embodiments include a prosthesis capable of being worn on the eye of a wearer.
  • the prosthesis has a convex surface and a concave surface.
  • An aperture widening . 7 . zone is located oil the convex surface.
  • the prosthesis is a comeo- scleral contact lens that widens the natural palpebral fissure of the wearer's eye by at least 1 mm,
  • Some em ' bodimenis include a prosthesis- having a convex surface and " a concave
  • the prosthesis is a scleral ring that widens the natural palpebral fissure of the wearer's eye by at least 1 mm,
  • Some embodiments indudfc a prosthesis capable of being worn on the eye of a wearer.
  • the prosthesis has a convex surface and a concave surface.
  • An. aperture widening z is located on the convex surface..
  • the aperture widening zone includes at least one surface feature. The prosthesis widens the natural palpebral fissure of the wearer's eye by at least 1 mm.
  • Some embodiments include a prosthesis capable of being worn -on the eye of a wearer having a convex surface, a concave surface-, and a peripheral edge.
  • the prosthesis also has an aperture w dening zone located on the convex surface.
  • the aperture-widening zone including an outer slope and an inner slope with a maxtnium change in tfneknes located in between. The outer slope and: the inner slope are different
  • Some embodiments include a prosthesis capable of being worn on the eye of a wearer having a convex surface, a concave surface, and a peripheral edge.
  • the prosthesis also has an aperture widening zone located on the convex surface.
  • the aperture widening zone including an outer slope and an inner slope with a maximum, change in thickness located i between.
  • Some embodiments include a prosthesis capable of being worn en the eye of a wearer.
  • Th prosthesis has a convex, surface and a concave surface,.
  • An aperture widening zone is located on the convex surface.
  • the aperture widening zone has at least one surface feature.
  • the aperture widening zone also has a. minimum vertical dimension,.
  • Some embodiments include a prosthesis capable of bein worn on the eye of a wearer.
  • the prosthesis has a convex surface, a concave surface, a peripheral edge, and. ' a geometric center.
  • An aperture widening zone is located on the convex surface.
  • the aperture widening zone has at least one surface feature. At least a portion of the at least one surface feature is located at o outside 5.25 mm from the geometric center of the prosthesis.
  • the prosth esis has an overal l diameter of at least 13,0 ' mm. in other embodiments the prosthesis has an overall diameter of at least 13.5 nun. in some: embodiments the prosthesis has an overall diameter of at least 14.0 nt in some embodiments the prosthesis has an overall diamete of at least 14.5 mm. In still some other embodiments the prosthesis has an overall diameter of at least 15.0 mm dr larger, in some other em edments the prosthesis has an overall diameter of at least 15.5 rum. In some other embodiments, the prosthesis has an overall diameter of at least 16,0 mm
  • the prosthesis is a rotational ty symmetric lens, in some embodiments the prosthesis is capable of rotating. In some embodiments the prosthesis is not capable of rotating.
  • the aperture widening zone depresses a lower eye lid of the wearer by at least 1 mm. In some embodiments die aperture widening zone elevates an upper eye fid of the wearer by at least 1 mm.
  • the prosthesis includes a colore accent color.
  • the colored accent color is around a. portion of the prosthesis which fits near or at the iirnbus of the ey when the prosthesis is worn.
  • the colored accent color is a lirnbal ring, circle ring, or circle lens.
  • the prosthesis is multifocal contact lens. In some embodiments the prosthesis is a tone contact lens. In some embodiments the prosthesis is a single vision contact lens.
  • the aperture widening zone comprises an area of increased surface friction.
  • the increased surface friction is provided by a surface treatment, a coating, a different material surface dimples, surface irregularities, chemical treatment, etching, or combinations thereof
  • the aperture widening zone also includes an outer slope and an inner slope with, a maximum change in thickness located i between.
  • the outer slope and inner slope are different.
  • the outer slope is greater than the inner slope.
  • the outer slope has an: angle between 3° and 45*.
  • the outer slope ha an angle between 5° and 25"
  • the inner slope comprises an angle between 1 0 and 1 3 ⁇ 4: . j 00181
  • the aperture- widening zone has an incremental thickness and a maximum change m thickness.
  • the maximum change in thickness is within a. range of 25 microns to U)00 microns.
  • the maximum change in thickness is within a range of 100 microns, to 500 microns, in some em odiments the maximum change in thickness is within » range of 75 microtis to 400 microns, In some embodiments the maximum change in thickness is located between 1 ,0 mm and 2.5 mm from an. outer edge of the prosthesis. In some embodiments the .maximum change in thickness is located at or exterior to the corneal linib s of the wearer' eye when the prosthesis is worn on. the eye.. In. some embodiments, the maximum change in thickness is located, at least 5.5 ram.
  • the maximum change in thickness is located at least 6,0 .mm from the geometrical center of the prosthesis.
  • the m x mum change in thickness is located at least 6.5 mm from the geometrical center of the prosthesis,.
  • the incremental thickness is an increase in thickness. In some embodiments the incremental thickness is a decrease in thickness.
  • a outermost pari of the aperture widening zone is located, within, a range of 3 mm to $5 mm imm a geometric center of the prosthesis, in some •embodiments an outermost part of the aperture widening zone is located within- a range of 5 mm to 7.75 mm from geometric center of the prosthesis, in some embodiments an innermost part of the aperture widening zone is located between a peripheral edge o the prosthesis and 6 mm from a peripheral edge of the prosthesis.
  • a minimum vertical dimension of the aperture widenin zone is larger than a maximum vertical diameter of the natural palpebral fissure of the wearer's eye.
  • a minimum vertical dimension o the aperture widening mm is- equal to or greater than 10.5 mm.
  • a minimu vertical: dimension of the aperture widening zone is equal to or greater than 1 1.0 mm.
  • a minimum vertical dimension, of the aperture widening 3 ⁇ 4ooe is equal to or greater than 1 1.5 mm.
  • a minimum vertical dimension of the aperture widening zone is equal to or greater than 12 ram.
  • minimum vertical dimension of the aperture widening zone is a vertical distance between an uppermost part of the aperture widening ne and a. lowermost ' part of the aperture widening zone.
  • the aperture widening zone includes at least one surface feature. In some embodiments the aperture widening zone has a plurality of surface features. 0022 ⁇ some embodiments the prosthesis is a eorneo-seleral contact lens. In some embodiments the prosthesis is a sclera! ring.
  • the aperture widening zdne has a minimum vertical dimension.
  • the prosthesis also has a peripheral ed e, a geome ric center * and at least one surface feature, In some embodiments the at least ne surfac feature or at least a portion of the at least one surface is located at or outside 5,25 mm fro t the geometric center of the prosthesis.
  • the peripheral edge has knife edge shape, a rounded shape, a blunt shape, or semi-rounded shape, in some embodiments th peripheral edge has a thickness between 25 microns and 100 microns.
  • to some embodiments the prosthesis has a hybrid design. In some embodiments the prosthesis has a homogeneous design.
  • the aperture widening zone comprise a ring, mailt pie- rings, a partial ring, multiple partial rings, a island, multiple islands, a band, hands, partial bands, a segmented area, or multiple segmented areas,
  • the prosthesis can be worn by the wearer continuously.
  • the prosthesis can be worn by the wearer uon-contwuousfy.. in some embodiments the prosthesis can be wont by the wearer daily, weekly , or monthly.
  • the prosthesis is disposable. In some embodiments the prosthesis is reusable.
  • the prosthesis comprises an optical power. In some embodiments die prosthesis does not comprise an optical power,
  • Some embodiments include a prosthesis having an aperture widening -zone.
  • the aperture widening zone has an outer slope, an inner slope, a point of maximum added thickness delta, and an incremental thickness diameter
  • the prosthesis also has peripheral edge, a geometrical center, and an overall diameter.
  • the overall diameter is measured, from a first point on the peripheral edge to a second point on the opposing peripheral edge thru the- geometrical center of the prosthesis and the aperture widening 3 ⁇ 4one.
  • the overall diameter Is 14.5 mm or greater.
  • the outer slope is with the range of 5 degrees and 25 degrees.
  • the point of maximum added thickness delta of the aperture widening zone is 75 microns or greater.
  • the point of maximum added thickness delta of the aperture widening zone is located between 1. t n and 3 mm from, t e ⁇ peripheral edge.
  • the incremental thickness diameter is 10.5 mm or greater.
  • the prosthesis is free to rotate. In some embodiments, the prosthesis is not free to rotate.
  • the incremental thickness diameter is I mm larger than the vertical measurement of the natural aperture of the wearer's eye .
  • the prosthesis Is a single vision contact lens. In some embodiments the prosthesis is a multifocal contact lens. In some embodiments the prosthesis is a ionc contact lens,
  • the prosthesis includes -a hydrogel. in some embodiments- the prosthesis includes a silicone hydrogel In some embodiments the prosthesis includes a homogenous material, in some embodiments the prosthesis includes hybrid materials.. (Q035J In some embodiments the aperture widening zone begins at or adjacent to the peripheral edge, in some embodiments the aperture widening 2one begins internal to the peripheral edge.
  • the point of maximum added thickness delta is 1 0 microns: or greater. In some embodiments the point of maximum added thickness delta is 125 microns or greater, in same embodiments the point of maximum added thickness delta is 150 microns or greater. In some embodiments the point of maximum added thickness delta i 200 microns or greater. In some embodiments the point of maximum added thickness delta is 225 microns or greater. In. some embodiments the point of maximum added thickness delta is 250 microns or greater.
  • the prosthesis is one of: daily wear, disposable, continuous wear, weekly wear, or monthly wear,
  • the prosthesis is not stabilised.
  • the aperture widening zone Is a round ring.
  • the aperture widening mne is a series of partial segments mat make up ring.
  • S me embodiments provide for a. method of widening the -natu al palpebral fissure of a wearer's eye by providing a protocol or instructions for widening the wearer's natural palpebral fissure b at least 1mm. and providing at least one prosthesis comprising an aperture widening zone located on it convex surface.
  • the protocol or instructions include directions to determine a vertical dimension of the wearer's natural palpebral fissure, and to provide the weareF with a prosthesis having a minimum vertical dimension at least Imm greater than a maximum vertical dimension of th natural palpebral fissure,
  • Some embodiments are directed to a prosthesis capable of being worn on the eye of a wearer including convex surface, a concave surface, an aperture widening, zone comprising a surface feature that is located on the convex or concave surface of the prosthesis, the surface feature having an outer slope, an inner slope, and maximum added thickness delta located between the outer slope and the inner slope, where the aperture widening zone is configured to widen the natural, palpebral fissure of a wearer's eye.
  • the aperture widening zone has a minimum- vertical dimension of greater than or equal to 10.5 mm.
  • the surface topography of at. least one of the outer slope and the inner slo e- is defined: by a spline curve function.
  • the spline curve function is a Bezier/ curve function.
  • the maximum added thickness delta is located at least 5,5 mm from a geometrical center of the lens. In some embodiments, the maximum added thickness delta is located at or exterior to the corneal limbus of the wearer's eye when the prosthesis is worn on the eye,
  • the aperture widening zone begins at least 0.0.1 mm from a peripheral edge of the prosthesis-.
  • the outer slope begins at least 0.01: mm. f om, a peripheral edge of the prosthesis.
  • the maxtnwto added thickness delta is located within a range of 0,25 mm to 0.75 mm from a peripheral edge of the prosthesis,
  • the prosthesis is a earneo-seleral lens.
  • a peripheral edge of the eorneo-sderai tens is not altered rom thai which Is commercially available tor a specific brand and ty e of corneoscleral contact lens.
  • the aperture widening zone has a minimum vertical dimension of greater than or equal to 1.2.0 mm
  • the outer slope intersects the convex or concave surface at a firs junction point and the inner slope intersects the convex or concave surface at a second junction point and wherein the first junction point ha first and second order continuity.
  • the second junction point has first and second order continuity*
  • the entire surface of the surface feature has first and second order c ntinu ty ⁇ In some embodiments, the entire surface having the surface featur located thereon has first and second order continuity.
  • Some embodiments are directed to a method of designing a prosthesis capable -of being worn, o the eye of a wearer, the method including, selecting a base prosthesis profile having a. convex surface and a concave surface; selecting an are for a. surface feature located on the convex surface or the concave surface of the base prosthesis profile, the are having a height different from a normalised convex surface of the base prosthesis profile or a normalized concave surface of the base prosthesis profile, a peak located at a maximum, height of the arc, and an. outside edge located and an inside edge; selectin the location of the peak relative a.
  • peripheral edge o the base prosthesis profile; selecting a first control point located on the base prosthesis profile at a distance A from a peripheral edge of the base prosthesis profile; selecting a second control point located on the outside edge of the arc; selecting a third control point located on the inside edge of the are; selecting a fourth control point located on the base prosthesis profile at a distance B from an edge of an optica! 3 ⁇ 4one of the base prosthesis profile; and designing the prosthesis having the surface feature on. the base prosthesis profile using the control points and a spline curve function.
  • the surface feature begin at the first control point and ends at the fourth control point.
  • the method includes selecting a. fifth control point located tangential to the surface of the base prosthesis profile at the first control point and at a distance C fr m, the first control point towards the peak of the arc; selecting a sixth control point located tangential to the outside edge of the arc at the second control point and at a distance 0 from the second control point towards the peripheral edge of the base prosthesis profile; selectin seventh control point located, tangential to the inside edge of the are at the third control po i and at a distance E from the third control point toward the peripheral edge of the base prosthesis profile; selecting an eighth control point located tangential to the surface of the base prosthesis profile at the fourth control point and at a distance F from the fourth contra!, point towards the peak of the arc; and designing- the surface feature using the control points and a spline curve function.
  • the arc has a constant radius.
  • the inside edge of the arc is located at a height, between, the normalized convex surface or normalised concave surface of the base prosthesis profil and the peak of the are.
  • the outside edge of the are s located at a height, between the normalized convex surface of normalized concave surface of the base prosthesis profile and the peak of the arc,
  • A in the range of 0.01 mm to 2.0 mm.
  • B is in the range of ⁇ mm to 3.0 mm.
  • C is in the range of 0 mm to 2.0 mm.
  • D is in the range of 0 ram to 2,0 mm. in some -embodiments, 12 is in the range of 0 mm to 2.0 mm.
  • F is in the range of 0 mm to 2,0 mm,
  • the spline curve function is a Bezier curve fonetion.
  • the fust, second, third, and fourth control points are located on a single cross-sectional plane of the base prosthesis profi le that interests a geometrical center of the base prosthesis profile and the peripheral edge of the base prosthesis profile.
  • the convex or concave surface of the prosthesis has first order continuity as the first control point. n sotne embodiments, the convex or concave surface of the prosthesis has first order and. second order continuity at the first control point. In some embodiments, the convex or concave surface of the prosthesis has first order and second, order continuity at the outside edge of the are. In some embodiments, the convex or concave surface of the prosthesis has first order and second order continuity at the fourth control, point, in some embodiments, the convex concave surface of the prosthesis has first: order and second order continuity at the inside edge of the are. In some embodiments, the entire surface feature lias first and second order continuity, including at the first and fourth control points. In. some embodiments:, the entire surface having the surface feature located, thereon has first, and second order continuity,
  • the first control point is located at least 0.01 mm from the peripheral edge of the base prosthesis profile.
  • Some embodiments are directed to a method of manufacturing a prosthesis capable of being worn on the eye of a wearer, the method including the method including - so - selecting base prosthesis profile having convex surface and a concave surface; selecting an arc for a surface feature located on the convex surface or the concave surface of the base prosthesis profile, the are having a freight different from a normalized convex .surface of the base prosthesis profile or a normalized concave surface of the base prosthesis profile, a peak, located at a maximu height of the arc:, and an outside edge located and an inside edge; selecting the locaiion of the peak .relative a peripheral edge of She base prosthesis profile; selecting a first control point located OH the base prosthesis profile at a distance A from peripheral edge of the base prosthesis profile; selecting a second control point located on the outside edge of the arc; selecting a third control point located on the inside edge of the are; selecting a fourth control point located on di base
  • forming the prosthesis comprises molding. In som embodiments, forming the prosthesis comprises lathe cutting.
  • Some- embodiments are directed to a raefhod of making a mold for a prosthesis capable of being worn on the eye of a wearer, the method Including selecting a base moid profile having a convex surface and a concave surface;, selecting an are for a surface feature located on the convex surface or the concave surface of the base moid profile, the arc including a height different from a normalized convex surface of the base mold profile or the normalized concave surface of the base mold profile, peak located at a maximum height of the are, and an outside edge and an inside edge; selecting the location of the peak relative a peripheral edge of the base mold profile; selecting a first control point located on the base moid profile at a distance A from a peripheral edge of the base moid profile; selecting a second control point located on the outside edge of the are; selecting a third coniroi.
  • forming the mold comprises injection molding.
  • a prosthesis capable of being worn on the eye of a wearer, the prosthesis Including a convex surface,, a concave surface, an aperture widening zone comprising a surface feature that is located on the convex or concav .Surface of the prosthesis., the surface feature including an art* located at a height different from the convex surface the prosthesis or the concave surface of the prosthesis, the arc comprising a radius, an outside edge, arid an insid edge.
  • the surface feature also including a peak located at a maximum added thickness delta of the arc, an outer slope extending from the outside edge of the are towards a peripheral region of the prosthesis, and an inner slope extending from, the inside edge of the arc towards a central region of the prosthesis.
  • the outer slope intersects ie peripheral region at a first junction point, and wherein the first junction point has first and second order continuity
  • the inner slope intersects the cental region at a. second junction poiiit, and wherein the second junction point has first and second order continuity
  • the radius of the arc is in the range of 0 mm to 5 mm
  • the radius or the ate is in the range of 0.5 mm. to 3 mm.
  • the maximum added thickness delta is greater than or equal to 25 microns. In some embodiments, the maximum added thickness delta is greater than or equal to 200 microns. In. some embodiments, the maximum added thickness delta is in the range of 25 microns to 1000 microns.
  • the arc is a circumferential arc disposed around an optica! zone of the prosthesis.
  • the circumferential are is continuous.
  • ihe circumferential arc is non-conti toos
  • FIG. I shows an individual, having congenital ptosis on the right eye.
  • FIG. 2 illustrates a visual field that shows functional. blockage due to a ptotic lid. fiK)70
  • FIGS. 3-7 illustrate various individuals afflicted by ptosis.
  • FIGS, S»l ⁇ illustrate various individuals with wide eyes that are not afflicted by ptosis.
  • FIG'S. I 2A.-B show a prosthesis having an aperture widening, mm- according one embodiment superimposed on the eyes of an individual
  • FIGS. 13.A- show a prosthesis having an aperture widening zone according to ope embodiment superimposed on the eyes of a individual
  • FIG. 14A shows a contact lens with an aperture widening zo e according to one embodiment.
  • FIG, I.4.B shows a scleral ring with an aperture widening torn according to one embodiment.
  • FIGS, I 5A.-0 show various emhodiniems of a contact leas with, different aperture. widening zones having an increments! thickness.
  • FIGS. I6A-D show various embodiments of a scleral ring wit different aperture widening zones having a incremental thickness.
  • FIGS. 17A.-F show various embodiments of a contact lens with di fferent aperture widening zones having increased surface friction.
  • FIGS. 18-19 show a comparison between the eyes of an individual with and without a prosthesis having an aperture widening zone.
  • FIG. 1.8 shows the individual's natural eyes and
  • FIG, 19 shows the same individual wearing prosthesis having an aperture widening zone.
  • FIGS. .20-21 show a comparison between the eye of an individual, with and without a prosthesis having an aperture widening zone.
  • FIG. 20 shows the individual's natural eye.
  • FIGS. 22A-8 show a comparison between an individual's left eye with and without a prosthesis having an aperture widening zone.
  • FIG. 22 A shows the individual's natural left eye
  • FIG. 2.2B shows the individual wearing a prosthesis having an aperture widening zone in the left, eye
  • FIG. 23 shows a comparison betwee the right and left eye of an individual.
  • the individual is wearing a prosthesis having an aperture widening zone on their right eye and is not wearing a prosthesis having an aperture widening: zone on their left eye.
  • FIGS. 24.A-B show a comp rison ' between, the eyes of an individual, with and without a prosthesis having an aperture widening zone.
  • FIG. 24.A shows the individual's natural eyes and ⁇ .24B shows the same individual wearing a prosthesis having an aperture widenin zone.
  • FIG'S. 25A-C show the surface profiles for prostheses according to various- embodiments.
  • FIG. 26 is a graph illustrating the thickness across prostheses according to various embodiments.
  • FIGS. 27A-B show the surface profiles for prostheses according to various embodiments.
  • FIG. 28 show s a perspective view of a prosthesis according to one embodiment
  • FIG. 29 shows a perspective view of a prosthesis according to one embodiment
  • FIG. 30 shows a perspective view of a prosthesis according to one embodiment
  • FiG. 1 shows a perspective view of a prosthesis according t one embodiment.
  • FIG. 3 shows a perspective view of a prosthesis according to one embodiment.
  • FIG. 33 shows a perspective view of a prosthesis according to one embodiment
  • FIG. 34 shows a perspective view of a prosthesis according to one emb diment
  • FIG * 35 shows an. aerial view of a prosthesis according to one embodiment
  • 0094) FiG. 36 shows an aerial view of a prosthesis according to one embodiment
  • FIG. 37 shows an aerial view of a prosthesis according to one embodiment.
  • FIGS. 39A-E illustrate the sartkce profile of a eoutecl fens 3900 according to one embodiment.
  • FiG. 39A shows an aerial view of the contact Sens
  • FIG. 39B shows a side view of the contact lens.
  • FIG. 39C shows a cross-sectional view of the contact lens along its central axis.
  • FIG. 390 shows the convex surface of the contact lens
  • FIG. 3915 shows the concave surface of the contac lens.
  • FIG. 40 shows a prosthesis according to one embodiment superimposed on an eye.
  • FIG. 41 shows a prosthesis according to one embodiment superimposed on an eye
  • FIG. 42 shows a prosthesis according to one embodiment superimposed on an eye
  • FIG. 43 shows a prosthesis according to one embodiment superimposed on an eye
  • FIG. 44 shows a hybrid contact lens according to one embodiment
  • FIG. 46 shows a hybrid contact Sens according to oni embodiment.
  • FIG. 4? shows a reverse hybrid contact lens accordiog to one embodiment
  • FIG- 48 shows example of a scale used for fitting prosthesis having an aperture widening zone.
  • FIG. 49 shows a scleral ring with an aperture widening zone having an incremental thickness according to one embodiment.
  • FIG, 50 shows a scleral ring with an aperture widening 3 ⁇ 4one having an incremental thickness according to one embodiment.
  • FIG. 51 shows a contact lens with aft aperture widening zone having an incremental thickness according to one embodiment.
  • FIG. 52 shows a contact le s with an aperture widening zone having m incremental, thickness according to one embodiment.
  • FIGS. 53A-C show various exemplary embodiments of scleral rings with aperture widening zones having a plurality of hands of incremental thickness.
  • Figures 53D and 53D show various exemplary embodiments of scleral rings with aperture widening zones having a plurality of hands of incremental thickness.
  • 53E show various exemplary embodiments of contact lenses with aperture widening zones having a plurality of bands of incremental thickness
  • FIGS. 54-56 show a comparison of an individual's eyes with and without a prosthesis having an aperture widening 3 ⁇ 4o «e.
  • FIG. 54 shows the individual's natural eyes and
  • FIG. 55 shows the same individual wearing a prosthesis having an aperture, idening ' zone.
  • FIG. 56 is a side by side comparison of FIGS. 54 and 55,
  • FIG, 57 is a graph illustrating the oute slope, inner slope and thickness of prosthesi accordin to one embodiment.
  • FIG. 58 is. a graph illustrating the outer slope, inner slope and thickness of a. prosthesis according to one embodiment.
  • FIG. 5 L ) i a graph illustrating the outer slope, inner slope and thickness of prosthesis according to one embodiment.
  • FIG. 60 is a graph illustrating the outer slope, inner slope and thickness of prosthesis according to one embodiment.
  • FIG. 61 illustrates the dimensions and fit to the eye of a. corneoscleral contact lens prosthesis according to one embodiment compared to the .structure of an eye.
  • FIG:. 62 illustrates the dimensions and fit to the eye of a scleral ring prosthesis according to one embodiment compared to the structure of an. eye
  • Fftl 63A illustrates how to measure the vertical. dimension of an; aperture widening zone on a prosthesis with a» outer edge in the shape of a circle.
  • 63C illustrate how to measure the vertical, dimension of an aperture wideriing zone on a prosthesis with an outer edge in the shape of a triangle.
  • FIG'S. 64.A-C illustrate various orientations of a prosthesis having an aperture widening zone with an outer edge having an oval shape.
  • FIG. 64A Illustrates an orientation having fil minimum vertical dimension.
  • FIGS. 64B and 64C illustrate orientations not having the minimum vertical dimension,
  • FIGS. 65A and 65B illustrate how to measure the minimum vertical dimension of an aperiore widening zone on a prosthesis with outer edges in the shape two partial, rings. j8122
  • FIGS. 66A-D illustrate how to measure the minimum, vertical dimension of an aperture widening zone on . a prosthesis having a plurality of isolated areas,
  • FIG. 67 shows an aerial view of a scleral ring having finger like members according to one embodiment
  • FIG. 68 shows an aerial view of a contact lens ha ing finger like members according to one embodiment.
  • FIG. 69 shows a side view -of a prosthesis having finger like members -according to one embodiment.
  • FIG. 70 shows an aerial view of a prosthesis according to an embodiment.
  • FIG. 71 A shows a cross-sectional view of a prosthesis according to an embodiment.
  • FIG. 7 L shows an enlarged cross-sectional view of portion of the prosthesis shown in FIG. 71 A..
  • FIG. 72 ⁇ shows cross-sectional view of a prosthesis having a tri-curve design according to an embodiment
  • FIG. 72B shows an. enlarged cross-sectlonal vie of a portion of the prosthesis shown, in FI ' G. 72A.
  • FIG. 73A shows a cross-sectional view of a prosthesis having a spline curve design according to an embodiment.
  • FIG.. 73 B shows an enlarged cross-sectional view of a portion of the prosthesis shown in FIG. 73 A.
  • FIG. 74 shows n enlarged, eross-seetional view of a portion of a prosthesis illustrating the location of control points according to an embodiment.
  • FIG:. 75 shows a .flowchart, illustrating a method of designing a prosthesis according to an embodiment
  • [0132 J Fftl 76A shows- a cross-sectional, view of a mold according to an embod ment.
  • FIG, 76 B shows an enlarged cross-sectional view of portion of the mold shown in FIG. 76A.
  • FIG. 78 shows a contact lens having an aperture widening zone designed using a tri-cnrve methodology accordi g to an embodiment showing- the dimensions of the co tact lens
  • FIG. 79 shows a contact lens having an aperture widening 3 ⁇ 4one designed: using a spline curve methodology according to art embodimen showing the dimensions of the contact lens.
  • FIG. BO shows a prosthesis having an aperture widening 3 ⁇ 4nie located on the concave surface of the prosthesis according to an embodiment
  • FIG. U l shows a schematic block diagram of an exemplary computer syste which embodiments may be im lemented
  • blepharoptosis also referred to as ptosis, which is defined as an abnormal low-lying upper eyelid margin within the eye in primary gaze.
  • the reduction in aperture size ca affect an individual's vision.
  • White a reduction of aperture size can afreet the vision of some individuals, some individuals may desire a larger eye aperture fo cosmetic purposes, either in combination with a desire to improve their vision or not.
  • Traditional corneo-seieral contact lexises soft contact lenses or hybrid contact
  • Senses that, fit on the cornea of one's eye (do not vault the cornea) and extend over the limb us and bulbar -conjunctiva thus covering part of the sclera are not being used tor correcting ptosis and/or the widening of the wearer's palpebral fissure. This is due to their geometrical design. Also corneal contact lenses (rigid or soft) that fit only the cornea and do not extend past the Htnbus are not used for correcting ptosis and/or the widening of the wearer's palpebral fissure due to geometrical design and overall diameter. Sclera!
  • contact lenses are ' hard/rigid and have been designed in the past to fit snugly against die sclera of the wearer's eye, "vault the cornea” and have a very thick edge design such to lift the upper lid of the wearer's eye having ptosis.
  • scleral contact lenses have existed in the past that will lift the upper lid- of the wearer's eye these: hard rigid scler contact lenses are highly uncomfortable, cause very red eyes and irritate the e-ye lid margin thus presenting severe limitations for the wearer, for these reasons the commercial success of sclera! contact lenses to correct for ptosis ha been a. major failure.
  • a contact lens that widens fee paplebrai fissure and provides a corrective prescription (i.e., an optical power), including that of piano (no optical: power).
  • a corneoscleral contact lens that widens the palpebral fissure (aperture) of a wearer's eye to caus the wearer to appear more alert and/or enhance the appearance of the wearer.
  • Such a contact tens should allow normal and natural blinking and allo for such normal natural blinking withou deeentertng the lens, irritating the upper o lower ii.d, and hurting the wearer when naturally blinking.
  • Various dimensions of a prosthesis may work as a "balanced system* * providing the appropriate nourishment to the- cornea of the eye, comfort for the wearer, and vision correction
  • Color enhancin soft contact lenses have been developed and have met with significant commercial success. These color enhancing soft contact Senses can enhance the colo of the wearer's eyes.
  • Certain soft contact lenses comprise a colored ring to make the eye of a wearer look larger when worn,. While colored sof contact lenses having a color ring or band have been used, to increase the perception that the eye of the wearer is larger, no soft contact lens ha been provided which both increases the perception that the eye of the wearer is larger and also physically widens the palpebral fissure of foe eye of the wearer.
  • the cosmetic enhancement may be achieved, by physically widening the natural palpebral fissure of an individual's eye (I.e.., Sifting tile upper lid and/or depressing the lower lid) and/or providing the perception that the eye of an individual, is larger.
  • Some embodiments include a. prosthesis capable of being worn on the eye of a wearer having a convex surface and a concave surface.
  • the prosthesis has an ape.riu.fe widening zone located on the convex surface. The prosthesis widens the natural palpebral fissure of the wearer's eye by at least 1 mm.
  • Some embodiments include a prosthesis capable of being worn on the eye of a wearer.
  • the prosthesis has a convex surface and a concave surface.
  • An aperture widening zone is located on the convex surface.
  • the prosthesis is a corneo-scleral .contact lens that widens the natural palpebral fissure of the wearer's eye- fey at feast 1 mm,.
  • Some embodiments include a prosthesis having a convex surface and a concave surface. An aperture widening zone is located, on the convex surface ' .
  • the prosthesis is scieral ring thai: widens the natural palpebral fissure of the wearer's eye by at least 1 mm.
  • Some embodiments include a prosthesi capable of being worn on the eye of a wearer.
  • the prosthesis has a convex surface and a concave surface.
  • An aperture widening zone is located on the convex surface.
  • the aperture widening zone includes at least one surface feature. The prosthesis widens the natural palpebral fissure of the wearer's eye b at least I. turn,
  • Some embodiments include a prosthesis capable of being worn on the eye . f a wearer having a- convex surface, a concave surface, and a peripheral edge. Hie prosthesis also has an aperture widening zone located on the convex surface. ' The aperture widening zone including an outer slope and an inner slope with a maximum change in thickness located in between. The outer slope and the inner slope are different. In some embodiments the outer slope is greater tha the inner slope. In other emfeodimenis the inner slope is greate than di outer slope.
  • Some embodiments include a prosthesis capable of being worn: on, the eye of a wearer having a convex surface, a concave surfiiee, and a peripheral edge.
  • the prosthesis also has n aperture widening so s located on the convex surface.
  • the aperture widening zone me! oiling an. outer slope and an inner slop with a maximum, change in thickness, located In between. The outer slope and the inner slope are the same.
  • Some embodiments include a prosthesis capable of being worn on the eye of a wearer.
  • the prosthesis has a convex surface and a concave surface.
  • An. aperture widening zone is located on the convex surface,.
  • the aperture widening z ne has at least one surface feature.
  • the aperture widening zone also has a minimum vertical dimension.
  • Some embodiments include a prosthesis capable of being worn on the eye of a wearer.
  • the prosthesis ha convex surface, a concave surface, a peripheral edge, -and a geometric center.
  • An. aperture widening zone is located on the convex surface.
  • the aperture widening zone has at least one surface feature. At least a. portion of the at least one surface feature is located at or outside 5.25 mm from the geometric center of the prosthesis,
  • the prosthesis has an overall diameter of at least 13.0 mm.
  • the prosthesis has a overall diameter -Of at least 13.5 mm. In some embodiments the prosthesis has an overall diameter of at least 14.0 mm. In some embodiments the prosthesis ha an overall diameter o at least 14.5 mm. In some embodiments the prosthesis has an overall diameter of at least 15 mm. in some embodiments the prosthesis has an overall diameter of at least IS, 5 mm, in some other embodiments die prosthesis has an overall diameter of at least 16,0 mm or larger *
  • the prosthesis is a rotationaSly symmetric lens, in some embodiments the prosthesis is capable of rotating. In some embodiments the prosthesis is not capable of rotating,
  • the aperture widening zone depresses a lower eye lid of the wearer by at least 1 mm.
  • the aperture widening 3 ⁇ 4one elevates an upper eye lid of the wearer by at least 1 mm
  • the prosthesis includes colored accent color.
  • the colored accent color is around a portion of the prosthesis which fits near or at the limbus, or extends past the limbus (meaning the diameter of the colored portion is larger than the diameter of e limbus to limbus measurement) of the eye when the: prosthesis ; is worn.
  • die colored accent color is a iinihai ring, circle ring; or circle lens.
  • the prosthesis is a nitifocaS contact lens, to some embodiments the prosthesis is a tone contact tern, in some embodiments the prosthesis is a single vision contact Sens,
  • me aperture widening zone comprises an area of increased surface friction.
  • the increased surface friction is provided by a surface treatment, a coating, a. different: material surface dimples, mrrfaee irregularities, chemical treatment, etching, or combinations thereof.
  • the aperture widening zone also includes an outer slope and an inner slope with a maximum change in thickness located in between, in some embodiments the outer slope and inner slope are different, in. some embodiments the outer slope is greater than the inner slope, in some embodiments the outer slope has an angle between 3° and 45*. In some embodiments die outer slope has an angle between 5° and 25°. in some embodiments the inner slope comprises an angle between P and 15°.
  • the aperture widening zone has an incremental thickness and a maximum change In thickness, In some embodiments the maximum change in thickness is within a range of 25 microns to 1,000 microns, in some embodiments the maximum change in thickness is withi a range of 100 microns to 50 microns. In some embodiments the maximum change in thickness is within a range of 75 microns to 400 microns.. In some embodimenis the maximum change in thickness is located, between 1.0 trail and 2.5 mm from an outer edge of the prosthesis, in some embodiments the maximum change in. thickness is located at or exterior to the corneal iirabus of the wearer's eye when the prosthesis is worn on the eye.
  • the maximum, change in thicknes is located at least 5.5 mm from the geometrical center of the prosthesis (i.e., at. least one half the diameter of the average human cornea, which is 1 1. - 12 mm), in some embodiments, the maximum change in thickness i located at least 6.0 mm from the g ometrical center of the prosthesis, in some embodiments, the maximum change in thickness is Ideated at least 6,5 mm from the geometrical center of the prosthesis, in some enibodiments the incremental thickness is an increase in thickness, in some embodiments the incremental t!nekriess is a decrease in thickness.
  • an outermost part of the aperture widening zone is located within a. range of 3 mm to 8.5 mm irot a geometric center of the : prosthesis, In some embodiments a outermost part of the aperture widening zone is located within a range of 5 mm to ?>75 mm from a geometric center of the prosthesis, i some embodiments an innermost part of the aperture widening zone is located betwee a peripheral edge of the prosthesis and 6 mm from a peripheral edge of the prosthesi s.
  • the aperture widening zone has a minimum vertieal dimension, in some embodiments, a minimum vertical dimension of the aperture widenin 3 ⁇ 4one is larger than a. maximum vertieal diameter of the natural palpebral fissure of the wearer's eye. In some embodiments a minimum vertical d m nsio of the aperture widening zone is equal to or greater than 10,5 mm. in some embodiments a minimum vertical dimension of the aperture widening zone is equal to or greater than 1 1.0 mm. In some embodiments a minimum vertical dimension of the aperture widening o is equal to or greater than I L5 mm.
  • a minimum vertical dimension of the aperture widening zone is equal to or greater tha 12.0 mm. In some embodiments a minimum vertical, dimension of the aperture widening zone is equal to or greate than 12,3 m!ii In some embodiments a minimum vertieal dimension of the aperture widening zo e is equal to or greater than 13.0 mm. m some embodiments a mmirautn vertieal dimension of the aperture widening zone is equal to or greate than 13,5 mm. In some embodiments a minimum vertical dimension of the aperture widening m is a vertical distance betwee an uppermost pan of the aperture widening 3 ⁇ 4one and a lowermost part of the aperture widening: zone,
  • the aperture widening zone includes at least one surface feature. In some embodiments the aperture widening zone has a plurality of surface features,
  • file prosthesis is a eorneo-scierai contact lens.
  • the prosthesis is a scleral ring.
  • the aperture widening zone comprises a ing, multiple rings,, a partial ring, multiple partial rings, an island, multiple.- islands, a hand, hands, partial bands,, a segme ted area, or multiple segmented areas, in some embodiments these partial areas are aligned to ring the prosthesis.. In other embodiments these partial areas are not aligned to ring the prosthesis.
  • the prosthesi can he worn by the wearer continuously-.
  • the prosthesis can be worn by the wearer non ⁇ oiUiuuoiisSy .
  • the prosthesis can be worn by the wearer daily, weekly, or monthly.
  • the prosthesis is disposable. In some embodiments the prosthesis Is reusable.
  • the prosthesis comprises an optical power. In some embodiments the prosthesi does not comprise an optical, power.
  • Some embodiments include a prosthesis having an aperture widenin zone.
  • the aperture widening zone has an outer slope, an inner slope, a point of maximum added thickness delta, and an incremental thickness diameter.
  • the prosthesis also has a peripheral edge, a, geometrical center, and an. overall diameter, The overall diameter is measured from a first point on the peripheral edge to second point on the opposing; peripheral edge thro the geometrical center of the prosthesis and the aperture widening one.
  • the overall diameter is 14.5 mm or greater.
  • the outer slope is with the range of 5 degrees and 25 degrees..
  • the point of maximum added thickness delta of the aperture widening zone 3 ⁇ 4 75 microns or greater.
  • toe prosthesis is free to rotate. In some embodiments the prosthesis is not free to rotate.
  • the incremental thickness diameter is I. ram larger than th vertical .measurement of the natural aperture of the wearer's eye In some embodiments the Incremental thickness diameter is at least I mm larger than the vertical measnnsment of the natural aperture of the wearer' s eye
  • the prosthesis is a corneo-sderal lens, in some embodiments the prosthesis is a scleral ring.
  • the prosthesis has optica! power. I some embodiments the prosthesis does not have optical power.
  • ie prosthesis is a single vision contact lens, in some embodiments the prosthesis is a multifocal contact lens, in seme embodiments the prosthesis is a terie contact lens.
  • the prosthesis includes a hyilrogeL
  • the prosthesis includes a silicone hydrogel in some embodiments the prosthesis includes a homogenous material.
  • the prosthesis includes hybrid materials, ⁇ til 81 i in some embodiments the aperture widening zone begins at or adjacent to the peripheral edge, in some embodiments the aperture widening zone begins interna! to the peripheral edge.
  • the point of maximum added thickness delta is 100 microns or greater, in some embodiments the point of maximum added thickness delta is 125 microns or greater. In some embodiments the point of maximum added thickness -delta is 1 0 microns or greater. In some embodiments the point of maximum added thickness delta is 200 microns or greater, In some embodiments the point of maximum added thickness delta is 225 microns or greater, in some embodiments the point of maximum added thickness delta is 250 microns or greater.
  • the prosthesi is one of: daily wear, disposable, continuous wear, weekly w ar, or monthly wear.
  • the prosthesis is not stabiiked.
  • the aperture widening zone is a round ring. In some embodiments the aperture widening zone is a series of partial segments thai make up a ring. 1 186 j Some embodiments provide for a method of widening the natural palpebral fissure of a wearer's eye by providing a protocol or instructions for widening the wearer's natural palpebral fissure by at least 1 mm.
  • the protocol or instructions include directions to determine a vertical dimension of the wearer's natural palpebral fissure, and to provide the wearer with a prosthesis having a m nimum vertical dimension at least 1 mm greater than a maximum vertieal dimension of the natural palpebral fissure (such a determi nation can be made by, way of example only, actual measurement, photography, visual estimate, or by one of; fitting a trial prosthesis, contact leas of a known diameter, or a prosthesis of a known diameter).
  • a prosthesis of this patent application in the form of a corHeo-scleral contact lens and a scleral ring has been developed that enhances widens the palpebral, fissure of a wearer's eye to enhance the cosmetic appearance of the wearer's eye (eyes) and can also be used to provide relief to patients suffering from drooping eyelids and/or ptosis.
  • enhancing the appearance of the wearer's eye it is meant thai it makes the eye took more open and/or larger, and more alert.
  • the novel prosthesis enhances the cosmetic appearance of the wearer by wa of pushing up (elevating) the upper eyelid and/or als pushing down (depressing) the lower eyelid thus enlargi g the wearer' palpebral fissure or aperture.
  • the prosthesis has been shown to open the aperture of a wearer 's eye by up to an additional 50% from its normal/natural eye aperture vertical dimension. Given that the average aperture of an individual's eye under the age of 40 would have a natural aperture having a vertical dimension (between, the upper lid.
  • the prosthesis comprises one or more, by way of example of: an augmentation in edge thickness, an internal incremental thickness zone, a regressive thickness 3 ⁇ 4one, or an increased surface friction 3 ⁇ 4one (either one) located at or external to the I nhus, thus also external to the pupillary or optic zone which takes the form on the convex surface, by way of example only, of one or more of; a ring, (rings) band, (bands), partial rings (ringlets), dome (domes), Island (islands), segmented region (regions),, convex -surface.
  • the prosthesis wlieii in the form of a corneoscleral contact lens can be that of a soft contact lens or hybrid contact lens,
  • the scleral ring comprises a cental open aperture without optical power.
  • the scleral ring can he made of a material found in one of a; hard contact lens, gas perm contact lens, soil contact lens; hybrid contact lens..
  • the incremental thickness- region (zone, area) or a regressive thickness region (zone, area), or increased surface friction region (zone, area) for the prosthesis can be one of: ro lonaliy symmetric,, rotation-ally asymmetric elliptical arch, like feature, and isolated, islands.
  • the - elliptical arch (arches) like fe ture (features) can: resemble the curve of the lid margin of the upper lid and/or the curve, of the lid margin of the lower lid.
  • the region of incremental thickness, or regressive thickness, or increased surface friction can be either continuous or discontinuous.
  • the incremental thickness region, regressive thickness region, or increased surface friction can be made of the same .material: o different materials.
  • the prosthesis can be worn as one of: continuous wear, daily wear weekly continuous wear, or monthly continuous wear.
  • the prosthesis can be disposable o reusable,. The prosthesis can be removed and reinserted by the wearer,
  • a prosthesis is designed for increasing the wearer's natural vertical palpebral fissure by at least 0,5 mrn !: whereby the prosthesis design comprises a spline surface topograph and a aperture widening 3 ⁇ 4one.
  • the spline surface topography can be that of a Bezjer Curve,
  • the prosthesis can be one of a soft contact lens, a eoraeo-sclerat contact lens, a hybrid, contact lens, and scleral ring.
  • a prosthesis comprising an aperture widening zone of a maximum increased delta thickness ranging from 50 microns to 1000 microns (preferably within, the range of 1:00 microns to 400 microns).
  • the outer edge of the aperture widening zone is located within the range of 0.01 mm to 2,0 mm to facilitate largely maintaining the nianiifaeturer's specific edge profile.
  • the prosthesis includes an aperture widening zone having a inimum vertical peak to peak dimension of 30.5 mm or greater, i some embodiments, the minimum vertical peak to peak dimension is 1 1.0 ram or greater. In some embodiments, the minimum vertical peak to peak dimension i 1 1 ,5 mm or greater. In some embodiments, the minimum vertical peak to peak dimension is 12.0 mm or greater, in some embodiments, the minimum, vertical peak to peak dimensio is 12,5 mm or greater. In some embodiments, the minimum vertical peak to peak dimension is 13,0 mm or greater. In some embodiments, the minimum vertical peak to peak dimension is 13,5 mm or greater.
  • m Apyrtare f the eye (Palpebral 3 ⁇ 4» e): is the area located between an eye3 ⁇ 4 upper Md and the lower lid when the eye lids are open.
  • Aperture Widening Zone (Also can be called one or more of an incremental thickness region /zone /area, a regressive thickness region /zone /area or an increased surface friction region / zone /area). Is a. region, zone, area that provides topography, or surface friction that raises (elevates) the upper lid and/or depresses (lowers the lower lid thus widening the aperture of the eye.
  • a Bi3 ⁇ 4der curve is a parametric curve requenily used in computer graphics and related fields. Generalizations of Bezier curves to higher dimensions are called Besder surfaces. In vector graphics,. Bexier curves are used to model smooth curves that can be scaled: indefinitely, 'Pat s," as they are commonly referred to in image manipulation programs, are combinations of linked Bezier curves. Paths are not bound by the limits of rasterized images and are intuitive to modify.
  • Blepharoptosis also referred to as ptosis.
  • Is defined as an abnormal low-lying upper eyelid margin with the eye in primary-' gaze.
  • the normal ' adult upper " I lies 1.5 mm below the superior corneal Ihnbus and is highest just nasal to the pupi l .
  • Biepharoptosts can be classified as congenital, as shown below, or acquired. Thi differentiation is based on age, A more comprehensive classification Is based on etiology and includes myogenic, aponeurotic., neurogenic, mechanical, traumatic, and pseudopioiie. The most common cause of congenital ptosis is myogenic due to the improper development of the levator muscle
  • ⁇ M91 ⁇ Blepharoplasty is the name of the surgical, procedure tha provides tor lid lifting.
  • Blepharoplasty is one of the top facial cosmetic surgical procedures performed for diose over the age of 40.
  • bi eyes are perceived to be more attractive than small eyes in today's global society
  • I 8 ⁇ Ceiitration of scleral .ring o contact lens As used herein is meant to be the proper centering of the scleral ring or contact lens so mat the wearer's limhus and/or pupil is mostly centered within the open aperture of the scleral ring or in the case of contact lens the wearer's pupil is mostly centered within the optic zone.
  • Central Open Aperture Means a hole or opening devoid of niate.rial that includes the geometrical center of the prosthesis.
  • the prosthesis may include a. color enhancing region.
  • the color enhancing region can be located on th outer convex surface or concave surface of the contact lens or ring, or buried between the inner convex surface and the outer opposing concave surface;
  • the color enhancing region can be located on or within the corneoscleral contact lens or scleral ring such, to cover a portion of tire limbal area of the wearer's eye when the prosthesis is being worn.
  • the- color enhancing region can be located on or within a comeo-sc Serai contact lens or .scleral ring so as to cover all of the lirnhal area of the wearer ' s eye and extend over the limbal area of the wearer's eye over a portion of the wearer's cornea, when the prosthesis is being worn, hi some embodiments the color enhancing region cars be located on or. within a corneoscleral contact lens or scleral ring such to extend over the lirabal area of the wearer's eye and over a portion of the sclera of the wearer's eye when die prosthesis is being worn.
  • the color enhancing: region can be located on or within the cornets scleral contact lens or scleral ring so as to extend over the timbal area of the wearer's eye, over a portion of the cornea of the wearer's eye and over a portion of the sclera of the wearer's eye when the prosthesis is being worn
  • the color enhancing region ca be rotationally symmetric on or within the prosthesis.
  • the color enhancin region can be aon-rotationall symmetric on or within the prosthesis.
  • the color enhancing region can be, by wa of example only, a ring, broken ring, zone, series of zones, a u fhrrn color, •multiple colors, multiple shade of a particular color, an accent color.
  • the color enhancing ' region can cause the perception of the wearer's iris to look, larger..
  • the color enhancing; region can change the color of the wearers eye.
  • the color enhancing region can make the wearer's eve look larger.
  • the color enhancing reaion can. only sitghtlv alter the color of the wearer's eye.
  • the color enhancing region can greatly alter the color of. the wearer's eye...
  • the color enhancing region can be a surface feature, in some embodiments, the entire color enhancing region may provide an increased surface friction,, in some embodiments, a portion of the color enhancin region may provide increased surface- friction.
  • the color enhancing region can be, by way of example- only, a limbal ring, a colored ring, a color enhanced iris area ie..g. s tinted iris ring), or an cce t color.
  • the color enhancing region can serve to both provide color and also as an eye aperture widening element, in som embodiments, the color enhancing region, can cover ail. of the limbus of the eye of the wearer and. also ail of the cornea of the eye of the wearer when the prosthesis is being worn.
  • the color enhancing region may overlap. In whole or in part, with an aperture widening zone..
  • j3 ⁇ 4202f Contact Lens Is a. thin lens designed to fit over the cornea and usually worn to correct defects in vision. Contact lenses generally fall into three major categories: #1 ⁇ corneal contact lens, #2) Comeo-seSeral contact lens, and #3) Scleral contact lens.
  • the three major categories can then be further broken down, into sub categories (by way of example only) A) daily wear (meaning onl used, dall for wearing and taking out when sleeping), B) continuous wear (meaning wearing day and night round the clock for a limited number of days, and C) disposable contact lenses which can be worn either daily or continuously, but are discarded when they become dirt or lose certain optical or comfort qualities, ⁇ ' is important to note thai the prosthesis being disclosed herein Is that of category #2 ⁇ comeo-scierai contact iem) therefore wheu the term contact Sens i s used it is meant to be that of a corneo-seleral contact lens).
  • Corneal contact leas Corneal Senses are supported exclusively by the cornea, and do not extend past the limbus (the junction between the cornea and the sclera).
  • An example of a corneal contact lens would be a hard rigid contact lens having a diameter no larger than the diameter of the wearer's cornea and in most: eases smaller tha the diameter of the wearer's cornea.
  • Corneal contact, lenses can also be soil contact lens.
  • Corneal-scleral Sens ma be made of a hydrogel materials, such as but not Limited to, a silicone hydrogel material.
  • Corneo-scier3 ⁇ 4l lenses are a type o contact Sens used to correct defects in vision.
  • the name refer to the area and resting points of the lens in the eye.
  • Conieo-scfcral lenses are supported by both the cornea and bulbar conjunctiva that is above the sclera, and do extend past the Iimbus, Examples of coraeo-seierai contact lens would be: soft contact lens and hybrid contact lens.
  • These Senses have diameter in excess of the diameter of the wearer's cornea and extend past the weareri limbaS area. They range generally (but not always) from 12.5 to 15 mm m diameter.
  • the tear reservoi underneath a comeo-seleral lens is very limited compared to full scleral contact lenses thai vault: the cornea. Comeo-sclera! lenses are the most common used.
  • Incremental Thickness, and M ximum Change in Thickness Is the difference in thickness between a point located within th incremental thickness region and the norma! thickness of the contact lens or scleral ring measured ai. the same point.
  • the maximum delta is the point where the thickness differential or maximum delta thickness is the greatest or said another way, the poin where the .maximum change in thickness i fou d;0306 ⁇ Delta Regressive TMekoess, Regressive Thickness Delta, Delta of Regressive
  • Thickness, and aximum Change in Thickness Is the difference in thickness between a point located within the regressive thickness region compared to a thickness of a near (closely located) area of the contact lens or scleral ring internal (on the side towards the center of the prosthesis).
  • the maximum delta is the point where the thickness differential or maximum delta thickness is die greatest, or said another way, the point where the tnaxirmarj change in thickness is found.
  • the edge of the contact lens or scleral ring as used herei is the outer peripheral circumference of the contact lens or in the case of a scleral ring, either die Outer peripheral edge or inner peripheral edge closest to the ope aperture of the scleral ring.
  • the inner edge of a scleral ring (adjacent to the open center aperture) has a similar contour as that of the outer edge of the scleral ring.
  • First order continuity is a measure of smoothness for a carve or surface.
  • First Order continuity means that the first parametric derivatives of two eurve/sur&ee sections are proportional at their boundary.
  • first order continuity means that, ai a point of intersection between, a first curve/surface and a second curve/surface, the first derivatives for the first curve surface and. the second enrve/soriaee are continuous.
  • a contact lens comprising a rigid material that is permeable to oxygen; such a material is used, in gas perm corneal contact lenses that are of a diameter equal to or less than the diameter of the wearer's eomea or in the central rigid gas permeable region, of a hybrid contact- lens whereby the. materia! which is central to that of a soft hydrophiiic skirt Is of a gas permeable material. fill!
  • Geometrical Center As used herein s meant to be the absolute center of a scleral ring or contact lens, in the ease of a contact lens it is real; in the case ofa scleral ring it is imaginary given the central open aperture.
  • a hybrid contact leas as used herein is a contact lens or scleral, ring comprised of two or more materials bonded together.
  • An exam le of this would be like that of today's commercially available hybrid contact lens comprising a central gas permeable material and an outer soft Irydrophilic contact tens skirt.
  • Three additional embodiments discussed herein are: #1) An embodiment taught herein whereby the outer periphery of the hybrid contact len i rigid and the center is soil or #2) in the case of a scleral ring, a rin thai rests over the sclera being of a more rigid (less soft or more rigid) material, however, having affixed to the scleral ring, a softer more pliable material that forms part or .all of the incremental thickness zone thai provides the widening effect..
  • Incremental Thickness I that of the increased differential or delta thickness when taking a poin on the base scleral ring o contact lens of a normalized conve surface or normalized concave surface calculating the differential from that poin to that of the same point on the scleral ring or contact len taught herein. Said another way; after mathematically normalising ' the convex, surface curvature of the scleral rin or contact lens, is the additional thickness added over and beyond the normalized convex surface o normalized concave surface of the scleral ring or contact lens.
  • the convex surface of the optic zone is not considered in the calculation of the normalized convex surface and thus excluded, as the optic zone may have a differen convex curvature due to the specific optical power of the contact lens.
  • the maximum incremental thickness is the peak thickness delta or the maximum change in thickness. It Is important to n te that incremeutal thickness can be created by being surrounded or adj cent to a regressive thickness region,
  • Thickness l>ianieter The incremental thickness diameter is the distance along the vertical axis from a point of maximum delta thickness or maximum change in thickness proceeding through the geometrical center of the prosthesis in a. straight line to that of a point of maximum delta thickness or maximum change in thickness located on the opposite side from the previous point of maximum delta thickness.
  • incremental thickness zone is the additional thickness of a ione : , region, area that is added over and beyond, the normalized convex surface or normalize concave surface of the contact lens or scleral ring.
  • the incremental thickness 3 ⁇ 4one can also be made up of a plurality of zones or regions of incremental thickness and can he further brokers into an. area of areas of incremental thickness, hi most, but not ali eases, the incremental thickness zone or region provides no useful vision correction, for the wearer.
  • the increrricntal thickness zone is also called the aperture widening zone.
  • the purpose of the incremental thickness region or zone is that of providin a force against the upper lid (lids) io Hit (elevate) arid/or the lower lid to lower (depress) such to widen the eye's palpebral -fissure (aperture) of the wearer.
  • Incremental Thickness Zm Width Is the width measurement on the convex surface of the scleral, ring or contact lens where the incremental thickness zone begins and ends. This is the width of the incremental thickness zone usually measured from the portion closest to the outer edge of the prosthesis to the portion closest to that of the geometrical center of th prosthesis.
  • Inner Stupe The "inner ** slope is the slope oi the aperture widening zone between the point of maximum thickness delta and where the aperture widening zone ends closest to the geometrical center of the prosthesis.
  • junction as used herein is meant to he the location of a conventional hybrid contact lens where the gas permeable central region's outer peripheral edge meets the inner peripheral edge of the outer soft skirt or in the case of a hybrid scleral ring or a reverse hybrid lens is the location of where the two different materials meet,
  • Minimum Vertical lmensimi is one way to measure and/or quantify structural features of a prosthesis with an aperture w dening zone, Minimum vertical dimension Is a parameter used to quantify some, but not necessarily all, embodiments described here.
  • “Vertical dimension” is the vertical distance between the highest part of aft aperture widening zone near the top of the prosthesis, and the lowest part of an aperture widening zone near the bottom of the prosthesis, in other words, the ' Vertical dimension * ' defines the vertical distance between the uppermost part of the prosthesis that pushe the upper eyelid op, and the lowermost par of die prosthesis that pushes the lower eyelid down.
  • the 'Vertical dimension" of the aperture widening mm corresponds to the vertical size (overall diameter) of the prosthesis.
  • the "vertical dimension” is die distance between a projection of the highest and lowest points onto a vertical axis, if the aperture widening is not rotationatiy symmetric, the vertical distance may chang as die prosthesi i rotated.
  • the "m nimum vertical; dimension'' is the vertical dimension that corresponds to th rotational position(s) of the prosthesis that has the smallest vertical dimension.. Pre ure from the eye lid will, in many cases, tend to rotate the prosthesis into this rotational position,
  • Minimum vertical peak to peak dimension is a parameter used to quantity some, but not necessarily all, embodiments described here.
  • “Vertical peak: to peak dimension” is the vertical distance between the highest part of an aperture widening 3 ⁇ 4one located at a .maximum added thickness delta near the top of the prosthesis, and.
  • the ''vertical, peak, to peak dimension defines: the vertical distance between the uppermost part of the maximum added thickness delta of the aperture widening 3 ⁇ 4one and the lowermost part of die maximum added thickness delta of the aperture widening zone. If the highest and lowest maximum added thickness delta do not lie on the same vertical axis, then the "'vertical peak to peak dimension *' ' the distance between a projection of the highest and lowest points onto a vertical axis.
  • the vertical peak, to peak distance may change as die prosthesis is rotated
  • the "niimrnur vertical peak, to peak dimension" is- the vertical dimension that corresponds to the rotational positk)n(s) of the prosthesis that has the smallest vertical dimension -from one point of maximum added thickness delta to another point of added maximum thickness delta. Pressure from the eye lids will, in man eases, tend to rotate the prosthesi into thi rotational position,
  • Multifocal Contact hem Is a contact lens comprised of two or more optical power regions. Such a contact lefts is used to correct presbyopia as well as at a minimum the wearer's distance vision. Some multifocal contact lenses will correct distance, intermediate and near vision of the wearer,
  • the natural palpebral .fissure is the space or area of the palpebral fissure when not wearing a contact Sens, when the eye or e es are relaxed arid while the individual is expressionless and not squinting, stniting or f owning etc.
  • Normalized Front Convex Surface Is meant to mean a front convex surface without any incremental thickness added io that of a normal front convex surface of a contact lens or scleral ring.
  • the normal front convex surface can be thai of a non- spherical convex curvature or a spherical convex curvature. In most,, hut not all, cases the .normalised front surface is thai of a spherical curvature. Said another way the iTO.rffiali.zed front convex curvature- equals the convex curvature- minus the incremental thickness added.
  • surface of a contact lens the normalized surface does not take into account the convex surface of the optic zone as the- optic zone may have a different curvature influenced by the optical power of the contact lens.
  • Normalized Back Concave Surface Is meant to mean a back concave surface without any incremental thickness added to that of a normal hack concave surface of a coniact lens or scleral ring, lie norma! back concave surface can he that of a non- spherical convex curvature or a spherical convex curvature.
  • the normalized hack concave surface can be that of an aspherie surface. In most, hut not all cases the normalized hack Concave surface is that of a spherical, curvature. Said another way the normalized back concave curvature equals the concave curvature minus the incremental, thickness added,
  • Optk 3 ⁇ 4 ⁇ ne is the central zone of the contact lens that comprises optical power
  • the optic zone is of a fixed size and in a fixed location, within the contact lens.
  • the term optic zone and optical. ' zone are .meant to mean the s me.
  • the optic zone of soil contact lenses ran es etween 7 ram ie 9 mm i diameter.
  • the optic zone diameter is generally larger than the pupillary zone diameter io prevent glare and light scatter when the pupil dilates at night.
  • the scleral ring does not have an optic ne, but rather an open aperture.
  • Outer Diameter The diameter measured from the outer edge of the prosthesis across the prosthesis through the geometrical center to the opposing outer edge.
  • Outer Slope The "outer" slope is the slope of the aperture widening zone between the point of maxim m thickness delta and where the aperture widening zone ends closest to the outer edge of the prosthesis.
  • J Prosthesis A device worn by a wearer that provides a benefit for the wearer, in the case of the disclosure disclosed, herein the benefit can he that of a cosmetic benefit or a vision benefit,
  • Ptosis A drooping of the upper eyelid caused by way of example only: from paralysis of the oculomotor nerve.
  • Ptosis refers to abnormal dr oping -of the -upper eyelid which can affect one or both the eyes. It may be constant or intermittent in nature. Ptosis can be congenital, if present since birth, or it may be acquired when it develops later in life. Usually ptosis occurs as an isolated, disorder but may also be associated with various other conditions.
  • Ptosis may afflict both children and the adult population, incidence of ptosis has been reported to be 0.18% in children, but occurs more frequently in older adults, probably due to the aging factor, and may affect up to i% of the population or more. Both men and women are e ually susceptible to ptosis.
  • Ptosis occurs when the muscles that raise the eyelid (levator and Mailers muscles) are .not strong enough to do so properl . It can affect one eye w both eyes and is more common n the elderly, as muscles in the eyelids may begin to deteriorate. Ptosis •usually result ' s due to failure of eyelid muscles to function, properly. This may occur due to localized damage to eyelid muscles or damage to nerves supplying the eyelid muscles. I may also occur as a normal aging process. Individuals with diseases like Myasthenia gravis.
  • Diabetes mei!itus, stroke, Horner's syndrome a d brain tumor are at increased risk of acquiring ptosis, in fact myasthenia gravis, which is a neuromuscular disorder, is one of the common causes of acquired ptosis.
  • myasthenia gravis which is a neuromuscular disorder
  • myasthenia gravis which is a neuromuscular disorder
  • FIG. 1 shows an individual with congenital pto i on the left eye.
  • FIG. 2 illustrates a visual field that shows the functional blockage due to a piotie fid
  • Ptosis can affect the visual field of the wearer's eye thus limiting the area f .functional vision, if the ptosi is of the upper lid and whereby the upper lid covers portion of the pupil the individual having the ptosis will lose the ability to see in a portion of his or her superior visual field.
  • FfGS, 3-7 show four individuals afflicted with ptosis. Ptosis can afflict all ages with the highest incidence in those over the age of 40,
  • Pupillary Zone A osed herein is the zone of a contact lens when wor by wearer, whereby the wearer's pupil would be in optical communication with (or said another way where the pupil of the wearer s eye would receive light through),
  • the papillary 3 ⁇ 4one is of a larger area at night or dim iilyuiinatiors when the pupil is dilated and of a smaller area in higher levels of ambient light.
  • the pupillary z ne of the prosthesis described herein generally mages from, approximately 6 mm in diameter to 8 mm in diameter (or a radios of 3 mm to 4 mm from the geometrical center of the contact lens) in order to cover the pupil when the pupil dilates due to a low level of ambient light.
  • the pupillary zone is generall smal ler than the contact lens optic zone, of optical zone.
  • the pupillary zone is located within the scleral ring central open aperture.
  • piggyback or piggybacking is thai of: of a smaller, rigid contact lens on the surface of a larger, soft contact ' lens. These techniques give the vision corrections benefits of a rigid lens and the comfort benefits of a soft lens. The term can also apply to two or more soft contact lenses being worn simultaneousl .
  • Region The terms region, zone, area all have the s me meaning in this disclosure.
  • Regressive Thickness Diameter The incremental thicknes diameter is the distance along the vertical axis from a point of maximum delta thickness proceeding Renauer the .geometrical center of the prosthesis in a straight line to that of a point of maximum delta thickness located on the opposite side from the previous point of maximum delta thickness.
  • one" is a region whereby the normalized thickness of the prosthesis is reduced such to form by way of example only, a "valley” like area, region, zone of topography o the convex surface of the prosthesis or a "partial” valley like area, region, zone whereby one side increases so thickness and the other side maintains the same thickness or decreases further in thickness.
  • a regressive thickness region generally (but not always) result in an incremental thickness region,
  • Regressive Thickness Zone Width is the width measurement on the convex surface of the sclera! ring or contact lens where the regressive thickness zone begins and ends. It is generall (but not always) measured from where it starts closest to the outer edge of the prosthesis to where it ends on the side closer to the geometrical center of the prosthesis.
  • Reverse H b id Contact Lens This is a hybrid prosthesis whereby the miter skirt is made of a rigid material and the center zone is made of a soft lefts roaieriaL
  • Rigid center Is meant to be the area of a contact lens; conventional gas perm or hybrid gas perm being made of a rigid material
  • the terra ring as used herein can be that of a continuous ring or a discontinuous ring.
  • a ring of incremental thickness can be one that is a continuous ring or a broken discon.tir.uons ring.
  • A. ring can also be called one of a band (bands), zone ( ⁇ ones), island (islands), region (regions), and segment (segments) that rings the prosthesis either continuously or discontinuously,
  • a prosthesis device which fits over the sclera of the eye of a wearer, lias a topography (aperture wi denin g zone) located on its convex outer surface thai provides for widening of the palpebral fissure of the w3 ⁇ 4arer an comprises a open central aperture such to not interfere with the line of sight of the wearer,
  • a scleral ring can comprise one material (homogenous) o multiple materials in the case of a hybrid scleral ring,
  • a hybrid scleral ring can comprise finger like members that lift the upper lid nd/or lower the lower lid.
  • the scleral ring does not comprise Optical power. In most, but not all cases, the scleral ring does not cover parts of the cornea. However, in some embodiments the scleral ring will cover tbe limbus and a very limited peripheral region the cornea,
  • a scleral lens is a specially designed large-diameter "rigid" contact lens that vaults the cornea (meaning it does not rest on the cornea). They can range from 14 mm to over 20 mm in. diameter. They are called “scleral” lenses because they completel cover and vault the cornea (the clear dome of tissue that covers the colored part of the eye) and extend onto the sclera (the white part of the eye that forms the outer wall of the eye). Scleral lenses are supported exclusively by the sclera, and completely vault the cornea and the iioibus. Scleral lens fit very tightly on die sclera of the wearer's eye,
  • Second Order Continuity is a measure of smoothness for a curve or surface.
  • Second order .continuity means that both the first and second parametric derivatives of two eurve sut kce sections are proportional at their boundary, in other words, first and second order continuity means that, at a point of intersection between a first curve/surface; and a second curve/surface, the first and second derivatives for die first curve/surface and the second curve/surface are continuous.
  • Silicone Hydrogei is a material used for soft contact lenses.
  • silicone hydrogels became available. Silicone hydrogels have both the extremely high oxygen permeability of silicone and the comfort and clinical erformance of the conventional hydrogels. Because silicone allows more oxygen permeability than water, the oxygen permeability of silicone bydrogels is nor tied to the water content of the lens. Lenses ha ve now been developed with so much oxygen permeabilit that they are approved or overnight wear (extended wear). Lenses approved for daily wear are also available in silicone hydrogei material
  • silicone bydrogels are slightly stiller and the lens surface can be hydrophobic and less "wet-able.” These factors can influence the comfort of the lens. Ne manufeeturing technique and changes to multipurpose solutions have minimized these effects.
  • a surface modification processes called plasma coating alters the hydrophobic nature of the lens surface.
  • Another technique incorporates internal re wettin agents to make the lens surface hydrophi!ic.
  • a third process uses longer backbone polymer chains that result in less cross linking and increased wetting without surface alterations or additive agents.
  • Single Vision Contact Lens A contact lens comprising a single optical power.
  • the optical power can be to correct one or more of: hyperopia, myopia, and astigmatism.
  • [935 1 Slope Is the curvature or topography of an external surface. More specifically the slope in this disclosure is characterized as the degree of incline or decline of the aperture widening zone, region or area. The slope is characterized by the outer slope and the inner slope.
  • Soft skirt is the outer circular m of soft hydrophiiic material found located on a hybrid contac lens or scleral ring.
  • Stabilization mtm A region, zone, area that stabilizes the prosthesis such as b way of example only; eo-axia! stabilization zones, truncation, prism ballast, slab oiX weighted.
  • a stabilization zone will substantially reduce or stop rotation of the prosthesis when in the eye upon lid blinks.
  • the .stabili ation zone generally touches the lid margin to prevent the lens from rotating. Stabilization zones or features can cause a reduction in oxygen transmission by a soft contact lens to the wearer's cornea.
  • a surface feature located on the surface of the prosthesis that is different from the rest of the prosthesis. This feature can be, by way of example only, an increased/decreased thickness, increased surface friction, a region made of a different material, dimples, bumps, surfaces Irregularities, any change in surface topography, and any combination thereof
  • a surface feature can include an aperture widening zone.
  • a surface feature can be located within an aperture widening zone, surface feature can include or can be an area of increased surface friction.
  • A. surface feature can be located within, an area of increase surface f iction.
  • a surface feature can be of a rotationally symmetric design.
  • a surface feature can be of a ringed design.
  • a surface feature ean be: of a broken ring design.
  • a surface feature can be of a nou-rotationaliy symmetric design.
  • a surface feature can be created by, for example, but not limited to: molding,, stamping, laser etching, chemical etching, laser treatment, chemical treatment, deposition, gas exposure, printing, altering the exposed external surface, the addition of .different material, the addition of the same material, modifying the exposed convex surface material.
  • a surface feature may Include a raised surface relative to the norrna&ed front convex surface of prosthesis.
  • the surface feature may have a raised height of 1 angstrom or more.
  • a surface feature in some einbodiiBents, a surface feature ma have no raised surface relative to the normalized front con ex surface of a prosthesis (i.e., may be flat relative to the normalized front convex surface), in other words, the area of increased surface icti n may take m the normal curvat re- of the cot) vex surface of the prosthesis.
  • a surface feature can comprise an irregular surface.
  • e a surface area, zone, region of the -convex surface of the prosthesis which provides for an increased surface friction when contacted by the eye lids of the wearer of the prosthesis.
  • This area on the convex surface of the prosthesis can be located on the aperture widening 3 ⁇ 4o «e.
  • This area or 3 ⁇ 4one can be provided on the- surface: of the zone or region of incremental thickness or in place of the zone or region of incremental thickness.
  • An increased surface friction region, one, area can be flat or raised.
  • Thickness Region or one Hie region or zone of the contact lens where the incremental thickness is added to that of a base contact lens. This region or zone is where thickness is added to the convex: external sartace. It ca also be referred to as the incremental t ickness zone,
  • Thickness differential is a region, zone, area of the prosthesis whereby first point is thinner than a second point which is adjacent to die first point, in most cases (not all) this thickness differential is gradual and not step function resultin in a discontinuity * Thickness differential can be found, on the prosthesis in the regio of incremental thickness, or a regressive thickness region.
  • Thickness Slope Hie measured thickness per traveled mm along a horizontal axis of a surface topography having an incline or decline.
  • the thickness slope can be calculated using incremental thickness or regressive thickness, and -also by way of the -overall thickness.
  • the thickness slope can he located, at the onter thickness slope region or the inner thickness slope region both of which are associated, with the aperture widening zone.
  • I026 J Toric Contact Lens is a contact lens that is comprised, of a toric region or zone that corrects for an astigmatic error of the wearer,
  • a toric lens o thi type can be cylindrical corrective power or a sphero-cylindrical optical power.
  • a toric lens may he stabilized by way of example only, a truncation, prism weighting, and the topography design of its convex surface.
  • FIGS. 8 ⁇ ⁇ 1. 1 are examples of eyes that ma he excluded from the patient population being fit with the prostheses (e.g., contact, lenses) being taught herein. It should be noted that the upper lids of the individuals in FIGS. 8 - 1.1. do not come within 2 mm of the upper edge of the pupil or the . lower lid does not come within 2 mm of the lower edge of the pupil
  • a prosthesis which widens the palpebra! fissure (aperture) of the eye for a "non-wearer" of contact lenses.
  • Such a prosthesis is described herein as another embodiment in the form- of a scleral ring, A scleral ring is not intended to be a contact lens. A. scleral ring does not comprise an optic zone or any optical power. The central region of a scleral ring is that of a central ope aperture. However, the scleral ring as taught herein comprises an aperture widenin zone that widens the palpebral fissure or eye aperture of the wearer,
  • contact lens when the term "contact lens” is used herein, unless mentioned as that, of one of a scleral contact lens, a gas perm cornea! contact lens, or a hard corneal contact lens, is meant to he that of a corneoscleral contact lens.
  • the contact lens which, is disclosed herein is that of a corneoscleral contact Sens. Therefore when reading this disclosure the term “contact leos” should always be interpreted to be that of a corneoscleral contact lens with, the exception noted within this paragraph.
  • the term sclera! ring should be understood to have the -meaning as defined in the definitions which are contained herein. A.
  • sclera ring can be made- of soft lens materials by way of example only, h drogeis, silicone hydrogeis or gas perm materials or mm gas perm / standard hard leas materials. Such s ft, gas perm, or non gas perm materials are well known in the art,
  • the embodiments disclosed herein teach a prosthesis in the form of a corneoscleral contact lens and in the form of a sclera! ring.
  • the corneoscleral contact lens has a regio or m of a mi imum of 25 or more microns of incremental thickness located anywhere within a region outside of a point TO mm from the geometrical center of tire contact lens, whereby the corneoscleral, contact lens thru its optic zone provides the appropriate optical power to largely correct the wearer' uncorrected refractive error and whereby the incremental thickness is the thickness delta measured at the same point compared to thai of the same manufacturer's conventional contact lens fo providing the same optical power correction, and of me same type and whereby the region of incremental thickness causes a widening of the palpebral fissure of the wearer's eye.
  • the eonieo-seleral contact lens can be by way of example only, a soft contact lens o a hybrid contact lens.
  • the corneoscleral contact lens can be of an. optical design of an one o more of a single vision, multifocal,, tone, and astigmatic contact lens.
  • the soft contact lens can. be that of a. continuous wear, daily wear, planned replacement or disposable.
  • the corneoscleral contact !ens can have a colored, tinted iris ring, limhal ring or circular band located appropriately removed from the optic zone of the contact lens to further accentuate a widening of the palpebral fi sure of the wearer, .-A. portion of this colored.
  • iinied ring or band can be located a proximately adjacem but over that of the limbus of the eye of the wearer and can extend beyond the limbus of the wearer. Meaning the outer diameter of the colored portion t colored portion can be larger man the diameter of tire limbus to limbus measurement.
  • the scleral ring is that of a ring which generally, but not always, has its outer peripheral edge located ' under the upper and lower lids when the eye is opened normally and has its inner peripheral edge located outside of the wearer's pupil diameter (when naturally dilated for darkness) such to not. interfere with the line of sight of the wearer.
  • the inner edge of a scleral ring (adjacent to the open center aperture) has a similar contour as that of the outer peripheral edge of the scleral ring. This helps to prevent discomfort for the wearer when he or she blinks.
  • the scleral ring has an open central aperture which allows for the wearer ' s line of sight to be uninhibited..
  • the scleral ring can be comprised of any of the various contact lens materials; hard, gas erm, soft hybrid.
  • the scleral ring can comprise an. aperture widening zone or region of incremental thickness, regressive thicknes and/or an area of increased surface friction.
  • An increased surface f iction zone can he Oat or raised on the convex surface of the prosthesis.
  • the region or ne of incremental thickness can be, by way of example only, made of one material (which is that of the base material of the ring) or of multiple materials such that more pliable softer material is affixed to the more rigid, less pliable soft material of the main, scleral ring.
  • a hybrid scleral ring in some > but not ail, embodiments can comprise finger like members that lift, the tipper lid and/or lower the lower lid.
  • the scleral ring does not comprise optical power.
  • the mechanism of action is that the u pper and lower lids pro vide a force when closing or closed that overcomes the normal force needed to fold or bend the finger like member, but upon the lids being reopened the force needed t fold or bend the finger like member becomes less than that imposed by the structure of the finger like member and thus the finger like member springs back into position thus now overcoming and elevating or lifting the upper lid and/or depressing or lowering the lower lid.
  • the hybrid scleral rin the finger like member is bent or folded into a receiving trench which was pre ⁇ ibrmed (designed) in an outer surface of the scleral ring.
  • the location, of the trench o trenches is provided in the proper location relative to each finger like member. This allows for the finger lik member (members) to be folded almost flat as it blinks so that die Hd cars easily close or open over i finger tike member (members).. It should be also pointed out that while the disclosure shows aiid teaches the finger like members being associated with the scleral ring prosthesis they can also be associated with a contact lens prosthesis,
  • the incremental zone can be comprised of a homogenous material when the scleral ring and contact leas is made of one material or a hybrid zon whe the scleral ring or contact leas is made of two materials.
  • the prosthesis there may or may riot be an incremental thickness zone or region or a regressive thickness zone or region, but rather the surface of the z ne or region, is altered to provide to provide additional lid friction.
  • This region or zone of increased surface friction can be easily over come during an eye lid blink or forced closure, but upon opening the eye lid ibis: region of increased friction elevates the upper lid and/or depresses the lower lid thus opening the aperture of the eye.
  • An increased surface friction »>ne, region, area can be flat or raised •on the convex surface of the prosthesis.
  • An increased serfaoe friction m , region, area can be an aperture widening 3 ⁇ 4 ⁇ «e, region, area.
  • the mm of incremental thickness or increased surface -friction found in some embodiments of the prosthesis taught herein can be shaped, by way of example only, as that: of a: ring (rings), ringlets, partial rings, band, bands, partial bands, dome, a series of domes, isolated regions or islands of any geometrical shape, segmented area s or segmented areas.
  • the zone of incremental thickness ca be expressed a the area- f thickness that elevates from that of the normalized outer convex surface curvature of the contact lens or scleral ring. In most, but not all, preferred embodiirsenis of the contact lens or sclera!
  • the zone of incremental thickness (of aperture widening zone) is connected to that of the outer convex surface curvature at the point where its outer slope meets the convex surface or its inner slope meets the convex surface in a continuous manner (meaning the convex curvature of the contact lens or scleral ring is that of continuous surface), in some other embodiments tire convex surface has discontinuity or discontinuities i parted there-upon which are located adjacent to or near the region or regions of incremental thickness and. tiros is not a continuous surface.
  • the incremental thickness zone is formed by way of a discontinuous surface where one material is affixed to another material.
  • the ring When speaking of a homogenous scleral ring, the ring is made out of one material and in most eases utilizes an incremental thickness region (aperture widening zone) to provide the lifting of t e upper lid and/or lowering of the l er lid
  • prosthesis as used herein is meant to be one of: a corneoscleral contact lens, or a scleral ring.
  • contact lens as used herein is meant to be that of a eorneo-selerai contact lens which can be one of: rigid, soft, gas perm, or hybrid,
  • the zone /region /area of incremental thickness which comprises the zone of incremental thickness in .most, but not all, embodiments is located on the convex surface adjacent to the outer edge of die papillary zone and outside the pupillary zone of the contact lens or scleral ring.
  • the pupillary zone is the same size or smaller than the contact lens optical zone and is located within the central Open aperture of the sclera! ring.
  • the maximum thickness delta of the incremental th ckness zone is located at (in alignment with) or external (outside of) to the limbo of the wearer' eye whe the prosthesis being that of a contaet lens or scleral ring is worn.
  • the maximum thickness delta or .maximum change in thickness of the incremental thickness zone is equal to or of a larger diameter than the measurement of the Simons to iirnbus diameter (outside corneal diameter ⁇ thru the geometrical center of the cornea of the eye to which the contaet lens or scleral rin is being worn or intended to be worn.
  • the contaet lens or scleral ring as taught herein, is that of a contact ietis or scleral ring comprising an incremental thickness zone, whereby the incremental thickness zone has an incremental thickness, a slope and.
  • the incremental thickness diameter is within the range of 1 mm to 10 mm larger than the natural palpebral fissure of the wearer's eye.
  • the zone of incremental thickness is located on the convex surface and acts as an elevator of die upper lid and/or a depressor of the lower lid.
  • a regressive thickness region is provided o the convex surface design such to provide a topography that will also cause the eye aperture widening effect, in this case the regressive thickness region forms a valley In the convex Surface such to cause the uppe lid to be elevated/lifted and the lower lid to he towered depressed;
  • the surrounding topography of the valley becomes an incremental thickness region, zone, area, etc. 028 ⁇
  • the regressive thickness region is really the effect of a subtraction of thick ss in the regressive thickness region.
  • the area located internal closer to- the center of the lens
  • the prosthesis having a regressive thickness: regio will be thicker in total surface area than thai of a prosthesis comprising an incremental thickness region. In most cases a prosthesis having a thinner overall surface area, is preferable to a thicker overall surface area.
  • the incremental thickness region and/or the regressive thickness region can be one of: rotationally symmetric,- rotationaliy asymmetric * elliptical arc like feature (features), island or island like areas.
  • the elliptical, arch (arches ⁇ like feature (features) can .resemble the curve of lid margin, of the upper lid and / or the curve of the lid margin of the lower lid.
  • the incremental thickness xone can form somewhat vertical islands located on either side (right or left) of the optic zone (in the ease of a contact lens) or open aperture (in the case of a scleral ring).
  • 1)2821 T e incremental thickness region of the prosthesis can have a maximum, delta thickness differential, (added thickness ⁇ within the -range of 25 microns io 1,000 microns with a preferred, range of 100 microns to 500 microns, with a more preferred range of 100 microns to 400 - icrons, with a more preferred range of 75 to 400 microns.
  • the .maximum delta thickness can he 25 .microns, 50 microns, 100 microns, ISO microns, 200 microns, 250 microns, 300 microns, 350 micro s, 400 microns, 450 microns, 500 microns, 550 microns, 600 microns, 650 microns, 7(H) microns, 750 microns, 800 microns, or 1000 microns.
  • the maximum delta thickness differential can be located 0.5 ram to 3 mm from the outer peripheral edge of the prosthesis.
  • the incremental thickness region can be located beginning/starting at or near the outer edge of the prosthesis to 6 mm from the outer edge.
  • the incremental thicknes region can be either at die uter edge or 0.1 t n to .3 mm from the outer edge of the prosthesis,
  • the delta of ma im m incremental thickness i in most eases within the range of 0.25 mm to 3.0 .mm internal to the edge of the prosthesis, in some embodiments, the delta of ma imum incremental thickness is within, a range of 0.25 mm. to 3.0 mm interna! to the edge of the prosthesis, in some embodiments, the axi u incremental thickness i within a range of 0.25 mm to 0,75 mm. internal to the edge of the prosthesis.
  • the nias.imu.iv) incremental thickness is within a range of LO mm to 2.5 iiitu internal to the edge of the prosthesis.
  • the incremental thickness diameter (measured from the point o maximum added thickness thru the geometrical center of the prosthesis to the opposing point of maximum added thickness) can be; 10.5 mm or greater, 1 ! .0 mm or greater, 1. 1.5 mm or greater, 12.0 mm or greater, 12.5 mm or greater, 1 mm or greater, 13.5 mm or greater, or 14.0 mm or greater.
  • the regressive thickness region, of the prosthesis can have a maximum: delta thickness differential (reduced thickness) within the range of 25 microns to 1,000 microns with a preferred range of 1 0 microns to 5(KL with a more preferred range of 100 microns to 400 microns, with a more preferred range of 75 microns to 400 microns.
  • the maximum delta thickness can be- 2.5 microns, 50 microns, ⁇ 0 ⁇ microns, iSO microns, 200 microns, 250 microns, 300 microns, 350 microns, 400 microns, 450 microns, 500 microns, 550 microns, 600 microns, 050 microns, 700 microns, 750 microns, 800 microns, or 1000 microns.
  • the regressive thickness region can be located from the outer edge to 6mm from the outer edge, in some embodiments the regressive thickness region can be 0.1 mm to 3 mm from the outer edge of the prosthesis.
  • the delta of maximum incremental thickness is in mos cases within the range of 0,25 aim.
  • the delta of maximum incremental thickness Is within a range of 0.5 mm to 3,0 mm internal to the edge of the prosthesis, in some embodiments, the maximum incrementai thickness is within, a range of 0.25 mm to 0.7.5 mm internal t the edge of the prosthesis. In some embodiments, the maximum -incremental thickness is withi -a range of 1.0 mm to 2.5 mm internal to the edge of the prosthesis.
  • the aperture widening zone whe caused, by incremental thicknes comprises tw slopes divided by a point of maximum change thickness ⁇ maximum thickness delta ⁇ . These two sl pes are called the outer slope and the inner slope.
  • the ""outer" slope on the side closest to the outer edge of the pros thesis of the aperture widening zone helps to achieve the aperture widening effect.
  • the "outer" slope can he, by way of example only, 50 microns per mm or greater, 100 microns per mm or greater, ISO .microns per mm or greater, 200 microns per mm or greater, 250 microns per mm or greater.
  • the "inner” slope can be, by way of example only, SO microm er m or less, 100 -microns per mm or less, 150 microns per mm or less, 200 microns per mm or less, 250 microtis per mm or less, 300 microns per ram or less, 350 microns per mm or less. If the "outer" slope lias a change in thickness of less than 50 microns per mm the widening effect is: minimised.
  • a range of an outer slope of the aperture widening zone on the side closest to the outer edge of the prosthesis is within a minimum of 3 degrees to a maximum of 45 degrees, and preferably within a range of 5 degrees to 25 degrees,
  • A. range of an * 3 ⁇ 4trier s slope of the aperture widening zone on die side closest to die geometrical center of the prosdtesis can be within the range of a minimum- of 1 degree to a -maximum of 15 degrees, in some, but not all •embodiments, the outer slope is greater tha the inner slope. In some embodiments the outer slope is approximately equal to that of the inner slope. And in some embodiments the inner slope is greater than the outer slope,
  • the prosthesis can comprise an aperture- widening zone
  • the prosthesis can comprise an aperture widening mm (incremental, thickness- region or incrementa regressive thickness region) o its concave surface, whereby the aperture widenin zone causes a hump on the convex surface that provides for the aperture widenin effect
  • Thi bump which is caused by incremental thickness or regressive thickness
  • the aperture widening zone's outer slope can begin at or adjacent to the outer peripheral edge of the prosthesis and continues to the maximum thickness delta of the aperture widening zone. In some embodiments, when the outer slope begins at or adjacent to the outer peripheral edge the outer slope will be within 2 degrees of the slope of the outer edge. In most, but not all embodiments, die location of the maximum thickness delta is achieved within the range of 0.25 mm to 3 mm from ttie outer peripheral edge, in some embodiments, the location of the maximum thickness delta is achieved within the range of I mm to 3 mm from the outer edge.
  • the aperture widening zone can comprise a width of J mm to 6 mm when measured from the outer edge proceeding across the aperture widening zone towards the geom rical center of the prosthesis.
  • the size, shape, and configuration, of the aperture widening zone described herein may he tailored tor individuals, or groups of indi viduals, having specific natural palpebral fissure vertical dimensions, eye aperture characteristics, and/or eyelid characteristics/anatomies.
  • Caucasian eyes have large natural palpebral fissures (i.e., natural palpebral fissures with larger vertical dimensions) when compare to Asian eyes.
  • the size, shape, and configuration for an aperture widening zon show to effectively widen the natural palpebral fissure of a Caucasian eye may not work as effectively on it Asian eye,
  • a smaller overall diamete prosthesis and/or a prosthesis having a smaller incremental thickness diamete (or minimum vertical dimension) . may be needed to provide desirable widening effects.
  • the reason for this may be that if the maximum thickness delta, increased surface friction, etc. is located too tar up under the upper lid relative to the tarsal plate of the upper lid (or too far up under the lower lid relative to the tarsal plate of the lowe lid), the lid lifting (or towering) effect of the prosthesis may to be minimized,
  • the aperture widening zone must have a diameter (or minimum vertical dimension) thai, is at least 1: m or larger than that of the vertical dimension of the vertical measurement of the na tural palpebral fissure of the wearer s ey e to provide a palpebral widening effect that is noticeable to an observer looking at th eye of the wearer,
  • contact lenses having a large overall diameter may be difficult for a wearer to insert. While large aperture widening zones may be placed on large contact lenses, it may he preferable that the size. Shape, and configuration, tor an aperture widening zone is tailored to fit onto a relatively small, contact lens (e.g., at most 1 .8 mm in overall diameter).
  • the size, shape, and configuration of the aperture- widening zone may he tailored for lens having different overall diameters. This may be accomplished by adjusting one or more of, but not imited to, the following: the location of the aperture widening zone ⁇ i.e., the beginning of the zone closest to die peripheral edge of a prosthesis and ' the end of the zone closest to the geometrical center of the prosthesis), the outer slope width, the inner slope width, the .maximum incremental/regressive t i kness * and. the coefficient of friction tor an area of Increased surface friction.
  • the location of the aperture widening zone i.e., the beginning of the zone closest to die peripheral edge of a prosthesis and ' the end of the zone closest to the geometrical center of the prosthesis
  • the outer slope width the inner slope width
  • the coefficient of friction tor an area of Increased surface friction.
  • die selection and location of control points may dictate the location of the aperture widening zone (i.e.., the beginning of the zone closest to the peripheral edge of a prosthesis and the e d of the zone closest to the geometrical center of the prosthesis), the outer slope width, th inner slope width, the maximum iiicremental regressive thickness, etc.
  • the width of the aperture widening zone Outer slope for a 14.3 mrn lens ma he 1 ra or less compared to- the aperture widening outer slope zone width being approximately 1.5 mm for that of 15,5 mm. soft lens, ' this will increase the outer slope angle for the 1 ,5 mm lens compared to the outer slope angle of ih 15.5 mm lens.
  • both a 14.5 mm overall diameter Sens and. also a 15.5 mm overall diameter tens can have, for example, a 12.5 mm aperture widening zone diameter that will have the same ' ; widening effect.
  • the aperture widening zone diameter may be, for exam le,.
  • a prosthesis having an overall diameter of 13,0 mm or larger; such as by way of example only; 13,5 mm, LIB. mm, 14.0 mm, 14,5 mm, 14.8 mm, 15.0 mm, 15.5 ram, or 16,0 mm may be preferable for a wearer.
  • the aperture widening zone diameter, minimum vertical dimension, thickness, and slopes for an aperture widening zone may be tailored to- prevent undesirable light reflections within a wearer ' s eyes.
  • an aperture widening zone having a large maximum thickness delta and a small aperture widening zone diameter or minimum vertical dimension e,g., .10 mm or smaller ⁇ may create undesirable light reflections near the pnpi! of a wearer.
  • Undesirable light refections have also been observed for some patients wearing BE Y2A which has an aperture widening zon diameter of 11.10 mm as shown below in Table 3.
  • this may be due to the amount of material used to create sucfe an aperture widening (e.g., the lees material used to create the outer slope. Inner slope, and thickness delta).
  • the large amount of material may act similar to a prism, thus resulting in undesirable light reflections or refracted light thai rimy b redirected within the pupil of the eye of the wearer, which may irritate the wearer.
  • increasing the incremental thickness of an aperture widening close t the optical/pupillary zone of a prosthesis ma exaggerate and/or increase the -undesirable light reflections.
  • An area of increased surface friction alone may not produce undesirable light reflection dne to a lack of incremental thickness.
  • Smaller incremental thickness and/or larger aperture widening zone diameters may reduce this undesirable: Sight reflection..
  • the maximum incremental thickness (i.e., maximum added thickness delta) of an aperture widening mm may be located at least 5,5 mm or more Irons the geometrical of a prosthesis (tints outside the nighttime -dilated pupil diameter of the eye).
  • a distance at least 5 J mm from the geometrical center of the prosthesis makes it possible to add an area of increased surface friction that reduces the transmission of light to the maximum added, thickness delta of the aperture widening zone, in this case, combining (i.e., overlapping in whole or in part) an area of increased surface friction with an area of incremental thickness may prevent undesrred light reflections by altering the surface characteristics of the incremental thickness zone, thereby altering the transniisslon and/or reflection, of light, at the surface of the prosthesis.
  • a colored accented, ring or band which i located around the zone of incremental added thickness of the aperture widening zone can also reduce irritating or annoying light reflections which can occur in certain eases when the maximum delt thickness of an aperture widenin zone is too close to the geometrical center of a prosthesis ⁇ e.g., les than 5.5 mm from, the geometrical center of the prosthesis),. This occurs due to a prismatic refraction of light into the pupil of the eye at an angle which strikes a peripheral portion of the retina.. And in some embodiments a combination of a colored accented ring, along with an.
  • the colored ri g or band may be located on the convex surface of the prosthesis and may be designed to provide increased surface fried OR.
  • the thickness, slopes, diameter, snrface friction, and/or minimum vertical dimension of an. aperture widening zone may be tailored for a specific individual, or set of Individuals having similar eye anato ies, to avoid undesirable ligh t reileetions.
  • effective aperture widenin may be achieved when the aperture widening z n 's outer slope diameter, including the peak of incremental thickness, when worn on the eye of a wearer aligns outside of the limbus and corne of eye of the wearer.
  • the outer slope of the aperture widening zon is located when worn and aligned on the eye of a wearer external t that of the cornea and limbtis of the eye of the wearer.
  • the aperture widening zone diameter is iarser than the diameter of die average human cornea - limbos in each example
  • the length of the aperture widening zone diameter is 1 mm or longer than the vertical dimension length of the palpebral fissure of a wearer's eye. In some, but not all embodiments, the aperture widening zone diameter is also larger than the diameter of the cornea plus the iimhus of the wearer's eye of the soft contact lens.
  • a least one bump is located above and belo the geometrical, center along an imaginary vertical axis mat crosses the geometrical center of the prosthesis.
  • a least one hump is located on either side of the geometrical center so as to be intersected by an imaginary horizontal axis that crosses the geometrical center of the prosthesis.
  • multiple isolated bumps can be located SO as to be intersected by an imaginary axis going through the geometrical center of the prosthesis, by way of example only , two or more of: 40 degrees, 45 degrees, 90 degrees, 135 degrees, 150 degrees, 180 degrees, 210 degrees, and 330 degrees, relative to the geometrical center of the prosthesis,
  • The. location of the peak delta incremental thickness (maximum change i thickness) region (zone, area) or the peak delta regressive thickness (maxi um- change- in thickness) region (zone, area) of the prosthesis can be located 0.1 mm or more superior (above) with respect to the upper lid margin and/or 0 ⁇ mm or greater inferior (below) with respect to the lower lid margin of the wearer, bat more preferably located 0.5 mm or more superior (above) to the upper lid.
  • the upper lid when wearing the prosthesis the upper lid is elevated by a minimum of 0.5 mm or more and/or the lower lid is depressed (lowered) by a minimum of 0,5 mm or more.
  • the aperture widening of the prosthesis can be further accentuated by way of a colored accent color.
  • the colored accent color can be a colored limbal ring or a colored circle ring (which can be referred to as a colored circle lens) located on the prosthesis.
  • a colored limbal ring or a colored circle ring which can be referred to as a colored circle lens
  • a portion of the colored accent color will be located at (above and adjacent to) or external to the limbus of the wearer's eye when the color accented prosthesis is being worn. This means that a portion of the color accented prosthesis is located, when worn, on top of or external to the limbal area of the eye of the wearer.
  • the diameter of a portion of the colored accent portion is equal to or large in diameter to thai of the outside diameter of the corne of the wearer * f0302f
  • a prosthesis that is of & contact lens multifocal design and/or e that corrects tor astigmatism and thus requires optical power having a torie component and a stabilisation mm (feature or member) i employed, in some embodiments * such as by wa of example only, when a prosthesis thai is a scleral ring or one that is a single vision contact lens having only spherical optical power the prosthesis is fee to rotate upon normal blinking and thus devoid of a stabilization zone (feature, member).
  • a stabilization zone is employed for a single vision spherical ' ower contact lens.
  • a stabilization zone feature or member
  • it can be built onto o into the design of the aperture widening z ne (thus they are specially designed to be one in the same) or it can be separate from the aperture widenin zone.
  • An increased surface friction rcgron/zone/are can be located on the convex surface of the prosthesis and can increase the aperture of a wearer's eye.
  • An increased surface friction xone region/area can be called an aperture widening zone/reg on/area.
  • the increased surface ction region/zone/ area can be flat, irregular, raised, or integrated on the convex surface of the prosthesis.
  • the increased surface friction, region's width can have a width that includes die outer edge of the prosthesi s to a point 6 mm from the outer edge.
  • the increased surface friction can fee expressed as a region on the convex surface of the prosthesis ha ving a 1% increase in one of surface friction or drag friction compared to that of other regions of the convex surface of the prosthesis.
  • the increased surface friction region is located within 0.1 mm and 6 mm from the outer edge of the prosthesis.
  • the increased surface friction region can he flat and thus approximate a zorte/region/area on the convex, surface of the aperture widening zone or a portion thereof of the prosthesis comprising an increased surface friction region the egion: has no thickness slope. In other embodiments there i a thickness slope.
  • An increased, surface friction region ca be fabricated on the convex surface of aperture widening zone of the prosthesis or portion thereof, by way of any know means including,, by way of example only; molding, thertnofonrring, surface treatment, coating, etching, deposition, gas etching, gas trea tnent, laser etching, laser treatment.
  • any convex surface re3 ⁇ 4ion/3 ⁇ 4one area of the prosthesis located within the range of 0 mm to 6 mm from the outer edge of the prosthesis which comprises 1% or greater in one of drag friction or surface friction compared to an area of the convex surface located b yond 6 mm from the outer edge - would be considered m increased surface friciion region zone area.
  • the increased surface friction regionfeooe/area ay comprise .1% or greater drag: friction or surface friction compared -to a portion of the convex, surface adjacent to the area of increased surface friction.
  • the increased surface friction region/zone/area may comprise 25% o greater drag friction or surface friction, compared to a portion of the convex surface adjacent to the area of increased surface friction.
  • the increased surface friciion region/zone/area may comprise 33% or greater drag friction or surface friction compared to a portion, of the convex surface adjacent to the area of increased surface f iction:.
  • such. an. increased surface friction convex surface regson/zone/area could be: a coated surface, -a dimpled surface, a crazed surface, surface bumps, surface rings, surface lines, non- slick ..surface,, irregular surface, or a combination thereof In.
  • the drag friction or -surface friction of an area of increased surface friciion is uniform (i.e., the entire area of increased surface friction has the same drag friction or surface friction). In some embodiments, the drag friction or surface friction of an area of increased surface friction is variable.
  • the percentage difference between the surface friciion for the region/zone/area of increased surface friction and the portion of the convex surface adjacent to ie region/OTne/area of increased surface friction may depend on the coefficient of friction (e,g., friction drag coefficient) of the material used to make the prosthesis.
  • the percentage difference for a prosthesis made with, a materia! having a coefficient of friciion equal, to 1.0 may he greater than the percentage difference for a prosthesis made wit a material having a coefficient of friction equal to 1.5.
  • the percentage difference may depend on the ske and configuration of the region/zone/are of increased surface friction.
  • a reg.ion/3 ⁇ 4one/area of increased surface friction that has a relatively thin increased surface friction zone width may have a larger percentage difference in coefficient of friciion compared to a region/zone/are of increased: surface irktion having a relatively thick increased surface friction zone width (e.g., a ring having a width of 3x)
  • the percentage difference may depend on whether or not the region zone/area of increased surface friction overlaps, n. whole or in part, an. area of incremental thickness.
  • a region/zons/area of increased surface friction that overlaps, in whole o in. part, an area of incremental thickness may achieve the same widening effects with a percentage difference that is smaller than a region/zone/area of increased surface nction (flat or raised) alone. This may be due to widening effects imparted by the incremental thickness, which is separate from the widening effect imparted by the increased surface friction. Accordingly, the percentage difference may also depend on the maximum thickness delta of the area -of incremental thickness.
  • the dimples, bumps, rings, and. lines of the increased, surface region/zone area have a vertical depth.
  • the vertical dept is defined b the distance between a peak and trough of the dimple, bump, ring, or I. e.
  • the vertical depth of these features is within the range of 500 angstroms to 50 microns, and preferably within the range of 1 micron to 10 microns.
  • the features may result in a roughed and/or pattered area that is flat relative to the normalized convex surface of a prosthesis.
  • the features may not extend beyond the normalized con vex surface of a prosthesis, in such embodiments, troughs located between each feature, are recessed below the normalized convex surface of the prosthesis, hi some embodiments, the features may result in a roughed and/or pattered area that is raised relative to the normalized convex surface of a prosthesis.
  • each feature may extend above the normal teed con vex surface and troughs located between the features may be located at depths that are the same as the normalized, convex surface of the prosthesis, in some embodiments, the features may extend above the normalized convex surihee and troughs located between the features may be located at depths that are recessed below the normalized convex surface.
  • An area of increased surface frict ion may include a combination of raised md flat areas of increased surface friction.
  • An area of increased surface friction created by the coating or deposition of a material may be considered a raised area because the coated or deposited material may extend above the normalized convex surfac of the prosthesis (tine to the thickness of the coated/deposited material).
  • the increased surface friction rcgiori%oue area can be a stand-alone feature located on the convex surface of the prosthesis. Or an increased surface, friction area may be combined with (i.e., overlap with), in full, or in part, as area of incremental thickness.
  • the increased surface friction: region/zone/atea can be located on the oute slope of an aperture widening zone or a portion thereof. But an area of increased surface friction itself does not have an incremental thickness.
  • the increased surface friction region/zone/arca can als be created by not polishing all or pari of the aperture widening zone or? the convex surface of the prosthesis. This will result in a regkm-'zone area defined by the aperture widening zone that has an increased surface friction relative to the rest convex surface, which is polished.
  • p is the mass density of a. fluid (eg., tears),
  • A is the reference area
  • v is the speed of the object relative to the fluid
  • i is the unit vector in direction normal to the surface dA.
  • FIGS 12A ⁇ B and 13 A. - B ittostnte two ways ia. which an aperture widening:
  • FIGS. 1.2A and OA show an individual, not wearing a prosthesis as described herein and FIGS. J 3A and 13B show the same individual with a prosthesis having an aperture widening zone superimposed onto her eyes.
  • 0314j FKL 12B shows a» embodiment of a prosthesis 1200 whereby a maximum delta
  • Ihickness 1202 fails outside of the natural aperture of the eye. Said another way, when worn the maximum delta thickness 1202 of an aperture widening zone (zones) of the prosthesi 1200 is located above the up er lid margin and. below the lower ltd margin when the eye is relaxed and looking straight ahead.
  • the iaeremental thickness diameter (which is the diameter measured from a point of maximum added thickness thru the geometrical center of the prosthesis to the opposing point of maximum added thickness) is larger than the distance between the upper Hd margin and the lower lid margin.
  • the Incremental thickness diameter and also the regressive thickness diameter is the distance along an xis from a point of maximum delta thickness proceeding through the geometrical center of the prosthesis In a straight line to that of a point of maximum delta thickness located on the opposite side from the previous point of maximum delta thickness.
  • the embodiments disclosed hereto teach when fitting the prosthesis to fit. the prosthesis whereby the maximum delta thickness (also called the peak thickness delta) is located at a minimum 0 J mm above with respect, to the opper lid margin and/ or 0, 1 mm below with respect to the lower lid margin,
  • the incremental thickness diameter and the regressive thickness diameter of the prosthesis can be of any diameter depending upon the overall diameter (outer most diameter) of the prosthesis, however, in most cases the incremental and regressive thickness diameter is within the range of 1 ,5 mm. to 15 mm..
  • the location of the maximum delta thickness. 1202 on prosthesis 1200 is located under and above with respect to the upper lid .margm and located under and below with respect to the lower lid margin, thus widening the palpebral fissure (aperture) of the eye.
  • the location of the maximum delta thickness does not fall within the natural aperture of the eye as it falls outside or a larger distance measurement than the vertical measurement of the natural aperture of the eye (meaning the incremental, thickness diameter is greater than the vertical measurement of the natural eye aperture), in the case of this embodiment the upper eye lid is lifted due to the aperture widening go e being one or more of an incremental thickness zone, regressive thickness 3 ⁇ 4one s or increased surface friction region.
  • the method of action in the case of an embodiment having a regressiv thickness zone results by wa of either the upper lid margin and lower ltd margin being -contacted by the slope where the regressive thickness z& border begins to- add significant thickness on the side closest to th pupil of the eye or being contacted and held within the valley of the regressive thickness zone.
  • the method of action in the ease of an embodiment having an increased surface friction results by way of either the added thickness poshing out and up the tipper lid and pressing -down a d -out the lower ltd.
  • FIG. ⁇ 3 B shows the location of a .ma imu delta thickness 1302 on a prosthesis
  • FIG. 1300 being -located at the upper lid margin and the lower lid margin. Note how the dotted lines in FIG 13B are smalle in diameter (the incremental thickness diameter or tir regressive thickness diameter) compared to the same doited lines of the embodimen described in FIG. I2B.
  • FIG. 128 has a larger incremental thickness -diameter or regressive thickness diameter compared to FIG-. I3B.
  • the method of action of thi embodiment utilizes the outer slope across the width of the incremental thickness zone to accomplish the widening effect By having a.
  • the slope acts as a sliding board o prism shaped wedge that causes the upper lid to move up and the lower lid to move down thus opening the eye's aperture.
  • FIGS, I4A ⁇ ⁇ ⁇ 1.7B illustrate various embodiments of aperture widening zones/incremental thickness regions present on the convex surface of a prosthesis.
  • FIG. 14 A illustrates a scleral ring .1400 according to one embodiment. Scleral ring
  • Scleral ring 1400 has a central open aperture 1404 with a geometric center 1402 located in the center.
  • Scleral ring 1400 includes two incremental thickness regions 1 08- located on opposite sides of pen aperture 1404.
  • Eae incremental thickness region 1 0& has a m ximum inerernental thickness (peak, delta thickness) 1 ( 6.
  • Incremental thickness regions I40S ate capable of increasing the palpebral fissure- of a wearer's eye when worn,
  • I F!O. I.4 Illustrate a contact leas 1450 according to another embodiment.
  • Contact lens 1 50 has an optical region 1454 with a. geometric center 1452 located in the center.
  • Contact lens 1450 includes two incremental thickness regions 1458 located on opposite sides of optical region 1454 both in the shape of raised isl ands.
  • Each i ncremental thickness region 1458 has a maximum incremental thickness (peak delta thickness) 1456.
  • incremental thickness regions 1458 are capable of increasing the palpebral fissure of a user's eye when worn.
  • FIG. I SA illustrates -a contact, lens 1500 according to another embodiment.
  • Contact lens 1500 includes an opt c zone 1502 surrounded by a ring-shaped incremental thickness or regressive thickness region 1504. Contact lens 1500 also includes a regressive thickness regio 1506 surrounding incremental thickness or regressive thickness region 1504 and ex tending towards the edge of contact tens 1500.
  • FIG. I SB illustrates a contact lens 1520 according to another embodiment.
  • Contact lens 1520 includes an. optic zone 1522 surrounded by an oval-shaped incremental thickness or regressive thickness region 1524, Contact lens 1520 also includes a. regressive thickness region 1526 surrounding incremental thickness or regressive thickness region 1524 and extending towards the edge of contact lens 1520.
  • Contact lens 1540 aid tides- an optic zone 1542 with two incremental thickness or regressive thickness regions 1544 located around it, one above and one below.
  • Bach incremental thickness -or regressive thicknes region 1544 has a partial-ring shape.
  • Contac lens 1540 also includes a regressive thickness region 1546 located outside of incremental thickness or regressive thickness regions 1524 and extending towards the: edge of contact lens 1540,
  • Contact lens 1560 includes an optic- zone 1562 with a plurality of band-shaped incremental thickness or regressive thickness regions 1564.
  • incremental thickness Of regressive thicknes regions 1564 are located around optic zone 1562 in a spoke-like fashion.
  • Incremental thickness or regressive thickness regions 1564 can extend to the edge of contact lens 1560 fas shown) or can extend to a point inside of the edge (not shown),
  • HG. !6A illustrates a scleral ring 1600 according to another embodiment.
  • Scleral ring 1600 includes an open central aperture 1602 surrounded by a ring-shaped incremental thickness or regressive thickness region. 1.604.
  • Scleral, ring 160 also includes a regressive thickness region 1606 surrounding incremental .th kness or regressive thickness region 1604 and extending towards tire edge of scleral ring 1600.
  • ⁇ 03271 F.IG:> 16B illustrates a scleral ring 1 20 according to another embodiment.
  • Scleral ring .1620 includes an open central aperture 1622 surrounded by a oval-shaped incremental thickness or regressive thickness region 1624, Scleral, .ring 1620 also includes a regressive thickness region 1626 surrounding incremental thickness or regressive thickness re ion 1 24 and extending towards the edge of scleral dug 1620.
  • FIG. 16C illustrates a sclera! ring 1.640 according to another embodiment
  • Scleral ring 1 40 includes an open central aperture 1642 with two incremental thickness o regressive thickness regions 1644 located around it, one above and one below. Each incremental thickness or regressive thickness region 1 44 has a partial -ring shape.
  • Scleral ring 1 40 also includes a regressive thickness region 1646 located outside of incremental thickness or regressi ve thickness regions 1 24 and extending towards the edge of scleral ring 1640.
  • FIG. 160 illustrates a. scleral ring 1660 according to another embodiment.
  • Scleral ring 1660 includes an open central apertur 1662 with a plurality of band-shaped incremental- thickness or regressive thickness regions 1664.
  • Incremental thickness or regressive thickness regions 1 64 are located around, open central aperture 1662 in a spoke- 1 ike fashion.
  • Incremental thickness or regressive thickness regions 1664 can extend to the edge of scleral ring 1660 (as shown) or can. extend to a poin inside of the edge (not shown),
  • FIGS. 17A-C illustrate various embodiments of a contact lens having an increased surface friction region(s)
  • FIG.. 17 shows a contact lens 1700 having an optical region 1702 and a ring-shaped, increased surface friction region 1704 surrounding optical regi n 1702
  • FIG. 17B shows a contact lens 1710 having an optical region 1712 and an oval- shaped increased surface friction regio 1714 surrounding optical region 1712.
  • FIG, I C shows a contact lens 1720 having a optical regio 17.22 and two increased surface friction regions 1724 located around optical region 1722, one afcove and one below.
  • Each increased surface friction region 1724 has a partial-ring shape
  • FIGS. I7D- illustrate various embodiments of a scleral ring having an increased surface .friction regionfs
  • FIG. 1.7D shows a scleral ring 1730 having a- central open: aperture. 1732 and: a .ring-shaped increased surface friction region 1734 surrounding central open aperture 1732
  • FIG. 17E shows a .scleral ring 1740 having a central pen aperture 1742 and a oval-shaped increased surface friction region 1744 surrounding central open aperture 1 42
  • FIG, 1.7F shows a. scleral rin 1750 having a central, open aperture 1752 and two Increased surface friction regions 1.754 located around central open aperture 1 752, one above and one below.
  • Each increased surface friction region 1754 has a partial - ring shape
  • the prosthesis allows for modifying " n of more" of the following to optimiz the lid. lifting effect or palpebral (aperture) widening effect of the rosthe is; ' ) Overall Diameter
  • a larger diameter is most effective.
  • iASnnrt 15.0mm, 15.5mro, 16,0mm, 16..5nini (in the case of a scleral ring the outer diameter may be of the above dimension or it coold be 16,0 mm or larger)
  • the extreme peripheral edge thickness of the contact lens or scleral ring is left unchanged from that normally provided by a contact lens .manufacturer of a specific brand lens, of a specific type, and of a specific optical power.
  • the outer edge in most cases, but not all cases, approximates that of a conventional eorneo-scleral contact, lens,
  • the extreme peripheral, edge thickness is increased in thickness
  • the extreme peripheral edge thickness of the contact lens or scleral ring is left unchanged from that normally provided by a contact Sens manufacturer of a specific brand lens, of a. specific type, and of specific optical power, ' ikes the pater edge in post eases, but not all cases, approximates that of a conventional corneo-sclerat contact lens.
  • an area inside (towards the center of the prosthesis front the outer edge) of 0.5 mm from the outer edge to 3 ram from the outer edge of th contact fens is increased, in thickness.
  • an area inside ⁇ towards the center of the prosthesis from the outer edge) of 0,5 rain from the outer edge to 7 mm from the outer edge of the contact lens is increased in thickness.
  • the "width" of the aperture widening zone can be within a range of 2.5 ram to 6.5 nini depending upon the overall diameter of the contact Sens, i certain other embodiments the width of the aperture widening zone can be within the range of 1 mm to 7 mm, once again depending upon the overall diameter of the contact lens.
  • the aperture widening zone extends . from the outer edge of the prosthesis to. within the range of 2.5 mm to 5 m inside of the outer edge of the prosthesis. The precise distance from the outer edge depends upon the type of prosthesis and also the overall diameter of the prosthesis.
  • an area within a range of 0.5 mm to 3,5 mm from the extreme peripheral edge of the prosthesis provides the ma imum delta thickness (but preferabl withi the range of 0.5 mm to .2.0 mm from, the extreme peripheral edge of the contact. lens or scleral ring).
  • the maximum delta thickness may be in the range of .0.25 mm to 0.75 from the extreme -peripheral edge of the contact lens or scleral ring.
  • a region or regions of ' incremental ' .thickness- or regressive thickness are located adjacent to or outside 3,0 mm. of the geometrical center of the contact lens. Region or regions of incremental thickness or regressive thickness are generall located adjacent to or outside the pupillary 3 ⁇ 4one of the contact lens or scleral ring open aperture.
  • Such a region or regions can comprise an area or areas on the convex surface of the contact lens, by way of example only, a ring, (rings) band, (bands) or partial rings (ringlets), dome (domes), island (islands), segmented area, segmented areas or of any geometrical shape.
  • the region can he that of a roiat.ionahy symmetric region or a. foiationaliy asymmetric region.
  • m the region or regions incremental thickness the surface geometry of the region or regions is compri sed of an increased coo vex curvature
  • the surface geometry comprises a continuous surface with that of the overall convex surface of the contact lens or sclera! ring.
  • incremental thickness can range from 0.1 microns ' to L000 microns, hi most,, but not ail embodiments of the prosthesis the incremental thickness region can have a point of m ximum added thickness.
  • the maximum added thickness can range fro 25 microns to 1000 microns.
  • the maximum change in thickness / maximum thickness delta is within a range of 100 microns to 500 microns. In some embodiments the maximum change in thickness is within a range of 75 microns to 400 microns,
  • Embodiments that utilize increased .surface friction can he thai of surface friction on. the convex surface of the prosthesis forming the apermre widening zone or as part of the incremental: thickness zone.
  • the touch area of slide resistance between the contact lens or sclera! ring and the ltd or lids is increased. This is accomplished by increasing the friction between the lid (lids) and the convex surface of the contac lens, but doing so in such a limited way that it is accomplished without irritating the lid (iids).
  • a difference of 1% or more of increased drag friction within the aperture widenin zone can be meaningful compared to the surface friction of the rest of the prosihesis outside of the aperture widening zone.
  • Area of increased surface friction differs from, area having an incremental thickness.
  • an area of increased surface friction is either flat or only slightly raised (e.g., raised dimples or a coated or deposited •material), which may result in less added weight,
  • the interaction between an eyelid and an area of incremental thickness may be different than the interaction between an eyelid an. area of increased: surface friction.
  • the eyelid- will pass over an area of incremental thickness (including the maximum, thickness delta) thereby tending to pull the area of incremental thickness (and; the prosthesis) upward*
  • the upper eyelid passes the maximum delta, thickness (e.g., when it is fully open) it will begin to push the area of increased thickness (and the prosthesis) downward.
  • interaction between an eyelid, and an area of incremental thickness may be used to stabilize a prosthesis within an eye by causing rotation into a specific rotational, position. The position is held by the upper eyelid pushing down on the area of incremental thickness when, the eyelid is open. The same interaction may occur for the lower eyelid, expect for the lower eyelid will tend to pus areas of incremental thickness upward, rather than downward.
  • th convex surface shap near and/or around the periphery " of the contact lens is altered compared to that normally provided, by a contact lens .manufacturer of a specific brand lens, of a specific type, and of a specific optical power. 8) Slop difference
  • the steepest slope is that of the outer slope of the incremental thickness region and the less steep slope is on the inner slope of the incremental thick ess region which is closest to the geometrical center of the contact lens or sclera! ring " .
  • the steepest slope is thai of the inner slope of the incremental thickness region and the less steep slope is on the outer slope of the incremental thickness region which is closest to the outer edge of the contact len or scleral ring,
  • the outer slope of the incremental thickness region is equal to the inner slope of the incremental thickness region
  • the lens material is that of one of a silicone hydrogel or a hydrogel material
  • the lens material is that of one of a gas permeable material or a rigid material.
  • a different material is added/bonded, inserted, affixed to th contact lens or scleral ring thus altering a region (regions) or area (areas) of the contact lens convex outer surface material.
  • the scleral ring is made of non-gas perm
  • the extreme peripheral edge shape is not altered from that which is available ⁇ e.g., commercially from a contact lens manufacturer) lor a specific brand, of a specific contact lens type, of a specific contact lens optical power.
  • the peripheral edge shape of a corneal-sclera! contact lens prosthesis may have the peripheral edge shape of an Acuvitel? contact lens manufactured by Vis akon% a division of Johnson St Johnson Vision Care, in Jacksonville, Florida.
  • 360f In some embodiments the edge shape is altered to haw a steeper slope on the- convex surfa e internally from the peripheral edge of the contact lens or sclera!
  • the edge shape is altered to be a less steep slope internally from the peripheral edge of the contact lens or scleral ring - o pared to that available (e.g., commercially from a contact lens manufacturer) for a specific brand, of a specific contact lens type, and of a specific contact tens optical power.
  • the edge thickness is preferably between 25 and 100 ' microns.
  • the edge thickness is preferably between 25 and 50 microns.
  • the edge thickness is preferably between 30 and 60 microns.
  • the edge can be a have a knife edge shape, a rounded shape,, a setm -round shape, or a Mint shape.
  • a portion of the edge of the contact len or scleral, ring is truncated, in some other embodiments two portions (one located adjacent to the upper lid, and one located adjacent to the lower lid) are truncated.
  • edge is associated with prism ballast.
  • edge of the lens is weighted
  • the base curve of the contact len or scleral rin is increased to be steeper than that, normally fit on the cornea or eye of a. wearer ⁇ with th understanding thai, in most. but. not all cases, the scleral ring is not fit on the cornea of a wearer).
  • the scleral ring is fit. on the cornea it fits only on the peripheral cornea outside of the -pupillary zone.
  • the base curve of the contact lens or scleral ring is decreased to be less steep than normally fit on the cornea or eye of a wearer ⁇ ⁇ with the understanding that, in most but not all cases, the scleral ring is not fit on the cornea of a wearer)., if the scleral ring is fit on the cornea it fits only on the peripheral cornea outside of the pupillary z e.
  • the bas curve of the contact lens or scleral: ring is the same as that normally fit on the cornea or eye of a wearer (with the understanding that the scleral ring, in most hut not all eases, is not fit on the cornea of a wearer).
  • the convex surface texture of the contact: lens or scleral ring can have a region, regions, area, areas of by way of example only dimples, non-smooth surface, humps, irregularities, less slick than the area of the prosthesis outside of the aperture widening zone and indentations.
  • This surface texture generally covers or is a portion of the aperture widening zone. Also, this surface texture may result in an increased surface friction compared to the portion of the convex surface lacking the surface texture,
  • contact lens disclosed herein contemplates ail prescription lens powers including that of piano (no power).
  • the fitting set can provide for one or more of the above 14 variables to be tested on the patient to •customize and understand the single best variable to alter or a combination- of variables: to alter when prescribing the contact lens.
  • lenses should be enough for fittin the majority of all potential wearers..
  • FIGS, 18 - .23 show various individuals' eyes with and without a prosthesis having an aperture widening zone.
  • FIG. 19 shows him wearing a prosthesis with an incremental thickness region (aperture widening zone). If can be seen, by comparing FIGS. 18 and 1.9, that the palpebral fissures of bis eyes are widened when wearing a prosthesis having an Incremental, thicknes region as described herein.
  • FIG, 1 has a base thickness of 100 microns and an incremental thickness region having an overall thickness of 300 microns, with the peak thickness delta or maximum thickness added being 200 microtis.
  • FIGS, 20 - 21 show the widening of a 45 year old female's palpebral fissure.
  • FIG. 21 shows er wearing a prosthesis having an incremental thickness region, on. her eye.
  • the upper Sid has been, raised in FIG.. 21. when compared to FIG. 20.
  • the prosthesis being worn in FI 21 has an incremental, thickness region (aperture widening zone) with a maximum added thickness or maximum thickness delt of 600 microns.
  • FIGS. 22A - B show the eye of a 66 year old male.
  • FIG. 22A shows his natural right eye having a ptosis of the upper lid and
  • FIG. 22B shows him wearing a prosthesis having an incremental thickness region (aperture widening zone) on the same eye.
  • FIG. 22 B shows that the prosthesis with an incremental thickness regio lifts his. upper right eyelid.
  • ope i g enlarghig the aperture quite dramatically.
  • FIG. 23 shows the right and left eye of a 40 year old iernale. She is wearing a prosthesis having an incremental thickness region in her right eye (left side of FIG. 23). She Is not wearing a prosthesis In her left eye (right side of FIG. 23), The prosthesis In her right eye has substantially widened the apemtre/palpebral fissure of her right eye whe compared to her left, eye. The prosthesis being worn on her right eye has an incremental thickness region (aperture widening zone) with a maximum increased thickness maximum, thickness delta o 200 microns located approximately F5 mm inside the oister peripheral edge of the prosthesis,
  • FIG. 24A shows a male's .natural eyes, i.e. Mm not wearing a prosthesis having an incremental thickness region
  • FIG. 248 shows him wearing a prosthesis with an incremental, thickness region (aperture widening zone), it can be seen., by comparing F IGS. 24A and 248 . , that the palpe ral, fissures of his eyes are widened when wearing a prosthesis having an incremental thickness region as described herein,
  • FIGS. 25A - C show various surface profiles to three different prostheses. Lenses
  • 2520, 2540 and 2560 all have a geometric center located at 250 and. a pupil zone Indicated by lines 2502.
  • Bach lens 2520 » 2540, and 2560 has an incremental thicknes region 2522, .2542, and 2546, respectively.
  • the outer slope of the incremental thickness region 2522 in FIG. 25 A is less than the inner slope of the incremental thickness region.
  • Note the outer slope of the incremental thickness region 2542 in FIG. .25 B is greater than the inner slope of th incremental thickness region.
  • Note the onter slope of the incremental thickness region 2546 in FIG. 25C is greater than the inner slope of the incremental thickness region.
  • the widt of the incremental thickness zone or region is the distance measured from its beginning (where incremental thickness begins) on the side towards the enter edge of the prosthesis t the end of the zone or region (where incremental thickness ends) on the side towards the center of the prosthesis.
  • the width of this 3 ⁇ 4one or region generally ranges between 1 mm to 7 mm, hut in some cases is between .2.5 mm and 6.5 mm, and in roos cases is between 2,5 mm and 5 nun.
  • the width of the increased surface frictio zone or region is the distance measured from its beginning (where increased surface friction begins) on the side towards the outer edge of the prosthesis t the end. of the mm or region (where increased surface friction ends) o the side towards the center of the prosthesis.
  • the width of this mm or region generally ranges between J ram: to 7 mm, hot in some cases is between 2,5 mm and 6,5 mm, and irs roost eases is between 2.5- mm and 5 mm,
  • Incremental Thickness Profile of the prosthesis can he of an incremental thickness zone that ranges between 0.1 microns to 1,000 microns of incremental thickness.
  • Hie incremental thickness zone can star at or adjacent to the outer edge of the prosthesis,
  • the incremental thickness zone can start 0,01 mm or more form the outer edge of the prosthesis, in some embodiments, the incremental thickness zone can start 0.25 mm or more form the outer edge of the prosthesis.
  • the maximum delta incremental thickness maximnm added thickness ranges between 35 microns and 1,000 microns, preferably between 100 mic o s to 800 microns with a preferred delta of 100 microns to .500 microns and a m m preferred range being 75 microns to 400 microns, in certain embodiments an area inside (towards the center of the prosthesis from the outer edge) of 0.5 mm from the outer edge to 3 .mm from the outer edge of the contact lens is increased in thickness, in other embod ments, an area inside (towards the center of the prosthesis f m the outer edge) of 0.5 mm Item the outer edge to ? .mm from the oute edge of the contact lens is increased in ihickness.
  • the "width" of the aperture widening zone can .he within a range of 2.5 mm to 6.5 mm depending upon the overall diameter of the contact Sens. In other embodiments the width of the aperture widening zone can be within the range of 1 mm to 7 mm, once again depending upon the overall diameter of the contact lens, in some embodiments the aperture widening zone extends from the outer edge of the prosthesis to within the range of 2.5 mm to 5 mm inside of the outer edge of the prosthesis. The precise distance from the outer edge depends upon the type of prosthesis arid also the verall diameter of th prosthesis
  • an area inside of 0.25 mm to 2.5 ram from the extreme peripheral edge of the prosthesis provides the maximum delta thickness, but preferably within the range of 0.25 mm to 2.0 mm from ttie extreme peripheral edge of the contact lens or scleral ring, i some embodiments, the maximum delta thickness may be in the range of 0,25 mm to 0.75 from the extreme penpherai edge of the contact leas or scierai ring.
  • FIG. 26 is an illustration of th thickness profiles of the external convex surfac from the edge to the center for some embodiments of the prosthesis described herein.
  • the ⁇ lustration shows different possible examples of the convex surface profile (slope) and also the incremental thickness region or zone.
  • FIGS. 27 A ⁇ E illustrate variou incremental thickness regio s for five di Bfetent prostheses 2710, 2720, 2730, 2740, and 2750, Each prosthesis 2710, 2720, 2730, 2740, and 2750 has pupil zone 2700 surrounded, by areas of incremental thickness.
  • FIG, 27A shows prosthesis 2710 having incremental thickness regions 271 and 2714
  • FIG. 27B shows prosthesis 2720 having incremental thickness regions 2722, 2724, 2726 S and 2728.
  • FIG. 27C shows prosthesis 2720 having incremental thickness regions 2732 and 2734.
  • FIG. 27D stews prosthesis 2740 having incremental thickness: regions 2742 and 2744, F G, 27E shows prosthesis 2750 having incremental thickness regions 2752, 754, 2756, and 2758.
  • FIGS. 28 - 34 are perspective views of various contact lense having various types of aperture widening xoncs. While FIGS. 28-34 all illustrate contact lenses ii will be appreciated that the same features described in. reference to FIGS, 28 - 34 could be incorporated onto a scleral ring.
  • FIG. 28 shows a contact lens 2800 having a convex surface 2802, a concave surface 2804, and a peripheral edge 2806.
  • a incremental thickness region 2810 is located on convex: surface 28 2.
  • incre ental thickness region 2810 can be a continuous ring of increased thickness or a plurality of discontinuous pariial rings of increased thickness.
  • Incremental thickness region 2810 is located interior of peripheral edge 2806 and has a thickness different from, the rest of the contact len .28 0.
  • the thickness profile of the lens is Illustrated by a first thickness .2812, a second thickness .2814, a third thicknes 2816, and fourth thickness 281.8.
  • First thickness 2812, third thickness 2816, and fourth thickness 2818 are equal to the standard thickness of a conventional contact lens.
  • Second thickness 2814, located in the incremental thickness region 281 has a thickness greater than the standard, thickness.
  • FIG. 29 shows a contact lens 2900 having a convex surface 2902, a concave surface 2904, and a peripheral edge 2906, An increased surface friction region 2910 is located on convex surface 2902.
  • Increased surface friction region 2910 can be a continuous ring having increased surface friction or a plurality of discontinuous partial rings having increased surface friction, increased surface friction region 2910 is located, interior of peripheral edge 2906 and has a surface friction different from the rest of the contact lens 2900.
  • the surface friction profile of convex saria.ee 2902 is illustrated by a first surface friction 2912, a second surface friction 2914, a third surface fricti n 2916, and a fourth surface friction 2918.
  • First surface f iction 2912, third surface friction 2916, and fourth surface f iction 2 IS are equal, to d e standard surface friction of a conventional contact lens.
  • Second surface friction 2914, located in the increased surface friction region 2 10, has a surface friction greater than the standard surface friction.
  • FIG, 30 shows a contact lens 3000 having a convex surface 3002, a concave surface 3004, and a peripheral edge 3006.
  • An incremental thickness and increased surface friction region 3010 is located on convex surface 3002.
  • Incremental thicknes an increased surface friction region 3010 can he a continuous ring having incremental thickness and increased surface friction or a plurality of discontinuous pariial rings or areas having incremental thickness and increased surface friction.
  • Incremental thickness and increased surface tnetkra region 3010 is located interior of peripheral edge 3006 and has a thickness and surface friction different from the rest of the contact lens 3000.
  • the thickness and surface friction profile of convex, surface 3002 is illustrated by a first thickness and surface friction 3012, a second thickness and surface friction 3014, a third thickness and surface friction 3016, and a fourth thickness and surface f iction 3018.
  • First thickness and surface friction 3012, third thicknes and surface friction 3016, and: fourth thickness and surface friction 3018 are equal to the standard thickness a d standard surface friction of a conventional contact fens.
  • Second thickness and surface f iction 3014 located in the incremental thickness and increased surface friction egion 3010, lias a thickness and surface friction that are greater than the standard thickness and surface friction.
  • FIG. 31 shows a contact lens 3100 having convex surface ' 3102, a concave surface 3104, and a peripheral edge 3106, An incremental thickness region 31 1.0 is located on convex surface 3102.
  • Incremental thickness regio 3110 can be a continuou ring of increased thickness or a plurality of discontinuous partial rings or areas o increased thickness.
  • Incremental thickness region 110 i located interior of peripheral edge 3106 and has a thickness different from, the rest of the coniact lens 3100.
  • the thickness profile of the lens is illustrated by a first thickness 3 11.2, a second thickness 3114, a third, thicknes 31 16, and a fourth thickness 31 IS, First thickness 3112, third thickness 31 16, and fourth thickness 31 IS are equal to the standard thicknes of a conventional contact lens.
  • Contact lens 3100 also has a small truncation 3120 on peripheral edge 3106.
  • FIG:, 32 shows a contact lens 3200 having a convex surface 3202, a concave surface 3204, and a peripheral edge 3.206.
  • Aft incremental thickness region 3210 is located on. convex surface 3262.
  • Incremental thickness region 3210 can be a continuous ring of increased thickness or a plurality of discontinuous partial rings or areas of increased thickness.
  • Incremental thickness region 3210 is located interior of peripheral edge 3206 and has a thickness different from the rest of the contact lens 3200.
  • the thickness profile of the lens is illustrated by a first thickness 3212. a second thickness 321.4, a third thickness 321 , and a fourth thickness 321 .
  • First thickness 3 12, third thickness 3216, and fourth thickness 3218 are equal to the standard thickness of a conventional contact lens.
  • Second thickness 3214 located in the incremental thickness region 3210, has a thickness greater than the standard, thickness.
  • ' Contact lens 3200 also has a small truncation 3220 and a prism ballast 3222 located on peripheral edge 3206.Small truncation 3220 is located opposite prism ballast 3222 on peripheral edge 3206.
  • Fftl 33 shows a contact lens 3300 having a convex surface 3302, a concave surface 3304, mid a peripheral edge 3306.
  • An incremental thickness region 3310 is located on convex surface 3302.
  • Incremental thickness region 3310 is located interior of peripheral edge 3306 and has a thickness different f om the rest of the contact lens 3300, The thickness profile of the lens is illustrated by a first thickness. 331.2, a second thickness 3314, a third, thickness 3316, and a fourth thickness 33 I S. First thickness 3312, third thickness 3316, and fourth thickness 3 18 are equal to the standard thickness of a conventional contact lens. Second thickness 3344, located in the Incremental thickness region 3310, has a thickness greater than the standard thickness.
  • Contact lens 3300 also has a small truncation 3320 and a small irnncation/prisni ballast 332.2 on peripheral edge 3306. Small truncation 3320 is located opposite small truacation prisnr ballast 3322 on peripheral edge 3306.
  • FIG. 34 shows a contact lens 3400 having a convex surface 3402, a concave surface 3404, and a peripheral edge 3406.
  • Incremental thickness region 3410 can be a continuous ring of increased thickness or a plurality of discontinuous partial rings or areas of increased thickness.
  • Incremental thickness region 3410 is located interior of peripheral edge 3406 and has a thickness different from the rest of the contact lens 3400, The thicknes profile of the lens is illustrated by a first thickness 3412, a second thickness 3414, a third thickness 3416, and a fourt thickness 34 I S.
  • First thickness 3412, third thickness 3416, and fourth thickness 341.8 are equal to the standard thickness of a conventional contact lens.
  • Second thickness 3414, located in the incremental thickness region 3410 has a thickness greater than the standard thickness.
  • Contact Sens 3400 also has a smalt truncatioa' rism ballast 3422 located on peripheral edge 3406.
  • FIGS. 35 - 38 show aerial views of a plurality of contact lenses having various types of aperture widening zones. While FIGS. 35 - 38 all illustrate- contact lenses it will he appreciated that the same features described in reference to. FIGS. 35 - 38 could be incorporated onto a scleral ring.
  • FIG, 35 shows a contact sens 3500 having a peripheral edge 3502 and pupil zone 3510.
  • Pupil zone 3510 may have optical power or ma be devoid of optical power and has a standard thickness and convex curve as that of a co.ftvettt.iona! contact lens having a specified optical power or lack: thereof;
  • Located between peripheral edge 3502 and pupil zone 351.0 is an incremental thickness region 3506.
  • the incremental thickness region (aperture widening zone) 3506 can start at or acc , to the outer edge of the prosthesis. While a single ring is shown for incremental thickness region 3506 it is appreciated that there may be multiple rings or partial rings. SwroufKiing incremental thickness region 3506 and located between peripheral edge 3502 and incremental thickness region 3506 is a peripheral region 3504. Peripheral region 3504 has thickness and curvature equal to the standard thickness and curvature, of a conventional contact lens. An internal region 3508 Is located between pupil zone 351.0 and incremental thickness region 3506. interna! region 3508 lias a thickness and curvature equal to that of a conventional contact Sens,
  • FIG. 36 shows a contact lens 3600 having a peripheral edge 3602 and pupil zone
  • Pupil zone 36 JO may have optical power or may be devoid: of optical power and. has a standard surface friction, thickness, and convex curvature as that of a conventional contact lens having a specified optical power or lack thereof
  • Increased Surf ce Motion region 3606 includes a textured surface that increases surface friction.
  • the textured surface cap be created by, but not limited to, a different material, dimples, bumps, surfaces irregularities, any change in surface topography; or any combination thereof While a single ting is shown for increased surface friction region (aperture widening zone) 3606 it is appreciated that there may he multiple rings.
  • Peripheral region 3604 Surrounding increased surface friction region 3606 and located between peripheral edge 3602 and increased surface friction region 3606 is a peripheral region 3604.
  • Peripheral region 3604 has a surface friction equal to the standard surface friction of a conventional contact lens.
  • An .internal, region 3608 is located between pupil zone 361.0 and. increased surface: friction region 3606,
  • Internal region 3608 has a surface friction, thickness, and curvature equal to that of a conventional contact lens,
  • FIG. 37 shows a contact lens 3700 having a peripheral edge 3702 and pupil zone
  • Pupil 3 ⁇ 4one 3710 may have optical power or may be devoid of optical power and has a standard surface friction, thickness, and convex curvature as; that of a conventional contact lens having a specified optical power or lack thereof
  • Located between peripheral edge 3702 and pupil zone 3710 is an incremental thickness and increased surface friction region 3706.
  • incremental thickness and. increased surface, friction region (aperture widening ns) 3706 includes an increased thickness and textured " suriace that increase surface friction.
  • the textured surface ca be created by, but not limited to, a different iiiaieriaf. suriace treatment, dimples, humps, surface irregularities, any change in surface topography, or any combination thereof.
  • An internal region 3708 is located, between pupil zone 3710 and increased surface friction region 3706.
  • Internal region 3708 has a thickness, surface friction* and curvature equal to that of a con ventional contact, lens-.
  • FIG. 38 shows a contact lens 3800 having a peripheral edge 3802 and pupil mm
  • Pupil zo e 3810 may have optical power or may he devoid of optical power and has a standard thickness and convex curvature as that of a conventional contact lens having a specified optical power or lack thereof Pupil z ne 3810 ca also include an astigmatic optica! power.
  • Located above and below pupil 3 ⁇ 4o.ne 3 10 are two incremental thickness regions 3806. It should be noted that .each of the two incremental thickness regions 3806 (aperture widening zones) will, have an outer slope, inner siope and point of maximum thickness delta / m ximum increased thickness.
  • Each incremental thickness regio 3806 has a hemispherical, shape.
  • Contact lens 3800 also includes- two internal regions 3808 located on either side of pupil zone 3S 10.
  • Each internal region 3808 has a thickness and curvature equal to a. standard thickness and -curvature of a conventional contact lens.
  • Surrounding the periphery of the lens is a peripheral region .3804 which also has a thickness and curvature equal to a standard thickness and curvature of a conventional contact lens,.
  • each of he two incremental thickness regions could start at or adjacent to the outer edge of the contact lens.
  • incremental thickness regions 3806 can also include a. textured sin-face that increases surface friction. Additionally, incremental thickness regions 3806 can be replaced with increased surface friction regions having a textured surface and having conventional thickness and curvature.
  • FIGS. .39 A - £ illustrates the surface profile of a contact ' Sens 39(H) according to one embo iment Contact lens 3900 ha an optical power ofO,0 ⁇ ,OOD
  • contact lens 3900 includes a first surface 3904, a second ..surface 3906, third: suffice 3908,. and a fourth .surface 3910.
  • First surface 3904 has radius of curvatur ranging betwee 6,50 mm. and 9.5 mm.
  • Second surface 3906 exemplifies an incremental thickness region in. the form of a bump (aperture widening zone). The radius of curvature of second surface 3906 ranges between 4,50 mm and 7.50 ⁇ mm.
  • Second surface 3906 can have a width betweeri 2, mm and.4,0 mm *
  • Third, surface 3908 has a radius of curvature ranging between -6.50 mm and 9,50 nun.
  • Fourth suriace 39 ⁇ is located oh the outer most periphery of contact lens 3900 and has a radius of curvature ranging from 2,0 mm and 8.0 mm.
  • Th overall diameter of contact lens 3900 can range from 1 1 ,0 mm to 16,5 .mm
  • FIG, 39B shows a side view of contact lens 3900
  • FiG. 39C shows: a cross-section of contact lens 3900 along line 3902 ra FiG. 39 A.
  • FIG. 39D shows the convex, .surface of contact lens 3900 and FiG. 39B shows the concave surface of contact lens 3900.
  • FIG. 40 shows a contact tens 4000 having a spherical optical power superimposed on an eye 4014.
  • Eye 4014 has an tipper Sid 4012 and a. lower Sid 4008,
  • Contact Sens 4000 includes an area of incremental thickness (aperture widening zone) 4002, a pupil zone 4006, and a peripheral edge 4004, It can be seen in FIG. 40 that contact lens 4000 has an area 4010 that fits under upper lid 4012. Included in area 4 10 is pari of incremental thickness region 4002.
  • FIG, 41 shows a contact lens 4100 having an astigmatic optical power superimposed on an eye 41 1.4
  • Eye 4! 14 has an upper lid 41 1 and a lower lid 41 8
  • Contact lens 4100 includes an incremental thickness region (aperture widening: zone) 1 2, a pupil zone 41 6, and a peripheral edge 4104. It can he seen in FIG. 41 that contact lens 4100 lias an. area 4 HO that fits under upper lid 41 12, included in area 4110 is part of incremental thickness region 4102, Contact lens 410 also has a weighted/siabili atioii zone 4116 located on the bottom,.
  • FIG. 42 shows a contact lens 4200 having a spherical optical power .superimposed on an eye 421 .
  • Bye 4214 has an upper Sid 4212 and a. lower Sid 4208.
  • Contact len 4200 includes an incremental thickness region (aperture widening zone) 423.8 having a plurality of partial rings 4202, a pupil zone 4206, and a peripheral edge 4204. It can be seen in FIG, 42 that contact lens 4206 has an area 421.0 that fits under uppe Hd 4 12. ⁇ SO -
  • Included m area 4210 is a plurality of partial, rings 4202 located in incremental thickn ss region 42 I S.
  • FIG. 43 shows a contact Sens 4300 ' havin -a spherical optical power superimposed on an eye 4314.
  • Eye 4314 has an upper lid 4312 and a lower lid 4308.
  • Contact lens 4300 includes an incremental, thickness region, (aperture widening zone ⁇ 4318 having a plurality of partial rings 4302, a pupil zone 4306, and a peripheral edge 4304. It can be see in. FIG.. 43 that contact lens 4300 has an area 4310 that fits under tip er lid 4312.. included in area 4310 is a plurality of the partial rings 4302 located in incremental thickness region. 4318.
  • Contact lens 4300 also has a weighted'stabilization zone 4316 located on the bottom.
  • FIG. 44 shows an embodiment of a hybrid multifocal contact lens 4400.
  • Contact lens 4400 includes a peripheral edge 4402 surrounding a soft skirt 4404.
  • Soft skit 4404 includes an incremental thickness region ⁇ aperture widening zone) 4406.
  • a junction 4416 is located at the periphery of incremental, thickness region 4406. Junction 4416 connects incremental thickness region 4406 to gas permeable rigid zone 4408, Gas permeable rigid zone 4408 has a continuous graduation of power 441 and include aspherie distance zone 4410 and aspherie near zone 4414.
  • FIG. 44 shows incremental thick ess region 4406 located near peripheral edge 4402 it can be located anywhere adjacent to or peripheral to gas permeable rigid zone 4408 ⁇ . By this it is meant that incremental thickness region 4406 can be located adjacent to or outside of 3.0 mm of a geometric center of hybrid contact lens 4400.
  • FIG. 45 shows an embodiment of hybrid contact lens 4500 superimposed on an eye.
  • Contact lens 4500 includes: a peripheral edge 4502 surroundin a soft .skirl 4504.
  • Soft skit 4504 includes an incremental thickness region 4506 (aperture widening zone) and has a junction 4516 located on its peripheral edge.
  • Junction. 4 16 connects soft skit 4504 to a gas permeable rigid zone 4508.
  • Gas permeable rigid zone 4508 can include a spherical optical, power or an astigmatic optical power.
  • FIG. 46 shows an embodiment of a soft multifocal contact lens 4600, Contact: lens
  • peripheral edge 4602 includes a peripheral edge 4602, an area of incremental thickness (aperture widenin zone) 4604, a near distance zone 4606 (illustrated as the ring that circles the geometrical center of the contact lens), an intermediate zone 4608 (illustrated as the ring that circles the geometrical center of the contact lens), and a distance zone 4610 (illustrated as the larger central dark area which is surrounded by intermediate, zone 4608).
  • FIG. 47 shows an. embodiment of a reverse hybrid contact lens 4700.
  • a rigi outer skirt 4704 surrounds a soli center 4710 and includes an incremental thickness region (aperture widening tone) 4706.
  • Junction 4708 s located between rigid outer skit 4704 and soft center 471.0.
  • the prosthesis provides the significant cosmetic enhancement widenin of the palpebral fissure of the wearer's eye when fitted on an eye that has an upper iid margin within 2 mm to 3 mm or less of the upper edg of the pupil and/or a lower lid margin is within 2 mm to 3 mm or less of the lower edge of the pupil
  • Another way of establishing patient selection tor th prosthesis is the selection of any eye where the upper or lower Sid, in a resting location with, the lids open, covers the upper and/or lowe limbal area of the eye.
  • the embodiments disclosed herein also teach an. instrument that projects an image of known diameters onto the skin and. facial eye region of a potential wearer.
  • the instrument allows for taking a photo of the projected image on the eye and the adjacent facia! region of the potential wearer,. By doing this it is possible to quickly understand the appropriate diameter contact Sens or scleral ring needed ' m provide the bes palpebral widening effect.
  • infrared light is used t project light onto the eye of the wearer so to minimise any constriction of the wearer' pupil.
  • low levels of visible light rc projected In still other ' embodiments an infra-red camera is used.
  • the process iuriher contemplates a Siting set of the prosthesis whereby m the case of the contact lens prosthesis a set of rings or series of dots or lines are painted or affixed to the contact lens; each dot, line or ring by way of example onl being i ram les diameter than, the outermost adjacent dot line or ring.
  • This then allows an eye care professional to visually determine quickly when the prosthesis is tried on the eye of the wearer which contact lens provides the maximum, aperture widening.
  • the professional can also then simply indicate the number of hues or rings present in the open aperture of various trial lenses thus allowing selection of the one that presents tlie greatest nuniier of lines or rings within the aperture of the wearer's eye.
  • a patient alter viewing the appearance of wearer s eye (this can be done solely by the eye care professional and/or b feedback from the patie t being fit);
  • thai is within the range of I mm to 10 mm. wider than the palpebral fissure just measured of the intended wearer being fit, however i most cases it will, b .2 mm to 4 nim. wider.
  • tha provides good eentrahon and has an overall outer diameter that is within the range of 1 mm to 10 mm wider than the palpebral fissure just measured of the intended wearer being fit, however in most cases it will be 2 mm to 4 mm wider.
  • Image 4800 includes a scale 4802 with a plurality of markings 4804, Markin 4804 are used to measure the individual's palpebral fissure and used to determine the diameter o prosthesis that will raise the upper Hd, or depress th lower lid, thereby widening the individual's palpebral fissure.
  • ptical powers including piano, static or dynamic focusing, contact lenses, any known optical powers required tor astigmatic, spherical, and presbyopic correction can he considered to apply to the prosthesis (contact lens or sclera! ring) described herein.
  • the contact lens can be; single vision with spherical only optical power, single vision with sphero-cyiinder optical power, multifocal with spherical only optical power, multifocal with sphero- cyiinder optical power.
  • a prosthesis i the fo m: of a scleral rin would not have optical power and will not be considered single vision or multifocal,
  • the embodiments as disclosed herein cover any means by which a soft contact lens or hybrid contact lens or scleral, .ring increase the stee of the wearer's palpebral fissure by way of "one o more" of the following features- of the contact lens, by way of example only; “incremental thickness region (aperture widening zone)", Increased overall thickness, increased edge thickness, increased ' overall diameter, localized area of increased thickness, increased convex surface- eiion, localized area of increased convex surface -friction, increased partial area of raised thickness on convex surface, regressive thickness mm, convex, surface treatment (material and or texture), truncation, to superior edge of lens, truncation to the interior edg of the lens, truncation to the superior and inferior edge of the lens,, increased thickness of the edge of the lens, (partial or complete) band (bands) or ring (rings), dome (dome
  • the prosthesis has an increased thickness region superior to the pupil zone.
  • the prosthesis has an Increased thickness region
  • tire prosthesis has an increased thickness region superior and inf rior to the pupil zone.
  • the prosthesis provide inmeatiof) and/or weighting to stabilize the prosthesis.
  • die len edge is that of a conventional prosthesis thickness and edge.
  • the lens edge has a thicker overall thickness and edge compared to traditional, contact lenses.
  • one of a soft or hybrid contact lens is of spherkjal ptical power., however ill ⁇ area peripheral to the pupilary zone is configured like that of a minus aspherie torie lens having an axis of 180 (+/-20 degrees) in terms of thickness, meaning the thickness above and below the pupilar zone is thicker than normal,
  • one of a soft or hybrid contact lens is of spherical optical
  • the area peripheral to the pupilary zone is configured like that of one of a soil or hybrid contact lens in terms of thickness, with the exception of this peripheral area be ing o f increased thickness compared to that of a conventional/traditional soft or hybrid spherical power contact lens for the same optical power, diameter and base curve.
  • one of a soft or hybrid contact lens comprises astigmatic optical power
  • the area peripheral to the pupilary is configured like that of a minus aspherie tone lens having an axis of 180 (+/-20 degrees) in terms of thickness, meaning the thickness "above and below' 5 the pupilary zone i thicker than normal for a typical astigmatic correcting soft or hybrid contact lens
  • Some embodiments contemplate spherical lenses with no optical power axis bein such that the area superior and inferior to the pupil zone of the soli contact lens or hybrid contact lens is thicker th would be expected for a soft or hybrid contact lens having such a spherical or astigmatic optical power.
  • Some embodiments contemplate astigmatic lenses having a optical axis being such that the area superior and inferior to the pupil zone of the soft contact lens or hybrid contact len is thicker tha would, be expected for a soft or hybrid, contact lens having such a spherical or astigmatic optical power.
  • Some embodiments contem late an incremental thickness region izam,. area) or a regressive thickness region (zone, area) located on the convex surface of the prosthesis that i rot tional ly symmetrical.
  • Some embodiments contemplate an incremental thickness region (zone,, area) or a regressive thickness region ⁇ zone, area) located on the convex surface of the prosthesis that is roiationally asymmetrical. 104311 Some em odiments contemplate an incremental thickness region : ⁇ 3 ⁇ 4one, area) or a regressive thickness region (zone:, area) located on the convex surface of the prosthesis that is now --rotational ly symmetrical.
  • Some embodiments contemplate an incremental, thickness region (zone, area) or a regressive thickness region (ione, area) located on the convex surface of the prosthesis that approximates the curve of the upper lid margin and / Or the curve of the lower lid margin.
  • the incremental thickness region (aperture widening zone) of the rosthesis can have a tmsira w delta thickness differential (added thickness) within the range of 25 microns to 1,000 microns, with a preferred range of 100 microns to 500 microns, with a more preferred range of 75 microns t 400 microns,
  • the regressive thickness region, (aperture widening zone) of the prosthesis can have a maximum delta thickness differential (reduced thickness) within the range of ISniicro io 1 ,000 microns, with a p eferred range of 100 microns to 500 microns, with a more preferred range of 100 microns to 400 microns, with a more preferred range of 75 microns to 400 microns,
  • the convex surface region of incremental thickness (aperture widening zone) of the prosthesis can be located within the range of 3 mm to S.5 mm from the geometrical center of the contact lens, and more eferably within 5 mm to 7.75 mm torn the geometrical center of me contact lens.
  • the region of incremental thickness or regressive thickness is in most cases internal to the edge of the prosthesis. However in some cases, not most, it can start at the outer edge of the prosthesis.
  • the width of the incremental t ickn ss region (zone, area) (aperture widening zone) or the regressive thickness .region (zone, are) (aperture widening zone) can be 0.5 mm to 6 ran.
  • the mcteme «ta.l. thickness diameter and the regressive thickness diameter may fall within the range of 7 mm to 15 mm.
  • the region or zone of incremental thickness has a slope and a delta of maximum thickness, whereby the outer slope on the outside of the delta of maximum incremental thickness (closer t the outer edge of the prosthesis) is steeper than the inner slope on the inside (closest to the center of the prosthesis),
  • th region or zone of regressive thickness has an outer slope and a delt of omximum regressive thickness, whereby the inner slope on the side of the delta of maximum regressive thickness (closer to the center of the prosthesis) is the steepest.
  • the region or zone of regressive thickness- has an outer slope and a delta of maxi vum regressive thickness, whereby the inner slope on the side of the delta of maximum regressive thickness (closer the center of the prosthesis) is equal to the ⁇ outer slope.
  • the prosthesis in the form of a contact lens or scleral ring can comprise finger like members thai fold towards the center of the scleral ring when the eye lid closes or blinks and opens away (unfolds) from the center of the scleral ring when the eye lid is opened .
  • the finger like members can be located on the region of the sclera! ring above and below the pupil, of the eye.
  • the finger like members c n elevate the upper lid and depress or lower the lower lid when the eye lid is open and not blinking or closed.
  • contact lens i provided or used in this disclosure it is meant to be that of one of;, a eomeo-seleraS contact lens or hybrid contact: lens. - *
  • some embodiments of the prosthesis there may or may not be an incremental thickness zone (region, area), or a. regressive thickness zone (region,, area) but rather the surface of the zone or region is altered to provide increased lid friction compared t other areas of the prosthesi s.
  • This region or zone of increased surface friction can be easily over come during an eye lid blink or forced closure but upon opening the eye !id this regi n of increased friction elevates the upper lid and/or depresses the Sower lid thu opening the aperture of the eye.
  • the prosthesis disclosed herein can be stabilized (by the use of a stabilization zone) to prevent rotation m the ease, by example only, of a multifocal or a tone single vision lens or a tone multifocal.
  • the prosthesis disclosed herein can be devoid of stabilization (not -stabilised / free to rotate) in the case, by example only, of a single vision spherical lens.
  • the prosthesis disclosed herein can be free to rotate upon natural normal blinking of the eyes always when in the ftwm of scleral ring. And also in most (bu not ⁇ all embodiments) when in the form of a single vision contact lens comprising solel spherical optical power and. devoid of a stabilization zone, feature or member.
  • the prosthesis in some embodiments disclosed, herein is not free to rotate upon natural / normal blinking of the eyes al ways when in the forrn of a scleral ring.
  • the aperture widening .zone and the stabilization zone can be one and the same by design. In other embodiments the aperture widening zone is separate from the stabilization zone, feature or member.
  • FIGS. 4 - 53 illustrate exemplary embodiments of a prosthesis having an aperture widenin zone.
  • FIG. 49 shows a scleral ring 4900 having an aperture widening zone 4906 spaced apart from its peripheral edge 4902. Located between peripheral edge 4902 and .aperture widening zone 4906 is a first regio 4904.
  • First region 4904 has a thickness and curvature equal to that of a conventional scleral ring.
  • Aperture widening zone 4 116 has an. outer edge 4908 and an. inner edge 4916..
  • Aperture widening zone 4906 has an incremental thickness defined by an outer slope 4910 and an inner slope 9.14 with a maximum incremental thickness 4912 located between outer slope 4 10 and inner slope: 491 .
  • a second, region. 4918 is located adjacent to inner edge 4916 and. extends towards an. open central aperture 4920. Similar to first region 4904, second region 4918 has a thickness and curvature equal to that of a conventional scleral ring. Located in the center of open central aperture 4920 is the geometric center 4922 of scleral ring 4900.
  • FIG. 49 also shows the vertical dimension (VD) of scleral ring 4900. The vertical dimension ( VD) bein measured from the upper most point of outer edge 4908 to the lower most point of oilier edge 4908.
  • FIG. 50 shows a scleral rin 5000 having m aperture widening zone 5004 beginning at its peripheral edge .5002.
  • Aperture widening zone 5004 has an incremental thickness defined fey an outer slope 5006 and an inner slope 5010 with a maximum incremental thickness 5008 located between outer slope 5006 and inner slope 5010,
  • Aperture widening zone 5004 includes an inner edge 5012 adjacent to an open central aperture 5014.
  • Located n the center of open central, aperture 5014 is the geometric center 5016 of scleral ring 5000, PIG. 50 also shows the vertical dimension (VD) of scleral ring 5000.
  • the vertical dimension. (VD) being measured from, the upper most part of peripheral edge 5002 to the lower most part of peripheral edge 5002.
  • FIG. 51. shows a contact lens 5100 having an aperture widening zone 5106 spaced apart from its peripheral edge 5102, Located between peripheral edge 51 2 and aperture widening zone 51 6 is a first region 5104.
  • First region 510 has a thickness- and curvature equal to that, of a conventional; contact lens.
  • Aperture widening zone 5.106 has an outer edge- 5. I OH and an inner edge 51 1.6.
  • Aperture widening zone 5106 has an incr ment l thickness defined by an outer slope 51 10 and an inner slope 51 14 with a maximum incremental thickness 5112 located between outer slope 5110 and inner slope 51 1 ..
  • a second region 51 18 is located adjacent to inner edge 511 and extends toward the geometrical center S 120 of the- contact lens 51 0.
  • Second region 51 18 can have an optical power or can. be devoid of optical, power and has a. thickness ' and curvature equal to that of a conventional, contact lens having a specific optical power or lack thereof
  • FIG. 51 also shows the vertical dimensio (VD) of contact lens 5100.
  • the vertical dimension (VD) being measured from the upper most part, of outer edge 51 8 to the lower most part of outer edge 51 OS,
  • FIG. 52 shows a contact lens 5200 having an aperture widening zone 5204 eginning at its peripheral, edge 5202.
  • Aperture widening mm 5:204 has a incremental thickness defined by an. outer slope 5206 and an. inner slope 52 1.0 with a maximum incremental thickness 5208 located between outer slope 5206 and inner slope 5210.
  • a second region 5214 is located adjacent to an inner edge 5212 -of aperture widening zone 5204 a id extends towards die geometric center 5216 of th contact lens 5200.
  • Second region 5214 cat* have an optical power or can be devoid of optical power and has a thickness and curvature equal to that of a conventional contact lens having a specific optical power or lack thereof
  • FIG. 52 also shows the vertical dimension (YD) of contact tens 5200.
  • the vertical dimension. (VD) being measured from the upper most part of peripheral edge 5202 to th lo was most pari of peripheral edge 5202,
  • FIGS. 53A - - E show various exemplary embodiments of aperture widening zones having a plurality of bands of incremental thickness 5304.
  • the bands: of incremental thickness are arranged in a spoke-like fashion around either an open -central aperture 5300 or an ptic zone 5302. While a plurality of different . patterns are shown in FIGS. 53A E it Is appreciated that any number or orientation of bands of incremental thickness 5304 can be present in the aperture widening zone.
  • FIGS. 54 ⁇ 56 illustrate the palpebral fissure widening effect of an aperture widening zone described herein
  • FIG. 54 shows an individual's natural palpebral fissure.
  • the maximum diameter of the individual's left nat ural palpebral fi ssu re ⁇ right side of FIG, 54) is .approximately 6 mm.
  • FIG, 55 shows the same individual wearing a prosthesis having an aperture widening zone as described herein. It can he seen from FIG. 55 that the palpebral fissure of his left eye has been widened.
  • the maximum diameter of his left eye's palpebral fissure is now approximately 9,5 rum, an increase of approximately 3,5 mm.
  • FIG. 56 shows the left eye in FIGS, 54 and 55 side by side tor comparison,
  • FIGS.. 57 - 6 show variou graphs exemplifying the surface profile of embodiments of the prosthesis as described herein.
  • FIGS. 57 - 60 quantify the inner and outer slopes of various aperture widening zones.
  • FIGS. 57 and 58 show prostheses having -a maximum, change in thickness located approximately 5.7 mm, f om, the: geometrical center of the prostheses.
  • PIG. 59 shows a prosthesis having a maximum change i ihickness Located approximately 5.3 mm f om the geometrical center of the prosthesis.
  • FIG. 60 shows a prosthesis having a maximum change in thickness located approximately 5.55 mm from, the geometrical center of the prosthesis.
  • FIG. 61 illustrates th dimensions of a contact lens 6130 compared to the anatomy of a hu an eye.
  • the hitmao eye has an upper lid 6120, a lower lid 6122,, cornea 6124, and a sclera 6128.
  • Located at the interlace of cornea 6124 and sclera 6128 is a W h 6126.
  • limbos 6126 is located adjacent- to the outer peripheral edge of cornea 6124 and adjacent to sclera 6128.
  • the a verage diameter of the cornea is 1 1.71 * ⁇ /- 0.42 mm.
  • the average corneal diameter is 1 1.77 0.37 mm in males compared with I L64 + - 0.47 mm in females,
  • contact lens 6130 having an aperture widening zone 6132 is shown as being, worn on the eye and extends across cornea 6124 and lirabus 6126 to sclera 6128 on both sides of cornea 6124.
  • a visual representation 6300 of contact Sens 6130 is shown to the left of the eye (this is not Hie actual lens, but rather a representation showin the various dimensions of contact lens 6130).
  • contact lens 6130 has an aperture widening zone 6132 located adjacent t a peripheral edge 6102.
  • Aperture widening zone 6132 is defined by an outers Lope 6104, a maximum incremental thickness 6106, an inner slope 6108,. and an inner edge 6130.
  • Located inside of inner edge 61. 10 is an optical power zone 61 12 with a geometric center 61 14 located therein. It can be seen from FIG. 61. thai maximum incremental thickness 610 is located outside of tim iis 126 on. both sides of the eye.
  • FIG. 62 illustrates the dimensions of a scleral ring 6230 compared to the anatomy of a human eye.
  • the human eye has an appe lid 6220, a Lower lid 6222, a cornea 6224, and a sclera 6228. Located at the interface of cornea 6224 and sclera 6228 is a limbus 6226.
  • Scleral ring 6230 having an aperture widening zone 6232 is shown as being worn: on the eye and extends across cornea 6224 and limbus 6226 to sclera 6228 on both sides of cornea 6224,
  • a visual representation 6200 of scleral ring 6230 is shown to the left of the eye (this is not the actual lens, but rather a representation showing the various dimensions of scleral ring 6230).
  • scleral ring 6230 has an aperture widening zone 6232 located adjacent to a peripheral edge 6202.
  • Aperture widening zone 623 is defined by an outer slope 6204, a maximum incremental thickness 6206. an nner slope 6208, and an inner edge 6210.
  • Inner edge 621.0 Located inside of Inner edge 621.0 is an open central aperture 6212 with a geometric center 6214 located therein. It can be seen from F G. 62 that uiaximuiti incremental thickness 6206 is located outside of limb ' s 6226 on both sides of the eye.
  • FIG'S. 63 A. - 66D illustrate examples of how to measure tire vertical dimension and/or the minimum, vertical -dimension for various shapes. While these figures are simplified versions of exemplary shapes o ' aperture widening zones it is appreciated that any shape will have a vertical dimension and a mini mum -vertical dimension. For purposes of these illustrations it will be assumed that the paints used to measure vertical dimensions and/or minimum vertical dimensions would he located on the upper most part of an aperture widening zone and the lower most part of an aperture widening zone.
  • FIG. 63 A shows a prosthesis 6300 having an aperture widening zone with an outer edge 6306 in tile shape of a circle.
  • the upper most point of outer edge 6306 is shown at point 6302 and the lower most point of outer edge 6306 is shown at point 630
  • the vertical dimension (VD), measured, fr m tipper roost point 6302 to lower most point 6304 and projected onto a vertical axis, is shown on the left side of f 1G. 63A, Because outer edge 6306 is in the shape of a circle the vertical dimension (VD) is equal to the minimum vertical dimension (MVD). For a circle, this is true fo any rotational orientation of the prosthesis.
  • FIG. 638 shows a prosthesis 6350 having an aperture widening zone with an outer edge 635 in the shape of an equilateral triangle.
  • the upper most point of outer edge 6356 is shown, at point 6352 and the Sower most point of outer edge 6356 i shown at point 6354.
  • the vertical dimension (VD) measured- from upper most point 6352 to lowe most point 6354 and projected onto a vertical axis, is shown on the left side of FIG, 63B. In FIG, 63B this is the height of the equilateral triangle which is also the minimum vertical dimension (MVD).
  • -Because outer edge 6336 is in the shape of an equilateral ' triangle the vertical dimension will change based on the orientation of the lens.
  • VD vertical dimension
  • This rotational orientation of the triangle resolts in a larger vertical dimension.
  • This larger vertical dimension results from t e fact that all equilateral triangles have a height that is less than the length of their sides.
  • FIGS. 64A - C ilkstrate how to measure a vertical dimension. (VD) and th minimum vertical dimension (MVD) of an aperture widening zone located, on a prosthesis 6400 having an outer edge 6420 in the shape of an oval.
  • IG. 64A shows prosthesis 6400 in a first rotational orientation where the oval is positioned such that its minor axis is oriented in the vertical direction.
  • the orientation in FI(1 64A shows a vertical dimension equal to minimum vertical dimension (MVD) for the oval
  • the minimum vertical irnension (MVD) is measured from upper most point 6402 io lower most point 6404 and projected onto a vertical axis, FIGS.
  • FIG. 64B and C show other orientations of the oval where its vertical dimension (VD) is not its minimum vertical dimension.
  • VD vertical dimension
  • VDf measured from point 641 to point 6412
  • MVD minimum vertical dimension
  • FIG. 64C shows a vertical dimension (VD), measured from point 6406 to point 6408, that is greater than the minimum vertical dimension (MVD) shown in FiG. 64A.
  • FIGS, 65.A - B show another example of how to measure a vertical dimension
  • FIG. 65 shows an orientation of the prosthesis where the vertical dimension (VD) is equal to the minimum vertical dimension (MVD) for the aperture widening z ne The minimum vertical dimension (MVD) being measured fern upper most point 6502 to lower most point 6504.
  • FIG, 65B shows an orientation of prosthesis 6500 where the vertical dimension (VD) is not the -minimum vertical dimension (MVD).
  • the vertical dimension (VD) in FIG,. 6SB is measured from tipper most point 6506 to lower most point 6508 and is larger than the minimum vertical dimension shown in FIG. 65A.
  • FIGS. 66 - B illustrate how to measure a vertical dimension and the m uhmira vertical: dimension of an aperture widening zone on a prosthesis 6600 -defined by a plurality of isolated areas with outer edges 6610 arranged in the shape of a square.
  • FIG, 66A shows a first orientation of prosthesis 6600 where the vertical dimension (VD) for the aperture widening zone is equal to the minimum vertical dimension (MVD).
  • Outer edges 661.0 have points 6602, 6604, 6606, and 6 08 which are located furthest from the center of prosthesis 6600.
  • the minimurn vertical i en n (MVD) is •measu ed from an.
  • PIG. 66B shows a second orientation of prosthesis 6600 illustrating- a vertical dimension. (VD) that is not the minimum vertical dimension (MVD).
  • VD vertical dimension
  • YD vertical dimension
  • the vertical dimension (YD) in FIG. 66B is measured from upper most point 6604 to lower most point 6606 and projected onto a vertical axis show on the left, side of FIG. 66B, It can be seen, that the vertical dimension (VO) in FIG. 66B is larger than the minimum vertical dimension (MVD) shown, in FIG. 66 A >
  • FIGS. 66C ⁇ - D illustrate how to measure a vertical dimension and the minimum vertical dimension of an aperture widening zone on a prosthesis 6650 defined by a plurality of isolated areas with outer edges 6660 arranged in the shape of a triangle.
  • F!G. 66C shows a first orientation, of prosthesis 6650 wherein the vertical dimension (VD). is the distance between upper most point 6652 and lower roost point 6654.
  • FIG. 66D shows a second orientation wherein the vertical dimension is equal ' to- the minimum vertical dimension (MVD), As shown in PIG. 66D the minimum vertical dimension (MVDX measured from upper most point 6654 to lower most point 6656, is projected onto vertical axis to the lef of FIG. 66D.
  • FIG:. 67 shows a scleral ring 6700 having a peripheral edge 671 and an. open aperture 6702. Located above open aperture 6702 is an incremental thickness region having an upper finger member 6704 and located below open aperture 6702 is an incremental thickness region havin a lower finger member 6706, Scleral ring 6700 can also have trenches 6708 designed to receive linger members 6704 and 6706 when they are folded down fey the eyelids of a wearer.. Trenches 6708 are located adjacent to the inside of finger member 6704 and 6706. I should be noted, thai trenches 6808 are optional,
  • FIG, 68 shows a contact lens 6800 having peripheral edge 68T0 and an optic zo 6802, Located above optic zone 6802 is an incremental thickness region having an upper finger member 6804 and located below optic zone 6802 is an incremental thickness region having a lower finger member 6806.
  • Contact lens 6800 can also have trenches 6808 designed to receive linger members 6804 and 6806 when they are folded down by the eyelids of a wearer. Trenches 6808 are located -adjacent to the inside of finger members 6804 and 6806, It should be noted that trenches 8 8: are optional. 0478 ⁇ FIG, 6 shows a side view of a contact lens 6900 having an optica!
  • FIG. 69 art upper eyelid 6906 is shown in contact with upper finger member 6910. (Jpper finger member 6910 lifts (elevates) upper eyelid 6906 when contact lens 6900 is worn.
  • FIG;. 6 also shows a Sower eyelid 6904 in contact with lower finger .member 6908.
  • Lower finger member 6909 depresses (lowers) lower eyelid 6904 when contact fens 6900 is worn, While a contact lens is shown in FIG. 69 it will be appreciated that a scleral ring with finger members (see above description with respect to FIG. 67) would also be capable of lifting (elevating) and/or depressing ( lowering) the upper and iower eyelid in the same way as described in FIG. 69.
  • the minimum vertical peak to peak dimension for various shapes of an aperture widening zo ma be measure in the same way as discussed above for a, minimum vertical dimension. But the relevant points on the prosthesis would be the maxi um thickness deltas rather than the uppermost and lowermost points of the aperture widening zone.
  • max thickness delta hump LO mm-1 iOmm in from outer edge of the lens / aperture widening zone begins at the outer edge of the lens general base thickness (excluding bump ⁇ fe outer edge) within the range -of approximately 1.25.mierons-l 75raicrons / optical powe equals -0.500
  • max thickness delta bump at 1.5 mm*2.tas in from the outer edge of the lens / aperture widening zone begins at th outer edge of the lens / general base thickness (excluding bump & outer edge) within the range of approximately 125raicrons ⁇ ⁇ 5 microns / optical power equals -O.50D
  • Table 2 illustrates that specific tens work best for different individuals and that most individual's palpebral fissure can be widened by wearing a prosthesis comprising an aperture widening zone as: described herein, it i appreciated thai Table 1 is only an example of various lenses that an be worn and is not meant to limit the dimensions and/or widening capacities of prostheses described herein.
  • Some embodiments include a prosthesi capable o being worn by wearer comprising an. aperture widening zone located on its convex outer surface.
  • the prosthesis has an overall diameter of X ram, and the wearer's eye comprises vertical aperture •measurement, of Y mm, whereby X mm is at least Im longer than Y mm.
  • the aperture widening zone widens the palpebral fissure of the eye of a wearer
  • the aperture widening zone depresses (lowers) the lower lid of a wearer. n some embodiments the aperture widening zone lifts (elevates) the upper lid of a wearer. In some embodiments the aperture widening zone lifts (elevates) ihe upper lid by at least 1 mm. In some embodiments the aperture widening, zone depresses (lowers) the lower lid by at least 1 mm. In some embodiments the aperture widening zone elevates the tipper lid by less than 1 mm and/or depresses the lower lid by less than I mm but widens the palpebral fissure of the wearer's eye by at least I nini.
  • the prosthesis comprises a material that is one of: hydrogef silicone ydrogel, silicon, gas perm, hydrophiUe, rigid and ilexible.
  • the prosthesis that is corneoscleral, contact lens in some embodiments the prosthesis is a soft contact lens. In some embodiments the prosthesis is a hybrid contact leas. In some embodiments the prosthesis is a scleral ring.
  • the aperture widening zone i located internal to the edge of the prosthesis. In some embodiments the aperture widening zone begins at the outer edge of th e prosthesis.
  • the aperture widening zone is: rotatienaily symmetric. In some embodiments the aperture widening zone is rotationaily asymmetric.
  • the aperture widening zone has a maximum incremental thickness delta that i within the range of 23 microns and 1 ,000 microns. In some embodiments the aperture widening zone has a maximum incremental thickness delta that is within the range of 100 microns and.4(10 microns,.
  • the aperture widening zone is located within range of 3 rnm and 8.5 mm from a geometrical center of the prosthesis. In some embodiments the aperture widening zone is located within range of 5 mm and 7..7S mm from a geometrical center of die prosthesis,
  • the aperture widening zone is located within a range of 0..1 mm i 6.0 mm from an outer peripheral edge of the prosthesis.
  • tli aperture widening ne is located within a range from an outer peripheral edge of the prosthesis to 6, mm from the outer peripheral edge of the prosthesis.
  • the aperture widening zone has a maximum delta thickness located within a range of 0.25 mm to 3.0 mm from an outer peri heral edge of the prosthesis. In some embodiments the aperture widening 3 ⁇ 4o «e has a maximum delta thickness located within a range of 0.5 mm to 3.0 mm f om an outer peripheral edge of the prosthesis. In some embodiments the aperture widening zone has a maximum delta thickness located within a range of 0.25 mm to 0,75 mm trom an outer peripheral edge of the prosthesis.
  • the aperture widening zone comprises, a bum on the convex surface of the lens.
  • the scleral ring in some embodiments comprises an open central aperture. In some embodiments the scleral ring comprises a homogenous design. In some embodiments the scleral ring comprises a hybrid design.
  • the scleral ring comprises a flexible finger like member.
  • the finger like member folds upon the blink of an eye in a direction towards the geometrical center of the scleral ring, in some embodiments the finger like
  • the prosthesis ca be worn for a time of one of continuously * daily, weekly and monthly.
  • the prosthesis Is disposable. In some embodiment the prosthesis is reusable.
  • the prosthesis comprises an optical power. In som embodiments the prosthesis is devoid of optical power.
  • ie aperture widening zone has a slope and a delta of maximum incremental thickness.
  • the slope o the outside of the delta of ma imum incremental, thickness ⁇ closest to the outer edge of the prosthesis) ' is steeper than the slope on the inside (closest to the center of the prosthesis).
  • the prosthesis comprises a zone or region of increased
  • the prosthesis is devoid of a zone of incremental thickness or regressive thickness, hut rather has a mm of increased surface friction located on its on er convex surface,.
  • the width of die aperture widening zone ' is within the range of 0 * 5 mm to 6 mm.
  • the outer edge of the prosthesis approximates- the edge of a conventional comeo-scleral contact lens.
  • the peak delta thickness corresponds to a point located within the natural aperture of the wearer's eye.
  • me peak deha thickness corresponds to a point located outside the natural aperture of the wearer's eye (meaning the distance of peak delta thickness to peak delta thickness measured thru the geometrical center of the prosthesis Is larger than the vertical measurement between the upper lid margin and the lower lid margin (the vertical eye aperture).
  • the aperture widening zone has a diameter (not the width of the aperture widening zone) that falls within the range of 7 mm to 35 mm.
  • the prosthesis is a corneoscleral eoniaei lens, hi some embodiments the coraeo-sele.rai contact Jens is a spherical single vision contact lens, in some embodiments the comeo-scleral contact lens is a multifocal contact lens, in some embodiments the eoraeo-seieral contact lens ha a tone optical power.- i some embodiments the coraeo-scieral contact lens is a single vision sphero-cy Under contact lens,
  • the prosthesis comprises a rotationally symmetric aperture- widening zone and is not stabilized. In some embodiments the prosthesis comprises a totationaliy symmetric aperture widening zone and the prosthesis is devoid o a stabilization zon .
  • the prosthesis is devoid of a stabilization zone and thus free: to rotate, In some em odiments the prosthesis is stabilized and thus nor free to rotate. 1 511 J In. some embodiments the prosthesis has an. aperture widening 3 ⁇ 4one and separate aperture stabilization zone,
  • tire prosthesis has an aperture widening zone nd the prosthesis is free to rotate during natural blinking
  • the prosthesis comprises a colored area which adds to the cosmetic appearance of a larger eye when worn on the eye of a wearer.
  • the colored area is one of; a liffibal ring, colored ring, or accent color.
  • the aperture widening zon is located above and .belo the geometrical center: along an imaginary vertical axis which crosses the geometrical ce te of the prosthesis
  • the prosthesis comprises an aperture widening zone located to the right or left of the geometrical center along an imaginary vertical axi which crosses the geometrical center of the prosthesis,
  • Some embodiments include a prosthesis for a wearer's eye having an overall diameter of X mm, and the wearer's eye having a vertical aperture measurement of Y mm, wherein. X mm is at least 1 mm longer than Y mm.
  • the prosthesis has an aperture widening zone with an outer slope within the range of 3 degrees to 45 ⁇ degrees-.
  • Some embodiments include a prosthesis for a wearer' eye having an overall diamete of X mm, and the wearer's eye having a vertical aperture measurement of Y mm, wherein X mm is at least, i mm longer than Y mm.
  • the prosthesis has an aperture widening zone with an inne slope within the range of I degree to IS degrees.
  • Some embodiments include a prosthesis having an aperture widening zone located superior and interior to its geometrical center.
  • the aperture widening- zone has a thickness slope. The thickness slope exceeding 50 microns of added, thickness per millimeter
  • Some embodiments include a prosthesis having an aperture widening zone on its convex surface..
  • the aperture widening zone c using a ' bump on the convex surface.
  • the aperture widening zone has an outer slope thickness that is greater than 50 microns of added thickness per mm.
  • jOSlilf Some embodiments include a prosthesis ' having an aperture widening zone on it convex surface. The aperture widening zone causing a bump on the conv x surface.
  • the aperture widening zone has an inner slope thickness that is less than 50 microns of added thickness per ran ;.
  • die outer slope thickness of the aperture widening zone is greater than 100 microns of added thickness per mm, in. some embodiments the outer slope, thickness of die aperture widening zone is greater than 1.50 microns of added thickness per mm. In some embodiments the outer slope thickness of the aperture widening zone is greater than 200 microns of added thickness per mm, in ome embodiments the outer slope thickness of the aperture widening zone is greater than 300 nherons of added thickness per mm.
  • the inner slope thickness of the aperture widening zone is less ten 100 microns of added thickness per mm., in some emksdirnent the inner slope thickness of the aperture- widening zone is less than 1.50 micron of added thickness per torn. In some embodiments the inner slope thickness of the aperture widening zone is less than 200 microns of added thickness per mm. in some embodiment the inner slope thickness of the apertu re w idening zone is iess than 30 microns o f added thickness per rarn
  • the aperture widening zone has a bump on the convex surface of the prosthesis, i some embodiments the bump is located- vertically above and below the geometrical center of the prosthesis.
  • the aperture widening zone may include a surface feature comprising an outer slope, an inner slope, and a maximum -added thickness delta located between the outer slope and the inner slope.
  • the surface feature may be located on the convex or concave surface of a prosthesis.
  • the prosthesis ma include a surface feature located on the convex surface of the prosthesis and a surface feature located on the concave surface of the prosthesis,, hi such embodiments, the surface features located on the convex and. concave surfaces ma overlap, in whole or i part.
  • the surface feature, or a portion thereof may be designed using a tri- curve methodology.
  • the surface feature,, or a. portio thereof may be designed using a spline curve methodology, in other words, the surface feature, or a portion thereof * may be defined by one or more spline curve functions,
  • the spline curve ihnciion(s) may be Bezier curve f3 ⁇ 4nctioo(s),
  • the surface feature m y not have fi st and/or second orde continuity, partially at the points where the outer slope and the inner slope meet a. convex or concave surface of a prosthesis, in other words, the points where the outer slope and inner slope meet the convex or concave surface of the prosthesis may not be extremely smooth, in tri -curve embodiments, the smoothness of the outer slope may fee increased by intersecting the outer slope with, the peripheral edge of the prosthesis.
  • a peripheral edge e.g., a manufacture's peripheral edge
  • a peripheral edge is typically sloped itsel this may help to increase the overall smoothness of the surface and the junction points between the outer slope and the concave or convex surface of a prosthesis.
  • intersecting the outer slope with the peripheral edge of the prosthesis ma alter tile edge design tor a prosthesi (eg., a manufacture's edge design). While this may be suitable in some circumstances, manufactures generally want to preserve the shape and design of their peripheral edge for the reasons discussed above,
  • the surface feature is designed using a spline curve methodology (see eg,, FIGS. 73 A. - B), at least a. portion of the surface feature is designed using a spline curve function.
  • the outer slope may be designed using a spline curve function.
  • the outer slope ma have firs order continuity, including at the points where it meets the convex or concave surface of the prosthesis.
  • the outer slope may have first and second order continuity, including at the points where it meets the convex or concave surface of the prosthesis, hi so e embodiments.
  • the inner slope may be designed -using a spline curve function.
  • the inner slope may have first orde continuity, including at. the points where it meets the convex or concave surface of the prosthesis .
  • the inner slope may have first and second order continuity, including at the points where it meets the convex or concave surface of the prosthesis.
  • the entire surface feature may foe designed, using spline curve functions, in some embodiments, the entire surface of the surface feature may have at least first order continuit (and, in some embodiments, first and second order continuity).
  • the entire surface on which a surface feature is located i..e., the convex, o - 1.04 - concave surface
  • the entire concave o convex, surface may have at least first order continuity (and in some embodiments, second order continuity) * including at any junction point between two adjacent, curve/surface- sections..
  • Designing a surface feature, or a portio thereof, using a spline curve ft eiion may provide a high degree of sm othness for the s rface feature, which may turn increase the comfort for a wearer,
  • a wearer's eyelids may primarily interact, with the outer slope of a. surface feature to push up (i .e., lift) th upper eyelid, and push down fie,, depress) the lower eyelid
  • designing the outer slope using a spline eurve function may increase comfort for a wearer.
  • designing a surface feature using a spline curve function may help to preserv a manufacture's edge for a specific prosthesis while also preserving the smoothness of the convex or concave surface of the prosthesis, in particular, designing the outer slope of a surface feature using a spline curve function may facilitate a smoot conve or concave surface that does not interfere with a tnanufactexe " s edge .
  • FIGS. 70 and 71 A - B sho a prosthesis 7000 having an aperture widening l e
  • Aperture widening zone 7010 located on a convex surface 7008 according to an embodiment
  • Aperture widening zone 7010 includes a. surface feature havin an outer slope 7014, an inne slope 7020 and a maximum added thickness delta 7012. in. some embodiments; as shown in FIGS. 70 and 71 A - B, aperture widening zone 7010 may include a surface feature in the shape of a continuous ring surrounding a geometric center 7004 of prosthesis 7000,
  • Prosthesis 7000 may be composed of a sil icon hydrogel (but can be of any known soft contact lens material).
  • the sfiefcries-s (i.e., surface frietion) of the material used to make prosthesis 7000 may affect, the size and shape of aperture widening zone 7010. For example, if a less slick material is selected, the maximum added thickness delta may be reduced in height, compared to a prosthesis made using a more slick material The maximum added thicknes delta may be reduced because it is believed that a less slick material (i.e., a material having higher suriaee friction) will have stronger interaction with a wearer's eyelids,
  • the base thickness of prosthesis 7000 may be approximately 75 microns (the general thickness of a conventional molded or lathe cut soft on act lens). As used herein, base thickness does not account for any added incremental thickness of aperture widening z ne 7 10. In other words, it is the thickness of rosthesis 7000 in th absence of aperture widening zone " 010.
  • the base curve for prosthesis 7000 may ' be any known base curve to pro vide appropriate centering and fit for a user.
  • the base curve .for prosthesis 7000 may he, but is net limited to, X 8,4, 8.6, arid 8,8.
  • Prosthesis 7000 may have any suitable front optic diameter, such as, but not limited to 8,5 mm, which is a standard optic diameter for a soil contact lens, in some embodiments, the front optic diameter may be 7.0 or 7.5 mm.
  • An optical zone 7006 of prosthesis 7000 may have any suitable optical power, including no optical power (Le.-, piano),
  • Prosthesis 7000 may have any suitable overall diameter 7030, such as the overall diameters discussed herein.
  • overall diameter 7030 of prosthesis 7000 may be 1 ,5 mm or larger,
  • Outer slope 7014 may meet convex surface 7008 at an outer slope junction point
  • Outer slope junction point 7016 may be located at a distance 7018 from a peripheral edge 7002 of prosthesis 7000.
  • distance 7018 may be i the range of 0,01 mm to 2,0 mm.
  • distance 7018 may be 0.25 mm or greater
  • inner slope 7020 may meet convex surface 7008 at an inner slope junction point 7022
  • inner slope junction point 7022 may be located at a -distance 7024 from optical zone 7006 (or central open aperture in the ease of a scleral ring) of prosthesis 7000.
  • distance 7024 may be in the range of 0 mm to 3.0 mm. 5331
  • the width of outer slope 701 may be, but is not limited to 1.0 mm to. 2.0 mm.
  • Aperture widening zone 7010 may have an suitable aperture widening tone diameter.
  • the aperture widening zone diameter may be 10.5 mtn or greater.
  • th aperiure widening zone diameter may be 1 1,5 mm or greater.
  • the aperture widening zone diameter may be 12.5 mm or greater.
  • the aperiure widening z ne diameter may be 13.5 mm or greater.
  • the aperture widenin zone diameter may be 13,65 mm. i some embodiments, the aperture widening zone diameter may be 12.5 ram.
  • the aperture widening zone diameter may be 12,0 mm. $53 1
  • the slope of outer slope 7014 may be, but is not limited to, greater than.6 degrees.
  • the slope of outer slope 701 may be approximately 13,15 degrees, fo some embodiments, the slope of outer slope 7014 may be approximately .12 degrees.
  • the slope of inner slope 7020 may be, but is riot limited to, less than. 6 degrees.
  • the slope of hrner, slope 7020 may be 3.25 degrees.
  • the slope of Inner slope 7020 may b approximately 4 degrees.
  • the slope of inner slope 7020 may be l ess than or equal to 1 1 degrees .
  • the slope of outer slope 701 and/or the slope of inner slope 7620 may be constan t, hi some embodiments, the slope of outer slope 7014 and/or the slope of Inner slope 7020 may be non-constant.
  • the slope of outer slope 701 may decrease when approaching the convex or concave surface of a prosthesis to increase the smoothnes of junction point 7016 (see e.g., slope of outer slope 7314 in FIG. 73B). This may be similar at junction point 7022 for an. inner slope 7020 designed using a spline surface function,
  • aximum added thickness delta 7012 may have any suitable added ..thickness as discussed herein, for example, 300 microns or 200 microns. In some embodiments, maximum added thickness delta 7012 may be greater than or equal to 1 50 microns. In some embodiments, maximum added thickness delta 7 12 may be located on an arc that defines the uppermost (i.e., thickest) part of aperture widening zone 7010, The are may have any suitable shape, including, but not limited to, a spherical shape, an elliptical shape, or an ovoid shape. In some embodiments, the are ma be a spherical are having a radius in. the range of 0 rn.ro to 5.0 mro. In a some embodiments, the arc may be a spherical are having a radius of 2,0 mm.
  • Maximum added thickness delt 7012 may be located at any suitable location as discussed herein.
  • the maximum added thickness delta 7012 may be located in the range of 0,25 mm to 0,75 mm from peripheral, edge 7002.
  • the slope of an outer slope 7014 and/or the slope of an inner slope 7020 may be opiimisied based on the thickness and location of maximum added thickness delta 7012. for example, outer slope 7014 may be increased as the location of maximum, added thickness delta 7012 is moved closer to peripheral edge 7002.
  • designing outer slope 7014 using a spline curve function facilitate the optimization of outer slope 7014: without interfering with a manufacture's edge design.
  • the slope o (niter slope 7014 is within the range of 5 degrees to 45 degrees, of greater.
  • Any portion of prosthesis 7000 may be designed using one or more spline curve functions.
  • aperture widening zone 7010, or a portion thereof, may be designed using one or more spline curve functions as discu sed- below in reference to. FIGS, 7 and 75.
  • a prosthesis such as prostheses 7000
  • Th vertical dimension of the palpebral fissure of a wearer's eye may be measured using at least one of the following methods: taking a photograph of the individual's eye and measuring the ertical dimension of the individual's palpebral fissure in the photograph, physically measuring the vertical dimension of the individual's palpebral fissure, visually estimating the vertical dimension of the individual's palpebral fissure, fitting a trial prosthesis having markings that indicate one or more vertical dimensions on the individual's ey * and fitting a trail prosthesis
  • the optimal maximum added thickness delta 7012 for an individual may be determined by starting with a 300 micro maximum added thickness delta.
  • prostheses having different base curves may be fitted to determine which base curv provides optimal centering of the prosthesis in an individuals eye and appropriate movement upon blink hut maintains good, centering (e.g., re-centers) when an individual blinks (generally a A base curve is a good starting point).
  • the individual For each base curve tried, the individual (wearer) may be allowed to perience the prosthesis for 2 ⁇ ⁇ ⁇ 3 minutes before observing centering, movement, and/or the comfort level for the wearer,, if the initial base curve, or any subsequent base curve, does not provide optimum centering and appropriate movement on blink., the base curve may be altered until the optimum, base curve is determined, Once the appropriate base curve is provided for the individual, the individual may he asked about comfort.
  • the maximum added thickness delta may be reduced in 50 microns step until comfort is achieved and the appropriate palpebral fissure widening is maintained, if the patient does not complain of disconrii , die maximum added thickness delta may be increased in 50 micron steps until appropriate palpebral fissure widening is maintained and/or " until, the earer complains of discomfort
  • FIGS. 72A - B show a prosthesis 7200 having a convex surface 7208, a concave surface 7209,. and an aperture widening zone 7.210 having a surface feature located on convex surface 7208 and designed using a cri -curve methodology according to an embodiment.
  • Aperture widening zone 7210 includes a. surface feature having an outer slope 7214, an. inner slope 7220-, and a maximum added thickness, delta 721.2.
  • aperture widening zone 7210 may nclude a surface- feature in the shape of a continuous circumferential ring surrounding a geometric center 7204 (and optic stone 7206) of prosthesis 7200. But,, the surface feature(s ⁇ of aperture widening zone 7210 may have any size, shape, and/or eon figuration as described herein.
  • the uppermost (i.e., thickest) part of aperture widening mm 7.210 may be defined by an arc 721 1 having a height different from a normalized convex surface 723 of prosthesis 7200. While arc 721 1 is shown as a broken line in FIGS. 72 A. ⁇ 13, the broken line i for illustration purposes only and does not denote any structural and/or surface characteristics of arc 721 1.
  • Maximum added thickness delta 7212 ma be located at. the peak of arc 7.21 1 between an outside edge 7213 and an inside edge 7215 of arc 7211. Outside edge 7.213 may be located at a height between normalized convex surface 7230 and maximum added thickness delta 7.212, Inside edge 721.5- may be located at a height between normalized convex surface 7230 and maximum added thickness delta 721 .
  • outer slope 7214 extends from: outside edge 7213 towards a peripheral edge 7202 of prosthesis 7200, And inner slope 7220 extends from inside edge 7215 towards optic- zone 72.06.
  • outer slope 7214 ma meet convex surface 7208 at -an outer slope function point But, in some .-embodiments, as shown in FIGS. 72A. - B, outer slope 7014 may meet convex surface 7208 at peripheral edge 7202, In such embodiments, the shape of peripheral edge 7202 may be influenced by outer slope 7214, which, as discussed, above, may be undesirable in some eases.
  • Inner slope 7220 meets convex surface 7208 at inner slope junction point 7222, Inner slope junction point 7222 may be located at a distance in the range of 0 innt to 3.0 mm from Optic z ne 7206:, $544 ⁇
  • arc 72 ! I may have a constant radius.
  • the radius of are 721 1. may be in the range of 0 mm to 5.0 mm.
  • the radius of arc 7211 may be in the range of 0.5 ram to 3.0 ram.
  • the radius of are 7:2.1.1 may be in the rang of 1.0 mm to 2.0 rnm.
  • FIGS, 72A - B show a cross-sectional view of arc 7 1 L are 7211 is a three-dimensional shape, such as, but not limited to, a spherical, shape, an elliptical shape, a ovoid shape, a continuous cireum Schlierentiai ring shape with a spherical, elliptical, conical, or ovoid exterior surface, or a non-condnuoMS circumferential ring shape with spherical, elliptical, conical, or ovoid exterior surfaces.
  • Angle 7240 illustrates this discontinuity. Angle 7240 is the angle between a line 7242 tangent to normalized convex surface 7230 of prosthesis 7200 at inner slope junction point 7222 and a. line 7244 tangent to inner slope 7220 at inner slope junction point 7222,.
  • angle 7240 i dictated by the slope of inne slope 7220 at inner slope junction point 7222, In embodiments where inner slope is designed using a tri-enrve methodology, angle 7240 i greater than 0 degrees, thus creating a .discontinuity at inner sk pe juncti n point 7222, j0546
  • Angle 7250 is die angle between line 725 tangent to the normalized convex, surface 7.230 of prosthesis 7200 at peripheral edge 7202 and a line 7254 tangent to outer slope 7214 at peripheral edge 7202, In embodiments where outer slope 7214 is designed using a tr -curve methodology, angle 7250 is greater than 0 degrees. Accordingly, angle 7250 is dictated by ihe slope of outer slope 7 1 . In contrast, a manufacture's edge may not be influenced by such an outer slope because their edges have been designed in the absence of an aperture widening zone ' and/or surface feature: being located at or near the edge of the prosthesis,
  • Prosthesis 7200 may have any suitable overall diameters as discussed herein.
  • the overall diameter of prosthesis 7200 may be in the range of 15.5 mm to 1.4.5 mm. in a preferred embodiment, the overall, diameter of prosthesis 7200 may be 1.4.5 mm.
  • Maximum added thickness delta 7.212 may have any suitable thickness as described herein. In some embodiments, maximum added thickness delta 7212 may be in the range of 0.25 mm to 035 mm. in a preferred- em ' bodi.nient, maximum added thickness delta 7212 may foe 030 mm.
  • Hie slope of outer slope 7214 m3 ⁇ 4y have -any -suitable angl as discussed, herein, in some embodiments, the slope of ooter slope 7214 may be in the range of 5 degrees to IS degrees. In a preferred embodiment the slope of outer slop 725 may be .1.0 degrees..
  • the slop of inner slops 7220 may ve aiiy suH&hte angle as discussed herein, fa some embodiments, the slope of inner slope 7220 may be in the range of 3 to 7 degrees,. In a preferred embodiment ' , th slops of inner slope 7220 may h 5 degrees.
  • Aperture widening zone 721.0 may have any suitable aperture widenin zone diameter as discussed herein,, in some embodiments, aperture widening zone 7210 may have an aperture widening zone diameter m the range of 12,0 trim to 1 ,0 mm. In a- preferred embodiment aperture widening zone 72 0 may have an aperture widening 3 ⁇ 4cme diameter of 2.70 t.nm. In a preferred embodiment, the front ' optic diameter of prosthesis 7200 may be 8,5 mm.
  • FIG. 78 shows a contact lens 7800 having an aperture widening zone 7808 designed using a tri-eurve methodology according to an embodiment showing the dimensions of contact lens 7800.
  • Contact lens 7800 includes a peripheral edge 7802, geometric center 7804,. and an optic zone 7806.
  • Aperture widening zone 7808 has an aperture widening zone outer diameter 7810 measured from an outer edge of aperture widening zone 7808 ⁇ ie,, where an outer slope 7822 of aperture widening zone 7808 meets the convex surface of contact lens 7800 ⁇ across contact lens 7800 and through geometrical center 7804 to the opposing outer edge of aperture widening zone 7808.
  • aperture- widening zone outer diameter 7 10 may be equal to an overall otter diameter 7 12 of contact lens 7800, In some embodiments, aperture widening zone outer diameter 7810 may be less than overall ⁇ outer diameter 7812. In some embodiments, aperture widening zone outer diameter 7810 may be 0,02 mm or less than overall outer diameter 7812. In some embodiments, aperture widening zon outer diameter 7810 may b 0,02 nun to 2,0 mm less tha overall outer diameter 7812, in some embodiments, aperture widening zone outer diameter 7810 ma be 0.02 mm to 4,0 ram less than overall outer diameter 7832. Overall outer diameter 7812 m y have any overall outer diameter discussed herein, including, but not limited to, 14,0 mm, 1 .5 .mm, 1 , mm, and 1.5,0 mm.
  • aperture widening zone 7808 may include maximum added thickness delta 7816, an outer slope 7822, and an. inner slope 7820.
  • delta 7816 may be measured from normalised convex surface of contact lens 7800 to maximum added thickness delta 7816, Maximum added thickness delta 7816 amy have any suitable thickness discussed herein.
  • Contact Sens 7800 may also include an aperture widening; zone diameter 7814 measured from a first point of maximum, added thickness delta across contact leas 7800 and through geometrical center 7804 to a second (opposi ng) point of maximum added thi ckness del ta .
  • Aperture widening zone diameter 7814 may have an diameter discussed herein.
  • inner slope 7820 and outer slope 7822 may have any suitable angle discussed herein.
  • Inner slope 7820 extends from a location on the convex suriace of contact lens 7800 to an edge of an are of aperture widening zone 7808 (see e.g., inner slope 7220 in FIGS. 72A - B).
  • outer slope 7822 extends from a location on the convex surface of contact lens 7800 (which may at or interior to peripheral edge 7802 ⁇ to an edge of an are of aperture widening zone 7808 (see e.g., outer slope 7214 hi FIGS. 72A --B).
  • FIG. 78 also shows inner slope angle 7821 and outer slope angle 7823.
  • inner slope angle 7821 and. outer slope angle 78.23 may be constant:.
  • the slope of inner slope 7820 and the slope of outer slope 7822 may be constant across the width, of inner slope 7820 and outer slope 7822, respectively, in some tri-curve embodiments, inner slope angle 7821 and oute slope angle 7823 may be non-constant.
  • FIG, 78 also shows the distance 781.8 between peripheral edge 7802 and maximum added thickness delta 7816.
  • distance 7818 may be in the range of 0,25 mm to 3.0 mm, in some embodiments, distance 781.8 may Be in the range of 0.5 mm to 3.0 mm. In some embodiments, distance 7818 may be in the range of 0,25 ram to 0.75 mm. It should, be appreciated that if thickness 7817 of maximum added thickness delta 781.6 is held constant and distance 7818 is decreased, outer slope angle 7823 will increase.
  • inner slope angle 7821 may be the angle between a line tangential, to the convex surface of contact lens 7800 and. a line tangential to the surface of inner slope 7820 at the junction point of the convex surface of contact lens 7800 and inner slope 7820.
  • outer slope angle 7823 may be the angle between a line tangential to the normalized convex surface of contact lens 7800 at peripheral, edge 7802 and a line tangential to outer slope 7822 at peripheral edge 7802,
  • An aperture widening zone e.g., aperture widening zone 7808 designed using a iri-eurve methodology may fee designed by selecting a suitable arc 721 1 , a suitable base prosthesis profile (e.g., normalized convex surface), and selecting suitable values for th various dimensions of the prosthesis.
  • FIGS. 73 A - B show a prosthesis 7300 having a convex surface 7308, a concave surface 7309,. and an aperture widening zone 7310 having a surface feature located cm convex surface 7308 and designed using a spline curve methodology according to an embodiment.
  • Aperture widening zone 7310 includes a surface feature having an outer slope 7314, an. inne slope 7320, and a- maximum added thickness delta 731.2.
  • aperture widening zone 7310 may nclude a surface feature in the shape of a continuous circumferential ring surrounding a geometric center 7304 (and an optic zone 7306) of prosthesis 7300. But, the surface feature(s ⁇ of aperture widening zone 731.0 may have any size, shape, and/or configuration as described herein.
  • the uppermost (i.e., thickest) part of aperture widening zone 7310 may he defined by an arc 731 1 having a height different from a normalized -convex: surface 7330 of prosthesis 7300. While are 7 1 1. is shown as a broken line in FIGS,. 73 A. ⁇ B, the broken l ne is for illustration purposes only and does not denote any structural and/or surface characteristics of arc 73.1 1. Maximum added thickness delta 7312 ma be located at. the peak of arc 731 1 between an outside edge 7313 and an inside edge 73 15 or arc 731 1.
  • Outside edge 73.13 may be located at height between normalized convex suria.ee 7330 and maximum added thickness delta 7312
  • Inside edge 73 1.5 may be located at -a height between, normalized convex surface 7330 and .maximum added thickness delta 7.312.
  • jOSSSj As shown in FIGS. 73 A - B, outer slope 7 14 extends rom outside edg 7 13 towards a peripheral edge 7302 of prosthesis 7300. And inner slope 7320 extends from inside edge 7315 towards optic zone 7306. In.
  • outer slope 731 ma be designed using- a spline curve function, in such embodiments, outer slope 7314 ma have first order continuity, particularly at a junction point 7316 where it meets convex surface 7308 and/or wher it. meet outside edge 7313.
  • outer slope 731.4 may have first and second order continuity,, particularly at a junction point 7316 where it meets convex surface 7308 and/or where it meets outside edge 7 13.
  • Junction point 7316 may be located at a distance 73-18 ' from peripheral edge 7302:.
  • Distance 7318 may in the range of 0.01 mm to 2.0 ram. j$5S6J
  • inner slope 7320 may be designed using a splin curve function. In.
  • inner slope 7320 may have ' first order continuity, •pa ticularly at a junction, point 7322 where it meets con vex -surface 730S and/or where it meets inside edge 7315.
  • outer slop 731.4 may have first and second order continui * particularly at junction point 7322 where it meets convex, surface 7308 and/or where it meets inside edge 7315.
  • Junction point 7322 may be located, at a distance 7324 from optic zone 73-06.
  • the entire surface feature may be designed using a spline carve function.
  • the entire surface of the surface feature may have first order continuity, including outer slope 7314, inner slope 7320, are 7311 * . and at all intersection points between the slopes 7314/7320, arc 7 1 1, and convex surface 7308.
  • the entire surface of the surface feature may have first and second order continuity, including outer slope 7314, inner slope 7320, arc 731 1, and. at all intersection points between the slopes 7314/7320, arc 731 1, and convex surface 7308.
  • the entire convex surface 7308 may be designed using, spline curve functions, in some embodiments, the entire convex surface 7308 may have first order continuity, in some embodiments, the entire convex surface 7308 ma have first and second order continuity.
  • arc 73.1 1 may have a constant radius, in some embodiments, the radius of arc 731 1, may be in the range of 0 mm to- 5.0 mm. in some embodiments, the radius of arc 73 I t may be in the range of 0.5 mm. to 3.0 n l In some eiBbodimenis, the radius of are 731 1 may be in the range of 1.0 m to 2,0 mm, While
  • FIGS. 73 A B show a cross-sectional, view of arc 731 1 , are 731 i is a three-dimensional shape, such as, but. not limited, to, a. spherical, shape, an elliptical shape, an ovoid shape, a continuous circumferential ring shape with a spherical, elliptical, conical, or ovoid exterior surface, or a non-coHiinoous circumferential ring shape with spherical, elliptical, conical, or ovoid exterior surfaces.
  • Spline inner angle 7370 is the angl between a line 7372 tatigent to the n rmalize convex surface 7330 of prosthesis 7300 at maximum added thickness delta 731.2 and a line 7.374 tangent to inside edge 7315 of arc 731 1.
  • Spline inner angle 7370 may be in the range of 5 to 25 degrees. In some embodiments, spline inner angle 7370 is in the range between 10 to 20 degrees.
  • Spline inner angle 7370 ma b used to describe the slope of Inner slope 7320. Also, angle 7370 may be used to manipulate the spline function for inner slope 7320.
  • the angle 7350 at junction point 731 is zero or substantially equal to ze o.
  • the spline curve and the portion of convex surface 7308 adjacent to peripheral edge 73 2 are tangential, at junction point 731.6. Since angle 7350 is zero or substantially equal to zero, the surface feature, and specifically outer slope 731 , does not. aifeci the edge design for peripheral edge 7302, therefore allowing manufacture's own edge design to be -utilized.
  • outer slope 7314 may decrease as tt approaches convex surface 7308 to create a smooth junction point 7316 having at least first order continuity (and, in some embodiments, second order continuity)-
  • Outer slope 7314 joins to outside edge 7313 of arc 731 1 at a position that forms a predetermined spline outer angle 7360.
  • Spline outer angle 7360 is the angle between .a line 7362 tan en to the norraalked convex surface 72.30 of prosthesis at maxirtuirn added, thickness delta 7312 and a.
  • Spline outer angle 7360 may be n the range of 5 t 45 degrees, or greater, in some enibodinieuts, spline outer angle 7360 may be in the range of 1.0 to 20 degrees.
  • Spline outer angle 7360 -m y be used to describe the slope of outer slope 7 14,
  • angle 7360 may be used to manipulate the spline function for outer slope 7 14,
  • angles 7360 and 7370 may he the same, in some embodiments, angles 7360 and 7370 may be different
  • a spline curve allows for spline outer angle 7360 and the spline inner angle 7370 to be independent from other geometrical elements. For example, when utilizing a trt-cutve design including: an arc that is on axis to the optical axis of the lens (see e.g., FIGS. 72 - B and 78 ⁇ the corresponding angles at which an inner slope and outer slope -meet the convex surface .are dependent on the increase in thickness. This may not be true for an toner or outer slope designed using a spline curve function.
  • the spline curve also allows for a multitude of paths from the tangential/start point to- the tangential end point.
  • the spline curve can be manipulated by selecting various control points (e.g., control points 7440, 7442, 7444, 7446, 7448, 7450, 7452, and/or 7454), which allows fo a spline central angle ⁇ i.e*, the slope of a center portion of outer slope 7314 or toner slope 7320) to be altered.
  • This may be altered to accommodate different sized surface features on a convex or concave surface of a prosthesis.
  • the slope of center portion for any portion) of outer slope 731.4 may be increased in orde to fit a surface feature- on a smaller diameter prosthesis without having to change the size/shape of the arc and or the location of the maximum added thickness delta.
  • the slope of a center portion (or any portion) of Outer slope 73 ! 4 m y be increased in orde to locate a maximum added thickness delta, close (e.g., in the range between 0.75 mm to 0.25 mm) to the peripheral edge of a prosthesis without ' interfering with a manufacture's edge.
  • the spline curve may be replaced with other forms of curves that can be mathematicall defined such as series of sub-arcs- linked tarsgesitiaOy, curves defined using polynomial equations and other algorithms, and curves defined by a series of points.
  • Prosthesis 7300 may have any suitable overall, diameter as discussed herein.
  • the overall, diameter of prosthesis 7300 may be in the range o 15.5 mm to 14.5 mm. In a preferred embodiment, the overall diameter of prosthesis 7300 may ⁇ be .1 .5 mm.
  • Maximum, added thickness delta 7312 may have any suitable thickness as described herein, in some embodiments, maximum added thickness delta 7312 may be in the range of 0.20 mm to 0.40 ram. In. a preferred embodiment, maximum added thickness delta 731.2 may be 0,30 mm.
  • the slope of outer slope 7 14 may have any suitable angle: • as -discussed herein. In some embodiments, the slope of outer slope 7314 may be in.
  • the slope of outer slope 7314 may be in the range of 5 degrees to 25 degrees, for example, 1 degrees.
  • the slope of inner slope 7320 may have any suitable angle as discussed herein , in some embodiments, the slope of inner slope 7320 ma be in. the range of 5 to 25 degrees, for example, 10 degrees.
  • 0562J Aperture widening zone 7310 may have any suitable aperture widening zone diameter as discussed herein.
  • aperture widening zone 7310 may have an. aperture widening mm diameter in the range of 1 1 ,0 mm to 14.0 mm. in a preferred embodiment, aperture widening zone 7310 may have an aperture w denin zone diameter of 12.70 mm
  • the fron optic diameter of prosthesis 7300 may be 8.5 mm,
  • FIG, 7 shows a contact lens 7900 having an aperture widening zone 7908 des gned si g a id-curve, methodology according to an embodiment showioe the dimensions of prosthesis 7900, Prosthesis 7900 includes a peripheral edge 7902, a geometric center 7904, and an optic zone 7906.
  • Aperture widening zone 7908 has an aperture widening zone outer diameter 7910 measured from the outer edge of .aperture widening zone 7908 (i.e., where an outer slope 79.2.2 of aperture widening zone 7908 meets the convex surface of contact Jens 7900 ⁇ across contact iesis 7900 and throug geometrical center 7904 to the opposing outer edge of aperture widening zone 7908;.
  • Aperture widening zone outer diameter 7910 may he less than an overall outer diameter 7 1.2 of contact lens 7900.
  • aperture widening zone outer diameter 7910 may be 0.02 mm or less than overall outer diamete 7 12, In such embodiments, a manufacturer's peripheral edge may he maintained since the slope of outer slope 7922 will not affect the shape and curvature of the manufacturer's, edge.
  • aperture widening zone outer diameter 7910 may be 0.02 mm to 2,0 mm less than overall outer diameter 7912, in some embodtraeats-, aperture widening zone outer diameter 7910 may be 0.02 mm to 4,0 mm less than, overall, outer diameter 7912.
  • Overall outer diameter 7912 may have any overall outer diameter discussed herein, including, but not. limited to, 14.0 mm, 14.5 mm, 1 ,8 mm, and ! 5,0 mm,
  • aperture widening zone 7908 may include a maximum added thickness delta 7916, an outer slope 7922, and an inner slope 7920.
  • the thickness 7917 of maximum added thickness delta 7916 may be measured from normalized convex surface of contact lens 7900 to maximum added thickness delta 7 16, Maximum added thickness delta 7916 may have any suitable thickness discussed herein.
  • Contact lens 7900 may also include an aperture widenin zone diameter 791 measured from a first point of maximum added thickness delta across contact Sens 7900 and through geometrical center 7904 to a second (opposing) point of maximum added thickness delta.
  • Aperture widening zone diameter 7914 ma have any diameter discussed herein.
  • inner slope 7920 and outer slope 7922 may have any suitable angle- discussed herein, inner slope 7920 extends from a location on the convex surface of contact lens 7900 to an edge of a c of aperture widening zone 7908 (see e.g. , inner slope 7320 in FIGS. 73 A - ).
  • outer slope 7922 exten s from a location on die convex Surface of contact lens 7900 (which is i nterior to peripheral edge 7902 ⁇ to art edge of an arc of aperture widening z ne 7908 (see e.g., outer slope 7314 in FIGS. 73 A - B).
  • FIG, 79 shows inner slope angle 7921 and. outer slope angle 7923.
  • inner slope angle 7921 and outer slope angle 7923 are nan-constant due to the spline curve function used to design inner slope 7920 and/or outer slope 7922.
  • the slope of inner slope 7920 and/or the slope of outer slope 7922 may start at 0° (i.e., tangential to the convex surftee contact lens 7900), increase until reaching an inflection point, and then begin to decrease until intersecting with an inner or outer edge, respectively, of an are of aperture widening zone 7908 (seee.g.
  • inner slope angle 7921 may be the angle between line tangential to the normalized convex surface of contact lens 7900 at maximum added thickness delta 7916 and a line tangential to an inside edge of an arc of aperture widening n 7908.
  • outer slope angle 7923 may the angle between, a line tangential to the normalized convex surface of contact lens 7900 at maximum added thickness- delta 7 1,6 and a line tangent to art outside edge of an. arc of aperture widening 3 ⁇ 4one 7008.
  • FIG. 79 also shows the distance 7918 between peripheral edge 7902 and maximum added thickness delta 7916.
  • distance 7918 may be in the range of 0.25 mm to 3.. mm.
  • distance 7918 may be in me range of 0.5 mm to 3.0 mm.
  • distance 7918 may be in the range of 0.25 mm to 0.75 mm. It should be appreciated that if thickness 7 17 of max mum, added thickness delta 7916 is held constant and distance 7918 is decreased, outer slope angle 7923 may increase. Alternatively or additionally, die slope of a center portion of outer slope 7922 may increase.
  • a surface feature of an aperture widening zone may be designed using a spline curve function and one or more control points.
  • the control points may be used to control the location the surface feature, the characteristics of the inner slope of the surface feature, the characteristics of the outer slope of the surface features, -ete.
  • FIG. 74 shows an aperture widening mm 7410 located a convex surface 7408 of a prosthesis 74(30 according to an embodiment.
  • Aperture widening zone 7410 may be placed on a base prosthesis profile 7430 (i.e., normalized convex surface).
  • aperture idening z ne 741.0 includes a surface feature having an outer slope 7 14, an inner slope 7420, and a .maximum added thickness delta 741
  • FIG. 74 also illustrates the location of control points used in conjunction- with a sptme curve function to design the surface feature.
  • the uppermost .(i.e., thickest) part of aperture widening zone 7410 may be .defined by an arc 741 1.
  • Arc 7 1 1 may be the ame as or similar to are 731 1. While are 7411 is shown as a broken line in FIG. 74, the broken line is fo illustration purposes only and does not denote any structural and/or surface characteristics of arc 741 1,
  • a maximum- added thickness delta 7412 may be located at the peak: of arc 741 1 .
  • outer slope 7414 extends from arc 741 1 towards a peripheral edge 7402 of prosthesis 7400.
  • inner slope 7420 extends fern arc 741 1 towards an optic zone 7406 of prosthesis 7400.
  • FIG. 74 shows the location of eight control points, each of which may b used in conjunction wit one o more spline curve functions to design the surface feature of aperture widening zone 7410. I some embodiments, all eight control points may be used to design the surface feature. In some embodiments, a subset of the eight control points may be used to design the surlkee feature. As shown in FIG. 74, each of the control points may be located on a. single eross-seetional plane of base prosthesis profile 7430. lie: single plane illustrated in FIG.. 74 ma intersect a . geometrical cente of the base prosthesis profile 7430 and peripheral edge 74-02.
  • a first control point 7440 is located on. convex surface 7408 of base prosthesi profile 7430 at a distance 7441 from peripheral edge 7402 of base prosthesis profile 7430.
  • First control point 7440 may be located at the junction point between outer slope 7414 and convex surface 7408.
  • first control point 7440 i.e., distance 744!
  • the location of first control point 7440 may be selected based on number of parameters, including, hut not limited to, the: desired location f r the starting point of outer slope 7414 of aperture widening mm 7410, the desired shape/slope (e.g., steepness) of outer slope 7 1 , Hie overall diameter of base prosthesis profile 7430, and .m ximum added thickness delta 7412 of aperture widening zone 7410,
  • Distance 7441 may be in the range of 0.01 ram to 2.0 aim. In some embodiments, distance 7441 may be 0,25 mm or greater,
  • a second control point 7442 is located ' on the outside edge of the arc 7411 , Since second control point 7442 is located cm the outside edge of arc, its location is dictated by the location of arc 7 11 relative to base prosthesis profile 7430 and peripheral edge 7402, A third control point 7444 is located on the inside edge of are 741 1. Si milar to second control point 7442, the location of third control point 7444 is dictated b the location of arc 7411 relative to base prosthesis profile 7430 and peripheral edge 7402.
  • a fourth control point 7446 is located on convex surface 7408 of base prosthesis, profile 7430 a a distance 7447 front an edg of an optic zone 7406 of me base prosthesis profile 7430.
  • Fourth control, point 7446 may be located at the junction point between inner sl pe 7420 and convex surface 7408,
  • the location, of fourth control point 7446 i.e., distance 7447
  • the location, of fourth control point 7446 i.e., distance 7447
  • Distance 7447 may be in ire range of 0 mm to 3,0 mm.
  • a fifth control point 7448 is located tangential to convex surface 7408 of base prosthesis profile 7430 at first control point. 7440 and at a distance 7449 front first control poi nt 7448 towards .maxipnitn added thickness del la 7412 (fe., th e peak) o f the arc 741 1 ,
  • the location of fifth control point 7448 (fe,, distance 7449 ⁇ may be selected based on a number of parameters, including, but not limited to, the desired location ibr the starting point of outer slope 7414 of aperture widening zone 7410, the desired slope/shape (e.g., steepness) of outer slope 7434, the overall diameter of base prosthesis profile 7430, and maximum, added thickness delt 7412 of aperture widening zone 7410, Distance 7449 may he in the range of 0 mm to 2,0 mm.
  • a sixth control point 7450 is located tangential to the outside edge of arc 741 1 at second control poin 7442 and at a distance 7451 from second control point 7442 towards eripheral edge 7402 of base prosthesis profile 7430.
  • the location of sixth control point 745 i.e., distance 7451 ⁇ .may be selected based on a number of parameters, including, but not limited to, the desired location for the starting point Of outer slope 7414 of •aperture widening zone 7410, the desired slope/shape (e.g., steepness) of otuer slope 7414, the overall diameter of base prosthesis profile 7430, aid maximum added thickness delt 7412 of aperture widening zone 7410.
  • Distance 7451 may be in the range of 0 rani to 2.0 mm.
  • a seventh control point 7452 is located tangential to the inside edge of are 741 1 at third control point 7444 and at a distance 7453 from third control- point 7444 towards optic zone 7406 of base prosthesis profile 7430.
  • the location of seventh control point 7452 tie,, distance 7453) may be selected based oil a number of parameters, including, but not limited to, the desired location for the starting point of inner slope 7420 of aperture widening zo e 7410, die desired slope/shape ⁇ .-g., steepness) of inner slope 7420 s the overall diameter of base prosthesis profile 7430, arid maximum added thickness delta 7412 of aperture widening zone 7410.
  • Distance 7453 may fee in the range of 6 mm to 2.0 mm
  • An eighth control point 7454 is located tangential to convex surface 7408 of base prosthesis profile 7430 at fourth control point 7446 and at a distance 7455 from fourth control point 7446 towards maximum added thickness delta 7412 (i.e., the peak) of arc 741 L
  • the location of eig th, control point 7454 may be selected based on number of parameters, including, but not limited to, the desired location for the starting point of inner slope 7420 of aperture widening 3 ⁇ 4one 7410:.
  • Distance 7455 may be in the range of 0 mm to 2.0 mm.
  • the resulting prosthesis 7400 may have first and/or second order continuity at one or more of first control point 7440, second control point 7442,. third control point 7444, and fourth control point 7446.
  • the resulting prosthesis ' 7499 may have first - 12 ! - order and second order continuity at one- or more of first control point 7440.
  • FIG. 74 shows aperture widening zone 7410 located OH convex surface
  • aperture widening zone 7410 may be located cm- the concave surface 7409 of prosthesis 7400, In such embodiment's, the- location of control points will be determined in the same way discussed above, but the locations will be relative t concave surface 7409 rather than convex surface 7408.
  • FKX 75 shows a flowchart Illustrating a method for designing a p osthesis: according to an embodiment.
  • a base prosthesis profile 7430 having convex surface 7408 and co cave surface 7409 is selected.
  • Base prosthesis profile 7430 may be, but is not limited to, a standard contact lens profile for a commercially available contact tens. For example, an Acuvuei ) contact lens manufactured by Vistakon®, a division of Johnson & Johnson Vision Care, in Jacksonville, Florida.
  • Base prosthesis profile 7430 may be for a daily or extended wear contact iens, may have any optical power (including piano), and may be a tone contact lens.
  • Base prosthesis profile 7340 may be selected from a database containing one or more base prosthesis profiles.
  • the base prosthesis profiles may be generated by a user designing a prosthesis, for example by inputting certain aspects of the profile, such as the base curve, the edge design, the overall diameter, the front optic diameter, and the hack (concave .surface) vertex power, in some embodiments, the base prosthesis profile may be received from a contact lens manufacturer (e.g., Vistakon €5),
  • an are 7411 may be selected in 7504, And, in 7506, the location of arc 741 1 relative to base prosthesis profile 7430 may be selected.
  • the location of are 741 1 the location of maximum added thickness delta 7412 (i.e., the peak) of are 741. 1, is also selected.
  • the sfee and shape, as well as the location, of arc 741 1 may dictate, in part, the overall aperture widening !eeis for aperture widening zone 7411) since it defines the thickes portion of aperture widening zone 7 10.
  • Arc 7411 may have any size and shape as discussed herein.
  • FIG, 74 shows a cross-sectional view of are 74 I f it will be appreciated that three-dimensional arcs 7411 may he selected.
  • a two- dimensional arc may be- selected (i.e., a cross-section- of an are), a d software ma be used to -extrapolate the two-dimensional arc into a tkree-diniensional one (e g.,. the cross- sectional view of arc 74 ⁇ m FIG. 74 may foe extrapolated into a continuous ring are surrounding optic zone 74-06),
  • the location f first control point 7440 may be selected, in 7510, the location of second- control point 7442 may be selected, winch may have already been determined by the location, size, and shape of arc 741 L I 7512, the location of third control point 7444 may be selected, which may have already been determined by the location, size, and shape of arc 7 11 ,
  • the location- of fourth control point 7446 may he selected, io 7 16, the location of fifth control point 7448 may be selected.
  • the location of sixth control point 7450 may be selected In 7520, the location of seventh control point 7452 may be selected, in 7522, the location of eighth control point 745 may be selected.
  • second control point 7442 and third control point 7444 may, in actuality, he selected when the location, size, and shape of are 741 1 are selected.
  • spline curve function may be applied, using the control points as -reference points, to design the surface feature of aperture widening zone 7410.
  • a two-dimensional surface tea tore rpay designed i.e., a cross-section of a surface- feature
  • software may be used to extrapolate the two-dimensional surface feature into a three-dimensional one (e.g., the cross-sectional view of the surface feature- of aperture wi ening. stone- 7410 in FIG, 74 may be extrapolated into a continuous ring surrounding optic zone 7406),
  • a spline curve lor outer slope 7414 may be designed using only control points 7440 and. 7442, And a spline curve- for inner slope 7420 may be designed using only control points 7444 and 7446, As another example, for a surface feature having only an outer slope 741.4 designed using a spline curve function, only control points 7440, 7442, 7448, a 7450 may be used.
  • Software may be used to desig the spline curvets) of aperture widening zone 7410 based on the selected location of the control points.
  • the soft ware may be, but is not limited to, Uftravision Lens Design Application developed b intravision CLP.L
  • the design may be used to mamdaeiure a prosthesis.
  • the maniri3 ⁇ 4Cturing may include lathe- cutting.
  • the design created in 7524 may be used by a lathe cutting machine, including the appropriate software, to lathe cat prosthesis.
  • the manufacturing may include molding.
  • the design created in 7524 may be used to create a moid for molding a prosthesis with the design,
  • mold for molding a prosthesis may be designed using on or more control points and a spline carve function.
  • FIGS. 76A ⁇ B show a mold 7600 used to make a prosthesis including an aperture widening zone according to an embodiment.
  • Mold 7600 ma include an up e mold 7 10 and a: lower mold 7630.
  • npper moid 7610 includes a concave surface 7612, a convex surface 7614, and a convex surface edge 716
  • Convex surface 7614 may include the curvatufe(s)/design necessary to mold the concave surface of a prosthesis -(e.g., concave surface 7409 of prosthesis 7400).
  • Convex surface edge 7 16 may include the curva:t «re(s)/des!gn necessary to mold the peripheral edge of a prosthesis (e,g Stephen, peripheral edge 7402). which may include a niani 3 ⁇ 4efnre3 ⁇ 4 edge design.
  • lower mold 7620 includes a convex surface 7622, concave surface 7624, and a concave surface edge 7626
  • Concave surface 7624 surface may include the eun?ature(s)/de$ign necessary to mold the convex surface of a prosthesis (e.g., convex surface 7408 of prosthesis 7400 ⁇ having: an aperture widening zone (e,g,, aperture widening zone 7 10): located thereon.
  • Concave surface edge 7626 may include the cttrvature(s)/design necessary to mold the peripheral edge of a prosthesis (e,g. 5 peripheral edge 7402), which may include a. manufacture's edge design. In.
  • concave surface 7624 includes a cavity 7640 (or a pluralit of cavities 7640 dependin on the configuration of aperture widening zone 741 ⁇ corresponding to the desired shape, size, and configuration for aperture widening 3 ⁇ 4one 7410.
  • Cavity 7640 includes a surface fe ture having an outer slope 7644, a inner slope
  • outer slope 7644 extends from o side edge 7643 towards concave surface edge 7626.
  • timer slope 7646 extends- from inside edge 7645 towards the center of lower mold 7620.
  • Outer slope 7644 may he designed using a spline curve function.
  • outer slope 7644 may have at least first order continuity (and, in some embodiments, second order continuity ⁇ , particularly at a junction poin where it meets concave surface 7624 of lower mold 7620 and/or where it meets outside edge 7643. The location of the junction .
  • tuner slope 7646 may he designed using a. spline curve function.
  • inner slope 7646 may have at least first order continuity (arid, in some -embodiments, second order continuity), particularly at a junction point where it meets concave surface 7624 of lower mold 76.20 and/Or where it meets inside edge 7645.
  • the location of the j unction point may he the same as or similar to the location of junct ion point.
  • the entire cavity 7640 may be designed using a spline curve function, in some embodiments, the entire surface of cavity 7640 may have at least first order continuity (and, in some embodiments, second order continuity), including outer slope 7644. inner slope 7646, are 764 ! , and at all intersection points between the slopes 7644/7646,. are 7641 , and concave surface 7624. In some embodiments, the entire concave surface 7624 may he designed using spline curve functions..
  • FIG. 76B shows the location of eight mold control point (7650, 7652, 7654,
  • 7656, 7658, 7660, 7662, and 7664 each of which ma be used in conjunction with one or more spline curve functions to design cavity 7640.
  • all eight mold control points may be used t design, cavity 7640.
  • a subset of the eight, mold control points may be used t design cavity 7640.
  • the location the eight mold control points, relative to a base mold profile 7630 may be selected in the same fashion as discussed above id regard to the: eight control points (7440, 7443, 7444, 7446, 7448, 7450, 7452, and 7454) for prosthesis 7400... Also, the .location, of arc 7641 relative to base mold profile 7630 may selected in the same .fashion, discussed above In regards to are 741 1.
  • FIG. 77 shows a flowchart illustrating a method tor designing a lower mold 7S20 according to an embodiment
  • a base mold profile 7630 havin convex Surface 7608 and concave surface 7409 is selected.
  • Base mold profile 7630 may be, but is not limited to, a standard, contact lens mold profile tor a commercially available contact tens. For example, an Acuvue® contact Sens manufactured by Vistakon®, a division of Johnson & Johnson Vision Care, in Jacksonville, Florida.
  • Base mold profile 7630 may be for molding a dail or extended wear contact ism,, may be for molding a contact lens having an optical power (including piano), and ma be for molding a tone contact lens.
  • Base mold profile 7340 may be selected from a database containing one or more base moid, profiles, In some embodiments * a base mold profile may be generated by a user designing a lower mold, for example by inputting certain aspects of the profile, such as the base curve, the edge design, the overall diameter, and the front optic diameter for a desired prosthesis. In some embodiments, the base mold profile may be received from a contact lens manufacturer (e.g., Vistakon®),
  • a arc 7641 may be selected, in 7704.
  • the location of are 7641 relative to base mold profile 7630 may be selected.
  • the location of maximum change In thickness 7642 (i.e., the peak) of arc 7641 is also selected.
  • the size and shape, as well a the location, of arc 7641 may dictate, in. part, the overall aperture widening afreets, for an aperture widening zone ⁇ e.g., aperture widening zone 7410) since it will mold the thickest part of the aperture widening zone.
  • Arc 7641 may have any size and shape as discussed above in regards to arc 741 1.
  • FIG. 76B shows a eross-seetional view of are 7641, it will be appreciated that a three-dimensional arc may be seiecied, as discussed above in regards; to are 741 1.
  • first mold control point 7650 may be selected, in 771 , the location of second mold control point 7652 may be selected, which may have alread been determined by the location, size, and shape of arc 76 1.
  • the location: of third mold control point 7654 may be selected, winc may have already been determined b the location, size, and shape of arc 7641.
  • the location of fourth mold control point 7656 may be selected In 7716, the location of fifth moid control point 7658 may be selected.
  • tire location of sixth mold control point 7660 may be selected, in 7720» the location of seventh, mold control point 7662 may be selected.
  • the location of eighth mold control point 7664 may be selected, it should e appreciated that the order of selecting the mold control points does not necessarily have to be perforated in the order shown in FIG. 77. indeed, the location of second mold control point 7652 and third mold control point 7654 may, m actuality, be selected when the location, size, and shape of arc 7641 are selected.
  • a spline curve function may be applied, using the mold control points as reference points, to design the cavity 7640. Similar to the surface feature in FIG. 74, FIGS- 76A - B show a cross-sectional view of cavity 7640.
  • a twp-dimenskmal cavity may designed (i.e.., a cross-section of a . cavit ) discipline and software may be used, to extrapolate tire two-dimensional cavity into a three-dimensional one (e.g., the cross-sectional view of cavity 7604 in FIGS. 76 A - B may be extrapolated into a continuous cavity in the shape of a ring).
  • a spline carve for outer slope 764 may be designed using only mold control points 7650 and 7652, And a spline curve for inner slope 7646 may be designed using only mold control points 7654 and 7656.
  • a spline curve for inner slope 7646 may be designed using only mold control points 7654 and 7656.
  • only mold control points 7650, 7652, 7658, a. 7660 may be used.
  • Software may be used to design the spline curvets) of cavity 7640 based, on the selected location of the mold control points,.
  • the software way be, but. is not limited to, Ultravision Lens Design Application, developed by Ultravision CLFL.
  • Upper mold 7610 may be a. standard mold used to mold the concave surface of a prosthesis (e.g., concave surface 7409). Upper mold 7610 may be based on a standard mold profile for a commercially available contact lens. For exam le.: an Acuvue® contact lens manufactured by Visiakon®, a. division of Johnson & Johnson Vision.
  • the design of upper mold 7630 may be generated by a user designing an upper moid, for example by inputting certain aspects of the mold, such as the base curve, the edge design, and the overall diameter for a desired prosthesis, it should be appreciated that a mold for a prosthesi having an surface feature located on its concave surface may e designed in the same way as mold 7600. I such an embodiment, the cavity(ies ⁇ may be designed on convex surface 7614 of upper mold 7610 rather than on concave surface 7624 of lower mold 7620.
  • the designs may be .aed to manufacture a mold 7600,
  • the manufacturing may include lathe cutting.
  • the design created in 7724 and the design of upper mold 7610 may be used by a lathe cutting machine, including the appropriate software, to lathe cut upper mold 7610 and lower mold 7620.
  • the mamdaeturirig may include moldin e.g., injection molding).
  • th design created in 7724 and the design of upper mold 7610 may be used to create a mold for molding a prosthesis.
  • mold 7600 may be a mater template mold (e.g., a metal mold) Used to make disposable molds (e.g., one time use plastic molds ⁇ ., in some embodiments-, mold 7600 may be a disposable mold.
  • a mater template mold e.g., a metal mold
  • disposable molds e.g., one time use plastic molds ⁇ .
  • mold 7600 may be a disposable mold.
  • Table 3 shows a comparison of the widenin effects of various contact lenses: having different apertur widening zones.
  • Table- 3 shows the overall diameter and the aperture widening zone (AWZ) outer diameter for various contact lenses.
  • the AWZ oute diameter is the diameter measured from die outer edge of the AWZ across the contact lens through the geometrical center to the opposing A WZ outer edge, in one or more rotational positions, the AWZ outer diameter may be the minimum vertical dimensi n- of the AWZ,
  • Each contact lens in Table 3 includes an AWZ having an outer slope, and inne slope, and a maximum added, thickness delta, located between- the outer .slope- -and the inner slope.
  • Table .3 shows the maximum added delta thickness ("Max, Delta T' , the slope of die outer slope and the slope of the inner slope for each contact lens.
  • Table 3 als shows the aperture widening 3 ⁇ 4>ne diameter ("Delta T Diarrv" for each contact lens,, in Table 3, contact lens versions starting with a (e.g., BE VI .1 and BE VI, 2 ⁇ have an AWZ designed using a iri-eurve methodology.
  • contact lens versions starting with a "2" have an AWZ designed using a spline curve .methodology.
  • Table 3 The dimensions in Table 3 for tri-curve lens designs and spline curve lens designs are illustrated and described in reference to FIOS-, 78 and 79, respectively.
  • each patient's palpebral fissure without contact lens in his/her eye and after fitting each contact, lens having: a A WZ were measured using the following method. Patients were positioned chin, op with their forehead against a forehead rest of a Momieroscope. A camera was positioned 12 inches from the patients and video of eac patient's, palpebral fissure was recorded. Still images from the video were captured and analyzed to determine the vertical dimensions of each patient's palpebral fissure. The vertical dim nsi n of each patient's palpebral sure was measured using Inkscape 0..4H ⁇ m open source vector graphics drawing program that can draw dimensioned lines on an image). The measurements made using Infcscape 0.48 were calibrated by incorporating a ruler into the image by placing the ⁇ .ruler on the iorebead rest of the head restraint, on which each patient placed their head.
  • Table 3 shows that aperture widening can be achieved using each of the contact lens designs, with th exception of BE V 2.3, BE V 2.3 would not center on the eye and was so uncomfortable that it was onl tested on patient SP0.2. Analysis of the results In Table show thai lenses having: an AWZ designed using a spline curve methodology are more effective at widening the palpebral fissure of a patient's e e.
  • Table 4 shows the average percentage increase in VPA for each contact fens version fitted on each patient. It should be noted that some of the values are not actually "averages" because there is only a single data point for the percentage increase in VPA f r some lenses hi Table 3, While each lens version was capable of widening the palpebral fissure of a patient's eye, when comparing similar Sense it: can be seen that a contact lens having an AWZ. designed using a. spline curve methodology is more effective than a lens designed using a tri-carve methodology.
  • BE 1.3 and BE 2,1 have essentially the same AWZ design, but BE VI .3 includes tri-eurve design and BE 2.1 includes a spline carve design. While BE VI .3 has a smaller inner and outer slope than BE V2.1, this difference results from, the different design methodologie for the lens, Practically, the AWZ of BE VI .3 is the same as the AWZ of BE V2..1, except for the differences in the topography of the inner and outer slopes due to the differences between a tri-cnrve desig and a spline curve design. 06(I9
  • V2.1 produced an average percent increase i VPA that was 2.7% greater than thai for BE VI..3. While tins percentage is not a large number, it is significant because the maximum average percentage increase achieved using the lenses tested was 10,6%, and 2.7 is 25.5% of 10.6. Accordingly, iii the cont t of th se tests, BE V2,I perfor ed approximately 25% better than. BE VI, 3.
  • Table 4 also shows the average comfort for each contact lens tested.
  • the average comfort level deviated between the different versions of contact lenses, with BE. V I J. being the most comfortable and BE V2.4 being the least eomfbrtable.
  • the comfort level for BE V2.1. was slightly higher than the comfort level for BE V 3 ,3..
  • Table 5 shows the average percent increase in VPA for each lens design fitted on each patient
  • the designation of "N/A” means mat a. specific lens design was not fitted on a particular patient.
  • BE V2.3 has all "N/A" designations because, as discussed above, it was highly uncomfortable and. incapable of centeri g on a patient's eye.
  • Table 5 illustrates that without changing th : characteristics of an AWE (e.g., location and amount of max mum, delta thickness) the widening capabilities of an A.WZ can fee improved fey designing the AWZ using a spline curve methodology rather than a tri-curve methodology; This does not mean thai AWZs designed using a. tri-curve methodology are never preferable. Indeed, for example, manufacturing, considerations (e.g., equipment and. techniques available) may result in a iri-enrve design being more preferable, regardless of whether or not it shows a lesser capability of widening a wearer's palpebral fissure,
  • Table 6 shows the aperture widening effects of various other lenses designed using a spline curve methodology for various patients.
  • the vertical dimensions of each patient's palpebral fissure without a contact lens in his/her eye and after fitting each lens having an AWZ were measured using the following procedure. Patients were positioned chin up with their forehead against a forehead rest of a biomieroscope. A camer was positioned 1.2 inches from the patie ts and video of each patient's palpebral fissure was recorded. Still images torn the video were captured and analyzed to determine the vertical dimensions of each patient's palpebral: fissure.
  • PiselStiek is a software tool for measuring distances and angles on an. image displayed on a computer screen, A. circular sticker measuring 19 mm m diameter was placed between each patient's eyes k serve as a reference measurement for the PixelStick. software.
  • BE V2.1 The dimensions of BE V2.1 are shown in Table 3 above.
  • BE Y .8 has an. overall outer diameter of 14.5 m , an aperture widening zone outer diameter of 14,4 mm, an •aperture widening zone diameter of 1.2.7 mm, a maximum added thickness delta of 350 microns, an outer slope of 14 degrees, and an inner slope of 9 degrees.
  • BE ⁇ 2.9 has a overall outer diameter of 14.5 lira, an aperture widening one outer diameter of 14.4 mm. an aperture widening zone diameter of 13.0 mm, a maximum added thickness delta of 300 microns, an turter slope of 14 degrees, and an inner slope of 9 degrees.
  • BE V2J0 has •an overall outer diameter of 14,5 mm, an aperture widening nc outer diameter of 14.4 mm, an aperture widening zone diameter of 13.5 mm, a maximum added thickness delta of 300 microns, art outer slope of 14 degrees, and an inner slope of degrees.
  • Table 6 shows the effectiveness of aperture widening zones designed using a spline corve function, For a maj it of the patients, ie vertical dimension of their palpebral fissure increased significantl (i.e., more than 10%) when wearing one or more of lens designs.
  • Patient 7CJ has a congenital lid abnormality that affected the ability of the contacts lenses to widen the palpebral fissure of his eye.
  • Pat tents 2 .B and 6VP are affected by ptosis, hut the various lens designs showed an ability to increase the width of their palpebral, fissures.
  • tort BE V2.1Q was optimal for the patients having youth fill eyes unaffected by a lid abnormality or ptosis. This indicates that, for at least some individuals or groups of individuals, a larger aperture widening zone (e.g., an aperture widening zone having a large aperture widening zone diameter, such as 1.3.5 mm or bigger) may be more effective at widening the palpebral fissure.
  • a larger aperture widening zone e.g., an aperture widening zone having a large aperture widening zone diameter, such as 1.3.5 mm or bigger
  • BE V2J0 was just as comfortable, if not more comfortable, when compared to BE V2.1, BE V2.8, and BE V2,9. This is unexpected because usually when an object having larger sur fhce ' features i placed on a patien 's eye, he/she will generally complain about discomfort,
  • aperture widening zone 8010 having a surfac feature located on concave:: - 1.34 - surface 8009 according to an embo iment
  • Aperture widening zone 8010 ma be designed using a tti-eurve methodology or a spline curve methodology. Similar to. •aperture widening zones 7210 and 731 , aperture widening m SO S O includes a surface feature having an outer slope 8 1 , an inner slope 8020, and a maximum added thickness delta SO 1.2.
  • aperture widening zone 8010 may include surface feature in the shape of a continuous eireumterentia!
  • the surface featnrefs ⁇ of aperture widening zone 8010 may have any size, shape, and/or configuration as described herein.
  • the size, shape, location, etc. of the surface feature of aperture widening zone 8010 may be designed using the sizes, shapes, and dimensions discussed herein with regards to suriace features located on a convex surface of a prosthesis/contact lens, it should be appreciated that in embodiments where prosthesis 8000 is a scleral ring, optic zone 8 06 would be replaced with an open central aperture.
  • Figure 81 illustrates an exemplary computer system 8100 in which embodiments, or portions thereof; may be implemented as computer-readable code.
  • the design, of a prosthesis and/or a mold may he implemented in computer-system 8000 using hardware, software, firmware, tangible computer readable media having instructions stored thereon, or a combination thereof and ma be implemented in one or more ⁇ computer systems or other processing systems.
  • If programmable logic is used, such logic may execute on a commerciall available processing platform or a special purpose device.
  • at least one processor device and a m mory may be used to implement the above described embodiments.
  • a processor device may b a single processor, a plurality of processors, .or combinations thereof.
  • Processor devices may have one r more processor "cores.”
  • Processor device 8104 may be a special purpose or a general purpose processor device. As will be appreciated by persons skilled, in the relevant art, processor device 8104 may also he a single processor in a muki-cofe/muitiprocessor system, such system operating alone, of in a cluster of com uting devices operating in a cluster or server farm. Processor device 81 4 is connected to a communication infrastructure 8106, for example, a bus, message queue, network, or multi-core message-passing scheme.
  • a communication infrastructure 8106 for example, a bus, message queue, network, or multi-core message-passing scheme.
  • Computer system 8100 also includes a. main memory 81 OS, for example, random access, memory (RAM), and may also include a secondary memory 81 10, Secondar memory 81 10 may include, for example, a hard disk drive 8112:, or removable storage drive 81 14, Removable storage drive 81 14 may include floppy disk, drive, a magnetic tape dri ve, an optical disk dri ve, a flash memory, or the like. The removable storage drive. 81. 14 reads from and/or writes to a removable storage unit 8118 in a well-known mapner.. Removable storage unit 81 18 may include a floppy disk, magnetic tape, optical disk, etc. which is read by and written to by removable storage drive S I 14. As will be appreciated by persons skilled in the relevant art, removable stora.ge unit 81 18 includes a computer usable storage medium having stored therein computer software and/or data.
  • Computer stem: 8100 (optionally) includes a display interface 8102 (which can include Input and output devices such as keyboards, mice, etc,) that forwards graphics. text, and other data from communication infrastructure 8106 (or from a frame buffer not shown) for display on display unit 81.30.
  • display interface 8102 which can include Input and output devices such as keyboards, mice, etc,
  • secondary memory ⁇ 1 10 ma include other similar me ns for allowing com uter program or other nstructi ns to be loaded into compu er system S lOiK
  • Such, means may include, for example, a removable storage unit 8 22 and an interface 8120, Examples of such means may include a program cartridge and cartridge interlace (such as that found in video game devices), a removable memory chi (such as an EPRQM, or PROM) and associated socket, and other removable storage units 8122 and interlaces 812 which allow software and data to be transferred from the .removable storage unit 8122 to computer system 8100.
  • Computer system 8100 may also include a communication interface 8124,
  • Communication interface 81.24 allows software and data to be transferred between computer system 8100 and external devices.
  • Communication interface 8124 may .include a modem,, a network interface ⁇ such as an Ethernet card), a communication port, a PCMCIA slot and card, or the like.
  • Software and data transferred vi communication interface 8124 may be in the form of signals, which may be electronic, electromagnetic, optical, or other signals capable of being received by communication interlace 8124, These signals may be provided to communication interface 8124 via a communication path 8126.
  • Communication pat 1.26 carries signals and may be implemented using wire or ca le:, fiber optics, a phone line, a cellular phone link, an E.P link or other common i cation channels .
  • Computer program medium and computer usable medium'* are used to generally refer to media such as removable storage unit 81 18, removable storage unit 8122, and a hard disk installed in hard disk drive 81 12.
  • Computer program medium and computer usable medium may also refer to .memories, such as main memory 8108 and secondary memory 81 10, which may be memory semiconductors (e.g.. ORAM ' S, etc, ⁇ .
  • Computer programs (also called computer control logic) are stored, in main memor 81 8 and/or secondary memory 8.1 10, Computer ro rams may also be received via communication interface 8124, Such computer programs, when executed, enable computer system 8100 to implement the embodiments as discussed herein, in particular, the computer programs, when executed, enable processor device: 81.04 to implement the: processes of the embodiments discussed here. Accordingly, such computer program •represent controllers of the computer system 8100. Where the embodiments are implemented using software, the software may be stored in a computer program product and loaded into computer system 8.100 using removable storage drive 8. Li 4, Interface S320, and hard disk drive 81.1.2, or communication interface 8124.
  • Embodiments of the invention(s) also may be directed to computer program products comprising software stored on any computer useable medium. Such software, when executed in one or more data processing device, causes a data processing deviec(s) to operate as described herein.
  • Embodiments of the inve tion's) ma employ any computer useable or readable medium.
  • Examples of computer useable mediums include, but ate not limited to, primary storage devices (e.g., any type of random access memory), secondary storage devices (e.g, hard drives. Soppy disks, CD iOMS, ZIP disks, tapes, .magnetic- -storage devices, and optical storage devices, MEMS, nanoteehnologieal storage device, etc.).
  • references herein to "one embodiment ' ' an embodiment,” “an example embodiment,” or similar phrases, indicate that the embodiment described may incl de a . particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessaril referring to the same embodiment Further, when a particular feature, structure, or characteristic is described m connection with an embodiment, ii would be within the knowledge of persons skilled in the relevant art(s): to incorporate such feature, structure, or characteristic into other embodiments whether or not explicitly mentioned -or described herein,

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Abstract

A prosthesis capable of being worn on the eye of a wearer having a convex surface and a concave surface. The prosthesis has an aperture widening zone for widening the natural palpebral fissure of the wearer's eye. The aperture widening zone may include a surface feature having an outer slope, an inner slope, and a maximum added thickness delta located between the outer slope and the inner slope. At least a portion of the surface feature may be designed in using one or more spline curve functions. Methods for designing and manufacturing prostheses having a surface feature at least partially designed using one or more spline curve functions are also provided.

Description

APERTURE WIDENING PROSTHESIS INCLUDING SPLINE SURFACE TOPOGRAPHY AND METHODS OF MAKING THE SAME
Field of the invention
[βίΚί! I The present application relates to prostheses for use in the eye, and specifically, to the field of prostheses that enhance or alter the appearance of a wearer's eye.
Background
10002 Today's eomeo-selerai coniact lenses (soft contact lenses or hybrid contact leases) that fit on the cornea of one's eye (do not vault the cornea) and extend over the h bus and bulbar conjunctiva thus coveting part of the sclera are not being used for correcting ptosis and/or the widening of the wearer's palpebral fissure. This, is due to their geometrical design. Also cornea! contact lense (rigid r soft) that fit only the cornea and do not extend past the limbos are not. used for correcting ptosis and or the widening of the wearer's palpebral fissure due to geometrical design and overall diameter. Scleral coniact lenses are hard rigid and have been, designed in the past to fi snugly against the sclera of the wearer' eye, "vault the cornea" and. have a very thick edge design such to Sift the upper lid of the wearer's eye having ptosis. While scleral contact lenses have existed in the past that will lift the upper lid of the wearer's eye these hard/rigid sclera contact lenses are highly uncomfortable, cause very red eyes and irritate the eye lid margin thus presenting severe limitations for the wearer. For these reasons: the commercial success of scleral coniact lenses to correct for ptosis has bee a major failure. Thus nott-snrgical and comfortable means to widen the natural palpebral fissur of an individual's eye are of interest.
SUMMARY OF THE INVENTION
{QQ03! Some embodiments include a prosthesis capable of being worn on the eye of a wearer having a convex surface and a concave surface. The prosthesis has an aperture widening zone located on the convex surface. The prosthesis widens the natural palpebral fissure f the wearer's eye by at least J mm.
|β004| Some embodiments include a prosthesis capable of being worn on the eye of a wearer. The prosthesis has a convex surface and a concave surface. An aperture widening . 7 . zone is located oil the convex surface. The prosthesis is a comeo- scleral contact lens that widens the natural palpebral fissure of the wearer's eye by at least 1 mm,
0005! Some em'bodimenis include a prosthesis- having a convex surface and" a concave
Surface. An aperture widening zone is located on the convex .surface; The prosthesis is a scleral ring that widens the natural palpebral fissure of the wearer's eye by at least 1 mm,
0006! Some embodiments indudfc a prosthesis capable of being worn on the eye of a wearer. The prosthesis has a convex surface and a concave surface. An. aperture widening z is located on the convex surface.. The aperture widening zone includes at least one surface feature. The prosthesis widens the natural palpebral fissure of the wearer's eye by at least 1 mm.
000?! Some embodiments include a prosthesis capable of being worn -on the eye of a wearer having a convex surface, a concave surface-, and a peripheral edge. The prosthesis also has an aperture w dening zone located on the convex surface. The aperture-widening zone including an outer slope and an inner slope with a maxtnium change in tfneknes located in between. The outer slope and: the inner slope are different
0008 Some embodiments include a prosthesis capable of being worn on the eye of a wearer having a convex surface, a concave surface, and a peripheral edge. The prosthesis also has an aperture widening zone located on the convex surface. The aperture widening zone including an outer slope and an inner slope with a maximum, change in thickness located i between.
0 91 Some embodiments include a prosthesis capable of being worn en the eye of a wearer. Th prosthesis has a convex, surface and a concave surface,. An aperture widening zone is located on the convex surface. The aperture widening zone has at least one surface feature. The aperture widening zone also has a. minimum vertical dimension,.
0010} Some embodiments include a prosthesis capable of bein worn on the eye of a wearer. The prosthesis has a convex surface, a concave surface, a peripheral edge, and. 'a geometric center. An aperture widening zone is located on the convex surface. The aperture widening zone has at least one surface feature. At least a portion of the at least one surface feature is located at o outside 5.25 mm from the geometric center of the prosthesis.
0011 J in some embodiments the prosth esis has an overal l diameter of at least 13,0 'mm. in other embodiments the prosthesis has an overall diameter of at least 13.5 nun. in some: embodiments the prosthesis has an overall diameter of at least 14.0 nt in some embodiments the prosthesis has an overall diamete of at least 14.5 mm. In still some other embodiments the prosthesis has an overall diameter of at least 15.0 mm dr larger, in some other em edments the prosthesis has an overall diameter of at least 15.5 rum. In some other embodiments, the prosthesis has an overall diameter of at least 16,0 mm
18012) in some embodiments the prosthesis is a rotational ty symmetric lens, in some embodiments the prosthesis is capable of rotating. In some embodiments the prosthesis is not capable of rotating.
[00131 In some -embodiments the aperture widening zone depresses a lower eye lid of the wearer by at least 1 mm. In some embodiments die aperture widening zone elevates an upper eye fid of the wearer by at least 1 mm.
)O01 | in some embodiments the prosthesis includes a colore accent color. In some embodiments the colored accent color is around a. portion of the prosthesis which fits near or at the iirnbus of the ey when the prosthesis is worn. In. some embodiments the colored accent color is a lirnbal ring, circle ring, or circle lens.
(0015) In some embodiments the prosthesis is multifocal contact lens. In some embodiments the prosthesis is a tone contact lens. In some embodiments the prosthesis is a single vision contact lens.
|00i | In some embodiments the aperture widening zone comprises an area of increased surface friction. In some embodiments the increased surface friction is provided by a surface treatment, a coating, a different material surface dimples, surface irregularities, chemical treatment, etching, or combinations thereof
0017) In some embodiments the aperture widening zone also includes an outer slope and an inner slope with, a maximum change in thickness located i between. In som embodiments the outer slope and inner slope are different. In some embodiments the outer slope is greater than the inner slope. In some embodiments' the outer slope has an: angle between 3° and 45*. In. some embodiments the outer slope ha an angle between 5° and 25" In some embodiments the inner slope comprises an angle between 10 and 1 ¾:. j 00181 I some embodiments the aperture- widening zone has an incremental thickness and a maximum change m thickness. In some embodiments the maximum change in thickness is within a. range of 25 microns to U)00 microns. In some embodiments the maximum change in thickness is within a range of 100 microns, to 500 microns, in some em odiments the maximum change in thickness is within » range of 75 microtis to 400 microns, In some embodiments the maximum change in thickness is located between 1 ,0 mm and 2.5 mm from an. outer edge of the prosthesis. In some embodiments the .maximum change in thickness is located at or exterior to the corneal linib s of the wearer' eye when the prosthesis is worn on. the eye.. In. some embodiments, the maximum change in thickness is located, at least 5.5 ram. from the geometrical center of the prosthesis (i.e., at least one half the diameter of the a verage human, cornea, which is 1 1 - 12 mm), in some embodiments, the maximum change in thickness is located at least 6,0 .mm from the geometrical center of the prosthesis. In. me embodiments, the m x mum change in thickness is located at least 6.5 mm from the geometrical center of the prosthesis,. In some embodiments the incremental thickness is an increase in thickness. In some embodiments the incremental thickness is a decrease in thickness.
9\ In some embodiments a outermost pari of the aperture widening zone is located, within, a range of 3 mm to $5 mm imm a geometric center of the prosthesis, in some •embodiments an outermost part of the aperture widening zone is located within- a range of 5 mm to 7.75 mm from geometric center of the prosthesis, in some embodiments an innermost part of the aperture widening zone is located between a peripheral edge o the prosthesis and 6 mm from a peripheral edge of the prosthesis.
Of I some embodiments a minimum vertical dimension of the aperture widenin zone is larger than a maximum vertical diameter of the natural palpebral fissure of the wearer's eye. in some embodiments a minimum vertical dimension o the aperture widening mm is- equal to or greater than 10.5 mm. In some embodiments a minimu : vertical: dimension of the aperture widening zone is equal to or greater than 1 1.0 mm. In some enibodinients a minimum vertical dimension, of the aperture widening ¾ooe is equal to or greater than 1 1.5 mm. In some embodiments a minimum vertical dimension of the aperture widening zone is equal to or greater than 12 ram. In some embodiments minimum vertical dimension of the aperture widening zone is a vertical distance between an uppermost part of the aperture widening ne and a. lowermost' part of the aperture widening zone.
l.| In sonic embodiments the aperture widening zone includes at least one surface feature. In some embodiments the aperture widening zone has a plurality of surface features. 0022} some embodiments the prosthesis is a eorneo-seleral contact lens. In some embodiments the prosthesis is a sclera! ring.
Ϊ023| in some embodiments the aperture widening zdne has a minimum vertical dimension.
0024 In some embodiments the prosthesis also has a peripheral ed e, a geome ric center* and at least one surface feature, In some embodiments the at least ne surfac feature or at least a portion of the at least one surface is located at or outside 5,25 mm fro t the geometric center of the prosthesis. In some embodiments the peripheral edge has knife edge shape, a rounded shape, a blunt shape, or semi-rounded shape, in some embodiments th peripheral edge has a thickness between 25 microns and 100 microns. tMI25| to some embodiments the prosthesis has a hybrid design. In some embodiments the prosthesis has a homogeneous design.
00 6) In some embodiments the aperture widening zone comprise a ring, mailt pie- rings, a partial ring, multiple partial rings, a island, multiple islands, a band, hands, partial bands, a segmented area, or multiple segmented areas,
o1)27| in some embodiments the prosthesis, can be worn by the wearer continuously. In some embodiments the prosthesis can be worn by the wearer uon-contwuousfy.. in some embodiments the prosthesis can be wont by the wearer daily, weekly , or monthly.
0281 In some embodiments the prosthesis is disposable. In some embodiments the prosthesis is reusable.
)0291 to some embodiments the prosthesis comprises an optical power. In some embodiments die prosthesis does not comprise an optical power,
O03 | Some embodiments include a prosthesis having an aperture widening -zone. The aperture widening zone has an outer slope, an inner slope, a point of maximum added thickness delta, and an incremental thickness diameter, The prosthesis also has peripheral edge, a geometrical center, and an overall diameter. The overall diameter is measured, from a first point on the peripheral edge to a second point on the opposing peripheral edge thru the- geometrical center of the prosthesis and the aperture widening ¾one. The overall diameter Is 14.5 mm or greater. The outer slope is with the range of 5 degrees and 25 degrees. The point of maximum added thickness delta of the aperture widening zone is 75 microns or greater. The point of maximum added thickness delta of the aperture widening zone is located between 1. t n and 3 mm from, t e■peripheral edge.
The incremental thickness diameter is 10.5 mm or greater.
j0031 j In some embodiments the prosthesis is free to rotate. In some embodiments, the prosthesis is not free to rotate.
{0032J In some embodiments the incremental thickness diameter is I mm larger than the vertical measurement of the natural aperture of the wearer's eye .
(003 1 In some embodiments the prosthesis Is a single vision contact lens. In some embodiments the prosthesis is a multifocal contact lens. In some embodiments the prosthesis is a ionc contact lens,
(00341 in some embodiments the prosthesis includes -a hydrogel. in some embodiments- the prosthesis includes a silicone hydrogel In some embodiments the prosthesis includes a homogenous material, in some embodiments the prosthesis includes hybrid materials.. (Q035J In some embodiments the aperture widening zone begins at or adjacent to the peripheral edge, in some embodiments the aperture widening 2one begins internal to the peripheral edge.
f0036J in some embodiments the point of maximum added thickness delta is 1 0 microns: or greater. In some embodiments the point of maximum added thickness delta is 125 microns or greater, in same embodiments the point of maximum added thickness delta is 150 microns or greater. In some embodiments the point of maximum added thickness delta i 200 microns or greater. In some embodiments the point of maximum added thickness delta is 225 microns or greater. In. some embodiments the point of maximum added thickness delta is 250 microns or greater.
(0037] In some embodiments the prosthesis is one of: daily wear, disposable, continuous wear, weekly wear, or monthly wear,
[0038] In some embodiments the prosthesis is not stabilised.
(0039| In. some embodiments the aperture widening zone Is a round ring. In some embodiments the aperture widening mne is a series of partial segments mat make up ring.
(0040] S me embodiments provide for a. method of widening the -natu al palpebral fissure of a wearer's eye by providing a protocol or instructions for widening the wearer's natural palpebral fissure b at least 1mm. and providing at feast one prosthesis comprising an aperture widening zone located on it convex surface.. In some embodiments the protocol or instructions include directions to determine a vertical dimension of the wearer's natural palpebral fissure, and to provide the weareF with a prosthesis having a minimum vertical dimension at least Imm greater than a maximum vertical dimension of th natural palpebral fissure,
[0041 I Some embodiments are directed to a prosthesis capable of being worn on the eye of a wearer including convex surface, a concave surface, an aperture widening, zone comprising a surface feature that is located on the convex or concave surface of the prosthesis, the surface feature having an outer slope, an inner slope, and maximum added thickness delta located between the outer slope and the inner slope, where the aperture widening zone is configured to widen the natural, palpebral fissure of a wearer's eye. In some embodiments, the aperture widening zone has a minimum- vertical dimension of greater than or equal to 10.5 mm... i some embodiments, the surface topography of at. least one of the outer slope and the inner slo e- is defined: by a spline curve function.
|¾i042 In some embodiments, the spline curve function is a Bezier/ curve function.
[0043J In some embodiments, the maximum added thickness delta is located at least 5,5 mm from a geometrical center of the lens. In some embodiments, the maximum added thickness delta is located at or exterior to the corneal limbus of the wearer's eye when the prosthesis is worn on the eye,
[0044| In some embodiments, the aperture widening zone begins at least 0.0.1 mm from a peripheral edge of the prosthesis-.. In some embodiments, the outer slope begins at least 0.01: mm. f om, a peripheral edge of the prosthesis. In some embodiments, the maxtnwto added thickness delta is located within a range of 0,25 mm to 0.75 mm from a peripheral edge of the prosthesis,
[004S| In some embodiments, the prosthesis is a earneo-seleral lens. I some embodiments, a peripheral edge of the eorneo-sderai tens is not altered rom thai which Is commercially available tor a specific brand and ty e of corneoscleral contact lens.
[0O46| In. some embodiments, the aperture widening zone has a minimum vertical dimension of greater than or equal to 1.2.0 mm
|'0M7| In some embodiments, the outer slope intersects the convex or concave surface at a firs junction point and the inner slope intersects the convex or concave surface at a second junction point and wherein the first junction point ha first and second order continuity. In some embodiments, the second junction point has first and second order continuity*
{fJ 48f in some embodiments, the entire surface of the surface feature has first and second order c ntinu ty^ In some embodiments,, the entire surface having the surface featur located thereon has first and second order continuity.
fi)l}49| Some embodiments are directed to a method of designing a prosthesis capable -of being worn, o the eye of a wearer, the method including, selecting a base prosthesis profile having a. convex surface and a concave surface; selecting an are for a. surface feature located on the convex surface or the concave surface of the base prosthesis profile, the are having a height different from a normalised convex surface of the base prosthesis profile or a normalized concave surface of the base prosthesis profile, a peak located at a maximum, height of the arc, and an. outside edge located and an inside edge; selectin the location of the peak relative a. peripheral edge o the base prosthesis profile; selecting a first control point located on the base prosthesis profile at a distance A from a peripheral edge of the base prosthesis profile; selecting a second control point located on the outside edge of the arc; selecting a third control point located on the inside edge of the are; selecting a fourth control point located on the base prosthesis profile at a distance B from an edge of an optica! ¾one of the base prosthesis profile; and designing the prosthesis having the surface feature on. the base prosthesis profile using the control points and a spline curve function.
in some embodiments, the surface feature begin at the first control point and ends at the fourth control point.
jOOSil In some embodiments, the method includes selecting a. fifth control point located tangential to the surface of the base prosthesis profile at the first control point and at a distance C fr m, the first control point towards the peak of the arc; selecting a sixth control point located tangential to the outside edge of the arc at the second control point and at a distance 0 from the second control point towards the peripheral edge of the base prosthesis profile; selectin seventh control point located, tangential to the inside edge of the are at the third control po i and at a distance E from the third control point toward the peripheral edge of the base prosthesis profile; selecting an eighth control point located tangential to the surface of the base prosthesis profile at the fourth control point and at a distance F from the fourth contra!, point towards the peak of the arc; and designing- the surface feature using the control points and a spline curve function.
|(M)52| in some embodiments, the arc has a constant radius. In some embodiments the inside edge of the arc is located at a height, between, the normalized convex surface or normalised concave surface of the base prosthesis profil and the peak of the are. In some embodiments, the outside edge of the are s located at a height, between the normalized convex surface of normalized concave surface of the base prosthesis profile and the peak of the arc,
f0053{ In some embodiments, A in the range of 0.01 mm to 2.0 mm. In some embodiments, B is in the range of § mm to 3.0 mm. In some embodiments. C is in the range of 0 mm to 2.0 mm. In some embodiments, D is in the range of 0 ram to 2,0 mm. in some -embodiments, 12 is in the range of 0 mm to 2.0 mm. I some embodiments, F is in the range of 0 mm to 2,0 mm,
jO#S4f hi some embodiments, the spline curve function is a Bezier curve fonetion.
d0SS| some embodiments, the fust, second, third, and fourth control points are located on a single cross-sectional plane of the base prosthesis profi le that interests a geometrical center of the base prosthesis profile and the peripheral edge of the base prosthesis profile.
|90S6f In some embodiments, the convex or concave surface of the prosthesis has first order continuity as the first control point. n sotne embodiments, the convex or concave surface of the prosthesis has first order and. second order continuity at the first control point. In some embodiments, the convex or concave surface of the prosthesis has first order and second, order continuity at the outside edge of the are. In some embodiments, the convex or concave surface of the prosthesis has first order and second order continuity at the fourth control, point, in some embodiments, the convex concave surface of the prosthesis has first: order and second order continuity at the inside edge of the are. In some embodiments, the entire surface feature lias first and second order continuity, including at the first and fourth control points. In. some embodiments:, the entire surface having the surface feature located, thereon has first, and second order continuity,
[0057J in some embodiments, the first control point is located at least 0.01 mm from the peripheral edge of the base prosthesis profile.
fO058| Some embodiments are directed to a method of manufacturing a prosthesis capable of being worn on the eye of a wearer, the method including the method including - so - selecting base prosthesis profile having convex surface and a concave surface; selecting an arc for a surface feature located on the convex surface or the concave surface of the base prosthesis profile, the are having a freight different from a normalized convex .surface of the base prosthesis profile or a normalized concave surface of the base prosthesis profile, a peak, located at a maximu height of the arc:, and an outside edge located and an inside edge; selecting the locaiion of the peak .relative a peripheral edge of She base prosthesis profile; selecting a first control point located OH the base prosthesis profile at a distance A from peripheral edge of the base prosthesis profile; selecting a second control point located on the outside edge of the arc; selecting a third control point located on the inside edge of the are; selecting a fourth control point located on di base prosthesis profile at a distance B front an edge of an optical zone of the base prosthesis profile; and designing the prosthesis having the surface feature on the. base prosthesis profile using the control points and a spline curve function; and forming the prosthesis using the design.
{00591 i some embodiments, forming the prosthesis comprises molding. In som embodiments, forming the prosthesis comprises lathe cutting.
!@060'f Some- embodiments are directed to a raefhod of making a mold for a prosthesis capable of being worn on the eye of a wearer, the method Including selecting a base moid profile having a convex surface and a concave surface;, selecting an are for a surface feature located on the convex surface or the concave surface of the base moid profile, the arc including a height different from a normalized convex surface of the base mold profile or the normalized concave surface of the base mold profile, peak located at a maximum height of the are, and an outside edge and an inside edge; selecting the location of the peak relative a peripheral edge of the base mold profile; selecting a first control point located on the base moid profile at a distance A from a peripheral edge of the base moid profile; selecting a second control point located on the outside edge of the are; selecting a third coniroi. point located on the inside edge of the are; selecting fourt control point located on the base mold profile at. a distance B from an edge of an optical ¾one of the base mold profile; designing the mold having the surface feature us n the control points and a splin curve function; and forming the moid.
[0061 J In some embodiments, forming the mold comprises injection molding. - π - 0O62| Some embodiments are directed to a prosthesis capable of being worn on the eye of a wearer, the prosthesis Including a convex surface,, a concave surface, an aperture widening zone comprising a surface feature that is located on the convex or concav .Surface of the prosthesis., the surface feature including an art* located at a height different from the convex surface the prosthesis or the concave surface of the prosthesis, the arc comprising a radius, an outside edge, arid an insid edge. The surface feature also including a peak located at a maximum added thickness delta of the arc, an outer slope extending from the outside edge of the are towards a peripheral region of the prosthesis, and an inner slope extending from, the inside edge of the arc towards a central region of the prosthesis. In some embodiment, the surface topography of at least one of the onler slope arid the inner slope i defined by a spline curve function, i some embodiments, ihe aperture widening zone has a minimum vertical dimension of greater than, or equal to 10,5 mm,
j0O63j In some embodiments, the outer slope intersects ie peripheral region at a first junction point, and wherein the first junction point has first and second order continuity, In some embodiments,, the inner slope intersects the cental region at a. second junction poiiit, and wherein the second junction point has first and second order continuity, j 1)064 f In some embod ments, the radius of the arc is in the range of 0 mm to 5 mm, In some embodiments, the radius or the ate is in the range of 0.5 mm. to 3 mm.
ffl Sf in some embodiments, the maximum added thickness delta is greater than or equal to 25 microns. In some embodiments, the maximum added thickness delta is greater than or equal to 200 microns. In. some embodiments, the maximum added thickness delta is in the range of 25 microns to 1000 microns.
t(KK»6] in some embodiments, the arc is a circumferential arc disposed around an optica! zone of the prosthesis. In .some embodiments, the circumferential are is continuous. In some embodiments, ihe circumferential arc is non-conti toos,
0ί)67| It will be appreciated that various embodiments recited above with respect to the prosthesis and/or aperture widening mm can. he combined in any combination, except where features are mutually exclusive.
BRIEF DESCRIPTION OF THE DRAWINGS'
FIG. I shows an individual, having congenital ptosis on the right eye. f 0C»9j FIG. 2 illustrates a visual field that shows functional. blockage due to a ptotic lid. fiK)70| FIGS. 3-7 illustrate various individuals afflicted by ptosis.
\Wfl{ FIGS, S»l ί illustrate various individuals with wide eyes that are not afflicted by ptosis.
|O072J FIG'S. I 2A.-B show a prosthesis having an aperture widening, mm- according one embodiment superimposed on the eyes of an individual,
0073} FIGS. 13.A- show a prosthesis having an aperture widening zone according to ope embodiment superimposed on the eyes of a individual
|O074f FIG. 14A shows a contact lens with an aperture widening zo e according to one embodiment. FIG, I.4.B shows a scleral ring with an aperture widening torn according to one embodiment.
j T5 FIGS, I 5A.-0 show various emhodiniems of a contact leas with, different aperture. widening zones having an increments! thickness.
i; #76j FIGS. I6A-D show various embodiments of a scleral ring wit different aperture widening zones having a incremental thickness.
£0077} FIGS. 17A.-F show various embodiments of a contact lens with di fferent aperture widening zones having increased surface friction.
j0078| FIGS. 18-19 show a comparison between the eyes of an individual with and without a prosthesis having an aperture widening zone. FIG. 1.8 shows the individual's natural eyes and FIG, 19 shows the same individual wearing prosthesis having an aperture widening zone.
j¾079] FIGS. .20-21. show a comparison between the eye of an individual, with and without a prosthesis having an aperture widening zone. FIG. 20 shows the individual's natural eye.
j0080} FIGS. 22A-8 show a comparison between an individual's left eye with and without a prosthesis having an aperture widening zone. FIG. 22 A. shows the individual's natural left eye and FIG. 2.2B shows the individual wearing a prosthesis having an aperture widening zone in the left, eye,
|0 M{ FIG. 23 shows a comparison betwee the right and left eye of an individual. The individual is wearing a prosthesis having an aperture widening zone on their right eye and is not wearing a prosthesis having an aperture widening: zone on their left eye. [0082) FIGS. 24.A-B show a comp rison 'between, the eyes of an individual, with and without a prosthesis having an aperture widening zone. FIG. 24.A shows the individual's natural eyes and ΨΙϋ.24B shows the same individual wearing a prosthesis having an aperture widenin zone.
|0083j FIG'S. 25A-C show the surface profiles for prostheses according to various- embodiments.
[0084) FIG. 26 is a graph illustrating the thickness across prostheses according to various embodiments,
[008&J FIGS. 27A-B show the surface profiles for prostheses according to various embodiments.
[0086) FIG. 28 show s a perspective view of a prosthesis according to one embodiment
[0087] FIG. 29 shows a perspective view of a prosthesis according to one embodiment
[0088) FIG. 30 shows a perspective view of a prosthesis according to one embodiment
[0089) FiG. 1 shows a perspective view of a prosthesis according t one embodiment. J0090) FIG. 3 shows a perspective view of a prosthesis according to one embodiment.
[0091 { FIG. 33 shows a perspective view of a prosthesis according to one embodiment,
[0092| FIG. 34 shows a perspective view of a prosthesis according to one emb diment [ΘΘ93) FIG* 35 shows an. aerial view of a prosthesis according to one embodiment, |0094) FiG. 36 shows an aerial view of a prosthesis according to one embodiment
[00 51 FIG. 37 shows an aerial view of a prosthesis according to one embodiment.
1 0 61 FiG, 38 shows an aerial view of a prosthesis according to one embodiment
[009 ! FIGS. 39A-E illustrate the sartkce profile of a eoutecl fens 3900 according to one embodiment. FiG. 39A shows an aerial view of the contact Sens, FIG, 39B shows a side view of the contact lens. FIG. 39C shows a cross-sectional view of the contact lens along its central axis. FIG. 390 shows the convex surface of the contact lens, FIG. 3915 shows the concave surface of the contac lens.
[0098) FIG. 40 shows a prosthesis according to one embodiment superimposed on an eye.
[0099.1 FIG. 41 shows a prosthesis according to one embodiment superimposed on an eye,
[0100) FIG. 42 shows a prosthesis according to one embodiment superimposed on an eye,
[0 ΘΙ I FIG. 43 shows a prosthesis according to one embodiment superimposed on an eye,
[01.021 FIG. 44 shows a hybrid contact lens according to one embodiment,
[01.031 FiG, 45 shows a hybrid contact lens according to one embodiment. 10104) FIG. 46 shows a hybrid contact Sens according to oni embodiment.
[0105| FIG. 4? shows a reverse hybrid contact lens accordiog to one embodiment,
[0106] FIG- 48 shows example of a scale used for fitting prosthesis having an aperture widening zone..
[0107) FIG. 49 shows a scleral ring with an aperture widening zone having an incremental thickness according to one embodiment.
[0!08{ FIG, 50 shows a scleral ring with an aperture widening ¾one having an incremental thickness according to one embodiment.
[91(i9f FIG. 51 shows a contact lens with aft aperture widening zone having an incremental thickness according to one embodiment.
{0110) FIG. 52 shows a contact le s with an aperture widening zone having m incremental, thickness according to one embodiment.
[0 11 J FIGS. 53A-C show various exemplary embodiments of scleral rings with aperture widening zones having a plurality of hands of incremental thickness. Figures 53D and
53E show various exemplary embodiments of contact lenses with aperture widening zones having a plurality of bands of incremental thickness
[0112| FIGS. 54-56 show a comparison of an individual's eyes with and without a prosthesis having an aperture widening ¾o«e. FIG. 54 shows the individual's natural eyes and FIG. 55 shows the same individual wearing a prosthesis having an aperture, idening' zone. FIG. 56 is a side by side comparison of FIGS. 54 and 55,
'[01 131 FIG, 57 is a graph illustrating the oute slope, inner slope and thickness of prosthesi accordin to one embodiment.
i0H4j FIG. 58 is. a graph illustrating the outer slope, inner slope and thickness of a. prosthesis according to one embodiment.
[0115! FIG. 5L) i a graph illustrating the outer slope, inner slope and thickness of prosthesis according to one embodiment.
[0116) FIG. 60 is a graph illustrating the outer slope, inner slope and thickness of prosthesis according to one embodiment.
[0H7| FIG. 61 illustrates the dimensions and fit to the eye of a. corneoscleral contact lens prosthesis according to one embodiment compared to the .structure of an eye.
[fll 18| FIG:. 62 illustrates the dimensions and fit to the eye of a scleral ring prosthesis according to one embodiment compared to the structure of an. eye, 0il9| Fftl 63A illustrates how to measure the vertical. dimension of an; aperture widening zone on a prosthesis with a» outer edge in the shape of a circle. FIGS, 63B and
63C illustrate how to measure the vertical, dimension of an aperture wideriing zone on a prosthesis with an outer edge in the shape of a triangle.
(M2(i| FIG'S. 64.A-C illustrate various orientations of a prosthesis having an aperture widening zone with an outer edge having an oval shape. FIG. 64A Illustrates an orientation having fil minimum vertical dimension. FIGS. 64B and 64C illustrate orientations not having the minimum vertical dimension,
[0I21f FIGS. 65A and 65B illustrate how to measure the minimum vertical dimension of an aperiore widening zone on a prosthesis with outer edges in the shape two partial, rings. j8122| FIGS. 66A-D illustrate how to measure the minimum, vertical dimension of an aperture widening zone on . a prosthesis having a plurality of isolated areas,
{0123] FIG. 67 shows an aerial view of a scleral ring having finger like members according to one embodiment,
|Θ124| FIG. 68 shows an aerial view of a contact lens ha ing finger like members according to one embodiment.
ί Ι25| FIG. 69 shows a side view -of a prosthesis having finger like members -according to one embodiment.
|θ!26| FIG. 70 shows an aerial view of a prosthesis according to an embodiment.
{8127| FIG. 71 A shows a cross-sectional view of a prosthesis according to an embodiment. FIG. 7 L shows an enlarged cross-sectional view of portion of the prosthesis shown in FIG. 71 A..
j0i28| FIG. 72Λ shows cross-sectional view of a prosthesis having a tri-curve design according to an embodiment, FIG. 72B shows an. enlarged cross-sectlonal vie of a portion of the prosthesis shown, in FI'G. 72A.
|0129f FIG. 73A. shows a cross-sectional view of a prosthesis having a spline curve design according to an embodiment. FIG.. 73 B shows an enlarged cross-sectional view of a portion of the prosthesis shown in FIG. 73 A.
|8130! FIG. 74 shows n enlarged, eross-seetional view of a portion of a prosthesis illustrating the location of control points according to an embodiment.
18.1.31! FIG:. 75 shows a .flowchart, illustrating a method of designing a prosthesis according to an embodiment [0132 J Fftl 76A shows- a cross-sectional, view of a mold according to an embod ment.
FIG, 76 B shows an enlarged cross-sectional view of portion of the mold shown in FIG. 76A.
j¾133j FKI:. 77 h ws a flowchart illustFatmg a. me hod of designing a mold according to
■an embodiment.
[0134} FIG. 78 shows a contact lens having an aperture widening zone designed using a tri-cnrve methodology accordi g to an embodiment showing- the dimensions of the co tact lens,
[0135} FIG. 79 shows a contact lens having an aperture widening ¾one designed: using a spline curve methodology according to art embodimen showing the dimensions of the contact lens.
}0!36j FIG. BO shows a prosthesis having an aperture widening ¾nie located on the concave surface of the prosthesis according to an embodiment
[0137} FIG. U l shows a schematic block diagram of an exemplary computer syste which embodiments may be im lemented
DETAILED DESCRIPTION
10138! This specification discloses one or more embodiments thai incorporate the features of this Invention. The disclosed embodiment! s) merely exemplify the invention,. The scope of the invention is not limited to the disclosed embodl mentis^ Multiple inventions may be described. The inveniion(s) are defined by the claims appended hereto.
[0 391 The e bodiments) described, and references in the sp c fication to "one embodiment", "an embodiment", "an example embodiment", etc, indicate that the embodiments) described ma include a particular feature, structure, or characteristic,, but every embodiment may not necessarily include me particular feature, structure, or characteristic, oreove , such phrases are not necessarily referring to die same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it i understood, that it is within the knowledge of one skilled in the art to implement such feature, structure, or characteristic i connection with oilier embodiments whether or not explicitly described. j014itf It is known that the aperture of the human eye .reduces in overall diameter by 1.5 mm or more as one matures -from that of a child to that of an adult of the age of 40 and even more as one matures to that of a senior of 60 years or older. This reduction in diameter can be fixed surgically through a procedure called blepharopfesty. Presently there are approximately 200,000 - 300,000 biepharoplasiy operations performed per year in the United States at the cost of approximately $2,500 per tipper lids surgery and $3 ,500 per Sower lids surgery. In addition to reduction in aperture size due to old age, some individuals suffer from blepharoptosis, also referred to as ptosis, which is defined as an abnormal low-lying upper eyelid margin within the eye in primary gaze. The reduction in aperture size ca affect an individual's vision. White a reduction of aperture size can afreet the vision of some individuals, some individuals may desire a larger eye aperture fo cosmetic purposes, either in combination with a desire to improve their vision or not. 0141 Traditional corneo-seieral contact lexises (soft contact lenses or hybrid contact
Senses) that, fit on the cornea of one's eye (do not vault the cornea) and extend over the limb us and bulbar -conjunctiva thus covering part of the sclera are not being used tor correcting ptosis and/or the widening of the wearer's palpebral fissure. This is due to their geometrical design. Also corneal contact lenses (rigid or soft) that fit only the cornea and do not extend past the Htnbus are not used for correcting ptosis and/or the widening of the wearer's palpebral fissure due to geometrical design and overall diameter. Sclera! contact lenses are 'hard/rigid and have been designed in the past to fit snugly against die sclera of the wearer's eye, "vault the cornea" and have a very thick edge design such to lift the upper lid of the wearer's eye having ptosis. While scleral contact lenses have existed in the past that will lift the upper lid- of the wearer's eye these: hard rigid scler contact lenses are highly uncomfortable, cause very red eyes and irritate the e-ye lid margin thus presenting severe limitations for the wearer, for these reasons the commercial success of sclera! contact lenses to correct for ptosis ha been a. major failure.
|-W42'| Also there have been attempts in. the distant past to widen the eye usin a glass dome that covers the cornea and exposed sclera of the eye having hook like members to keep an upper paralysed lid raised and. attempts to use magnets stitched into the upper lid used with a prosthesis also containing magnetic material for the purposes of attempting to elevate the uppe lid. But there is no eomeo-sclerai contact lens; such as by wa of example only, a soft contact lens or hybrid contact lens that widens die paplehral. fissure: of .a cross section of wearer' s eyes. And, more specifically,, there is not a contact lens that widens fee paplebrai fissure and provides a corrective prescription (i.e., an optical power), including that of piano (no optical: power). As such, there is a pressing need for a corneoscleral contact lens that widens the palpebral fissure (aperture) of a wearer's eye to caus the wearer to appear more alert and/or enhance the appearance of the wearer. Such a contact tens should allow normal and natural blinking and allo for such normal natural blinking withou deeentertng the lens, irritating the upper o lower ii.d, and hurting the wearer when naturally blinking. Various dimensions of a prosthesis, as discussed herein, may work as a "balanced system** providing the appropriate nourishment to the- cornea of the eye, comfort for the wearer, and vision correction
101431 Color enhancin soft contact lenses have been developed and have met with significant commercial success. These color enhancing soft contact Senses can enhance the colo of the wearer's eyes. Certain soft contact lenses comprise a colored ring to make the eye of a wearer look larger when worn,. While colored sof contact lenses having a color ring or band have been used, to increase the perception that the eye of the wearer is larger, no soft contact lens ha been provided which both increases the perception that the eye of the wearer is larger and also physically widens the palpebral fissure of foe eye of the wearer.
j0144| Thus there is a need for a non-surgical comfortable means to widen the natural palpebral fissttre of an individual !s eye. There is also need for a non-surgical means to both open up the aperture of the natural eye that is also capable of allowing an individual blink, without discomfort And, in some instances, there is the need to restore some of or all lost visual field function in the ease of ptosis due some degree of a paralysis or loss of function of the upper lid. Moreover, there, is a. need for a non-surgical means capable of enhancing the cosmetic look of an individual's eye(s (e.g., maintain a youthful look or a more alert look). The cosmetic enhancement may be achieved, by physically widening the natural palpebral fissure of an individual's eye (I.e.., Sifting tile upper lid and/or depressing the lower lid) and/or providing the perception that the eye of an individual, is larger.
1914$! Furthermore, soft contact lens manufacturers seek, whenever possible, to utilize their own edge designs as they develop and introduce new lens designs. These manufacturers have spent large sunis of capital in researching, developing, and. market testing various edge designs. Over time their efforts have culminated in a specific edge: design that ihey each try very hard to maintain with their individual soft contact lens products. Therefore, it is preferable that any prosthesis worn it) the eye that is capable of opening up (enlarging vertically) the aperture of an eye and that allows normal natural blinking be capable of being designed to .maintain closely the specific edge profile that each of the soft contact lms maniifacrurers over time have perfected (Le,, not interfere with a manufacture's specific edge design}*
146 j Embodiments of the present application described herein, or elements thereof, may accomplish one or more of these or other objectives,
0.1.4?1 'Some embodiments include a. prosthesis capable of being worn on the eye of a wearer having a convex surface and a concave surface. The prosthesis has an ape.riu.fe widening zone located on the convex surface. The prosthesis widens the natural palpebral fissure of the wearer's eye by at least 1 mm.
\M4%{ Some embodiments include a prosthesis capable of being worn on the eye of a wearer. The prosthesis has a convex surface and a concave surface. An aperture widening zone is located on the convex surface. The prosthesis is a corneo-scleral .contact lens that widens the natural palpebral fissure of the wearer's eye- fey at feast 1 mm,.
101 91 Some embodiments include a prosthesis having a convex surface and a concave surface. An aperture widening zone is located, on the convex surface'. The prosthesis is scieral ring thai: widens the natural palpebral fissure of the wearer's eye by at least 1 mm.
{01 SOf Some embodiments include a prosthesi capable of being worn on the eye of a wearer. The prosthesis has a convex surface and a concave surface.. An aperture widening zone is located on the convex surface. The aperture widening zone includes at least one surface feature. The prosthesis widens the natural palpebral fissure of the wearer's eye b at least I. turn,
{0151.| Some embodiments include a prosthesis capable of being worn on the eye . f a wearer having a- convex surface, a concave surface, and a peripheral edge. Hie prosthesis also has an aperture widening zone located on the convex surface. 'The aperture widening zone including an outer slope and an inner slope with a maximum change in thickness located in between. The outer slope and the inner slope are different. In some embodiments the outer slope is greater tha the inner slope. In other emfeodimenis the inner slope is greate than di outer slope. !#!$2J Some embodiments include a prosthesis capable of being worn: on, the eye of a wearer having a convex surface, a concave surfiiee, and a peripheral edge. The prosthesis also has n aperture widening so s located on the convex surface. The aperture widening zone me! oiling an. outer slope and an inner slop with a maximum, change in thickness, located In between. The outer slope and the inner slope are the same.
θί S3| Some embodiments include a prosthesis capable of being worn on the eye of a wearer. The prosthesis has a convex surface and a concave surface. An. aperture widening zone is located on the convex surface,. The aperture widening z ne has at least one surface feature. The aperture widening zone also has a minimum vertical dimension.
|01 S4 Some embodiments include a prosthesis capable of being worn on the eye of a wearer. The prosthesis ha convex surface, a concave surface, a peripheral edge, -and a geometric center. An. aperture widening zone is located on the convex surface. The aperture widening zone has at least one surface feature. At least a. portion of the at least one surface feature is located at or outside 5.25 mm from the geometric center of the prosthesis,
fill 55 j in some embodiments the prosthesis has an overall diameter of at least 13.0 mm.
In other embodiments the prosthesis has a overall diameter -Of at least 13.5 mm. In some embodiments the prosthesis has an overall diameter of at least 14.0 mm. In some embodiments the prosthesis ha an overall diameter o at least 14.5 mm. In some embodiments the prosthesis has an overall diameter of at least 15 mm. in some embodiments the prosthesis has an overall diameter of at least IS, 5 mm, in some other embodiments die prosthesis has an overall diameter of at least 16,0 mm or larger*
In some embodiments the prosthesis is a rotationaSly symmetric lens, in some embodiments the prosthesis is capable of rotating. In some embodiments the prosthesis is not capable of rotating,
157| in some embodiments the aperture widening zone depresses a lower eye lid of the wearer by at feast 1 mm. In some embodiments the aperture widening ¾one elevates an upper eye lid of the wearer by at least 1 mm,
[0158 J In some embodiments the prosthesis includes colored accent color. In some embodiments the colored accent color is around a portion of the prosthesis which fits near or at the limbus, or extends past the limbus (meaning the diameter of the colored portion is larger than the diameter of e limbus to limbus measurement) of the eye when the: prosthesis; is worn. In some embodiments die colored accent color is a iinihai ring, circle ring; or circle lens.
{01591 In some embodiments the prosthesis is a nitifocaS contact lens, to some embodiments the prosthesis is a tone contact tern, in some embodiments the prosthesis is a single vision contact Sens,
f{J160| in some embodiments me aperture widening zone comprises an area of increased surface friction. .In some embodiments the increased surface friction is provided by a surface treatment, a coating, a. different: material surface dimples, mrrfaee irregularities, chemical treatment, etching, or combinations thereof.
1 In some embodiments the aperture widening zone also includes an outer slope and an inner slope with a maximum change in thickness located in between, in some embodiments the outer slope and inner slope are different, in. some embodiments the outer slope is greater than the inner slope, in some embodiments the outer slope has an angle between 3° and 45*. In some embodiments die outer slope has an angle between 5° and 25°. in some embodiments the inner slope comprises an angle between P and 15°.
{01.621 In some embodiments the aperture widening zone has an incremental thickness and a maximum change In thickness, In some embodiments the maximum change in thickness is within a range of 25 microns to 1,000 microns, in some embodiments the maximum change in thickness is withi a range of 100 microns to 50 microns. In some embodiments the maximum change in thickness is within a range of 75 microns to 400 microns.. In some embodimenis the maximum change in thickness is located, between 1.0 trail and 2.5 mm from an outer edge of the prosthesis, in some embodiments the maximum change in. thickness is located at or exterior to the corneal iirabus of the wearer's eye when the prosthesis is worn on the eye. By exterior it is meant that the maximum change in thicknes diameter when measurin from one point of maximum added thickness thru the geometrical center of the prosthesis to: an opposing point of maximum added thickness is larger than when, measuring from one point on the Unions of the wearer's eye thru the center of the cornea to an opposing point on the limbos,
|&163| In some embodiments, the maximum, change in thicknes is located at least 5.5 mm from the geometrical center of the prosthesis (i.e., at. least one half the diameter of the average human cornea, which is 1 1. - 12 mm), in some embodiments, the maximum change in thickness i located at least 6.0 mm from the g ometrical center of the prosthesis, in some embodiments, the maximum change in thickness is Ideated at least 6,5 mm from the geometrical center of the prosthesis, in some enibodiments the incremental thickness is an increase in thickness, in some embodiments the incremental t!nekriess is a decrease in thickness.
| 164] in some embodiments an outermost part of the aperture widening zone is located within a. range of 3 mm to 8.5 mm irot a geometric center of the: prosthesis, In some embodiments a outermost part of the aperture widening zone is located within a range of 5 mm to ?>75 mm from a geometric center of the prosthesis, i some embodiments an innermost part of the aperture widening zone is located betwee a peripheral edge of the prosthesis and 6 mm from a peripheral edge of the prosthesi s.
{01 5) in some embodiments the aperture widening zone has a minimum vertieal dimension, in some embodiments, a minimum vertical dimension of the aperture widenin ¾one is larger than a. maximum vertieal diameter of the natural palpebral fissure of the wearer's eye. In some embodiments a minimum vertical d m nsio of the aperture widening zone is equal to or greater than 10,5 mm. in some embodiments a minimum vertical dimension of the aperture widening zone is equal to or greater than 1 1.0 mm. In some embodiments a minimum vertical dimension of the aperture widening o is equal to or greater than I L5 mm. in some embodiments a minimum vertical dimension of the aperture widening zone is equal to or greater tha 12.0 mm. In some embodiments a minimum vertical, dimension of the aperture widening zone is equal to or greate than 12,3 m!ii In some embodiments a minimum vertieal dimension of the aperture widening zo e is equal to or greater than 13.0 mm. m some embodiments a mmirautn vertieal dimension of the aperture widening zone is equal to or greate than 13,5 mm. In some embodiments a minimum vertical dimension of the aperture widening m is a vertical distance betwee an uppermost pan of the aperture widening ¾one and a lowermost part of the aperture widening: zone,
{0166) I some embodiments the aperture widening zone includes at least one surface feature. In some embodiments the aperture widening zone has a plurality of surface features,
{0167) In some embodiments file prosthesis is a eorneo-scierai contact lens. In some embodiments the prosthesis is a scleral ring. |0 8f So some embodiments the prosthesis also has a peripheral edge, a geometric center, and at least one surface feature. In some embodiments the at least one surface feature or at least a portion of the at least one surface is located at or outside 5 2S mm from the geometric center of the prosthesis.. In some emoo imerits t he peri pheral edge has a 'knife edge shape, a rounded shape, a blunt shape, or a semi-rounded shape. In some embodiments the peripheral edge has a thickness between 25 microns and 100 microns* it! som embodiments die prosthesis has a hybrid design. Irs some embodiments the prosthesis has a homogeneous design*
[01.701 In some embodiments the aperture widening zone comprises a ing, multiple rings,, a partial ring, multiple partial rings, an island, multiple.- islands, a hand, hands, partial bands,, a segme ted area, or multiple segmented areas, in some embodiments these partial areas are aligned to ring the prosthesis.. In other embodiments these partial areas are not aligned to ring the prosthesis.
[01.71 f In some embodiments the prosthesi can he worn by the wearer continuously-. In some embodiments the prosthesis can be worn by the wearer non^oiUiuuoiisSy . In some- embodiments the prosthesis can be worn by the wearer daily, weekly, or monthly.
j J72| hi some embodiments the prosthesis is disposable. In some embodiments the prosthesis Is reusable.
j0173| in some embodiments the prosthesis comprises an optical power. In some embodiments the prosthesi does not comprise an optical, power.
18-174} Some embodiments Include a prosthesis having an aperture widenin zone. The aperture widening zone has an outer slope, an inner slope, a point of maximum added thickness delta, and an incremental thickness diameter. The prosthesis also has a peripheral edge, a, geometrical center, and an. overall diameter, The overall diameter is measured from a first point on the peripheral edge to second point on the opposing; peripheral edge thro the geometrical center of the prosthesis and the aperture widening one. The overall diameter is 14.5 mm or greater. The outer slope is with the range of 5 degrees and 25 degrees.. The point of maximum added thickness delta of the aperture widening zone ¾ 75 microns or greater. The point of maximum added thickness delta of the aperture widening zone is located between 1 mm and 3 mm from the peripheral edge. The incremental thickness diameter is I ..5 mm or greater. |0!?SJ In some embodiments toe prosthesis is free to rotate. In some embodiments the prosthesis is not free to rotate.
{0176| In some embodiments the incremental thickness diameter is I. ram larger than th vertical .measurement of the natural aperture of the wearer's eye In some embodiments the Incremental thickness diameter is at least I mm larger than the vertical measnnsment of the natural aperture of the wearer' s eye
i 77{ In some embodiments the prosthesis is a corneo-sderal lens, in some embodiments the prosthesis is a scleral ring.
[0I78{ In some embodiments the prosthesis has optica! power. I some embodiments the prosthesis does not have optical power.
{0179} in some embodiments ie prosthesis is a single vision contact lens, in some embodiments the prosthesis is a multifocal contact lens, in seme embodiments the prosthesis is a terie contact lens.
I0.18OJ In some embodiments the prosthesis includes a hyilrogeL In some embodiments the prosthesis includes a silicone hydrogel in some embodiments the prosthesis includes a homogenous material. In some embodiments the prosthesis includes hybrid materials, {til 81 i in some embodiments the aperture widening zone begins at or adjacent to the peripheral edge, in some embodiments the aperture widening zone begins interna! to the peripheral edge.
{iil82f i some embodiments the point of maximum added thickness delta is 100 microns or greater, in some embodiments the point of maximum added thickness delta is 125 microns or greater. In some embodiments the point of maximum added thickness -delta is 1 0 microns or greater. In some embodiments the point of maximum added thickness delta is 200 microns or greater, In some embodiments the point of maximum added thickness delta is 225 microns or greater, in some embodiments the point of maximum added thickness delta is 250 microns or greater.
{01831 In some embodiments the prosthesi is one of: daily wear, disposable, continuous wear, weekly w ar, or monthly wear.
{(SI 84| in some embodiments the prosthesis is not stabiiked.
|0185f in some embodiments the aperture widening zone is a round ring. In some embodiments the aperture widening zone is a series of partial segments thai make up a ring. 1 186 j Some embodiments provide for a method of widening the natural palpebral fissure of a wearer's eye by providing a protocol or instructions for widening the wearer's natural palpebral fissure by at least 1 mm. and providing at least erne prosthesis comprising an ■aperture widening zone located on it con ex surface, in some embodiments the protocol or instructions include directions to determine a vertical dimension of the wearer's natural palpebral fissure, and to provide the wearer with a prosthesis having a m nimum vertical dimension at least 1 mm greater than a maximum vertieal dimension of the natural palpebral fissure (such a determi nation can be made by, way of example only, actual measurement, photography, visual estimate, or by one of; fitting a trial prosthesis, contact leas of a known diameter, or a prosthesis of a known diameter).
10187 J A prosthesis of this patent application in the form of a corHeo-scleral contact lens and a scleral ring has been developed that enhances widens the palpebral, fissure of a wearer's eye to enhance the cosmetic appearance of the wearer's eye (eyes) and can also be used to provide relief to patients suffering from drooping eyelids and/or ptosis. By enhancing the appearance of the wearer's eye it is meant thai it makes the eye took more open and/or larger, and more alert. The novel prosthesis enhances the cosmetic appearance of the wearer by wa of pushing up (elevating) the upper eyelid and/or als pushing down (depressing) the lower eyelid thus enlargi g the wearer' palpebral fissure or aperture.. The prosthesis has been shown to open the aperture of a wearer 's eye by up to an additional 50% from its normal/natural eye aperture vertical dimension. Given that the average aperture of an individual's eye under the age of 40 would have a natural aperture having a vertical dimension (between, the upper lid. .margin and the lower lid .margin) of approximately 10.5 mm and that after the age of 40 the average dimension from the same points is approximately 9 mm, or approximately a 15% reductio in aperture size ¾ can be seen that the prosthesis described herein can restore the youthful look dre of wearer's eyes,
{01 Si§ The prosthesis comprises one or more, by way of example of: an augmentation in edge thickness, an internal incremental thickness zone, a regressive thickness ¾one, or an increased surface friction ¾one (either one) located at or external to the I nhus, thus also external to the pupillary or optic zone which takes the form on the convex surface, by way of example only, of one or more of; a ring, (rings) band, (bands), partial rings (ringlets), dome (domes), Island (islands), segmented region (regions),, convex -surface. roughness/friction near or around the periphery of the Sens and/or within or covering the aperture widening zone, truncation (truncations), overall thickening of the co tact lens, larger diameter, and steeper base curve. The effect is to open- u - the palpebral fissure of the eye o the wearer and thus minimize the impact of blephatopio is on. visual, performance and/or enhance the cosmetic appearance of the patient/wearer. The prosthesis wlieii in the form of a corneoscleral contact lens can be that of a soft contact lens or hybrid contact lens, When the prosthesis is in the form -of a scleral ring as opposed to a contact lens the scleral ring comprises a cental open aperture without optical power. The scleral ring can he made of a material found in one of a; hard contact lens, gas perm contact lens, soil contact lens; hybrid contact lens.. The incremental thickness- region (zone, area) or a regressive thickness region (zone, area), or increased surface friction region (zone, area) for the prosthesis (bein a contact lens or scleral ring) can be one of: ro lonaliy symmetric,, rotation-ally asymmetric elliptical arch, like feature, and isolated, islands. The - elliptical arch (arches) like fe ture (features) can: resemble the curve of the lid margin of the upper lid and/or the curve, of the lid margin of the lower lid. The region of incremental thickness, or regressive thickness, or increased surface friction can be either continuous or discontinuous. The incremental thickness region, regressive thickness region, or increased surface friction can be made of the same .material: o different materials. The prosthesis can be worn as one of: continuous wear, daily wear weekly continuous wear, or monthly continuous wear. The prosthesis can be disposable o reusable,. The prosthesis can be removed and reinserted by the wearer,
jOI89f According to some embodi ents, a prosthesis is designed for increasing the wearer's natural vertical palpebral fissure by at least 0,5 mrn!: whereby the prosthesis design comprises a spline surface topograph and a aperture widening ¾one. The spline surface topography can be that of a Bezjer Curve, The prosthesis can be one of a soft contact lens, a eoraeo-sclerat contact lens, a hybrid, contact lens, and scleral ring. By utilizing a spline su.rfa.ee topography it is possible to design a prosthesis comprising an aperture widening zone of a maximum increased delta thickness ranging from 50 microns to 1000 microns (preferably within, the range of 1:00 microns to 400 microns). In some embodiments, the outer edge of the aperture widening zone is located within the range of 0.01 mm to 2,0 mm to facilitate largely maintaining the nianiifaeturer's specific edge profile. In. some embodiments, the outer edge o the aperture: widening zone Is located •within the range of 0.25 mm to 2.0 mm from the edge of the prosthesis, i some embodiments, the prosthesis includes an aperture widenin zone diameter that is greater than or equal to 1.0,5 mm. In some embodiments, the aperture widening zone diameter is within the range of .10.5 mm to 1 J) mm. In some embodiments, the aperture widening zone diameter is withi the range of 1 I.J) mm to .13.0 ram. In some embodiments, the prosthesis may also include one or more of a limbal. ring, a colored ring, an iris feature, an iris enhancement, and a eoior enhancement.
{0'J!HJf In some embodiments, the prosthesis includes an aperture widening zone having a inimum vertical peak to peak dimension of 30.5 mm or greater, i some embodiments, the minimum vertical peak to peak dimension is 1 1.0 ram or greater. In some embodiments, the minimum vertical peak to peak dimension i 1 1 ,5 mm or greater. In some embodiments, the minimum vertical peak to peak dimension is 12.0 mm or greater, in some embodiments, the minimum, vertical peak to peak dimensio is 12,5 mm or greater. In some embodiments, the minimum vertical peak to peak dimension is 13,0 mm or greater. In some embodiments, the minimum vertical peak to peak dimension is 13,5 mm or greater.
m Apyrtare f the eye (Palpebral ¾» e): is the area located between an eye¾ upper Md and the lower lid when the eye lids are open.
{0I.92| Aperture Widening Zone: (Also can be called one or more of an incremental thickness region /zone /area, a regressive thickness region /zone /area or an increased surface friction region / zone /area). Is a. region, zone, area that provides topography, or surface friction that raises (elevates) the upper lid and/or depresses (lowers the lower lid thus widening the aperture of the eye.
{01931 Aperture Wideniiig one Diameter. Is the dimension of the distance / length from a point o the peak incremental thickness (i.e., .maximum thickness delta) of the aperture widening, zone measured to the opposite like peak of incremental thickness through the geometrical center of a contact lens or scleral ring. This m y also be called the incremental thickness diameter. Or, when th aperture widening zone is flat, then it i measu e from the midpoint of the aperture widening zone to the opposite midpoint located on the aperture widening zone when measured through the geometrical, center of the e ntaet lens or scleral ring. |0I94| Area of ncremental thickness; The area located within the region or m of incremental thickness of the scleral ring or contact lens. Should (by way of example only) the region or zone of incremental thickness be a plurality of regions or zones the area of incremental t ckness would be referred t a areas of incremental thickness. It should be noted that an area of incremental thickness can be formed either by way of adding thickness to the surface or by removing thickness around the a ea of incremental thickness (thus by a regressi ve thickness sione).
jOI *>S| A Bi¾der curve: is a parametric curve requenily used in computer graphics and related fields. Generalizations of Bezier curves to higher dimensions are called Besder surfaces. In vector graphics,. Bexier curves are used to model smooth curves that can be scaled: indefinitely, 'Pat s," as they are commonly referred to in image manipulation programs, are combinations of linked Bezier curves. Paths are not bound by the limits of rasterized images and are intuitive to modify.
101:961 Blepharoptosis: also referred to as ptosis. Is defined as an abnormal low-lying upper eyelid margin with the eye in primary-' gaze. The normal' adult upper "I lies 1.5 mm below the superior corneal Ihnbus and is highest just nasal to the pupi l . Biepharoptosts can be classified as congenital, as shown below, or acquired. Thi differentiation is based on age, A more comprehensive classification Is based on etiology and includes myogenic, aponeurotic., neurogenic, mechanical, traumatic, and pseudopioiie. The most common cause of congenital ptosis is myogenic due to the improper development of the levator muscle
\M91\ Blepharoplasty is the name of the surgical, procedure tha provides tor lid lifting.
Presently there are approximately 200,000-300,000 blepharoplasty operations performed per year in the Uni ted States at the cost of approximately $2,500 per upper lids surgery and $3 S0G per lower lids surgery. Blepharoplasty is one of the top facial cosmetic surgical procedures performed for diose over the age of 40. In addition, i should also he noted, that bi eyes are perceived to be more attractive than small eyes in today's global society
| I 8{ Ceiitration of scleral .ring o contact lens: As used herein is meant to be the proper centering of the scleral ring or contact lens so mat the wearer's limhus and/or pupil is mostly centered within the open aperture of the scleral ring or in the case of contact lens the wearer's pupil is mostly centered within the optic zone. 0ί:99| Central Open Aperture: Means a hole or opening devoid of niate.rial that includes the geometrical center of the prosthesis.
Ϊ2 θ| Color Enhancing Region: A region, zone, area that provides ai least a color different t¾ rest of a prosthesis. "The prosthesis ma include a. color enhancing region. When the prosthesis is a coraeo-sekral contact, lens or scleral rin the color enhancing region can be located on th outer convex surface or concave surface of the contact lens or ring, or buried between the inner convex surface and the outer opposing concave surface; The color enhancing region can be located on or within the corneoscleral contact lens or scleral ring such, to cover a portion of tire limbal area of the wearer's eye when the prosthesis is being worn. In some embodiments the- color enhancing region can be located on or within a comeo-sc Serai contact lens or .scleral ring so as to cover all of the lirnhal area of the wearer's eye and extend over the limbal area of the wearer's eye over a portion of the wearer's cornea, when the prosthesis is being worn, hi some embodiments the color enhancing region cars be located on or. within a corneoscleral contact lens or scleral ring such to extend over the lirabal area of the wearer's eye and over a portion of the sclera of the wearer's eye when die prosthesis is being worn. In some embodiments, the color enhancing: region can be located on or within the cornets scleral contact lens or scleral ring so as to extend over the timbal area of the wearer's eye, over a portion of the cornea of the wearer's eye and over a portion of the sclera of the wearer's eye when the prosthesis is being worn The color enhancing region ca be rotationally symmetric on or within the prosthesis. The color enhancin region can be aon-rotationall symmetric on or within the prosthesis. The color enhancing region can be, by wa of example only, a ring, broken ring, zone, series of zones, a u fhrrn color, •multiple colors, multiple shade of a particular color, an accent color. The color enhancing' region can cause the perception of the wearer's iris to look, larger.. The color enhancing; region can change the color of the wearers eye. The color enhancing region can make the wearer's eve look larger. The color enhancing reaion can. only sitghtlv alter the color of the wearer's eye. The color enhancing region can greatly alter the color of. the wearer's eye...
201] When located on the surface of the contact lens or scleral ring, the color enhancing region can be a surface feature, in some embodiments, the entire color enhancing region may provide an increased surface friction,, in some embodiments, a portion of the color enhancin region may provide increased surface- friction.. The color enhancing region can be, by way of example- only, a limbal ring, a colored ring, a color enhanced iris area ie..g.s tinted iris ring), or an cce t color. The color enhancing region can serve to both provide color and also as an eye aperture widening element, in som embodiments, the color enhancing region, can cover ail. of the limbus of the eye of the wearer and. also ail of the cornea of the eye of the wearer when the prosthesis is being worn. The color enhancing region may overlap. In whole or in part, with an aperture widening zone..
j¾202f Contact Lens: Is a. thin lens designed to fit over the cornea and usually worn to correct defects in vision. Contact lenses generally fall into three major categories: #1} corneal contact lens, #2) Comeo-seSeral contact lens, and #3) Scleral contact lens. The three major categories can then be further broken down, into sub categories (by way of example only) A) daily wear (meaning onl used, dall for wearing and taking out when sleeping), B) continuous wear (meaning wearing day and night round the clock for a limited number of days, and C) disposable contact lenses which can be worn either daily or continuously, but are discarded when they become dirt or lose certain optical or comfort qualities, ø' is important to note thai the prosthesis being disclosed herein Is that of category #2 {comeo-scierai contact iem) therefore wheu the term contact Sens i s used it is meant to be that of a corneo-seleral contact lens).
[02ft3| Corneal contact leas: Corneal Senses are supported exclusively by the cornea, and do not extend past the limbus (the junction between the cornea and the sclera). An example of a corneal contact lens would be a hard rigid contact lens having a diameter no larger than the diameter of the wearer's cornea and in most: eases smaller tha the diameter of the wearer's cornea. Corneal contact, lenses can also be soil contact lens. Corneal-scleral Sens ma be made of a hydrogel materials, such as but not Limited to, a silicone hydrogel material.
|02(l4j Corneo-sderal: tenses* Corneo-scier¾l lenses are a type o contact Sens used to correct defects in vision. The name refer to the area and resting points of the lens in the eye. Conieo-scfcral lenses are supported by both the cornea and bulbar conjunctiva that is above the sclera, and do extend past the Iimbus, Examples of coraeo-seierai contact lens would be: soft contact lens and hybrid contact lens. These Senses have diameter in excess of the diameter of the wearer's cornea and extend past the weareri limbaS area. They range generally (but not always) from 12.5 to 15 mm m diameter. The tear reservoi underneath a comeo-seleral lens is very limited compared to full scleral contact lenses thai vault: the cornea. Comeo-sclera! lenses are the most common used.
[0205} Belta Incremental Thickness, Incremental T ckness Belta, elts .
Incremental Thickness, and M ximum Change in Thickness; Is the difference in thickness between a point located within th incremental thickness region and the norma! thickness of the contact lens or scleral ring measured ai. the same point. The maximum delta is the point where the thickness differential or maximum delta thickness is the greatest or said another way, the poin where the .maximum change in thickness i fou d;0306 { Delta Regressive TMekoess, Regressive Thickness Delta, Delta of Regressive
Thickness, and aximum Change in Thickness? Is the difference in thickness between a point located within the regressive thickness region compared to a thickness of a near (closely located) area of the contact lens or scleral ring internal (on the side towards the center of the prosthesis). The maximum delta is the point where the thickness differential or maximum delta thickness is die greatest, or said another way, the point where the tnaxirmarj change in thickness is found.
|0207| Edge: The edge of the contact lens or scleral ring as used herei is the outer peripheral circumference of the contact lens or in the case of a scleral ring, either die Outer peripheral edge or inner peripheral edge closest to the ope aperture of the scleral ring. The inner edge of a scleral ring (adjacent to the open center aperture) has a similar contour as that of the outer edge of the scleral ring..
|0208] First order continuity: is a measure of smoothness for a carve or surface. First Order continuity means that the first parametric derivatives of two eurve/sur&ee sections are proportional at their boundary. In other words, first order continuity means that, ai a point of intersection between, a first curve/surface and a second curve/surface, the first derivatives for the first curve surface and. the second enrve/soriaee are continuous.
{02i9f Gas perm contact le s. Is a contact lens comprising a rigid material that is permeable to oxygen; such a material is used, in gas perm corneal contact lenses that are of a diameter equal to or less than the diameter of the wearer's eomea or in the central rigid gas permeable region, of a hybrid contact- lens whereby the. materia! which is central to that of a soft hydrophiiic skirt Is of a gas permeable material. fill! (if Geometrical Center Ϊ Geometrical center as used herein s meant to be the absolute center of a scleral ring or contact lens, in the ease of a contact lens it is real; in the case ofa scleral ring it is imaginary given the central open aperture.
jffiS!lf Hybrid Contact Lens or Hybrid Scleral Ring: A hybrid contact leas as used herein is a contact lens or scleral, ring comprised of two or more materials bonded together. An exam le of this would be like that of today's commercially available hybrid contact lens comprising a central gas permeable material and an outer soft Irydrophilic contact tens skirt Three additional embodiments discussed herein are: #1) An embodiment taught herein whereby the outer periphery of the hybrid contact len i rigid and the center is soil or #2) in the case of a scleral ring, a rin thai rests over the sclera being of a more rigid (less soft or more rigid) material, however, having affixed to the scleral ring, a softer more pliable material that forms part or .all of the incremental thickness zone thai provides the widening effect.. This softer more pliable material can he in the form of finger like members thai extend away from the more rigid scleral ring. #3) In the ease of a soft contact lens having a member or surface treatment which is not of the same material that provides increased surface friction such to raise the upper lid and/or lower the lower lid.
j02l.2| Incremental Thickness: I that of the increased differential or delta thickness when taking a poin on the base scleral ring o contact lens of a normalized conve surface or normalized concave surface calculating the differential from that poin to that of the same point on the scleral ring or contact len taught herein. Said another way; after mathematically normalising' the convex, surface curvature of the scleral rin or contact lens, is the additional thickness added over and beyond the normalized convex surface o normalized concave surface of the scleral ring or contact lens. It is importan t note for a' contact lens the convex surface of the optic zone is not considered in the calculation of the normalized convex surface and thus excluded, as the optic zone may have a differen convex curvature due to the specific optical power of the contact lens. The maximum incremental thickness is the peak thickness delta or the maximum change in thickness. It Is important to n te that incremeutal thickness can be created by being surrounded or adj cent to a regressive thickness region,
(0213) Inc em nt. Thickness l>ianieter: The incremental thickness diameter is the distance along the vertical axis from a point of maximum delta thickness or maximum change in thickness proceeding through the geometrical center of the prosthesis in a. straight line to that of a point of maximum delta thickness or maximum change in thickness located on the opposite side from the previous point of maximum delta thickness.
|0214| Incremental Thickness Region /Zone /Area: (also is referred to as an
"Apertu e idening .Zone**) is a phrase coined for the purposes of this patent application, incremental thickness zone is the additional thickness of a ione:, region, area that is added over and beyond, the normalized convex surface or normalize concave surface of the contact lens or scleral ring. The incremental thickness ¾one can also be made up of a plurality of zones or regions of incremental thickness and can he further brokers into an. area of areas of incremental thickness, hi most, but not ali eases, the incremental thickness zone or region provides no useful vision correction, for the wearer. The increrricntal thickness zone is also called the aperture widening zone. The purpose of the incremental thickness region or zone is that of providin a force against the upper lid (lids) io Hit (elevate) arid/or the lower lid to lower (depress) such to widen the eye's palpebral -fissure (aperture) of the wearer.
1 2151 Incremental Thickness Zm Width; Is the width measurement on the convex surface of the scleral, ring or contact lens where the incremental thickness zone begins and ends. This is the width of the incremental thickness zone usually measured from the portion closest to the outer edge of the prosthesis to the portion closest to that of the geometrical center of th prosthesis.
|l) i6f Inner Stupe: The "inner** slope is the slope oi the aperture widening zone between the point of maximum thickness delta and where the aperture widening zone ends closest to the geometrical center of the prosthesis.
| 217j Junction: junction as used herein is meant to he the location of a conventional hybrid contact lens where the gas permeable central region's outer peripheral edge meets the inner peripheral edge of the outer soft skirt or in the case of a hybrid scleral ring or a reverse hybrid lens is the location of where the two different materials meet,
(12181 Limhus: T he marginal region of the cornea of the eye by which it is adjacent with the sclera. The average diameter of the cornea is approximately 11 - 12 mm and normally recognized to be approximately 1.1.5 ram on average. |0219J Minimum Vertical lmensimi: is one way to measure and/or quantify structural features of a prosthesis with an aperture w dening zone, Minimum vertical dimension Is a parameter used to quantify some, but not necessarily all, embodiments described here. "Vertical dimension" is the vertical distance between the highest part of aft aperture widening zone near the top of the prosthesis, and the lowest part of an aperture widening zone near the bottom of the prosthesis, in other words, the ' Vertical dimension*' defines the vertical distance between the uppermost part of the prosthesis that pushe the upper eyelid op, and the lowermost par of die prosthesis that pushes the lower eyelid down. Where the aperture widening ?one starts at the edge of the prosthesis, the 'Vertical dimension" of the aperture widening mm corresponds to the vertical size (overall diameter) of the prosthesis. If die highest and lowest parts do not tie on the same vertical axis, then the "vertical dimension" is die distance between a projection of the highest and lowest points onto a vertical axis, if the aperture widening is not rotationatiy symmetric, the vertical distance may chang as die prosthesi i rotated. The "m nimum vertical; dimension'' is the vertical dimension that corresponds to th rotational position(s) of the prosthesis that has the smallest vertical dimension.. Pre ure from the eye lid will, in many cases, tend to rotate the prosthesis into this rotational position,
j022(l{ Minimum 'Vertical Peak to Peak ]}| eii$¼n: h one way to measure and/or quantif structural features of a prosthesis with an aperture widening zone. Minimum vertical peak to peak dimension is a parameter used to quantity some, but not necessarily all, embodiments described here. "Vertical peak: to peak dimension" is the vertical distance between the highest part of an aperture widening ¾one located at a .maximum added thickness delta near the top of the prosthesis, and. the lowest part of an aperture widening zone located, at a maximum, added thickness delta near the bottom of die prosthesis,, in other wards, the ''vertical, peak, to peak dimension" defines: the vertical distance between the uppermost part of the maximum added thickness delta of the aperture widening ¾one and the lowermost part of die maximum added thickness delta of the aperture widening zone. If the highest and lowest maximum added thickness delta do not lie on the same vertical axis, then the "'vertical peak to peak dimension*'' the distance between a projection of the highest and lowest points onto a vertical axis. If the aperture widening zone is not rotationaliy symmetric, the vertical peak, to peak distance may change as die prosthesis is rotated The "niimrnur vertical peak, to peak dimension" is- the vertical dimension that corresponds to the rotational positk)n(s) of the prosthesis that has the smallest vertical dimension -from one point of maximum added thickness delta to another point of added maximum thickness delta. Pressure from the eye lids will, in man eases, tend to rotate the prosthesi into thi rotational position,
j 22i | Multifocal Contact hem: Is a contact lens comprised of two or more optical power regions. Such a contact lefts is used to correct presbyopia as well as at a minimum the wearer's distance vision. Some multifocal contact lenses will correct distance, intermediate and near vision of the wearer,
[D222 tural Palpebral Fissure (Natural Aperture): The space between the margins of the eyelids— -called also rima palpebrarum. The natural palpebral .fissure is the space or area of the palpebral fissure when not wearing a contact Sens, when the eye or e es are relaxed arid while the individual is expressionless and not squinting, stniting or f owning etc.
223') Normalized Front Convex Surface:; Is meant to mean a front convex surface without any incremental thickness added io that of a normal front convex surface of a contact lens or scleral ring. The normal front convex surface can be thai of a non- spherical convex curvature or a spherical convex curvature. In most,, hut not all, cases the .normalised front surface is thai of a spherical curvature. Said another way the iTO.rffiali.zed front convex curvature- equals the convex curvature- minus the incremental thickness added. When norroa!feing the convex, surface of a contact lens the normalized surface does not take into account the convex surface of the optic zone as the- optic zone may have a different curvature influenced by the optical power of the contact lens.
$224) Normalized Back Concave Surface: Is meant to mean a back concave surface without any incremental thickness added to that of a normal hack concave surface of a coniact lens or scleral ring, lie norma! back concave surface can he that of a non- spherical convex curvature or a spherical convex curvature. The normalized hack concave surface can be that of an aspherie surface. In most, hut not all cases the normalized hack Concave surface is that of a spherical, curvature. Said another way the normalized back concave curvature equals the concave curvature minus the incremental, thickness added,
$225) Optk ¾©ne: is the central zone of the contact lens that comprises optical power,
'The optic zone is of a fixed size and in a fixed location, within the contact lens. In die disclosure contained herein, the term optic zone and optical. 'zone are .meant to mean the s me. Generally the optic zone of soil contact lenses ran es etween 7 ram ie 9 mm i diameter. The optic zone diameter is generally larger than the pupillary zone diameter io prevent glare and light scatter when the pupil dilates at night. The scleral ring does not have an optic ne, but rather an open aperture.
0226} Overall Outer Diameter: The diameter measured from the outer edge of the prosthesis across the prosthesis through the geometrical center to the opposing outer edge. 227| Outer Slope: The "outer" slope is the slope of the aperture widening zone between the point of maxim m thickness delta and where the aperture widening zone ends closest to the outer edge of the prosthesis.
[0228| Overall Thickness: The thickness when measured, ai a point on the concave surface of the contact lens or scleral ring to a point on the outside convex surface at the same point relative to one au.oth.er.
\Q229\ Feak Thickness Delta (Maxhuara Thickness Delta): Is the ma im m- incremental thickness (added) or the -maximum regressive thickness (reduced). Said another way is the maximum change in thickness.
[0230 J Prosthesis: A device worn by a wearer that provides a benefit for the wearer, in the case of the disclosure disclosed, herein the benefit can he that of a cosmetic benefit or a vision benefit,
[0231 f Ptosis A drooping of the upper eyelid caused by way of example only: from paralysis of the oculomotor nerve. Ptosis refers to abnormal dr oping -of the -upper eyelid which can affect one or both the eyes. It may be constant or intermittent in nature. Ptosis can be congenital, if present since birth, or it may be acquired when it develops later in life. Usually ptosis occurs as an isolated, disorder but may also be associated with various other conditions. Ptosis may afflict both children and the adult population, incidence of ptosis has been reported to be 0.18% in children, but occurs more frequently in older adults, probably due to the aging factor, and may affect up to i% of the population or more. Both men and women are e ually susceptible to ptosis.
[ 2321 The most common feature of ptosis is drooping of the upper eyelid of the affected eye. Depending on the seventy of drooping, it is categorized into: minimal (1 - 2 mm), moderate (3 - 4 mm) and severe {> 4 mm), individuals with- ptosis may complain of increased tearing and blurred vision. Patients with significant ptosis may need to lift the eyelid with a finger, or raise their eyebrows for norma! straight vision and this may lead to tension headaches and eyestrain.
jil233 Ptosis occurs when the muscles that raise the eyelid (levator and Mailers muscles) are .not strong enough to do so properl . It can affect one eye w both eyes and is more common n the elderly, as muscles in the eyelids may begin to deteriorate. Ptosis •usually result's due to failure of eyelid muscles to function, properly. This may occur due to localized damage to eyelid muscles or damage to nerves supplying the eyelid muscles. I may also occur as a normal aging process. Individuals with diseases like Myasthenia gravis. Diabetes mei!itus, stroke, Horner's syndrome a d brain tumor are at increased risk of acquiring ptosis, in fact myasthenia gravis, which is a neuromuscular disorder, is one of the common causes of acquired ptosis. It has also bee reported that long term 'wearers of contact lenses may develop ptos s and also those who use Botox for cosmetic treatment of appearance, if left untreated, especially in children, ptosis may lead to' a complication called ' Lazy Eye" where the child cannot see properly wit one of his or her eyes. This •condition can be reversed if treated properly. There may be- -emotional disturbances in children due to visual defect and physical dist gunsment,
|0234| Regular monitoring of the condition is required in cases of mild ptosis, where n visual impairment is present. However, significant congenital ptosis may warrant surgical intervention which includes expertise of an eye specialist and a plastic surgeon. Surgical modalities include correction of eyelid muscles and procedures like Levator resection, Midler muscle resection or Frontalis sling operations are generally performed. Nonsurgical modalities like use of Crunch glasses Or special Scleral contact lenses are also popular nowadays. FIG. 1 shows an individual with congenital pto i on the left eye.
|Θ235| FIG. 2 illustrates a visual field that shows the functional blockage due to a piotie fid, Ptosis can affect the visual field of the wearer's eye thus limiting the area f .functional vision, if the ptosi is of the upper lid and whereby the upper lid covers portion of the pupil the individual having the ptosis will lose the ability to see in a portion of his or her superior visual field. FfGS, 3-7 show four individuals afflicted with ptosis. Ptosis can afflict all ages with the highest incidence in those over the age of 40,
{'0236] Pupillary Zone: A osed herein is the zone of a contact lens when wor by wearer, whereby the wearer's pupil would be in optical communication with (or said another way where the pupil of the wearer s eye would receive light through), The papillary ¾one is of a larger area at night or dim iilyuiinatiors when the pupil is dilated and of a smaller area in higher levels of ambient light. The pupillary z ne of the prosthesis described herein generally mages from, approximately 6 mm in diameter to 8 mm in diameter (or a radios of 3 mm to 4 mm from the geometrical center of the contact lens) in order to cover the pupil when the pupil dilates due to a low level of ambient light. The pupillary zone is generall smal ler than the contact lens optic zone, of optical zone. The pupillary zone is located within the scleral ring central open aperture.
| 237| i%g Back; The term "piggyback" or piggybacking is thai of: of a smaller, rigid contact lens on the surface of a larger, soft contact 'lens. These techniques give the vision corrections benefits of a rigid lens and the comfort benefits of a soft lens. The term can also apply to two or more soft contact lenses being worn simultaneousl .
Region: The terms region, zone, area all have the s me meaning in this disclosure.
|;0239 j Regressive Thickness: Is a reduction of thickness,
10240) Regressive Thickness Diameter: The incremental thicknes diameter is the distance along the vertical axis from a point of maximum delta thickness proceeding ihrough the .geometrical center of the prosthesis in a straight line to that of a point of maximum delta thickness located on the opposite side from the previous point of maximum delta thickness.
[02411 Regressive thickness .region: (Also referred to m an "Aperture idening
one") is a region whereby the normalized thickness of the prosthesis is reduced such to form by way of example only, a "valley" like area, region, zone of topography o the convex surface of the prosthesis or a "partial" valley like area, region, zone whereby one side increases so thickness and the other side maintains the same thickness or decreases further in thickness. A regressive thickness region generally (but not always) result in an incremental thickness region,
|0242'| Regressive Thickness Zone Width: is the width measurement on the convex surface of the sclera! ring or contact lens where the regressive thickness zone begins and ends. It is generall (but not always) measured from where it starts closest to the outer edge of the prosthesis to where it ends on the side closer to the geometrical center of the prosthesis. i243| Reverse H b id Contact Lens: This is a hybrid prosthesis whereby the miter skirt is made of a rigid material and the center zone is made of a soft lefts roaieriaL
{024 1 Rigid Center: Rigid center Is meant to be the area of a contact lens; conventional gas perm or hybrid gas perm being made of a rigid material
| 24S| Ring: The terra ring as used herein can be that of a continuous ring or a discontinuous ring.: Thus a ring of incremental thickness can be one that is a continuous ring or a broken discon.tir.uons ring. A. ring can also be called one of a band (bands), zone (^ones), island (islands), region (regions), and segment (segments) that rings the prosthesis either continuously or discontinuously,
{8 46} Sclera; The whitish covering of the eye which joins the eotnea at the limb us arid
Is covered in certa n regions of the eye by die bulbar conjiichvs.
|ft247| Scleral Ring Eye Enhancer {scleral r ng); A prosthesis device which fits over the sclera of the eye of a wearer, lias a topography (aperture wi denin g zone) located on its convex outer surface thai provides for widening of the palpebral fissure of the w¾arer an comprises a open central aperture such to not interfere with the line of sight of the wearer, A scleral ring can comprise one material (homogenous) o multiple materials in the case of a hybrid scleral ring, A hybrid scleral ring can comprise finger like members that lift the upper lid nd/or lower the lower lid. The sclera! ring does not comprise Optical power. In most, but not all cases, the scleral ring does not cover parts of the cornea. However, in some embodiments the scleral ring will cover tbe limbus and a very limited peripheral region the cornea,
{92 81 Scleral Contact lens; A scleral lens is a specially designed large-diameter "rigid" contact lens that vaults the cornea (meaning it does not rest on the cornea). They can range from 14 mm to over 20 mm in. diameter. They are called "scleral" lenses because they completel cover and vault the cornea (the clear dome of tissue that covers the colored part of the eye) and extend onto the sclera (the white part of the eye that forms the outer wall of the eye). Scleral lenses are supported exclusively by the sclera, and completely vault the cornea and the iioibus. Scleral lens fit very tightly on die sclera of the wearer's eye,
{'02491 Second Order Continuity: is a measure of smoothness for a curve or surface.
Second order .continuity means that both the first and second parametric derivatives of two eurve sut kce sections are proportional at their boundary, in other words, first and second order continuity means that, at a point of intersection between a first curve/surface; and a second curve/surface, the first and second derivatives for die first curve/surface and the second curve/surface are continuous.
!¾250f Silicone Hydrogei: is a material used for soft contact lenses. In 19 8, silicone hydrogels became available. Silicone hydrogels have both the extremely high oxygen permeability of silicone and the comfort and clinical erformance of the conventional hydrogels. Because silicone allows more oxygen permeability than water, the oxygen permeability of silicone bydrogels is nor tied to the water content of the lens. Lenses ha ve now been developed with so much oxygen permeabilit that they are approved or overnight wear (extended wear). Lenses approved for daily wear are also available in silicone hydrogei material
jftlSl I Disadvantages of silicone bydrogels are that they are slightly stiller and the lens surface can be hydrophobic and less "wet-able." These factors can influence the comfort of the lens. Ne manufeeturing technique and changes to multipurpose solutions have minimized these effects. A surface modification processes called plasma coating alters the hydrophobic nature of the lens surface. Another technique incorporates internal re wettin agents to make the lens surface hydrophi!ic. A third process uses longer backbone polymer chains that result in less cross linking and increased wetting without surface alterations or additive agents.
[8252| Single Vision Contact Lens: A contact lens comprising a single optical power.
The optical power can be to correct one or more of: hyperopia, myopia, and astigmatism.
11)2531 Slide Resistances The resistance imparted between the lid f lids) and the contact lens as the lid (lids) blink and move across the contact lens o scleral ring.
[935 1 Slope: Is the curvature or topography of an external surface. More specifically the slope in this disclosure is characterized as the degree of incline or decline of the aperture widening zone, region or area. The slope is characterized by the outer slope and the inner slope.
[02551 Soft skirt: Soft skirt is the outer circular m of soft hydrophiiic material found located on a hybrid contac lens or scleral ring.
[1)2561 Soft Contact Leas: While rigid Senses have been around for about 120 years, soft lenses are a much more recent development The principal breakthrough in soli lenses made by Otto Wichterle led to the launch of tie first soft hydrogei lenses in some countries in the 1960s and the approval of the "Softens" daily material (poiymaeon) y ihe United Slates FDA in 1971. Soft contact lenses are immediately comfortable, while rigid contact lenses require a period of adaptation before Ml comfort is achieved. The biggest improvements t soft tens polymers have been increasin oxygen peHneabiHiy, lens wettability, and overall co.mlb.rt.
f6257) Spline; A function that is defined on an interval, is used to approximate a given
Junction, and is composed of pieces of simple functions defined on suhintervaSs and joined at their endpoints with a suitable degree of smoothness.
[02581 Stabilization mtm A region, zone, area that stabilizes the prosthesis such as b way of example only; eo-axia! stabilization zones, truncation, prism ballast, slab oiX weighted. A stabilization zone will substantially reduce or stop rotation of the prosthesis when in the eye upon lid blinks. The .stabili ation zone generally touches the lid margin to prevent the lens from rotating. Stabilization zones or features can cause a reduction in oxygen transmission by a soft contact lens to the wearer's cornea.
j(J:2§9| Surface Feature: a feature located on the surface of the prosthesis that is different from the rest of the prosthesis. This feature can be, by way of example only, an increased/decreased thickness, increased surface friction, a region made of a different material, dimples, bumps, surfaces Irregularities, any change in surface topography, and any combination thereof A surface feature can include an aperture widening zone. A surface feature can be located within an aperture widening zone, surface feature can include or can be an area of increased surface friction. A. surface feature can be located within, an area of increase surface f iction. A surface feature can be of a rotationally symmetric design. A surface feature can be of a ringed design. A surface feature ean be: of a broken ring design. A surface feature can be of a nou-rotationaliy symmetric design. A surface feature can be created by, for example, but not limited to: molding,, stamping, laser etching, chemical etching, laser treatment, chemical treatment, deposition, gas exposure, printing, altering the exposed external surface, the addition of .different material, the addition of the same material, modifying the exposed convex surface material. I» some embodiments, a surface feature may Include a raised surface relative to the norrna&ed front convex surface of prosthesis. In some embodiments, the surface feature may have a raised height of 1 angstrom or more., in some einbodiiBents, a surface feature ma have no raised surface relative to the normalized front con ex surface of a prosthesis (i.e., may be flat relative to the normalized front convex surface), in other words, the area of increased surface icti n may take m the normal curvat re- of the cot) vex surface of the prosthesis. A surface feature can comprise an irregular surface. jft260| Su face Friction or Increased Su ace Friction; e n a surface area, zone, region of the -convex surface of the prosthesis which provides for an increased surface friction when contacted by the eye lids of the wearer of the prosthesis. This area on the convex surface of the prosthesis can be located on the aperture widening ¾o«e. This area or ¾one can be provided on the- surface: of the zone or region of incremental thickness or in place of the zone or region of incremental thickness. An increased surface friction region, one, area can be flat or raised.
10 61! Thickness Region or one; Hie region or zone of the contact lens where the incremental thickness is added to that of a base contact lens. This region or zone is where thickness is added to the convex: external sartace. It ca also be referred to as the incremental t ickness zone,
|0 62! Thickness differential; is a region, zone, area of the prosthesis whereby first point is thinner than a second point which is adjacent to die first point, in most cases (not all) this thickness differential is gradual and not step function resultin in a discontinuity* Thickness differential can be found, on the prosthesis in the regio of incremental thickness, or a regressive thickness region.
[0263| Thickness Slope: Hie measured thickness per traveled mm along a horizontal axis of a surface topography having an incline or decline. The thickness slope can be calculated using incremental thickness or regressive thickness, and -also by way of the -overall thickness. The thickness slope can he located, at the onter thickness slope region or the inner thickness slope region both of which are associated, with the aperture widening zone.
I026 J Toric Contact Lens: is a contact lens that is comprised, of a toric region or zone that corrects for an astigmatic error of the wearer, A toric lens o thi type can be cylindrical corrective power or a sphero-cylindrical optical power. A toric lens may he stabilized by way of example only, a truncation, prism weighting, and the topography design of its convex surface.
fi)26S| Vertical Dhnension; Is the distance between the highest and lowest points of the aperture widening zone projected onto a vertical axis. If the aperture : widening zone is not symmetrical la nature the vertical, dimension may vary as the lens rotates, i.e. the vertical dimension is a function of the rotational position of the lens,
0266] FIGS. 8 ···■ 1. 1 are examples of eyes that ma he excluded from the patient population being fit with the prostheses (e.g., contact, lenses) being taught herein. It should be noted that the upper lids of the individuals in FIGS. 8 - 1.1. do not come within 2 mm of the upper edge of the pupil or the . lower lid does not come within 2 mm of the lower edge of the pupil
0267] As discussed above scleral hard / rigid, contact lenses designed to lift the upper lid have been a major failure in the market place due to the significant discomfort associated with such a lens when the wearer normally blinks his or her lids. n addition, the cosmetics of the eye when wearing such a scleral contact lens is not pleasing for the wearer. For ail practical purposes such sclera contact lenses-designed, for correcting ptosis have largely ceased, being commercial since the 198()s. Rigid corneal contact lenses that fit only on the cornea are not capable of lifting the lid of a wearer as the lid will push the contact lens of? carter.
0268{ Conventional comeo-seleral contact lenses (those most popular in the world today) (prior to the eomeo-scleral contact lenses taught herein) due to their geometrical design have not been capable of lifting the lids or opening the palpebral fissures of a plurality of eomeo-scieral contact lens wearers, Coraeo-sclera! contact lenses provide a plurality of different optical corrections. The use of a the phrase a "plurality of different optical corrections or prescriptions" is meant to he the optical power or prescription of wearers of corneo-seleral contact lenses being of piano (no optical power) and als mostly all known optical prescriptions or optical powers provided by contact lenses.
2691 Thus there i an unmet need for a prosthesis in the tbrro of a corneo-sclerai contact lens (soft contact Sens and / or hybrid contact: leas) capable of being designed t provide mostly any and ail known optical powers including piano, a high level of comfort, good eenfration, and excellent nourishment that will lift the upper lid (in the ease of a ptosis) and/or lower the lower lid of the wearer thus widening the wearer's palpebral fissure (or fissures/apertures when wearing two such, contact lenses; one for the right eye and one for the left eye).
β2?0| hi addition, there is a pressin need for a prosthesis which widens the palpebra! fissure (aperture) of the eye for a "non-wearer" of contact lenses. Such a prosthesis is described herein as another embodiment in the form- of a scleral ring, A scleral ring is not intended to be a contact lens. A. scleral ring does not comprise an optic zone or any optical power. The central region of a scleral ring is that of a central ope aperture. However, the scleral ring as taught herein comprises an aperture widenin zone that widens the palpebral fissure or eye aperture of the wearer,
102711 It should be pointed out that when the term "contact lens" is used herein, unless mentioned as that, of one of a scleral contact lens, a gas perm cornea! contact lens, or a hard corneal contact lens,, is meant to he that of a corneoscleral contact lens. The contact lens which, is disclosed herein is that of a corneoscleral contact Sens. Therefore when reading this disclosure the term "contact leos" should always be interpreted to be that of a corneoscleral contact lens with, the exception noted within this paragraph. The term sclera! ring should be understood to have the -meaning as defined in the definitions which are contained herein. A. sclera ring: can be made- of soft lens materials by way of example only, h drogeis, silicone hydrogeis or gas perm materials or mm gas perm / standard hard leas materials. Such s ft, gas perm, or non gas perm materials are well known in the art,
[0272} The embodiments disclosed herein teach a prosthesis in the form of a corneoscleral contact lens and in the form of a sclera! ring. The corneoscleral contact lens has a regio or m of a mi imum of 25 or more microns of incremental thickness located anywhere within a region outside of a point TO mm from the geometrical center of tire contact lens, whereby the corneoscleral, contact lens thru its optic zone provides the appropriate optical power to largely correct the wearer' uncorrected refractive error and whereby the incremental thickness is the thickness delta measured at the same point compared to thai of the same manufacturer's conventional contact lens fo providing the same optical power correction, and of me same type and whereby the region of incremental thickness causes a widening of the palpebral fissure of the wearer's eye. The eonieo-seleral contact lens can be by way of example only, a soft contact lens o a hybrid contact lens. The corneoscleral contact lens can be of an. optical design of an one o more of a single vision, multifocal,, tone, and astigmatic contact lens. The soft contact lens can. be that of a. continuous wear, daily wear, planned replacement or disposable. The corneoscleral contact !ens can have a colored, tinted iris ring, limhal ring or circular band located appropriately removed from the optic zone of the contact lens to further accentuate a widening of the palpebral fi sure of the wearer, .-A. portion of this colored. iinied ring or band can be located a proximately adjacem but over that of the limbus of the eye of the wearer and can extend beyond the limbus of the wearer. Meaning the outer diameter of the colored portion t colored portion can be larger man the diameter of tire limbus to limbus measurement.
j02?3J The scleral ring is that of a ring which generally, but not always, has its outer peripheral edge located 'under the upper and lower lids when the eye is opened normally and has its inner peripheral edge located outside of the wearer's pupil diameter (when naturally dilated for darkness) such to not. interfere with the line of sight of the wearer. The inner edge of a scleral ring (adjacent to the open center aperture) has a similar contour as that of the outer peripheral edge of the scleral ring. This helps to prevent discomfort for the wearer when he or she blinks. The scleral ring has an open central aperture which allows for the wearer' s line of sight to be uninhibited.. The scleral ring can be comprised of any of the various contact lens materials; hard, gas erm, soft hybrid. The scleral ring can comprise an. aperture widening zone or region of incremental thickness, regressive thicknes and/or an area of increased surface friction. An increased surface f iction zone can he Oat or raised on the convex surface of the prosthesis. The region or ne of incremental thickness can be, by way of example only, made of one material (which is that of the base material of the ring) or of multiple materials such that more pliable softer material is affixed to the more rigid, less pliable soft material of the main, scleral ring. In most, but not ail cases, when speaking of a hybrid scleral ring the more pliable materia! (less rigid) provides the upper lid lift and lower lid depression, )2?4 A hybrid scleral ring in some> but not ail, embodiments can comprise finger like members that lift, the tipper lid and/or lower the lower lid. The scleral ring does not comprise optical power. The mechanism of action is that the u pper and lower lids pro vide a force when closing or closed that overcomes the normal force needed to fold or bend the finger like member, but upon the lids being reopened the force needed t fold or bend the finger like member becomes less than that imposed by the structure of the finger like member and thus the finger like member springs back into position thus now overcoming and elevating or lifting the upper lid and/or depressing or lowering the lower lid. In some embodiments, but not ail, of the hybrid scleral rin the finger like member is bent or folded into a receiving trench which was pre~ibrmed (designed) in an outer surface of the scleral ring. The location, of the trench o trenches is provided in the proper location relative to each finger like member. This allows for the finger lik member (members) to be folded almost flat as it blinks so that die Hd cars easily close or open over i finger tike member (members).. It should be also pointed out that while the disclosure shows aiid teaches the finger like members being associated with the scleral ring prosthesis they can also be associated with a contact lens prosthesis,
102751 The incremental zone can be comprised of a homogenous material when the scleral ring and contact leas is made of one material or a hybrid zon whe the scleral ring or contact leas is made of two materials. In some embodiments o the prosthesis there may or may riot be an incremental thickness zone or region or a regressive thickness zone or region, but rather the surface of the z ne or region, is altered to provide to provide additional lid friction. This region or zone of increased surface friction can be easily over come during an eye lid blink or forced closure, but upon opening the eye lid ibis: region of increased friction elevates the upper lid and/or depresses the lower lid thus opening the aperture of the eye. An increased surface friction »>ne, region, area can be flat or raised •on the convex surface of the prosthesis. An increased serfaoe friction m , region, area can be an aperture widening ¾©«e, region, area.
276) The mm of incremental thickness or increased surface -friction found in some embodiments of the prosthesis taught herein can be shaped, by way of example only, as that: of a: ring (rings), ringlets, partial rings, band, bands, partial bands, dome, a series of domes, isolated regions or islands of any geometrical shape, segmented areas or segmented areas. The zone of incremental thickness ts located on the convex outer surface of the contact lens. The zone of incremental thickness ca be expressed a the area- f thickness that elevates from that of the normalized outer convex surface curvature of the contact lens or scleral ring. In most, but not all, preferred embodiirsenis of the contact lens or sclera! ring the zone of incremental thickness (of aperture widening zone) is connected to that of the outer convex surface curvature at the point where its outer slope meets the convex surface or its inner slope meets the convex surface in a continuous manner (meaning the convex curvature of the contact lens or scleral ring is that of continuous surface), in some other embodiments tire convex surface has discontinuity or discontinuities i parted there-upon which are located adjacent to or near the region or regions of incremental thickness and. tiros is not a continuous surface. When speaking of a hybrid scleral ring in some embodiments the incremental thickness zone is formed by way of a discontinuous surface where one material is affixed to another material. When speaking of a homogenous scleral ring, the ring is made out of one material and in most eases utilizes an incremental thickness region (aperture widening zone) to provide the lifting of t e upper lid and/or lowering of the l er lid
7? The term prosthesis as used herein is meant to be one of: a corneoscleral contact lens, or a scleral ring. The term "contact lens" as used herein is meant to be that of a eorneo-selerai contact lens which can be one of: rigid, soft, gas perm, or hybrid,
78| The zone /region /area of incremental thickness (aperture widening zone) which comprises the zone of incremental thickness in .most, but not all, embodiments is located on the convex surface adjacent to the outer edge of die papillary zone and outside the pupillary zone of the contact lens or scleral ring. The pupillary zone is the same size or smaller than the contact lens optical zone and is located within the central Open aperture of the sclera! ring. The maximum thickness delta of the incremental th ckness zone is located at (in alignment with) or external (outside of) to the limbo of the wearer' eye whe the prosthesis being that of a contaet lens or scleral ring is worn. This means the maximum thickness delta or .maximum change in thickness of the incremental thickness zone (aperture widenin zone) is equal to or of a larger diameter than the measurement of the Simons to iirnbus diameter (outside corneal diameter} thru the geometrical center of the cornea of the eye to which the contaet lens or scleral rin is being worn or intended to be worn. The contaet lens or scleral ring as taught herein, is that of a contact ietis or scleral ring comprising an incremental thickness zone, whereby the incremental thickness zone has an incremental thickness, a slope and. a width, and whereby the incremental thickness diameter is within the range of 1 mm to 10 mm larger than the natural palpebral fissure of the wearer's eye. The zone of incremental thickness is located on the convex surface and acts as an elevator of die upper lid and/or a depressor of the lower lid. The net cosmetic effect is to wide the aperture- or palpebral fissure (aperture) of the wearer's eye.?9j I some further embodiment a regressive thickness region is provided o the convex surface design such to provide a topography that will also cause the eye aperture widening effect, in this case the regressive thickness region forms a valley In the convex Surface such to cause the uppe lid to be elevated/lifted and the lower lid to he towered depressed; The surrounding topography of the valley becomes an incremental thickness region, zone, area, etc. 028§| in most preferred embodiments the prosthesis can remain thinner in overall, area when an incremental thickness region is added/designed, as opposed to a regressive thickness region bein designed into the prosthesis. This is due to the fact that the regressive thickness region is really the effect of a subtraction of thick ss in the regressive thickness region. Thus In order to obtain (by way of a regressive region) the needed valley depth in the convex surface of the prosthesis such to provide for the aperture widening effect the area located internal (closer to- the center of the lens) must be thicker than the regressive region.. Thus the prosthesis having a regressive thickness: regio will be thicker in total surface area than thai of a prosthesis comprising an incremental thickness region. In most cases a prosthesis having a thinner overall surface area, is preferable to a thicker overall surface area. Now having said the above, n some embodiments of the prosthesis a regressive thickness region is utilized to provide the eye aperture widenin effect.
|i)2Sl| The incremental thickness region and/or the regressive thickness region.: can be one of: rotationally symmetric,- rotationaliy asymmetric* elliptical arc like feature (features), island or island like areas. The elliptical, arch (arches} like feature (features) can .resemble the curve of lid margin, of the upper lid and / or the curve of the lid margin of the lower lid. in some embodiments the incremental thickness xone can form somewhat vertical islands located on either side (right or left) of the optic zone (in the ease of a contact lens) or open aperture (in the case of a scleral ring).
1)2821 T e incremental thickness region of the prosthesis can have a maximum, delta thickness differential, (added thickness} within the -range of 25 microns io 1,000 microns with a preferred, range of 100 microns to 500 microns, with a more preferred range of 100 microns to 400 - icrons, with a more preferred range of 75 to 400 microns. The .maximum delta thickness can he 25 .microns, 50 microns, 100 microns, ISO microns, 200 microns, 250 microns, 300 microns, 350 micro s, 400 microns, 450 microns, 500 microns, 550 microns, 600 microns, 650 microns, 7(H) microns, 750 microns, 800 microns, or 1000 microns. The maximum delta thickness differential can be located 0.5 ram to 3 mm from the outer peripheral edge of the prosthesis. The incremental thickness region can be located beginning/starting at or near the outer edge of the prosthesis to 6 mm from the outer edge. In some embodiments the incremental thicknes region can be either at die uter edge or 0.1 t n to .3 mm from the outer edge of the prosthesis, The delta of ma im m incremental thickness i in most eases within the range of 0.25 mm to 3.0 .mm internal to the edge of the prosthesis, in some embodiments, the delta of ma imum incremental thickness is within, a range of 0.25 mm. to 3.0 mm interna! to the edge of the prosthesis, in some embodiments, the axi u incremental thickness i within a range of 0.25 mm to 0,75 mm. internal to the edge of the prosthesis. In some embodiments, the nias.imu.iv) incremental thickness is within a range of LO mm to 2.5 iiitu internal to the edge of the prosthesis. The incremental thickness diameter (measured from the point o maximum added thickness thru the geometrical center of the prosthesis to the opposing point of maximum added thickness) can be; 10.5 mm or greater, 1 ! .0 mm or greater, 1. 1.5 mm or greater, 12.0 mm or greater, 12.5 mm or greater, 1 mm or greater, 13.5 mm or greater, or 14.0 mm or greater..
jil.2$3j The regressive thickness region, of the prosthesis can have a maximum: delta thickness differential (reduced thickness) within the range of 25 microns to 1,000 microns with a preferred range of 1 0 microns to 5(KL with a more preferred range of 100 microns to 400 microns, with a more preferred range of 75 microns to 400 microns. The maximum delta thickness can be- 2.5 microns, 50 microns, Ϊ0Ο microns, iSO microns, 200 microns, 250 microns, 300 microns, 350 microns, 400 microns, 450 microns, 500 microns, 550 microns, 600 microns, 050 microns, 700 microns, 750 microns, 800 microns, or 1000 microns. The regressive thickness region can be located from the outer edge to 6mm from the outer edge, in some embodiments the regressive thickness region can be 0.1 mm to 3 mm from the outer edge of the prosthesis. The delta of maximum incremental thickness is in mos cases within the range of 0,25 aim. to 3,0 mm internal to the edge of the prosthesis, in some embodiments, the delta of maximum incremental thickness Is within a range of 0.5 mm to 3,0 mm internal to the edge of the prosthesis, in some embodiments, the maximum incrementai thickness is within, a range of 0.25 mm to 0.7.5 mm internal t the edge of the prosthesis. In some embodiments, the maximum -incremental thickness is withi -a range of 1.0 mm to 2.5 mm internal to the edge of the prosthesis.
$28 ) The aperture widening zone whe caused, by incremental thicknes comprises tw slopes divided by a point of maximum change thickness {maximum thickness delta}. These two sl pes are called the outer slope and the inner slope. The ""outer" slope on the side closest to the outer edge of the pros thesis of the aperture widening zone (incremental thickness region or regressive thickness region) helps to achieve the aperture widening effect. The "outer" slope can he, by way of example only, 50 microns per mm or greater, 100 microns per mm or greater, ISO .microns per mm or greater, 200 microns per mm or greater, 250 microns per mm or greater. 300 microns per mm or greater, 350 microns per mm or greater. 'The "inner" slope can be, by way of example only, SO microm er m or less, 100 -microns per mm or less, 150 microns per mm or less, 200 microns per mm or less, 250 microtis per mm or less, 300 microns per ram or less, 350 microns per mm or less. If the "outer" slope lias a change in thickness of less than 50 microns per mm the widening effect is: minimised. If the outer slope has a change in thickness of greater than 300 microns per mm the prosthesis becomes tittcemforla e- and may decenter A range of an outer slope of the aperture widening zone on the side closest to the outer edge of the prosthesis is within a minimum of 3 degrees to a maximum of 45 degrees, and preferably within a range of 5 degrees to 25 degrees, A. range of an *¾triers slope of the aperture widening zone on die side closest to die geometrical center of the prosdtesis can be within the range of a minimum- of 1 degree to a -maximum of 15 degrees, in some, but not all •embodiments, the outer slope is greater tha the inner slope. In some embodiments the outer slope is approximately equal to that of the inner slope. And in some embodiments the inner slope is greater than the outer slope,
In some embodiments, the prosthesis can comprise an aperture- widening zone
(incremental thickness region or incremental regressive thickness region) on its conve surface, wherehy the aperture widening zone causes a bump on the convex surface that provides for the aperture widening effect in some embodiments, the prosthesis can comprise an aperture widening mm (incremental, thickness- region or incrementa regressive thickness region) o its concave surface, whereby the aperture widenin zone causes a hump on the convex surface that provides for the aperture widenin effect Thi bump (which is caused by incremental thickness or regressive thickness) has a eurvatnre shape, slope angle, change in thickness per millimeter and maximum change in thickness (maximum delta thickness). In some embodiments' the aperture widening zone's outer slope can begin at or adjacent to the outer peripheral edge of the prosthesis and continues to the maximum thickness delta of the aperture widening zone. In some embodiments, when the outer slope begins at or adjacent to the outer peripheral edge the outer slope will be within 2 degrees of the slope of the outer edge. In most, but not all embodiments, die location of the maximum thickness delta is achieved within the range of 0.25 mm to 3 mm from ttie outer peripheral edge, in some embodiments, the location of the maximum thickness delta is achieved within the range of I mm to 3 mm from the outer edge. The aperture widening zone can comprise a width of J mm to 6 mm when measured from the outer edge proceeding across the aperture widening zone towards the geom rical center of the prosthesis.
6286) The size, shape, and configuration, of the aperture widening zone described herein may he tailored tor individuals, or groups of indi viduals, having specific natural palpebral fissure vertical dimensions, eye aperture characteristics, and/or eyelid characteristics/anatomies. For example, in most but not ail eases, Caucasian eyes have large natural palpebral fissures (i.e., natural palpebral fissures with larger vertical dimensions) when compare to Asian eyes. As such, the size, shape, and configuration for an aperture widening zon show to effectively widen the natural palpebral fissure of a Caucasian eye may not work as effectively on it Asian eye,
j628?{ For exemplary purposes only, for Asian eyes, a smaller overall diamete prosthesis and/or a prosthesis having a smaller incremental thickness diamete (or minimum vertical dimension) .may be needed to provide desirable widening effects. The reason for this may be that if the maximum thickness delta, increased surface friction, etc. is located too tar up under the upper lid relative to the tarsal plate of the upper lid (or too far up under the lower lid relative to the tarsal plate of the lowe lid), the lid lifting (or towering) effect of the prosthesis may to be minimized,
11)2881 In some embo ime t, the aperture widening zone, must have a diameter (or minimum vertical dimension) thai, is at least 1: m or larger than that of the vertical dimension of the vertical measurement of the na tural palpebral fissure of the wearer s ey e to provide a palpebral widening effect that is noticeable to an observer looking at th eye of the wearer,
I0289J Moreover, contact lenses having a large overall diameter (e,g„ larger than 14.8 mm in overall diameter) may be difficult for a wearer to insert. While large aperture widening zones ma be placed on large contact lenses, it may he preferable that the size. Shape, and configuration, tor an aperture widening zone is tailored to fit onto a relatively small, contact lens (e.g., at most 1 .8 mm in overall diameter).
ft 290| The size, shape, and configuration of the aperture- widening zone may he tailored for lens having different overall diameters. This may be accomplished by adjusting one or more of, but not imited to, the following: the location of the aperture widening zone■{i.e., the beginning of the zone closest to die peripheral edge of a prosthesis and' the end of the zone closest to the geometrical center of the prosthesis), the outer slope width, the inner slope width, the .maximum incremental/regressive t i kness* and. the coefficient of friction tor an area of Increased surface friction. In embodiments having -aperture widening zones designed using spline curve methodology e.g.» as discussed below in regards to FIGS. 73A - 75), die selection and location of control points .may dictate the location of the aperture widening zone (i.e.., the beginning of the zone closest to the peripheral edge of a prosthesis and the e d of the zone closest to the geometrical center of the prosthesis), the outer slope width, th inner slope width, the maximum iiicremental regressive thickness, etc.
tl291f For example, the width of the aperture widening zone Outer slope for a 14.3 mrn lens ma he 1 ra or less compared to- the aperture widening outer slope zone width being approximately 1.5 mm for that of 15,5 mm. soft lens, 'this will increase the outer slope angle for the 1 ,5 mm lens compared to the outer slope angle of ih 15.5 mm lens. As another example, the beginning of the aperture widening zone outer slope for a 14,5 mm lens, when compared to the aperture widening zone outer slope for a 15,5 mm lens may begin closer to the peripheral edge of the lens, Thus, by adjusting one or more of the outer slope width and location of the aperture widening: zone, both a 14.5 mm overall diameter Sens and. also a 15.5 mm overall diameter tens can have, for example, a 12.5 mm aperture widening zone diameter that will have the same'; widening effect.
0292 f In some embodiments, the aperture widening zone diameter may be, for exam le,.
1 1 ,5 mm, 12.0 ram, 1.2,5 ram, or greater. Depending on the vertical dimension of the Batumi palpebral fissure of the eye of the wearer, a prosthesis having an overall diameter of 13,0 mm or larger; such as by way of example only; 13,5 mm, LIB. mm, 14.0 mm, 14,5 mm, 14.8 mm, 15.0 mm, 15.5 ram, or 16,0 mm may be preferable for a wearer.
0293j In. some embodiments, the aperture widening zone diameter, minimum vertical dimension, thickness, and slopes for an aperture widening zone may be tailored to- prevent undesirable light reflections within a wearer's eyes. For x mpl , an aperture widening zone having a large maximum thickness delta and a small aperture widening zone diameter or minimum vertical dimension (e,g., .10 mm or smaller} may create undesirable light reflections near the pnpi! of a wearer. Undesirable light refections have also been observed for some patients wearing BE Y2A which has an aperture widening zon diameter of 11.10 mm as shown below in Table 3. Without be bound by a specific theory, this may be due to the amount of material used to create sucfe an aperture widening (e.g., the lees material used to create the outer slope. Inner slope, and thickness delta). The large amount of material may act similar to a prism, thus resulting in undesirable light reflections or refracted light thai rimy b redirected within the pupil of the eye of the wearer, which may irritate the wearer. As such, increasing the incremental thickness of an aperture widening close t the optical/pupillary zone of a prosthesis ma exaggerate and/or increase the -undesirable light reflections. An area of increased surface friction alone may not produce undesirable light reflection dne to a lack of incremental thickness. Smaller incremental thickness and/or larger aperture widening zone diameters (or •minimum vertical dimension) may reduce this undesirable: Sight reflection..
[029 j in some embodiments* the maximum incremental thickness (i.e., maximum added thickness delta) of an aperture widening mm may be located at least 5,5 mm or more Irons the geometrical of a prosthesis (tints outside the nighttime -dilated pupil diameter of the eye). Also in certain embodiments, a distance at least 5 J mm from the geometrical center of the prosthesis makes it possible to add an area of increased surface friction that reduces the transmission of light to the maximum added, thickness delta of the aperture widening zone, in this case, combining (i.e., overlapping in whole or in part) an area of increased surface friction with an area of incremental thickness may prevent undesrred light reflections by altering the surface characteristics of the incremental thickness zone, thereby altering the transniisslon and/or reflection, of light, at the surface of the prosthesis.
102951 in some embodiments, a colored accented, ring or band which i located around the zone of incremental added thickness of the aperture widening zone can also reduce irritating or annoying light reflections which can occur in certain eases when the maximum delt thickness of an aperture widenin zone is too close to the geometrical center of a prosthesis {e.g., les than 5.5 mm from, the geometrical center of the prosthesis),. This occurs due to a prismatic refraction of light into the pupil of the eye at an angle which strikes a peripheral portion of the retina.. And in some embodiments a combination of a colored accented ring, along with an. increased surface friction zone, which also contributes to light transmissio reduction in the region of the aperture widening zone, can also further assist in reducing and or eliminating irritating or annoying reflections, in some embodiments, the colored ri g or band may be located on the convex surface of the prosthesis and may be designed to provide increased surface fried OR.
j¾296| Accordingly, the thickness, slopes, diameter, snrface friction, and/or minimum vertical dimension of an. aperture widening zone may be tailored for a specific individual, or set of Individuals having similar eye anato ies, to avoid undesirable ligh t reileetions. j :297j in some embodiments, effective aperture widenin may be achieved when the aperture widening z n 's outer slope diameter, including the peak of incremental thickness, when worn on the eye of a wearer aligns outside of the limbus and corne of eye of the wearer. By this it is meant that the outer slope of the aperture widening zon (including that of the peak incremental thickness region) is located when worn and aligned on the eye of a wearer external t that of the cornea and limbtis of the eye of the wearer.
|#298f 'fable I provides some exemplary aperture widening zone diameters for individuals having palpebral fissures with various vertical dimensions.
Figure imgf000055_0001
Table 1: 'Exemplar Aperture- Widening Zone Diameters tor Various Palpebral 'Fissure
Vertical D mensions
The aperture widening zone diameter is iarser than the diameter of die average human cornea - limbos in each example,
0299'| While exemplary dimensions have been discussed, it should he understood that the dimensions provided herei are by way of example only. However, preferabl the length of the aperture widening zone diameter is 1 mm or longer than the vertical dimension length of the palpebral fissure of a wearer's eye. In some, but not all embodiments, the aperture widening zone diameter is also larger than the diameter of the cornea plus the iimhus of the wearer's eye of the soft contact lens.
03Οβ j In most, but not ail embodiments a least one bump is located above and belo the geometrical, center along an imaginary vertical axis mat crosses the geometrical center of the prosthesis. In some other embodiments a least one hump is located on either side of the geometrical center so as to be intersected by an imaginary horizontal axis that crosses the geometrical center of the prosthesis. Still in other embodiments multiple isolated bumps can be located SO as to be intersected by an imaginary axis going through the geometrical center of the prosthesis, by way of example only , two or more of: 40 degrees, 45 degrees, 90 degrees, 135 degrees, 150 degrees, 180 degrees, 210 degrees, and 330 degrees, relative to the geometrical center of the prosthesis,
The. location of the peak delta incremental thickness (maximum change i thickness) region (zone, area) or the peak delta regressive thickness (maxi um- change- in thickness) region (zone, area) of the prosthesis can be located 0.1 mm or more superior (above) with respect to the upper lid margin and/or 0Λ mm or greater inferior (below) with respect to the lower lid margin of the wearer, bat more preferably located 0.5 mm or more superior (above) to the upper lid. margin and/or 0.5 tarn, or greater inferior (below) to the Sower tid margin of the wearer, it is important to note that the above measurements contained in this paragraph are of the lids "without the prosthesis being: worn" and as of the time the wearer's eye is looking straight ahead and related, without straining to see clearly or in bright light (this being the natural aperture of the wearer's eye). Thus when wearing the prosthesis the uppe lid is elevated by a minimum of 0.1 m Of more and/o the lower lid is depressed I lowered ) by a .minimum of 0.1 mm or more. But in a more preferred example, when wearing the prosthesis the upper lid is elevated by a minimum of 0.5 mm or more and/or the lower lid is depressed (lowered) by a minimum of 0,5 mm or more. The aperture widening of the prosthesis can be further accentuated by way of a colored accent color. The colored accent color can be a colored limbal ring or a colored circle ring (which can be referred to as a colored circle lens) located on the prosthesis. Thus the more the wearer's eye aperture is widened by th prosthesis which has this colored accent color, such as a. colored limbal ring, the more colored li bal ring can he observed by someone looking at the eye of the wearer, litis provide a ver complementar effect which makes the colored limbal ring, color ring or colo accent more dramatic in. its cosmetic enhancement of the wearer's eye. A portion of the colored accent color will be located at (above and adjacent to) or external to the limbus of the wearer's eye when the color accented prosthesis is being worn. This means that a portion of the color accented prosthesis is located, when worn, on top of or external to the limbal area of the eye of the wearer. Thus the diameter of a portion of the colored accent portion is equal to or large in diameter to thai of the outside diameter of the corne of the wearer* f0302f In some embodtments, such as by way of example only, a prosthesis that is of & contact lens multifocal design and/or e that corrects tor astigmatism and thus requires optical power having a torie component and a stabilisation mm (feature or member) i employed, in some embodiments* such as by wa of example only, when a prosthesis thai is a scleral ring or one that is a single vision contact lens having only spherical optical power the prosthesis is fee to rotate upon normal blinking and thus devoid of a stabilization zone (feature, member). In some other embodiment a stabilization zone (feature or member) is employed for a single vision spherical ' ower contact lens. When a stabilization zone (feature or member) is employed it can be built onto o into the design of the aperture widening z ne (thus they are specially designed to be one in the same) or it can be separate from the aperture widenin zone.
[0303] An increased surface friction rcgron/zone/are can be located on the convex surface of the prosthesis and can increase the aperture of a wearer's eye. An increased surface friction xone region/area can be called an aperture widening zone/reg on/area. The increased surface ction region/zone/ area can be flat, irregular, raised, or integrated on the convex surface of the prosthesis. The increased surface friction, region's width can have a width that includes die outer edge of the prosthesi s to a point 6 mm from the outer edge. The increased surface friction can fee expressed as a region on the convex surface of the prosthesis ha ving a 1% increase in one of surface friction or drag friction compared to that of other regions of the convex surface of the prosthesis. In some other embodiments the increased surface friction region is located within 0.1 mm and 6 mm from the outer edge of the prosthesis. Give that in certai embodiments the increased surface friction region can he flat and thus approximate a zorte/region/area on the convex, surface of the aperture widening zone or a portion thereof of the prosthesis comprising an increased surface friction region the egion: has no thickness slope. In other embodiments there i a thickness slope.
[0304] An increased, surface friction region ca be fabricated on the convex surface of aperture widening zone of the prosthesis or portion thereof, by way of any know means including,, by way of example only; molding, thertnofonrring, surface treatment, coating, etching, deposition, gas etching, gas trea tnent, laser etching, laser treatment. - S7 - chemical -etching, and chemical treatment Any convex surface re¾ion/¾one area of the prosthesis located within the range of 0 mm to 6 mm from the outer edge of the prosthesis which comprises 1% or greater in one of drag friction or surface friction compared to an area of the convex surface located b yond 6 mm from the outer edge -would be considered m increased surface friciion region zone area. In some embodiments, the increased surface friction regionfeooe/area ay comprise .1% or greater drag: friction or surface friction compared -to a portion of the convex, surface adjacent to the area of increased surface friction. In some embodiments, the increased surface friction region/zone/area may comprise 25% o greater drag friction or surface friction, compared to a portion of the convex surface adjacent to the area of increased surface friction. In some embodiments, the increased surface friciion region/zone/area may comprise 33% or greater drag friction or surface friction compared to a portion, of the convex surface adjacent to the area of increased surface f iction:. By way of example only, such. an. increased surface friction convex surface regson/zone/area could be: a coated surface, -a dimpled surface, a crazed surface, surface bumps, surface rings, surface lines, non- slick ..surface,, irregular surface, or a combination thereof In. some embodiments, the drag friction or -surface friction of an area of increased surface friciion is uniform (i.e., the entire area of increased surface friction has the same drag friction or surface friction). In some embodiments, the drag friction or surface friction of an area of increased surface friction is variable.
The percentage difference between the surface friciion for the region/zone/area of increased surface friction and the portion of the convex surface adjacent to ie region/OTne/area of increased surface friction (e.g., percentage difference between friction drag coefficients} may depend on the coefficient of friction (e,g., friction drag coefficient) of the material used to make the prosthesis. For example, the percentage difference for a prosthesis made with, a materia! having a coefficient of friciion equal, to 1.0 may he greater than the percentage difference for a prosthesis made wit a material having a coefficient of friction equal to 1.5. Additionally, the percentage difference may depend on the ske and configuration of the region/zone/are of increased surface friction. As a non- limiiiiig example, a reg.ion/¾one/area of increased surface friction that has a relatively thin increased surface friction zone width (e.g., a ring having a width of x) may have a larger percentage difference in coefficient of friciion compared to a region/zone/are of increased: surface irktion having a relatively thick increased surface friction zone width (e.g., a ring having a width of 3x)„
| 3ί>6 Moreover, the percentage difference may depend on whether or not the region zone/area of increased surface friction overlaps, n. whole or in part, an. area of incremental thickness. As a non-limiting example, a region/zons/area of increased surface friction that overlaps, in whole o in. part, an area of incremental thickness may achieve the same widening effects with a percentage difference that is smaller than a region/zone/area of increased surface nction (flat or raised) alone. This may be due to widening effects imparted by the incremental thickness, which is separate from the widening effect imparted by the increased surface friction. Accordingly, the percentage difference may also depend on the maximum thickness delta of the area -of incremental thickness.
03¾7| The dimples, bumps, rings, and. lines of the increased, surface region/zone area have a vertical depth. The vertical dept is defined b the distance between a peak and trough of the dimple, bump, ring, or I. e. The vertical depth of these features is within the range of 500 angstroms to 50 microns, and preferably within the range of 1 micron to 10 microns.
|03#8f While these features do have a depth resulting in $ roughened' and or patterned area, they do not alone result in an are of incremental thickness. In some embodiments* the features may result in a roughed and/or pattered area that is flat relative to the normalized convex surface of a prosthesis. In other words, while these features do have a vextieat depth, they may not extend beyond the normalized con vex surface of a prosthesis, in such embodiments, troughs located between each feature, are recessed below the normalized convex surface of the prosthesis, hi some embodiments, the features may result in a roughed and/or pattered area that is raised relative to the normalized convex surface of a prosthesis. In such embodiments, each feature may extend above the normal teed con vex surface and troughs located between the features may be located at depths that are the same as the normalized, convex surface of the prosthesis, in some embodiments, the features may extend above the normalized convex surihee and troughs located between the features may be located at depths that are recessed below the normalized convex surface. fi>309} An area of increased surface frict ion may include a combination of raised md flat areas of increased surface friction. An area of increased surface friction created by the coating or deposition of a material may be considered a raised area because the coated or deposited material may extend above the normalized convex surfac of the prosthesis (tine to the thickness of the coated/deposited material).
[031 1} The increased surface friction rcgiori%oue area can be a stand-alone feature located on the convex surface of the prosthesis. Or an increased surface, friction area may be combined with (i.e., overlap with), in full, or in part, as area of incremental thickness. For example, the increased surface friction: region/zone/atea can be located on the oute slope of an aperture widening zone or a portion thereof. But an area of increased surface friction itself does not have an incremental thickness.
j031 I} The increased surface friction region/zone/arca can als be created by not polishing all or pari of the aperture widening zone or? the convex surface of the prosthesis. This will result in a regkm-'zone area defined by the aperture widening zone that has an increased surface friction relative to the rest convex surface, which is polished.
[0312f The surface friction of regions on the convex surface of a prosthesis may be formula:
Figure imgf000060_0001
where Q is friction drag coefficient,
p is the mass density of a. fluid (eg., tears),
A is the reference area,
v is the speed of the object relative to the fluid,
n K the normal direction to the surface with area dA
/ is the tangential direction to the surface with area dA,
TV is the shear stress acting on the surface dA,
i is the unit vector in direction normal to the surface dA.
[03131 FIGS 12A ~ B and 13 A. - B ittostnte two ways ia. which an aperture widening:
¾)ne is capable of widening the palpebral fissure of an individual's eyes. FIGS. 1.2A and OA show an individual, not wearing a prosthesis as described herein and FIGS. J 3A and 13B show the same individual with a prosthesis having an aperture widening zone superimposed onto her eyes. 0314j FKL 12B shows a» embodiment of a prosthesis 1200 whereby a maximum delta
Ihickness 1202 fails outside of the natural aperture of the eye. Said another way, when worn the maximum delta thickness 1202 of an aperture widening zone (zones) of the prosthesi 1200 is located above the up er lid margin and. below the lower ltd margin when the eye is relaxed and looking straight ahead. The iaeremental thickness diameter (which is the diameter measured from a point of maximum added thickness thru the geometrical center of the prosthesis to the opposing point of maximum added thickness) is larger than the distance between the upper Hd margin and the lower lid margin.
0315 The Incremental thickness diameter and also the regressive thickness diameter is the distance along an xis from a point of maximum delta thickness proceeding through the geometrical center of the prosthesis In a straight line to that of a point of maximum delta thickness located on the opposite side from the previous point of maximum delta thickness. The embodiments disclosed hereto teach when fitting the prosthesis to fit. the prosthesis whereby the maximum delta thickness (also called the peak thickness delta) is located at a minimum 0 J mm above with respect, to the opper lid margin and/ or 0, 1 mm below with respect to the lower lid margin,
Ό316Ί The incremental thickness diameter and the regressive thickness diameter of the prosthesis can be of any diameter depending upon the overall diameter (outer most diameter) of the prosthesis, however, in most cases the incremental and regressive thickness diameter is within the range of 1 ,5 mm. to 15 mm..
31 1 The location of the maximum delta thickness. 1202 on prosthesis 1200 is located under and above with respect to the upper lid .margm and located under and below with respect to the lower lid margin, thus widening the palpebral fissure (aperture) of the eye. To be clear in this embodiment the location of the maximum delta thickness does not fall within the natural aperture of the eye as it falls outside or a larger distance measurement than the vertical measurement of the natural aperture of the eye (meaning the incremental, thickness diameter is greater than the vertical measurement of the natural eye aperture), in the case of this embodiment the upper eye lid is lifted due to the aperture widening go e being one or more of an incremental thickness zone, regressive thickness ¾ones or increased surface friction region. And the lower lid is pushed down also due to the aperture widening zone bein one or more of a incremental thickness zone, regressive thickness ¾one, or increased surface friction region. The method of action, in the ease of an embodiment laving an incremental thickness zom (region, area) results by wa of either the added thickness pushing oat and up the upper Hd and pressing dow and out the lower 'lid. The method of action in the case of an embodiment having a regressiv thickness zone (region, area) results by wa of either the upper lid margin and lower ltd margin being -contacted by the slope where the regressive thickness z& border begins to- add significant thickness on the side closest to th pupil of the eye or being contacted and held within the valley of the regressive thickness zone. The method of action in the ease of an embodiment having an increased surface friction (region, area) results by way of either the added thickness poshing out and up the tipper lid and pressing -down a d -out the lower ltd.
[0318} FIG. ί 3 B shows the location of a .ma imu delta thickness 1302 on a prosthesis
1300 being -located at the upper lid margin and the lower lid margin. Note how the dotted lines in FIG 13B are smalle in diameter (the incremental thickness diameter or tir regressive thickness diameter) compared to the same doited lines of the embodimen described in FIG. I2B. FIG. 128 has a larger incremental thickness -diameter or regressive thickness diameter compared to FIG-. I3B. The method of action of thi embodiment utilizes the outer slope across the width of the incremental thickness zone to accomplish the widening effect By having a. steep slope (crossing the incremental thickness zone width, or the regressive thickness zone width) which ascends (grows) in thickness from its beginning on the side facing the outer edge of the of the prosthesis IJOO to the maximum delta thickness 1302 located just inside of the natural aperture of the eye, the slope acts as a sliding board o prism shaped wedge that causes the upper lid to move up and the lower lid to move down thus opening the eye's aperture.. With this embodiment it is possible for the incremental, thickness diameter or regressive thickness diameter to have a maximum delta thickness that falls withi the normaimatural aperture of the eye,
j03l9| FIGS, I4A ·■■· 1.7B illustrate various embodiments of aperture widening zones/incremental thickness regions present on the convex surface of a prosthesis.
f032i| FIG. 14 A illustrates a scleral ring .1400 according to one embodiment. Scleral ring
1400 has a central open aperture 1404 with a geometric center 1402 located in the center. Scleral ring 1400 includes two incremental thickness regions 1 08- located on opposite sides of pen aperture 1404. Eae incremental thickness region 1 0& has a m ximum inerernental thickness (peak, delta thickness) 1 ( 6. Incremental thickness regions I40S ate capable of increasing the palpebral fissure- of a wearer's eye when worn,
{032! I F!O. I.4 Illustrate a contact leas 1450 according to another embodiment.
Contact lens 1 50 has an optical region 1454 with a. geometric center 1452 located in the center. Contact lens 1450 includes two incremental thickness regions 1458 located on opposite sides of optical region 1454 both in the shape of raised isl ands. Each i ncremental thickness region 1458 has a maximum incremental thickness (peak delta thickness) 1456. incremental thickness regions 1458 are capable of increasing the palpebral fissure of a user's eye when worn.
| 322) FIG. I SA illustrates -a contact, lens 1500 according to another embodiment.
Contact lens 1500 includes an opt c zone 1502 surrounded by a ring-shaped incremental thickness or regressive thickness region 1504. Contact lens 1500 also includes a regressive thickness regio 1506 surrounding incremental thickness or regressive thickness region 1504 and ex tending towards the edge of contact tens 1500.
(0323) FIG. I SB illustrates a contact lens 1520 according to another embodiment.
Contact lens 1520 includes an. optic zone 1522 surrounded by an oval-shaped incremental thickness or regressive thickness region 1524, Contact lens 1520 also includes a. regressive thickness region 1526 surrounding incremental thickness or regressive thickness region 1524 and extending towards the edge of contact lens 1520.
[0324} FIG. I SC' Oiiistfaies a contact lens 1540 according to another embodiment.
Contact lens 1540 aid tides- an optic zone 1542 with two incremental thickness or regressive thickness regions 1544 located around it, one above and one below. Bach incremental thickness -or regressive thicknes region 1544 has a partial-ring shape. Contac lens 1540 also includes a regressive thickness region 1546 located outside of incremental thickness or regressive thickness regions 1524 and extending towards the: edge of contact lens 1540,
|0325| FKl 15D illustrates a contact Sens 1560 according to another embodiment.
Contact lens 1560 includes an optic- zone 1562 with a plurality of band-shaped incremental thickness or regressive thickness regions 1564. incremental thickness Of regressive thicknes regions 1564 are located around optic zone 1562 in a spoke-like fashion. Incremental thickness or regressive thickness regions 1564 can extend to the edge of contact lens 1560 fas shown) or can extend to a point inside of the edge (not shown),
{03.261 HG. !6A illustrates a scleral ring 1600 according to another embodiment. Scleral ring 1600 includes an open central aperture 1602 surrounded by a ring-shaped incremental thickness or regressive thickness region. 1.604. Scleral, ring 160 also includes a regressive thickness region 1606 surrounding incremental .th kness or regressive thickness region 1604 and extending towards tire edge of scleral ring 1600.
{03271 F.IG:> 16B illustrates a scleral ring 1 20 according to another embodiment. Scleral ring .1620 includes an open central aperture 1622 surrounded by a oval-shaped incremental thickness or regressive thickness region 1624, Scleral, .ring 1620 also includes a regressive thickness region 1626 surrounding incremental thickness or regressive thickness re ion 1 24 and extending towards the edge of scleral dug 1620.
f0328f FIG. 16C illustrates a sclera! ring 1.640 according to another embodiment Scleral ring 1 40 includes an open central aperture 1642 with two incremental thickness o regressive thickness regions 1644 located around it, one above and one below. Each incremental thickness or regressive thickness region 1 44 has a partial -ring shape. Scleral ring 1 40 also includes a regressive thickness region 1646 located outside of incremental thickness or regressi ve thickness regions 1 24 and extending towards the edge of scleral ring 1640.
103291 FIG. 160 illustrates a. scleral ring 1660 according to another embodiment. Scleral ring 1660 includes an open central apertur 1662 with a plurality of band-shaped incremental- thickness or regressive thickness regions 1664. Incremental thickness or regressive thickness regions 1 64 are located around, open central aperture 1662 in a spoke- 1 ike fashion. Incremental thickness or regressive thickness regions 1664 can extend to the edge of scleral ring 1660 (as shown) or can. extend to a poin inside of the edge (not shown),
{'033(1 j FIGS. 17A-C illustrate various embodiments of a contact lens having an increased surface friction region(s), FIG.. 17 shows a contact lens 1700 having an optical region 1702 and a ring-shaped, increased surface friction region 1704 surrounding optical regi n 1702, FIG, 17B shows a contact lens 1710 having an optical region 1712 and an oval- shaped increased surface friction regio 1714 surrounding optical region 1712. FIG, I C shows a contact lens 1720 having a optical regio 17.22 and two increased surface friction regions 1724 located around optical region 1722, one afcove and one below. Each increased surface friction region 1724 has a partial-ring shape,
[03311 FIGS. I7D- illustrate various embodiments of a scleral ring having an increased surface .friction regionfs), FIG. 1.7D shows a scleral ring 1730 having a- central open: aperture. 1732 and: a .ring-shaped increased surface friction region 1734 surrounding central open aperture 1732, FIG. 17E shows a .scleral ring 1740 having a central pen aperture 1742 and a oval-shaped increased surface friction region 1744 surrounding central open aperture 1 42, FIG, 1.7F shows a. scleral rin 1750 having a central, open aperture 1752 and two Increased surface friction regions 1.754 located around central open aperture 1 752, one above and one below. Each increased surface friction region 1754 has a partial - ring shape,
[0332f The prosthesis allows for modifying " n of more" of the following to optimiz the lid. lifting effect or palpebral (aperture) widening effect of the rosthe is;' ) Overall Diameter
{03331 in most, but not all cases, a larger diameter is most effective. By way of example only 14.5mm, iASnnrt, 15.0mm, 15.5mro, 16,0mm, 16..5nini (in the case of a scleral ring the outer diameter may be of the above dimension or it coold be 16,0 mm or larger)
I) Overall TSiickness
{0334} in most but not. all embodiments, a. larger overall thickness is most effective.
3) Edge Thickness
[83351 in most, but not ail embodiments, the extreme peripheral edge thickness of the contact lens or scleral ring is left unchanged from that normally provided by a contact lens .manufacturer of a specific brand lens, of a specific type, and of a specific optical power. Thus the outer edge in most cases, but not all cases, approximates that of a conventional eorneo-scleral contact, lens,
[83361 In some embodiments the extreme peripheral, edge thickness is increased in thickness,
[03371 In most, but not ail embodiments, the extreme peripheral edge thickness of the contact lens or scleral ring is left unchanged from that normally provided by a contact Sens manufacturer of a specific brand lens, of a. specific type, and of specific optical power, 'ikes the pater edge in post eases, but not all cases, approximates that of a conventional corneo-sclerat contact lens.
4) Location of maximum added thickness r maximum thickness delta
0338| Irs. certain embodiments an area inside (towards the center of the prosthesis front the outer edge) of 0.5 mm from the outer edge to 3 ram from the outer edge of th contact fens is increased, in thickness. In other embodiments an area inside {towards the center of the prosthesis from the outer edge) of 0,5 rain from the outer edge to 7 mm from the outer edge of the contact lens is increased in thickness. In these embodiments the "width" of the aperture widening zone can be within a range of 2.5 ram to 6.5 nini depending upon the overall diameter of the contact Sens, i certain other embodiments the width of the aperture widening zone can be within the range of 1 mm to 7 mm, once again depending upon the overall diameter of the contact lens. In some embodiments the aperture widening zone extends . from the outer edge of the prosthesis to. within the range of 2.5 mm to 5 m inside of the outer edge of the prosthesis. The precise distance from the outer edge depends upon the type of prosthesis and also the overall diameter of the prosthesis.
0339J in most:, hut not ail embodiments, an area within a range of 0.5 mm to 3,5 mm from the extreme peripheral edge of the prosthesis provides the ma imum delta thickness (but preferabl withi the range of 0.5 mm to .2.0 mm from, the extreme peripheral edge of the contact. lens or scleral ring). In some embodiments, the maximum delta thickness may be in the range of .0.25 mm to 0.75 from the extreme -peripheral edge of the contact lens or scleral ring.
5) Regions of incremental' Thickness
$3 01 ϊτ¾ most, but not all embodiments, a region or regions of 'incremental '.thickness- or regressive thickness are located adjacent to or outside 3,0 mm. of the geometrical center of the contact lens. Region or regions of incremental thickness or regressive thickness are generall located adjacent to or outside the pupillary ¾one of the contact lens or scleral ring open aperture.
0341 J Such a region or regions can comprise an area or areas on the convex surface of the contact lens, by way of example only, a ring, (rings) band, (bands) or partial rings (ringlets), dome (domes), island (islands), segmented area, segmented areas or of any geometrical shape. The region can he that of a roiat.ionahy symmetric region or a. foiationaliy asymmetric region.
|il342| In most, but not ail embodiments, m the region or regions incremental thickness the surface geometry of the region or regions is compri sed of an increased coo vex curvature,
0343] i most, but not ail embodiments, in region or regions of incremental thickness the surface geometry comprises a continuous surface with that of the overall convex surface of the contact lens or sclera! ring.
j¾344f In. most, hut not ail contact lens embodiments, in the region or regions f incremental thickness the curvature change does not provide any visual, correction for the wearer. In all scleral ring embodiments, in the region or regions of incremental, thickness the curvature change does not provide any visual correction tor the wearer. In most, but not all embodiments, incremental thickness can range from 0.1 microns' to L000 microns, hi most,, but not ail embodiments of the prosthesis the incremental thickness region can have a point of m ximum added thickness. The maximum added thickness can range fro 25 microns to 1000 microns. In some embodiment the maximum change in thickness / maximum thickness delta is within a range of 100 microns to 500 microns. In some embodiments the maximum change in thickness is within a range of 75 microns to 400 microns,
6) increased Surface Friction.
0345| Embodiments that utilize increased .surface friction can he thai of surface friction on. the convex surface of the prosthesis forming the apermre widening zone or as part of the incremental: thickness zone.
|034ii] In- most, hot not all embodiments, the touch area of slide resistance between the contact lens or sclera! ring and the ltd or lids is increased. This is accomplished by increasing the friction between the lid (lids) and the convex surface of the contac lens, but doing so in such a limited way that it is accomplished without irritating the lid (iids A difference of 1% or more of increased drag friction within the aperture widenin zone can be meaningful compared to the surface friction of the rest of the prosihesis outside of the aperture widening zone.
j0347| Area of increased surface friction differs from, area having an incremental thickness. First, the widening effect of an area of increased surface friction results from an increase in suriace friction (e,g,, friction drag coefficient), not from an increase or decrease in thickness* Second, an area of increased surface friction may not add a significant amount of weight to an area of the prosthesis, incremental thickness areas add weight because a significant amount of material may be used to create the inner siope(s),. outer sl.ope(s), and maximum thickness deltais). in contrast, an area of increased surface friction is either flat or only slightly raised (e.g., raised dimples or a coated or deposited •material), which may result in less added weight,
348 j Third* the interaction between an eyelid and an area of incremental thickness may be different than the interaction between an eyelid an. area of increased: surface friction. For example, as an upper eyelid is opening, the eyelid- will pass over an area of incremental thickness (including the maximum, thickness delta) thereby tending to pull the area of incremental thickness (and; the prosthesis) upward* But »flce the upper eyelid passes the maximum delta, thickness (e.g., when it is fully open) it will begin to push the area of increased thickness (and the prosthesis) downward. In the ease of stabilisation zones located on a prosthesis, interaction between an eyelid, and an area of incremental thickness may be used to stabilize a prosthesis within an eye by causing rotation into a specific rotational, position. The position is held by the upper eyelid pushing down on the area of incremental thickness when, the eyelid is open. The same interaction may occur for the lower eyelid, expect for the lower eyelid will tend to pus areas of incremental thickness upward, rather than downward.
'{0-3491 In contrast, a area of increased surface friction does not have the same interaction with an eyelid, once the eyelid, is open. While the eyelid may push down/up the area of increased surface friction, it will not tend to cause rotation. The lack of incremental thickness (ie., slope) results in a lack Of rotation because of the lack of sloped surfaces for the eyelid to force downward/upward and towards a desired rotation position,
7) Convex Surface Shape
1035(1 J In most, bu not all embodiments, th convex surface shap near and/or around the periphery" of the contact lens is altered compared to that normally provided, by a contact lens .manufacturer of a specific brand lens, of a specific type, and of a specific optical power. 8) Slop difference
I.0351J in some embodiments the steepest slope is that of the outer slope of the incremental thickness region and the less steep slope is on the inner slope of the incremental thick ess region which is closest to the geometrical center of the contact lens or sclera! ring".
|6352f in certain embodiments the steepest slope is thai of the inner slope of the incremental thickness region and the less steep slope is on the outer slope of the incremental thickness region which is closest to the outer edge of the contact len or scleral ring,
0353J In certain other embodiments the outer slope of the incremental thickness region is equal to the inner slope of the incremental thickness region
9) Lens mat rial
J0354} I most, but not all embodiments, the lens material is that of one of a silicone hydrogel or a hydrogel material
f03S5j in some embodiments the lens material is that of one of a gas permeable material or a rigid material.
[03561 In. some embodiments a different material is added/bonded, inserted, affixed to th contact lens or scleral ring thus altering a region (regions) or area (areas) of the contact lens convex outer surface material.
j¾357| in some other scleral ring embodiments the scleral ring is made of non-gas perm
.material,
[{i358{ In some other embodiments the scleral ring material i that o a rigid non-ga permeable material
1(1) Edge Shape of the prosthesis
|03S9f In. most but not all embodiments, the extreme peripheral edge shape is not altered from that which is available {e.g., commercially from a contact lens manufacturer) lor a specific brand, of a specific contact lens type, of a specific contact lens optical power. As a oon-linilting example, the peripheral edge shape of a corneal-sclera! contact lens prosthesis may have the peripheral edge shape of an Acuvitel? contact lens manufactured by Vis akon% a division of Johnson St Johnson Vision Care, in Jacksonville, Florida. | 360f In some embodiments the edge shape is altered to haw a steeper slope on the- convex surfa e internally from the peripheral edge of the contact lens or sclera! ring when compared to that available (e.g., commercially from a contact lens manufacturer) for a Specific, brand, and of a specific contact lens- type, of a specific contact lens optical power.036.1 f some embodiments the edge shape is altered to be a less steep slope internally from the peripheral edge of the contact lens or scleral ring - o pared to that available (e.g., commercially from a contact lens manufacturer) for a specific brand, of a specific contact lens type, and of a specific contact tens optical power.
10362 The edge thickness is preferably between 25 and 100 'microns. For disposable type contact lenses the edge thickness is preferably between 25 and 50 microns. For non- disposable type contact lenses the edge thickness is preferably between 30 and 60 microns. The edge can be a have a knife edge shape, a rounded shape,, a setm -round shape, or a Mint shape.
11) Edge Treatment
10363 in some, but not all, embodiments a portion of the edge of the contact len or scleral, ring is truncated, in some other embodiments two portions (one located adjacent to the upper lid, and one located adjacent to the lower lid) are truncated.
|0364| in some., but not all, embodiments the edge is associated with prism ballast.
[0365] I some, but not all. embodiments the edge of the lens is weighted,
12) Base Curve
[0/366 [ In most, but not all, embodiments the base curve of the contact len or scleral rin is increased to be steeper than that, normally fit on the cornea or eye of a. wearer { with th understanding thai, in most. but. not all cases, the scleral ring is not fit on the cornea of a wearer). f the scleral ring is fit. on the cornea it fits only on the peripheral cornea outside of the -pupillary zone.
[0367} in some, but not all, embodiments the base curve of the contact lens or scleral ring is decreased to be less steep than normally fit on the cornea or eye of a wearer■{with the understanding that, in most but not all cases, the scleral ring is not fit on the cornea of a wearer)., if the scleral ring is fit on the cornea it fits only on the peripheral cornea outside of the pupillary z e. |03Ci8{ In. some, but not all, embodiments the bas curve of the contact lens or scleral: ring is the same as that normally fit on the cornea or eye of a wearer (with the understanding that the scleral ring, in most hut not all eases, is not fit on the cornea of a wearer).
13) Convex Surface Texture
10369] In some, but not all embodiments the convex surface texture of the contact: lens or scleral ring can have a region, regions, area, areas of by way of example only dimples, non-smooth surface, humps, irregularities, less slick than the area of the prosthesis outside of the aperture widening zone and indentations. This surface texture generally covers or is a portion of the aperture widening zone. Also, this surface texture may result in an increased surface friction compared to the portion of the convex surface lacking the surface texture,
14) Optical power
j037itj It should be pointed out that the contact lens disclosed herein contemplates ail prescription lens powers including that of piano (no power).
flJ371| 'The embodiments of the prosthesis {being that of a contact len and a scleral ring) disclosed herein contem late the need for a fitting set that the professional will use to test fit on a patient to ensure the best lid lifting, result possible for that patient. The fitting set can provide for one or more of the above 14 variables to be tested on the patient to •customize and understand the single best variable to alter or a combination- of variables: to alter when prescribing the contact lens. However, It has been determined that with an optimal, fitting set 2 to 6 trial contact, lenses should be enough for fittin the majority of all potential wearers..
j(i372{ It should be pointed out, that the scleral ring disclosed comprises an open central aperture and "no" optical power. FIGS, 18 - .23 show various individuals' eyes with and without a prosthesis having an aperture widening zone.
j03?3| F l .18 shows a 65 year old. male's natural eyes, f e him: not wearing a prosthesis having an incremental thickness region. In contrast, FIG. 19 shows him wearing a prosthesis with an incremental thickness region (aperture widening zone). If can be seen, by comparing FIGS. 18 and 1.9, that the palpebral fissures of bis eyes are widened when wearing a prosthesis having an Incremental, thicknes region as described herein. The prosthesis being worn in. FIG, 1 has a base thickness of 100 microns and an incremental thickness region having an overall thickness of 300 microns, with the peak thickness delta or maximum thickness added being 200 microtis.
(037 FIGS, 20 - 21 show the widening of a 45 year old female's palpebral fissure. FIG.
20 s ows her natural eye and FIG. 21 shows er wearing a prosthesis having an incremental thickness region, on. her eye. As can he seen the upper Sid has been, raised in FIG.. 21. when compared to FIG. 20. The prosthesis being worn in FI 21 has an incremental, thickness region (aperture widening zone) with a maximum added thickness or maximum thickness delt of 600 microns.
|¾37Sf FIGS. 22A - B show the eye of a 66 year old male. FIG. 22A shows his natural right eye having a ptosis of the upper lid and FIG. 22B shows him wearing a prosthesis having an incremental thickness region (aperture widening zone) on the same eye. it can be seen, in FIG. 22 B, that the prosthesis with an incremental thickness regio lifts his. upper right eyelid. Thus ope i g enlarghig the aperture quite dramatically.
|;0376] FIG. 23 shows the right and left eye of a 40 year old iernale. She is wearing a prosthesis having an incremental thickness region in her right eye (left side of FIG. 23). She Is not wearing a prosthesis In her left eye (right side of FIG. 23), The prosthesis In her right eye has substantially widened the apemtre/palpebral fissure of her right eye whe compared to her left, eye. The prosthesis being worn on her right eye has an incremental thickness region (aperture widening zone) with a maximum increased thickness maximum, thickness delta o 200 microns located approximately F5 mm inside the oister peripheral edge of the prosthesis,
j9377f FiG. 24A shows a male's .natural eyes, i.e. Mm not wearing a prosthesis having an incremental thickness region, in contrast, FIG. 248 shows him wearing a prosthesis with an incremental, thickness region (aperture widening zone), it can be seen., by comparing F IGS. 24A and 248., that the palpe ral, fissures of his eyes are widened when wearing a prosthesis having an incremental thickness region as described herein,
j0378j FIGS. 25A - C show various surface profiles to three different prostheses. Lenses
2520, 2540 and 2560 all have a geometric center located at 250 and. a pupil zone Indicated by lines 2502. Bach lens 2520» 2540, and 2560 has an incremental thicknes region 2522, .2542, and 2546, respectively. Note the outer slope of the incremental thickness region 2522 in FIG. 25 A is less than the inner slope of the incremental thickness region. Note the outer slope of the incremental thickness region 2542 in FIG. .25 B is greater than the inner slope of th incremental thickness region. Note the onter slope of the incremental thickness region 2546 in FIG. 25C is greater than the inner slope of the incremental thickness region.
i«379f Itfcrementaj Thickness Zow Width; The widt of the incremental thickness zone or region is the distance measured from its beginning (where incremental thickness begins) on the side towards the enter edge of the prosthesis t the end of the zone or region (where incremental thickness ends) on the side towards the center of the prosthesis. The width of this ¾one or region generally ranges between 1 mm to 7 mm, hut in some cases is between .2.5 mm and 6.5 mm, and in roos cases is between 2,5 mm and 5 nun.
[I 8!){ Increased Surface Friction Zone Width-: The width of the increased surface frictio zone or region is the distance measured from its beginning (where increased surface friction begins) on the side towards the outer edge of the prosthesis t the end. of the mm or region (where increased surface friction ends) o the side towards the center of the prosthesis. The width of this mm or region generally ranges between J ram: to 7 mm, hot in some cases is between 2,5 mm and 6,5 mm, and irs roost eases is between 2.5- mm and 5 mm,
|038I{ Incremental Thickness Profile of the prosthesis can he of an incremental thickness zone that ranges between 0.1 microns to 1,000 microns of incremental thickness. Hie incremental thickness zone can star at or adjacent to the outer edge of the prosthesis, In some embodiments, the incremental thickness zone can start 0,01 mm or more form the outer edge of the prosthesis, in some embodiments, the incremental thickness zone can start 0.25 mm or more form the outer edge of the prosthesis. The maximum delta incremental thickness maximnm added thickness ranges between 35 microns and 1,000 microns, preferably between 100 mic o s to 800 microns with a preferred delta of 100 microns to .500 microns and a m m preferred range being 75 microns to 400 microns, in certain embodiments an area inside (towards the center of the prosthesis from the outer edge) of 0.5 mm from the outer edge to 3 .mm from the outer edge of the contact lens is increased in thickness, in other embod ments, an area inside (towards the center of the prosthesis f m the outer edge) of 0.5 mm Item the outer edge to ? .mm from the oute edge of the contact lens is increased in ihickness. In these embodiments the "width" of the aperture widening zone can .he within a range of 2.5 mm to 6.5 mm depending upon the overall diameter of the contact Sens. In other embodiments the width of the aperture widening zone can be within the range of 1 mm to 7 mm, once again depending upon the overall diameter of the contact lens, in some embodiments the aperture widening zone extends from the outer edge of the prosthesis to within the range of 2.5 mm to 5 mm inside of the outer edge of the prosthesis. The precise distance from the outer edge depends upon the type of prosthesis arid also the verall diameter of th prosthesis
{0382} in most, but not all embodiments, an area inside of 0.25 mm to 2.5 ram from the extreme peripheral edge of the prosthesis provides the maximum delta thickness, but preferably within the range of 0.25 mm to 2.0 mm from ttie extreme peripheral edge of the contact lens or scleral ring, i some embodiments, the maximum delta thickness may be in the range of 0,25 mm to 0.75 from the extreme penpherai edge of the contact leas or scierai ring.
j;03$3j FIG. 26 is an illustration of th thickness profiles of the external convex surfac from the edge to the center for some embodiments of the prosthesis described herein. The ΪΙ lustration shows different possible examples of the convex surface profile (slope) and also the incremental thickness region or zone.
j0384J FIGS. 27 A ~ E illustrate variou incremental thickness regio s for five di Bfetent prostheses 2710, 2720, 2730, 2740, and 2750, Each prosthesis 2710, 2720, 2730, 2740, and 2750 has pupil zone 2700 surrounded, by areas of incremental thickness. FIG, 27A shows prosthesis 2710 having incremental thickness regions 271 and 2714, FIG. 27B shows prosthesis 2720 having incremental thickness regions 2722, 2724, 2726S and 2728. FIG. 27C shows prosthesis 2720 having incremental thickness regions 2732 and 2734. FIG. 27D stews prosthesis 2740 having incremental thickness: regions 2742 and 2744, F G, 27E shows prosthesis 2750 having incremental thickness regions 2752, 754, 2756, and 2758.
jOSSSf FIGS. 28 - 34 are perspective views of various contact lense having various types of aperture widening xoncs. While FIGS. 28-34 all illustrate contact lenses ii will be appreciated that the same features described in. reference to FIGS, 28 - 34 could be incorporated onto a scleral ring. FIG. 28 shows a contact lens 2800 having a convex surface 2802, a concave surface 2804, and a peripheral edge 2806. A incremental thickness region 2810 is located on convex: surface 28 2. incre ental thickness region 2810 can be a continuous ring of increased thickness or a plurality of discontinuous pariial rings of increased thickness. Incremental thickness region 2810 is located interior of peripheral edge 2806 and has a thickness different from, the rest of the contact len .28 0. The thickness profile of the lens is Illustrated by a first thickness .2812, a second thickness .2814, a third thicknes 2816, and fourth thickness 281.8. First thickness 2812, third thickness 2816, and fourth thickness 2818 are equal to the standard thickness of a conventional contact lens. Second thickness 2814, located in the incremental thickness region 281 , has a thickness greater than the standard, thickness.
[0386J FIG. 29 shows a contact lens 2900 having a convex surface 2902, a concave surface 2904, and a peripheral edge 2906, An increased surface friction region 2910 is located on convex surface 2902. Increased surface friction region 2910 can be a continuous ring having increased surface friction or a plurality of discontinuous partial rings having increased surface friction, increased surface friction region 2910 is located, interior of peripheral edge 2906 and has a surface friction different from the rest of the contact lens 2900. The surface friction profile of convex saria.ee 2902 is illustrated by a first surface friction 2912, a second surface friction 2914, a third surface fricti n 2916, and a fourth surface friction 2918. First surface f iction 2912, third surface friction 2916, and fourth surface f iction 2 IS are equal, to d e standard surface friction of a conventional contact lens. Second surface friction 2914, located in the increased surface friction region 2 10, has a surface friction greater than the standard surface friction.
103871 FIG, 30 shows a contact lens 3000 having a convex surface 3002, a concave surface 3004, and a peripheral edge 3006. An incremental thickness and increased surface friction region 3010 is located on convex surface 3002. Incremental thicknes an increased surface friction region 3010 can he a continuous ring having incremental thickness and increased surface friction or a plurality of discontinuous pariial rings or areas having incremental thickness and increased surface friction. Incremental thickness and increased surface tnetkra region 3010 is located interior of peripheral edge 3006 and has a thickness and surface friction different from the rest of the contact lens 3000. The thickness and surface friction profile of convex, surface 3002 is illustrated by a first thickness and surface friction 3012, a second thickness and surface friction 3014, a third thickness and surface friction 3016, and a fourth thickness and surface f iction 3018. First thickness and surface friction 3012, third thicknes and surface friction 3016, and: fourth thickness and surface friction 3018 are equal to the standard thickness a d standard surface friction of a conventional contact fens. Second thickness and surface f iction 3014, located in the incremental thickness and increased surface friction egion 3010, lias a thickness and surface friction that are greater than the standard thickness and surface friction.
£0388} FIG. 31 shows a contact lens 3100 having convex surface' 3102, a concave surface 3104, and a peripheral edge 3106, An incremental thickness region 31 1.0 is located on convex surface 3102. Incremental thickness regio 3110 can be a continuou ring of increased thickness or a plurality of discontinuous partial rings or areas o increased thickness. Incremental thickness region 110 i located interior of peripheral edge 3106 and has a thickness different from, the rest of the coniact lens 3100. The thickness profile of the lens is illustrated by a first thickness 3 11.2, a second thickness 3114, a third, thicknes 31 16, and a fourth thickness 31 IS, First thickness 3112, third thickness 31 16, and fourth thickness 31 IS are equal to the standard thicknes of a conventional contact lens. Second thickness 3114, located in the incremental thickness region 31.10, has a thickness greater than the standard, thickness. Contact lens 3100 also has a small truncation 3120 on peripheral edge 3106.
|03$9| FIG:, 32 shows a contact lens 3200 having a convex surface 3202, a concave surface 3204, and a peripheral edge 3.206. Aft incremental thickness region 3210 is located on. convex surface 3262. Incremental thickness region 3210 can be a continuous ring of increased thickness or a plurality of discontinuous partial rings or areas of increased thickness. Incremental thickness region 3210 is located interior of peripheral edge 3206 and has a thickness different from the rest of the contact lens 3200. The thickness profile of the lens is illustrated by a first thickness 3212. a second thickness 321.4, a third thickness 321 , and a fourth thickness 321 . First thickness 3 12, third thickness 3216, and fourth thickness 3218 are equal to the standard thickness of a conventional contact lens. Second thickness 3214, located in the incremental thickness region 3210, has a thickness greater than the standard, thickness. 'Contact lens 3200 also has a small truncation 3220 and a prism ballast 3222 located on peripheral edge 3206.Small truncation 3220 is located opposite prism ballast 3222 on peripheral edge 3206. |Θ390| Fftl 33 shows a contact lens 3300 having a convex surface 3302, a concave surface 3304, mid a peripheral edge 3306. An incremental thickness region 3310 is located on convex surface 3302. Incremental thickness region 33 0 cars be a continuous ring of increased thickness or a plurality of discontinuous partial, rings or areas' f increased thickness. Incremental thickness region 3310 is located interior of peripheral edge 3306 and has a thickness different f om the rest of the contact lens 3300, The thickness profile of the lens is illustrated by a first thickness. 331.2, a second thickness 3314, a third, thickness 3316, and a fourth thickness 33 I S. First thickness 3312, third thickness 3316, and fourth thickness 3 18 are equal to the standard thickness of a conventional contact lens. Second thickness 3344, located in the Incremental thickness region 3310, has a thickness greater than the standard thickness. Contact lens 3300 also has a small truncation 3320 and a small irnncation/prisni ballast 332.2 on peripheral edge 3306. Small truncation 3320 is located opposite small truacation prisnr ballast 3322 on peripheral edge 3306.
[0391 } FIG. 34 shows a contact lens 3400 having a convex surface 3402, a concave surface 3404, and a peripheral edge 3406. An incremental thickness region 3410 i located on. convex surface 3402. Incremental thickness region 3410 can be a continuous ring of increased thickness or a plurality of discontinuous partial rings or areas of increased thickness. Incremental thickness region 3410 is located interior of peripheral edge 3406 and has a thickness different from the rest of the contact lens 3400, The thicknes profile of the lens is illustrated by a first thickness 3412, a second thickness 3414, a third thickness 3416, and a fourt thickness 34 I S. First thickness 3412, third thickness 3416, and fourth thickness 341.8 are equal to the standard thickness of a conventional contact lens. Second thickness 3414, located in the incremental thickness region 3410, has a thickness greater than the standard thickness. Contact Sens 3400 also has a smalt truncatioa' rism ballast 3422 located on peripheral edge 3406.
10392| FIGS. 35 - 38 show aerial views of a plurality of contact lenses having various types of aperture widening zones. While FIGS. 35 - 38 all illustrate- contact lenses it will he appreciated that the same features described in reference to. FIGS. 35 - 38 could be incorporated onto a scleral ring. FIG, 35 shows a contact sens 3500 having a peripheral edge 3502 and pupil zone 3510. Pupil zone 3510 may have optical power or ma be devoid of optical power and has a standard thickness and convex curve as that of a co.ftvettt.iona! contact lens having a specified optical power or lack: thereof; Located between peripheral edge 3502 and pupil zone 351.0 is an incremental thickness region 3506. it should be pointed out that the incremental thickness region (aperture widening zone) 3506 can start at or acc , to the outer edge of the prosthesis. While a single ring is shown for incremental thickness region 3506 it is appreciated that there may be multiple rings or partial rings. SwroufKiing incremental thickness region 3506 and located between peripheral edge 3502 and incremental thickness region 3506 is a peripheral region 3504. Peripheral region 3504 has thickness and curvature equal to the standard thickness and curvature, of a conventional contact lens. An internal region 3508 Is located between pupil zone 351.0 and incremental thickness region 3506. interna! region 3508 lias a thickness and curvature equal to that of a conventional contact Sens,
j03 3| FIG. 36 shows a contact lens 3600 having a peripheral edge 3602 and pupil zone
3610. Pupil zone 36 JO may have optical power or may be devoid: of optical power and. has a standard surface friction, thickness, and convex curvature as that of a conventional contact lens having a specified optical power or lack thereof Located between peripheral edge 3602 and pupil zone 3610 is an increased surface friction region 3606. Increased Surf ce Motion region 3606 includes a textured surface that increases surface friction. The textured surface cap be created by, but not limited to, a different material, dimples, bumps, surfaces irregularities, any change in surface topography; or any combination thereof While a single ting is shown for increased surface friction region (aperture widening zone) 3606 it is appreciated that there may he multiple rings. Surrounding increased surface friction region 3606 and located between peripheral edge 3602 and increased surface friction region 3606 is a peripheral region 3604. Peripheral region 3604 has a surface friction equal to the standard surface friction of a conventional contact lens. An .internal, region 3608 is located between pupil zone 361.0 and. increased surface: friction region 3606, Internal region 3608 has a surface friction, thickness, and curvature equal to that of a conventional contact lens,
10394) FIG. 37 shows a contact lens 3700 having a peripheral edge 3702 and pupil zone
3710. Pupil ¾one 3710 may have optical power or may be devoid of optical power and has a standard surface friction, thickness, and convex curvature as; that of a conventional contact lens having a specified optical power or lack thereof Located between peripheral edge 3702 and pupil zone 3710 is an incremental thickness and increased surface friction region 3706. incremental thickness and. increased surface, friction region (aperture widening ns) 3706 includes an increased thickness and textured" suriace that increase surface friction. The textured surface ca be created by, but not limited to, a different iiiaieriaf. suriace treatment, dimples, humps, surface irregularities, any change in surface topography, or any combination thereof. While a single ring is -shown for incremental thickness and increased surface friction region 3706 it is appreciated that there may e •multiple rings. Surrounding incremental thickness and increased suriace friction region 370§ and located between peripheral edg 3702 and. incremental thickness and increased suriace region 3706 is a peripheral region 3704, Peripheral region 3704 has a thickness and surface friction equal to the standard thickness and surface friction, of a conventional contact lens. An internal region 3708 is located, between pupil zone 3710 and increased surface friction region 3706. Internal region 3708 has a thickness, surface friction* and curvature equal to that of a con ventional contact, lens-.
FIG. 38 shows a contact lens 3800 having a peripheral edge 3802 and pupil mm
381 , Pupil zo e 3810 may have optical power or may he devoid of optical power and has a standard thickness and convex curvature as that of a conventional contact lens having a specified optical power or lack thereof Pupil z ne 3810 ca also include an astigmatic optica! power. Located above and below pupil ¾o.ne 3 10 are two incremental thickness regions 3806. It should be noted that .each of the two incremental thickness regions 3806 (aperture widening zones) will, have an outer slope, inner siope and point of maximum thickness delta / m ximum increased thickness. Each incremental thickness regio 3806 has a hemispherical, shape. Contact lens 3800 also includes- two internal regions 3808 located on either side of pupil zone 3S 10. Each internal region 3808 has a thickness and curvature equal to a. standard thickness and -curvature of a conventional contact lens. Surrounding the periphery of the lens is a peripheral region .3804 which also has a thickness and curvature equal to a standard thickness and curvature of a conventional contact lens,. However, it should be noted that each of he two incremental thickness regions could start at or adjacent to the outer edge of the contact lens. It will be appreciated that incremental thickness regions 3806 can also include a. textured sin-face that increases surface friction. Additionally, incremental thickness regions 3806 can be replaced with increased surface friction regions having a textured surface and having conventional thickness and curvature. Θ396{ FIGS. .39 A - £ illustrates the surface profile of a contact' Sens 39(H) according to one embo iment Contact lens 3900 ha an optical power ofO,0÷ ,OOD, As seen in FIG. 39A, contact lens 3900 includes a first surface 3904, a second ..surface 3906, third: suffice 3908,. and a fourth .surface 3910. First surface 3904 has radius of curvatur ranging betwee 6,50 mm. and 9.5 mm. Second surface 3906 exemplifies an incremental thickness region in. the form of a bump (aperture widening zone). The radius of curvature of second surface 3906 ranges between 4,50 mm and 7.50· mm. Second surface 3906 can have a width betweeri 2, mm and.4,0 mm* Third, surface 3908 has a radius of curvature ranging between -6.50 mm and 9,50 nun. Fourth suriace 39ΤΘ is located oh the outer most periphery of contact lens 3900 and has a radius of curvature ranging from 2,0 mm and 8.0 mm. Th overall diameter of contact lens 3900 can range from 1 1 ,0 mm to 16,5 .mm, FIG, 39B shows a side view of contact lens 3900, FiG. 39C shows: a cross-section of contact lens 3900 along line 3902 ra FiG. 39 A. FIG. 39D shows the convex, .surface of contact lens 3900 and FiG. 39B shows the concave surface of contact lens 3900.
|0397J FIG. 40 shows a contact tens 4000 having a spherical optical power superimposed on an eye 4014. Eye 4014 has an tipper Sid 4012 and a. lower Sid 4008, Contact Sens 4000 includes an area of incremental thickness (aperture widening zone) 4002, a pupil zone 4006, and a peripheral edge 4004, It can be seen in FIG. 40 that contact lens 4000 has an area 4010 that fits under upper lid 4012. Included in area 4 10 is pari of incremental thickness region 4002.
j#3981 FIG, 41 shows a contact lens 4100 having an astigmatic optical power superimposed on an eye 41 1.4, Eye 4! 14 has an upper lid 41 1 and a lower lid 41 8 Contact lens 4100 includes an incremental thickness region (aperture widening: zone) 1 2, a pupil zone 41 6, and a peripheral edge 4104. It can he seen in FIG. 41 that contact lens 4100 lias an. area 4 HO that fits under upper lid 41 12, included in area 4110 is part of incremental thickness region 4102, Contact lens 410 also has a weighted/siabili atioii zone 4116 located on the bottom,.
f0399| FIG. 42 shows a contact lens 4200 having a spherical optical power .superimposed on an eye 421 . Bye 4214 has an upper Sid 4212 and a. lower Sid 4208. Contact len 4200 includes an incremental thickness region (aperture widening zone) 423.8 having a plurality of partial rings 4202, a pupil zone 4206, and a peripheral edge 4204. It can be seen in FIG, 42 that contact lens 4206 has an area 421.0 that fits under uppe Hd 4 12. ~ SO -
Included m area 4210 is a plurality of partial, rings 4202 located in incremental thickn ss region 42 I S.
(04$¾)f FIG. 43 shows a contact Sens 4300 'havin -a spherical optical power superimposed on an eye 4314. Eye 4314 has an upper lid 4312 and a lower lid 4308. Contact lens 4300 includes an incremental, thickness region, (aperture widening zone} 4318 having a plurality of partial rings 4302, a pupil zone 4306, and a peripheral edge 4304. It can be see in. FIG.. 43 that contact lens 4300 has an area 4310 that fits under tip er lid 4312.. included in area 4310 is a plurality of the partial rings 4302 located in incremental thickness region. 4318. Contact lens 4300 also has a weighted'stabilization zone 4316 located on the bottom.
£0401 [ FIG. 44 shows an embodiment of a hybrid multifocal contact lens 4400. Contact lens 4400 includes a peripheral edge 4402 surrounding a soft skirt 4404. Soft skit 4404 includes an incremental thickness region {aperture widening zone) 4406. A junction 4416 is located at the periphery of incremental, thickness region 4406. Junction 4416 connects incremental thickness region 4406 to gas permeable rigid zone 4408, Gas permeable rigid zone 4408 has a continuous graduation of power 441 and include aspherie distance zone 4410 and aspherie near zone 4414. While the embodiment of FIG. 44 shows incremental thick ess region 4406 located near peripheral edge 4402 it can be located anywhere adjacent to or peripheral to gas permeable rigid zone 4408·. By this it is meant that incremental thickness region 4406 can be located adjacent to or outside of 3.0 mm of a geometric center of hybrid contact lens 4400.
j¾4(>2f FIG. 45 shows an embodiment of hybrid contact lens 4500 superimposed on an eye. Contact lens 4500 includes: a peripheral edge 4502 surroundin a soft .skirl 4504. Soft skit 4504 includes an incremental thickness region 4506 (aperture widening zone) and has a junction 4516 located on its peripheral edge. Junction. 4 16 connects soft skit 4504 to a gas permeable rigid zone 4508. Gas permeable rigid zone 4508 can include a spherical optical, power or an astigmatic optical power.
|Θ4©3] FIG. 46 shows an embodiment of a soft multifocal contact lens 4600, Contact: lens
4600 Includes a peripheral edge 4602, an area of incremental thickness (aperture widenin zone) 4604, a near distance zone 4606 (illustrated as the ring that circles the geometrical center of the contact lens), an intermediate zone 4608 (illustrated as the ring that circles the geometrical center of the contact lens), and a distance zone 4610 (illustrated as the larger central dark area which is surrounded by intermediate, zone 4608).
( 4l)4| FIG. 47 shows an. embodiment of a reverse hybrid contact lens 4700. Contact Jens
4700 mclndes a peripheral edge 4702 and a geometric cente 4712. A rigi outer skirt 4704 surrounds a soli center 4710 and includes an incremental thickness region (aperture widening tone) 4706. Junction 4708 s located between rigid outer skit 4704 and soft center 471.0.
Patient Selection process for fitting the Prosthesis;
jO40Sj The prosthesis provides the significant cosmetic enhancement widenin of the palpebral fissure of the wearer's eye when fitted on an eye that has an upper iid margin within 2 mm to 3 mm or less of the upper edg of the pupil and/or a lower lid margin is within 2 mm to 3 mm or less of the lower edge of the pupil Another way of establishing patient selection tor th prosthesis is the selection of any eye where the upper or lower Sid, in a resting location with, the lids open, covers the upper and/or lowe limbal area of the eye.
HJ 06] The embodiments disclosed herein also teach an. instrument that projects an image of known diameters onto the skin and. facial eye region of a potential wearer. The instrument allows for taking a photo of the projected image on the eye and the adjacent facia! region of the potential wearer,. By doing this it is possible to quickly understand the appropriate diameter contact Sens or scleral ring needed 'm provide the bes palpebral widening effect. In some embodiments infrared light is used t project light onto the eye of the wearer so to minimise any constriction of the wearer' pupil. In other embodiments low levels of visible light rc projected. In still other 'embodiments an infra-red camera is used.
jft407f 'The process iuriher contemplates a Siting set of the prosthesis whereby m the case of the contact lens prosthesis a set of rings or series of dots or lines are painted or affixed to the contact lens; each dot, line or ring by way of example onl being i ram les diameter than, the outermost adjacent dot line or ring. This then allows an eye care professional to visually determine quickly when the prosthesis is tried on the eye of the wearer which contact lens provides the maximum, aperture widening. The professional can also then simply indicate the number of hues or rings present in the open aperture of various trial lenses thus allowing selection of the one that presents tlie greatest nuniier of lines or rings within the aperture of the wearer's eye.
ϊη a first fitting Method embodiment the following technique is followed in- fitting the prosthesis that is taught, herein:
#1) lake a photograph of Mended wearer's eye or eyes while pa&eni lntended wearer is relaxed without miling
#2) Display or print photograph;
#3) Measure the natural palpebral fissure m fehres as shown in the displayed or printed photograph;
#4) Choose a trial prosthesis thai, provides good eentratiori and has an overall outer diameter that is within the range of Imra
to 10mm wider than the palpebral fissure just measured of the
in tended wearer being lit however in roost eases it will be 2 mm to
4 mm wider;
#5) Choose a prosthesis to be prescribed and/or delivered to patient after viewing the appearance of wearer's eye (this can be
done solely by the eye care professional and/or by feedback from
the patient being fit);
#6) Repeat the appropriate steps for fitting the second eye of the intended wearer or patient.
In a Second fitting method embodiment the following technique is followed in fitting the prosthesis that is taught herein;
#1 ) Measure the natural palpebral fissure of die paiient's/intended wearer's eye or eyes while patient/intended
wearer is relaxed without smiling;
#2) Choose a trial prosthesis that provides good centra-ion and has an overall outer diameter that is within the range of I mm
to 10 mm wider than the palpebral fissure just measured of the intended wearer being fit, however in. most cases it will, be 2 mm to 4 mm wider;
#3) Choose a prosthesis to be prescribed and'Or delivered to
a patient alter viewing the appearance of wearer s eye (this can be done solely by the eye care professional and/or b feedback from the patie t being fit);
#4) .Repeat the appropriate steps for fitting the- second eye
of the intended wearer or patient
16410} Irs a third fitting method embodiment the following technique is followed in fitting the prosthesis that is taught herein:
#1) lake a photograph of intended wearers eye or eyes
while patient intended weare is relaxed without smiling;
#2) Display or print photograph;
#3) Measure the natural palpebral fissure or fissures as
shown In the displayed or printed photograph;
#4) Fit a prosthesis out of inventory or order a prosthesis
that provides good centrabon and has an overall outer diameter thai is within the range of I mm to 10 mm. wider than the palpebral fissure just measured of the intended wearer being fit, however i most cases it will, b .2 mm to 4 nim. wider.
16411} In a Fourth fitting uietbod ewi odinient the f llowlng technique is followe in
Siting the prosthesis that is taught herein:
#1 ) Measure the natural palpebral fissure of the
patient mtended wearer's eye or eyes while patient/intended wearer is relaxed without smiling;
#2) Fit a prosthesis out of inventory or orde a prosthesis
that provides good eentration and has an overall outer diameter that is within the range of 1 mm to 10 nun wider than the palpebral fissure just measured of the intended wearer being fit, however in most cases it will be 2 ram to 4 mm wider.
[(1412} in a Fifth fitting me hod embodiment the following technique Is followed in fitting the prosthesis that is taught herein:
#1 ) Fit the prosthesis out of inventor or order a prosthesis
tha provides good eentrahon and has an overall outer diameter that is within the range of 1 mm to 10 mm wider than the palpebral fissure just measured of the intended wearer being fit, however in most cases it will be 2 mm to 4 mm wider.
1 413 F!Ci 48 shows an example of a method for fitting a prosthesis as described hereto.
As seen in FIG, 48» an image 4800 is projected onto an individual's eye. Image 4800 includes a scale 4802 with a plurality of markings 4804, Markin 4804 are used to measure the individual's palpebral fissure and used to determine the diameter o prosthesis that will raise the upper Hd, or depress th lower lid, thereby widening the individual's palpebral fissure.
04I4| It should he understood that any and ail kno n contact lens treatments, colors, custom color designs (including color designs, such as by way of example only a lirabal ring,, color ring, or colored accent, imparted on the prosthesis to increase the appearanc of the size of the outer lirahus thus making the wearer's eye appear larger), coatings, materials, filtering of specific wavelength (lengths) of light contact lens designs, shapes. ptical powers including piano, static or dynamic focusing, contact lenses, any known optical powers required tor astigmatic, spherical, and presbyopic correction can he considered to apply to the prosthesis (contact lens or sclera! ring) described herein. By way of example only when the prosthesis is in the form of a contact lens the contact, lens can be; single vision with spherical only optical power, single vision with sphero-cyiinder optical power, multifocal with spherical only optical power, multifocal with sphero- cyiinder optical power. A prosthesis i the fo m: of a scleral rin would not have optical power and will not be considered single vision or multifocal,
|0415| It should be understood that the embodiments as disclosed herein, cover any means by which a soft contact lens or hybrid contact lens or scleral, .ring increase the stee of the wearer's palpebral fissure by way of "one o more" of the following features- of the contact lens, by way of example only; "incremental thickness region (aperture widening zone)", Increased overall thickness, increased edge thickness, increased' overall diameter, localized area of increased thickness, increased convex surface- eiion, localized area of increased convex surface -friction, increased partial area of raised thickness on convex surface, regressive thickness mm, convex, surface treatment (material and or texture), truncation, to superior edge of lens, truncation to the interior edg of the lens, truncation to the superior and inferior edge of the lens,, increased thickness of the edge of the lens, (partial or complete) band (bands) or ring (rings), dome (domes), segment (segments) of increased thickness on the convex surface of the contact lens external to ¾e pupil ¾one, and increased base curve fit. This list is not intended to be limiting.
04'161 ft should be understood that while some embodiments herein have been described in reference to the convex surface of a prosthesis havin an aperture widening zone with increased and/or regressive thickness, the aperture widening zones described herein may be -placed on t e concave surface of the prosthesis, if the prosthesis is made with a sufficiently flexible material, an increased. anoVor regressive thickness (i.e., thickness delta) located on the concave surface of the prosthesis will behave the same as or similar to as if it were located on the convex, surface.
|6417f In some, but not ail, embodiments the prosthesis has an increased thickness region superior to the pupil zone.
{04181 in some, but not all, embodiments the prosthesis has an Increased thickness region
Inferior to the pupil zone.
j¾ 19f In some, but not al l, embodiments tire prosthesis has an increased thickness region superior and inf rior to the pupil zone.
{04201 in some, but not all embodiments the prosthesis provide inmeatiof) and/or weighting to stabilize the prosthesis.
j 4211 In some, but not ail, embodiments die len edge is that of a conventional prosthesis thickness and edge.
{0422.1 I some, but not all embodiments, the lens edge has a thicker overall thickness and edge compared to traditional, contact lenses..
|0423| It is important to note that the increased thickness of the contact lens prosthesis
(whether within the pupil zone or external to the pupil zone) in most, but not all ~ - embodiments, does not alter the desired prescription or optical power of the portion of me contact lens that focuses light on the retina of the wearer of the contact tens.
(0424) in some embodiments one of a soft or hybrid contact lens is of spherkjal ptical power., however ill© area peripheral to the pupilary zone is configured like that of a minus aspherie torie lens having an axis of 180 (+/-20 degrees) in terms of thickness, meaning the thickness above and below the pupilar zone is thicker than normal,
jii425| Ϊ» other embodiments one of a soft or hybrid contact lens is of spherical optical
•power, however the area peripheral to the pupilary zone is configured like that of one of a soil or hybrid contact lens in terms of thickness, with the exception of this peripheral area be ing o f increased thickness compared to that of a conventional/traditional soft or hybrid spherical power contact lens for the same optical power, diameter and base curve.
(0426) in some embodiments one of a soft or hybrid contact lens comprises astigmatic optical power, and the area peripheral to the pupilary is configured like that of a minus aspherie tone lens having an axis of 180 (+/-20 degrees) in terms of thickness, meaning the thickness "above and below'5 the pupilary zone i thicker than normal for a typical astigmatic correcting soft or hybrid contact lens,
(0427f Some embodiments contemplate spherical lenses with no optical power axis bein such that the area superior and inferior to the pupil zone of the soli contact lens or hybrid contact lens is thicker th would be expected for a soft or hybrid contact lens having such a spherical or astigmatic optical power.
(04281 Some embodiments contemplate astigmatic lenses having a optical axis being such that the area superior and inferior to the pupil zone of the soft contact lens or hybrid contact len is thicker tha would, be expected for a soft or hybrid, contact lens having such a spherical or astigmatic optical power.
(0429] Some embodiments contem late an incremental thickness region izam,. area) or a regressive thickness region (zone, area) located on the convex surface of the prosthesis that i rot tional ly symmetrical.
0430.1 Some embodiments contemplate an incremental thickness region (zone,, area) or a regressive thickness region {zone, area) located on the convex surface of the prosthesis that is roiationally asymmetrical. 104311 Some em odiments contemplate an incremental thickness region :{¾one, area) or a regressive thickness region (zone:, area) located on the convex surface of the prosthesis that is now --rotational ly symmetrical.
j0432f Some embodiments contemplate an incremental, thickness region (zone, area) or a regressive thickness region (ione, area) located on the convex surface of the prosthesis that approximates the curve of the upper lid margin and / Or the curve of the lower lid margin.
}0433f The incremental thickness region (aperture widening zone) of the rosthesis can have a tmsira w delta thickness differential (added thickness) within the range of 25 microns to 1,000 microns, with a preferred range of 100 microns to 500 microns, with a more preferred range of 75 microns t 400 microns,
(04341 The regressive thickness region, (aperture widening zone) of the prosthesis can have a maximum delta thickness differential (reduced thickness) within the range of ISniicro io 1 ,000 microns, with a p eferred range of 100 microns to 500 microns, with a more preferred range of 100 microns to 400 microns, with a more preferred range of 75 microns to 400 microns,
104351 The convex surface region of incremental thickness (aperture widening zone) of the prosthesis can be located within the range of 3 mm to S.5 mm from the geometrical center of the contact lens, and more eferably within 5 mm to 7.75 mm torn the geometrical center of me contact lens.
104361 The region of incremental thickness or regressive thickness (aperture widening zone) is in most cases internal to the edge of the prosthesis. However in some cases, not most, it can start at the outer edge of the prosthesis.
|04371 The delta of maximu incremental thickness in most (bu not all) eases is within
0,25 mm to 3.0 mm internal to the edge of the prosthesis.
10 381 The delt of maximum regressive thickness in most (but: not ail) case is within:
0.25 mm to 3.0 mm internal to the edge of the prosthesis
I6439J The incremental thickness region (zone,, area) (aperture widening zone) is in most
(but not ail) cases within 0.1 mm. to 6.0 mm interna! to the outer edge of the prosthesis, (6446| The incremental thickness region pone, area) (aperture widening mm) in some cases can start at the outer edge of the prosthesis and proceed to 6 mm internal to die outer edge of the prosthesis. ~ H8 - 04411 The regressive thickness region (zone, area) (aperture widening zone) is in most
(but not all) ease within 0.1 mm to 6.0 mm internal to the edge of the prosthesis.
However in. some eases, not most, it can start at the outer edge of the prosthesis.
j0442f The width of the incremental t ickn ss region (zone, area) (aperture widening zone) or the regressive thickness .region (zone, are) (aperture widening zone) can be 0.5 mm to 6 ran.
jiS443| The mcteme«ta.l. thickness diameter and the regressive thickness diameter may fall within the range of 7 mm to 15 mm.
[i)444| In. some embodiments there ate multiple rings or zone of incremental thickness and or regressive thickness; wher b one ring is located interior to another ring (or closer to the .geometrical center of the lens).
j0445| in some embodiments., the region or zone of incremental thickness (aperture widening zone) has a slope and a delta of maximum thickness, whereby the outer slope on the outside of the delta of maximum incremental thickness (closer t the outer edge of the prosthesis) is steeper than the inner slope on the inside (closest to the center of the prosthesis),
|8446| In some embodiments, th region or zone of regressive thickness has an outer slope and a delt of omximum regressive thickness, whereby the inner slope on the side of the delta of maximum regressive thickness (closer to the center of the prosthesis) is the steepest.
|β447| In some embodiments, the region or zone of regressive thickness- has an outer slope and a delta of maxi vum regressive thickness, whereby the inner slope on the side of the delta of maximum regressive thickness (closer the center of the prosthesis) is equal to the■ outer slope.
|0448f In some embodiments, the prosthesis in the form of a contact lens or scleral ring; can comprise finger like members thai fold towards the center of the scleral ring when the eye lid closes or blinks and opens away (unfolds) from the center of the scleral ring when the eye lid is opened . The finger like members can be located on the region of the sclera! ring above and below the pupil, of the eye. The finger like members c n elevate the upper lid and depress or lower the lower lid when the eye lid is open and not blinking or closed.
10449) When the term contact lens i provided or used in this disclosure it is meant to be that of one of;, a eomeo-seleraS contact lens or hybrid contact: lens. - *
$450] When ihe term incremental, thickness region is used it is meant to be the aperture widening zone.
{04511 When the term regressive thickness reg on is used it Is meant to be the aperture widening zone.
10452] When the term, increased surface friction, region is used it is mean it) be the aperture widening zone
{04531 Ϊ» some embodiments of the prosthesis there may or may not be an incremental thickness zone (region, area), or a. regressive thickness zone (region,, area) but rather the surface of the zone or region is altered to provide increased lid friction compared t other areas of the prosthesi s. This region or zone of increased surface friction can be easily over come during an eye lid blink or forced closure but upon opening the eye !id this regi n of increased friction elevates the upper lid and/or depresses the Sower lid thu opening the aperture of the eye.
{04541 The prosthesis disclosed herein can be stabilized (by the use of a stabilization zone) to prevent rotation m the ease, by example only, of a multifocal or a tone single vision lens or a tone multifocal.
{04551 The prosthesis disclosed herein can be devoid of stabilization (not -stabilised / free to rotate) in the case, by example only, of a single vision spherical lens.
10456 j The prosthesis disclosed herein can be free to rotate upon natural normal blinking of the eyes always when in the ftwm of scleral ring. And also in most (bu not ■all embodiments) when in the form of a single vision contact lens comprising solel spherical optical power and. devoid of a stabilization zone, feature or member.
10 57] The prosthesis in some embodiments disclosed, herein is not free to rotate upon natural / normal blinking of the eyes al ways when in the forrn of a scleral ring.
{04581 i some embodiments the aperture widening .zone and the stabilization zone can be one and the same by design. In other embodiments the aperture widening zone is separate from the stabilization zone, feature or member.
{0459] FIGS. 4 - 53 illustrate exemplary embodiments of a prosthesis having an aperture widenin zone. FIG. 49 shows a scleral ring 4900 having an aperture widening zone 4906 spaced apart from its peripheral edge 4902. Located between peripheral edge 4902 and .aperture widening zone 4906 is a first regio 4904. First region 4904 has a thickness and curvature equal to that of a conventional scleral ring. Aperture widening zone 4 116 has an. outer edge 4908 and an. inner edge 4916.. Aperture widening zone 4906 has an incremental thickness defined by an outer slope 4910 and an inner slope 9.14 with a maximum incremental thickness 4912 located between outer slope 4 10 and inner slope: 491 . A second, region. 4918 is located adjacent to inner edge 4916 and. extends towards an. open central aperture 4920.. Similar to first region 4904, second region 4918 has a thickness and curvature equal to that of a conventional scleral ring. Located in the center of open central aperture 4920 is the geometric center 4922 of scleral ring 4900. FIG. 49 also shows the vertical dimension (VD) of scleral ring 4900. The vertical dimension ( VD) bein measured from the upper most point of outer edge 4908 to the lower most point of oilier edge 4908.
[0466} FIG. 50 shows a scleral rin 5000 having m aperture widening zone 5004 beginning at its peripheral edge .5002. Aperture widening zone 5004 has an incremental thickness defined fey an outer slope 5006 and an inner slope 5010 with a maximum incremental thickness 5008 located between outer slope 5006 and inner slope 5010, Aperture widening zone 5004 includes an inner edge 5012 adjacent to an open central aperture 5014. Located n the center of open central, aperture 5014 is the geometric center 5016 of scleral ring 5000, PIG. 50 also shows the vertical dimension (VD) of scleral ring 5000. The vertical dimension. (VD) being measured from, the upper most part of peripheral edge 5002 to the lower most part of peripheral edge 5002.
j 461 J FIG. 51. shows a contact lens 5100 having an aperture widening zone 5106 spaced apart from its peripheral edge 5102, Located between peripheral edge 51 2 and aperture widening zone 51 6 is a first region 5104. First region 510 has a thickness- and curvature equal to that, of a conventional; contact lens. Aperture widening zone 5.106 has an outer edge- 5. I OH and an inner edge 51 1.6., Aperture widening zone 5106 has an incr ment l thickness defined by an outer slope 51 10 and an inner slope 51 14 with a maximum incremental thickness 5112 located between outer slope 5110 and inner slope 51 1 .. A second region 51 18 is located adjacent to inner edge 511 and extends toward the geometrical center S 120 of the- contact lens 51 0. Second region 51 18 can have an optical power or can. be devoid of optical, power and has a. thickness' and curvature equal to that of a conventional, contact lens having a specific optical power or lack thereof FIG. 51 also shows the vertical dimensio (VD) of contact lens 5100. The vertical dimension (VD) being measured from the upper most part, of outer edge 51 8 to the lower most part of outer edge 51 OS,
ftl462f FIG. 52 shows a contact lens 5200 having an aperture widening zone 5204 eginning at its peripheral, edge 5202. Aperture widening mm 5:204 has a incremental thickness defined by an. outer slope 5206 and an. inner slope 52 1.0 with a maximum incremental thickness 5208 located between outer slope 5206 and inner slope 5210. A second region 5214 is located adjacent to an inner edge 5212 -of aperture widening zone 5204 a id extends towards die geometric center 5216 of th contact lens 5200. Second region 5214 cat* have an optical power or can be devoid of optical power and has a thickness and curvature equal to that of a conventional contact lens having a specific optical power or lack thereof FIG. 52 also shows the vertical dimension (YD) of contact tens 5200. The vertical dimension. (VD) being measured from the upper most part of peripheral edge 5202 to th lo wer most pari of peripheral edge 5202,
{0 63 FIGS. 53A - - E show various exemplary embodiments of aperture widening zones having a plurality of bands of incremental thickness 5304. The bands: of incremental thickness are arranged in a spoke-like fashion around either an open -central aperture 5300 or an ptic zone 5302. While a plurality of different .patterns are shown in FIGS. 53A E it Is appreciated that any number or orientation of bands of incremental thickness 5304 can be present in the aperture widening zone.
{M64j FIGS. 54 ~ 56 illustrate the palpebral fissure widening effect of an aperture widening zone described herein, FIG. 54 shows an individual's natural palpebral fissure. As seen in FIG . 54 the maximum diameter of the individual's left nat ural palpebral fi ssu re {right side of FIG, 54) is .approximately 6 mm. FIG, 55 shows the same individual wearing a prosthesis having an aperture widening zone as described herein. It can he seen from FIG. 55 that the palpebral fissure of his left eye has been widened. The maximum diameter of his left eye's palpebral fissure is now approximately 9,5 rum, an increase of approximately 3,5 mm. FIG. 56 shows the left eye in FIGS, 54 and 55 side by side tor comparison,
465] FIGS.. 57 - 6 show variou graphs exemplifying the surface profile of embodiments of the prosthesis as described herein. FIGS. 57 - 60 quantify the inner and outer slopes of various aperture widening zones. FIGS. 57 and 58 show prostheses having -a maximum, change in thickness located approximately 5.7 mm, f om, the: geometrical center of the prostheses. PIG. 59 shows a prosthesis having a maximum change i ihickness Located approximately 5.3 mm f om the geometrical center of the prosthesis. FIG. 60 shows a prosthesis having a maximum change in thickness located approximately 5.55 mm from, the geometrical center of the prosthesis.
j0466| FIG. 61 illustrates th dimensions of a contact lens 6130 compared to the anatomy of a hu an eye. The hitmao eye has an upper lid 6120, a lower lid 6122,, cornea 6124, and a sclera 6128. Located at the interlace of cornea 6124 and sclera 6128 is a W h 6126. is other words, limbos 6126 is located adjacent- to the outer peripheral edge of cornea 6124 and adjacent to sclera 6128. The a verage diameter of the cornea is 1 1.71 *·/- 0.42 mm. The average corneal diameter is 1 1.77 0.37 mm in males compared with I L64 + - 0.47 mm in females,
j0467f Contact lens 6130 having an aperture widening zone 6132 is shown as being, worn on the eye and extends across cornea 6124 and lirabus 6126 to sclera 6128 on both sides of cornea 6124. A visual representation 6300 of contact Sens 6130 is shown to the left of the eye (this is not Hie actual lens, but rather a representation showin the various dimensions of contact lens 6130). As show by visual representation 6100, contact lens 6130 has an aperture widening zone 6132 located adjacent t a peripheral edge 6102. Aperture widening zone 6132 is defined by an outers Lope 6104, a maximum incremental thickness 6106, an inner slope 6108,. and an inner edge 6130. Located inside of inner edge 61. 10 is an optical power zone 61 12 with a geometric center 61 14 located therein. It can be seen from FIG. 61. thai maximum incremental thickness 610 is located outside of tim iis 126 on. both sides of the eye.
j0468J FIG. 62 illustrates the dimensions of a scleral ring 6230 compared to the anatomy of a human eye. The human eye has an appe lid 6220, a Lower lid 6222, a cornea 6224, and a sclera 6228. Located at the interface of cornea 6224 and sclera 6228 is a limbus 6226. Scleral ring 6230 having an aperture widening zone 6232 is shown as being worn: on the eye and extends across cornea 6224 and limbus 6226 to sclera 6228 on both sides of cornea 6224, A visual representation 6200 of scleral ring 6230 is shown to the left of the eye (this is not the actual lens, but rather a representation showing the various dimensions of scleral ring 6230). As shown by visual representation 6200, scleral ring 6230 has an aperture widening zone 6232 located adjacent to a peripheral edge 6202. Aperture widening zone 623 is defined by an outer slope 6204, a maximum incremental thickness 6206. an nner slope 6208, and an inner edge 6210. Located inside of Inner edge 621.0 is an open central aperture 6212 with a geometric center 6214 located therein. It can be seen from F G. 62 that uiaximuiti incremental thickness 6206 is located outside of limb' s 6226 on both sides of the eye.
j0469J FIG'S. 63 A. - 66D illustrate examples of how to measure tire vertical dimension and/or the minimum, vertical -dimension for various shapes. While these figures are simplified versions of exemplary shapes o 'aperture widening zones it is appreciated that any shape will have a vertical dimension and a mini mum -vertical dimension. For purposes of these illustrations it will be assumed that the paints used to measure vertical dimensions and/or minimum vertical dimensions would he located on the upper most part of an aperture widening zone and the lower most part of an aperture widening zone.
|Μ7β FIG. 63 A shows a prosthesis 6300 having an aperture widening zone with an outer edge 6306 in tile shape of a circle. The upper most point of outer edge 6306 is shown at point 6302 and the lower most point of outer edge 6306 is shown at point 630 The vertical dimension (VD), measured, fr m tipper roost point 6302 to lower most point 6304 and projected onto a vertical axis, is shown on the left side of f 1G. 63A, Because outer edge 6306 is in the shape of a circle the vertical dimension (VD) is equal to the minimum vertical dimension (MVD). For a circle, this is true fo any rotational orientation of the prosthesis.
{(1471 FIG. 638 shows a prosthesis 6350 having an aperture widening zone with an outer edge 635 in the shape of an equilateral triangle. The upper most point of outer edge 6356 is shown, at point 6352 and the Sower most point of outer edge 6356 i shown at point 6354. The vertical dimension (VD), measured- from upper most point 6352 to lowe most point 6354 and projected onto a vertical axis, is shown on the left side of FIG, 63B. In FIG, 63B this is the height of the equilateral triangle which is also the minimum vertical dimension (MVD). -Because outer edge 6336 is in the shape of an equilateral 'triangle the vertical dimension will change based on the orientation of the lens. For example, as shown in FIG . 63C, i f the triangle were turned, o its side the upper most point would he point 635§ and the lower most point would be point 6360, The vertical dimension (VD), measured from point 6358 to point 6360 and projected onto a vertical axis, is shown on the left side of FIG, 630. This rotational orientation of the triangle resolts in a larger vertical dimension. This larger vertical dimension results from t e fact that all equilateral triangles have a height that is less than the length of their sides.
{0472| FIGS. 64A - C ilkstrate how to measure a vertical dimension. (VD) and th minimum vertical dimension (MVD) of an aperture widening zone located, on a prosthesis 6400 having an outer edge 6420 in the shape of an oval. IG. 64A shows prosthesis 6400 in a first rotational orientation where the oval is positioned such that its minor axis is oriented in the vertical direction. The orientation in FI(1 64A shows a vertical dimension equal to minimum vertical dimension (MVD) for the oval The minimum vertical irnension (MVD) is measured from upper most point 6402 io lower most point 6404 and projected onto a vertical axis, FIGS. 64B and C show other orientations of the oval where its vertical dimension (VD) is not its minimum vertical dimension. For example, in V\Q. 64B the oval's major axis is oriented in the vertical direction. This results in. a vertical dimension (VDf measured from point 641 to point 6412, that is larger than the oval's .minimum vertical dimension {MVD shown in FIG, 64A, Similarly, the orientation- of the oval io FIG. 64C shows a vertical dimension (VD), measured from point 6406 to point 6408, that is greater than the minimum vertical dimension (MVD) shown in FiG. 64A.
[0473} FIGS, 65.A - B show another example of how to measure a vertical dimension
(VD) and the minimum, vertical dimension (MVD) of an aperture widening zone on prosthesis 6500 defined by two partial rings having outer edges 6510. FIG. 65 shows an orientation of the prosthesis where the vertical dimension (VD) is equal to the minimum vertical dimension (MVD) for the aperture widening z ne The minimum vertical dimension (MVD) being measured fern upper most point 6502 to lower most point 6504. FIG, 65B shows an orientation of prosthesis 6500 where the vertical dimension (VD) is not the -minimum vertical dimension (MVD). The vertical dimension (VD) in FIG,. 6SB; is measured from tipper most point 6506 to lower most point 6508 and is larger than the minimum vertical dimension shown in FIG. 65A.
18 7 } FIGS. 66 - B illustrate how to measure a vertical dimension and the m uhmira vertical: dimension of an aperture widening zone on a prosthesis 6600 -defined by a plurality of isolated areas with outer edges 6610 arranged in the shape of a square. FIG, 66A shows a first orientation of prosthesis 6600 where the vertical dimension (VD) for the aperture widening zone is equal to the minimum vertical dimension (MVD). Outer edges 661.0 have points 6602, 6604, 6606, and 6 08 which are located furthest from the center of prosthesis 6600. In PIG. 66 A, the minimurn vertical i en n (MVD) is •measu ed from an. upper most point 6602 to a lower most point 6606 and projected onto a vertical axis located on the left of FIG. 66A. PIG. 66B shows a second orientation of prosthesis 6600 illustrating- a vertical dimension. (VD) that is not the minimum vertical dimension (MVD). The vertical dimension (YD) in FIG. 66B is measured from upper most point 6604 to lower most point 6606 and projected onto a vertical axis show on the left, side of FIG. 66B, It can be seen, that the vertical dimension (VO) in FIG. 66B is larger than the minimum vertical dimension (MVD) shown, in FIG. 66 A >
[04751 FIGS. 66C■- D illustrate how to measure a vertical dimension and the minimum vertical dimension of an aperture widening zone on a prosthesis 6650 defined by a plurality of isolated areas with outer edges 6660 arranged in the shape of a triangle. F!G. 66C shows a first orientation, of prosthesis 6650 wherein the vertical dimension (VD). is the distance between upper most point 6652 and lower roost point 6654. FIG. 66D shows a second orientation wherein the vertical dimension is equal ' to- the minimum vertical dimension (MVD), As shown in PIG. 66D the minimum vertical dimension (MVDX measured from upper most point 6654 to lower most point 6656, is projected onto vertical axis to the lef of FIG. 66D.
j0476| FIG:. 67 shows a scleral ring 6700 having a peripheral edge 671 and an. open aperture 6702. Located above open aperture 6702 is an incremental thickness region having an upper finger member 6704 and located below open aperture 6702 is an incremental thickness region havin a lower finger member 6706, Scleral ring 6700 can also have trenches 6708 designed to receive linger members 6704 and 6706 when they are folded down fey the eyelids of a wearer.. Trenches 6708 are located adjacent to the inside of finger member 6704 and 6706. I should be noted, thai trenches 6808 are optional,
4?7| FIG, 68 shows a contact lens 6800 having peripheral edge 68T0 and an optic zo 6802, Located above optic zone 6802 is an incremental thickness region having an upper finger member 6804 and located below optic zone 6802 is an incremental thickness region having a lower finger member 6806., Contact lens 6800 can also have trenches 6808 designed to receive linger members 6804 and 6806 when they are folded down by the eyelids of a wearer. Trenches 6808 are located -adjacent to the inside of finger members 6804 and 6806, It should be noted that trenches 8 8: are optional. 0478} FIG, 6 shows a side view of a contact lens 6900 having an optica! zone 6902, an upper finger member 6 10 and a i wer finger member 6908. In FIG. 69 art upper eyelid 6906 is shown in contact with upper finger member 6910. (Jpper finger member 6910 lifts (elevates) upper eyelid 6906 when contact lens 6900 is worn. FIG;. 6 also shows a Sower eyelid 6904 in contact with lower finger .member 6908. Lower finger member 6909 depresses (lowers) lower eyelid 6904 when contact fens 6900 is worn, While a contact lens is shown in FIG. 69 it will be appreciated that a scleral ring with finger members (see above description with respect to FIG. 67) would also be capable of lifting (elevating) and/or depressing ( lowering) the upper and iower eyelid in the same way as described in FIG. 69.
f(l479| The minimum vertical peak to peak dimension for various shapes of an aperture widening zo ma be measure in the same way as discussed above for a, minimum vertical dimension. But the relevant points on the prosthesis would be the maxi um thickness deltas rather than the uppermost and lowermost points of the aperture widening zone.
|IJ4 J Table 2 summarises the effects that four different exemplarily prosthese had on different individual's eyes..
Figure imgf000097_0001
Table 2: Aperture Widening Results for Four dlfferetJt example lenses (I» J, , and L [048.11 The specifications for lens I are as follows:
8.4 base curve- / 15.0 mm overall diameter 0 -microns
max thickness delta hump LO mm-1 iOmm in from outer edge of the lens / aperture widening zone begins at the outer edge of the lens general base thickness (excluding bump <fe outer edge) within the range -of approximately 1.25.mierons-l 75raicrons / optical powe equals -0.500
104821 The .specifications for lens J are as IMiows:
1,-4 base curve ' J. .0 mm overall diameter / 300 microns
max thickness delta bump 1.5 .mm~2.0mm in 'from outer -edge of the lens. / aperture widening zo e begins at the outer edge of the lens general base thickness (excluding bump & outer edge) within the range of approximately 125mkrons- 175'micron. / optical power equals -O.50D
104831 The specifications for lens K are as follows:
8,4 base curve / 15.5 mm overall diameter 150 microns
ma thickness delta hump 1 .0 mm- 1.5mm in from outer edge of the Sens / aperture widening zone begins at the outer edge of the fens / general base thickness (excluding- bump & outer edge) within the range of approximately 125n¾icrons- 1 TSmicrons / optica! power equals -0.-50D 0484J The specift cations for lens L are as follows
8.4 base carve / 1.5.5 mm. overall diameter 300 microns
max thickness delta bump at 1.5 mm*2.tas in from the outer edge of the lens / aperture widening zone begins at th outer edge of the lens / general base thickness (excluding bump & outer edge) within the range of approximately 125raicrons ~ Π5 microns / optical power equals -O.50D
10 851 Table 2 illustrates that specific tens work best for different individuals and that most individual's palpebral fissure can be widened by wearing a prosthesis comprising an aperture widening zone as: described herein, it i appreciated thai Table 1 is only an example of various lenses that an be worn and is not meant to limit the dimensions and/or widening capacities of prostheses described herein.
j048<if Some embodiments include a prosthesi capable o being worn by wearer comprising an. aperture widening zone located on its convex outer surface. The prosthesis has an overall diameter of X ram, and the wearer's eye comprises vertical aperture •measurement, of Y mm, whereby X mm is at least Im longer than Y mm. The aperture widening zone widens the palpebral fissure of the eye of a wearer,
JM87( In some embodiments the aperture widening zone depresses (lowers) the lower lid of a wearer. n some embodiments the aperture widening zone lifts (elevates) the upper lid of a wearer. In some embodiments the aperture widening zone lifts (elevates) ihe upper lid by at least 1 mm. In some embodiments the aperture widening, zone depresses (lowers) the lower lid by at least 1 mm. In some embodiments the aperture widening zone elevates the tipper lid by less than 1 mm and/or depresses the lower lid by less than I mm but widens the palpebral fissure of the wearer's eye by at least I nini.
[t)488j The prosthesis comprises a material that is one of: hydrogef silicone ydrogel, silicon, gas perm, hydrophiUe, rigid and ilexible.
{0 89J In some embodiment the prosthesis that is corneoscleral, contact lens, in some embodiments the prosthesis is a soft contact lens. In some embodiments the prosthesis is a hybrid contact leas. In some embodiments the prosthesis is a scleral ring.
|$490f ίπ some embodiments the aperture widening zone i located internal to the edge of the prosthesis. In some embodiments the aperture widening zone begins at the outer edge of th e prosthesis.
0 91 it? some embodiments the aperture widening zone is: rotatienaily symmetric. In some embodiments the aperture widening zone is rotationaily asymmetric.
492J I some embodiment the aperture widening zone has a maximum incremental thickness delta that i within the range of 23 microns and 1 ,000 microns. In some embodiments the aperture widening zone has a maximum incremental thickness delta that is within the range of 100 microns and.4(10 microns,.
|'0493f in some embodiments the aperture widening zone is located within range of 3 rnm and 8.5 mm from a geometrical center of the prosthesis. In some embodiments the aperture widening zone is located within range of 5 mm and 7..7S mm from a geometrical center of die prosthesis,
(04M| in some embodiments the aperture widening zone is located within a range of 0..1 mm i 6.0 mm from an outer peripheral edge of the prosthesis. In some embodiments tli aperture widening ne is located within a range from an outer peripheral edge of the prosthesis to 6, mm from the outer peripheral edge of the prosthesis.
| 495| In some embodiments the aperture widening zone has a maximum delta thickness located within a range of 0.25 mm to 3.0 mm from an outer peri heral edge of the prosthesis. In some embodiments the aperture widening ¾o«e has a maximum delta thickness located within a range of 0.5 mm to 3.0 mm f om an outer peripheral edge of the prosthesis. In some embodiments the aperture widening zone has a maximum delta thickness located within a range of 0.25 mm to 0,75 mm trom an outer peripheral edge of the prosthesis.
|Θ496| In some embodiments the aperture widening zone comprises, a bum on the convex surface of the lens.,
[0497 j The scleral ring in some embodiments comprises an open central aperture. In some embodiments the scleral ring comprises a homogenous design. In some embodiments the scleral ring comprises a hybrid design.
{0498} !n some embodiments the scleral ring comprises a flexible finger like member. In some embodiments the finger like member folds upon the blink of an eye in a direction towards the geometrical center of the scleral ring, in some embodiments the finger like
.member unfolds upon the opening of the eye lid in a direction away trom the geoinetrical center of the sclera l ri ng:.
|C14 9| The prosthesis ca be worn for a time of one of continuously* daily, weekly and monthly.
[8500} in some embodiments the prosthesis Is disposable. In some embodiment the prosthesis is reusable.
10581] hi some embodiments the prosthesis comprises an optical power. In som embodiments the prosthesis is devoid of optical power.
(05821 in some embodiments ie aperture widening zone has a slope and a delta of maximum incremental thickness. In some embodiments the slope o the outside of the delta of ma imum incremental, thickness {closest to the outer edge of the prosthesis)' is steeper than the slope on the inside (closest to the center of the prosthesis).
[0503j in some embodiments the prosthesis comprises a zone or region of increased
Surface friction. In some embodiments the prosthesis is devoid of a zone of incremental thickness or regressive thickness, hut rather has a mm of increased surface friction located on its on er convex surface,.
{0504} in some embodiments the width of die aperture widening zone 'is within the range of 0*5 mm to 6 mm.
|8585$ In some embodiments the outer edge of the prosthesis approximates- the edge of a conventional comeo-scleral contact lens.
[0506 J in some embodiments the aperture widening zone that lias a peak delta thickness which corresponds to a point located 0. 1, mm or greater above t e upper lid margin of the wearer when not wearing the prosthesis., in some embodiments the -aperture widening zone that has a peak delta thickness which corresponds to a point located 0, 1 mm or more below the lower lid. margin of the wearer when not wearin the prosthesis. In some embodiments the peak delta thickness corresponds to a point located within the natural aperture of the wearer's eye. In some embodiments me peak deha thickness corresponds to a point located outside the natural aperture of the wearer's eye (meaning the distance of peak delta thickness to peak delta thickness measured thru the geometrical center of the prosthesis Is larger than the vertical measurement between the upper lid margin and the lower lid margin (the vertical eye aperture).
[9507! In some embodiments the aperture widening zone has a diameter (not the width of the aperture widening zone) that falls within the range of 7 mm to 35 mm.
|β508 In some embodiments the prosthesis is a corneoscleral eoniaei lens, hi some embodiments the coraeo-sele.rai contact Jens is a spherical single vision contact lens, in some embodiments the comeo-scleral contact lens is a multifocal contact lens, in some embodiments the eoraeo-seieral contact lens ha a tone optical power.- i some embodiments the coraeo-scieral contact lens is a single vision sphero-cy Under contact lens,
{'0509 j In some embodiments the prosthesis comprises a rotationally symmetric aperture- widening zone and is not stabilized. In some embodiments the prosthesis comprises a totationaliy symmetric aperture widening zone and the prosthesis is devoid o a stabilization zon .
|65ϊβ| In some embodiments the prosthesis is devoid of a stabilization zone and thus free: to rotate, In some em odiments the prosthesis is stabilized and thus nor free to rotate. 1 511 J In. some embodiments the prosthesis has an. aperture widening ¾one and separate aperture stabilization zone,
{8512J in some emhodime«is tire prosthesis has an aperture widening zone nd the prosthesis is free to rotate during natural blinking,
jlS13{ In. some embodiments the prosthesis comprises a colored area which adds to the cosmetic appearance of a larger eye when worn on the eye of a wearer. In some embodiments the colored area is one of; a liffibal ring, colored ring, or accent color.
{851 | In some embodiments the aperture widening zon is located above and .belo the geometrical center: along an imaginary vertical axis which crosses the geometrical ce te of the prosthesis
|05iS| in some embodiments the prosthesis comprises an aperture widening zone located to the right or left of the geometrical center along an imaginary vertical axi which crosses the geometrical center of the prosthesis,
5161 Some embodiments include a prosthesis for a wearer's eye having an overall diameter of X mm, and the wearer's eye having a vertical aperture measurement of Y mm, wherein. X mm is at least 1 mm longer than Y mm. The prosthesis has an aperture widening zone with an outer slope within the range of 3 degrees to 45■ degrees-.
[9517{ Some embodiments include a prosthesis for a wearer' eye having an overall diamete of X mm, and the wearer's eye having a vertical aperture measurement of Y mm, wherein X mm is at least, i mm longer than Y mm. The prosthesis has an aperture widening zone with an inne slope within the range of I degree to IS degrees.
[8518} Some embodiments include a prosthesis having an aperture widening zone located superior and interior to its geometrical center. The aperture widening- zone has a thickness slope. The thickness slope exceeding 50 microns of added, thickness per millimeter
{8519J Some embodiments include a prosthesis having an aperture widening zone on its convex surface.. The aperture widening zone c using a 'bump on the convex surface. The aperture widening zone has an outer slope thickness that is greater than 50 microns of added thickness per mm. jOSlilf Some embodiments include a prosthesis 'having an aperture widening zone on it convex surface. The aperture widening zone causing a bump on the conv x surface. The aperture widening zone has an inner slope thickness that is less than 50 microns of added thickness per ran ;.
[0521} In some embodiments die outer slope thickness of the aperture widening zone is greater than 100 microns of added thickness per mm, in. some embodiments the outer slope, thickness of die aperture widening zone is greater than 1.50 microns of added thickness per mm. In some embodiments the outer slope thickness of the aperture widening zone is greater than 200 microns of added thickness per mm, in ome embodiments the outer slope thickness of the aperture widening zone is greater than 300 nherons of added thickness per mm.
j( 22| in some embodiments the inner slope thickness of the aperture widening zone is less ten 100 microns of added thickness per mm., in some emksdirnent the inner slope thickness of the aperture- widening zone is less than 1.50 micron of added thickness per torn. In some embodiments the inner slope thickness of the aperture widening zone is less than 200 microns of added thickness per mm. in some embodiment the inner slope thickness of the apertu re w idening zone is iess than 30 microns o f added thickness per rarn
j0523f In some embodiments the aperture widening zone has a bump on the convex surface of the prosthesis, i some embodiments the bump is located- vertically above and below the geometrical center of the prosthesis.
|i>524| i some embodiments, the aperture widening zone may include a surface feature comprising an outer slope, an inner slope, and a maximum -added thickness delta located between the outer slope and the inner slope. The surface feature may be located on the convex or concave surface of a prosthesis. In 0ne emhodiments, the prosthesis ma include a surface feature located on the convex surface of the prosthesis and a surface feature located on the concave surface of the prosthesis,, hi such embodiments, the surface features located on the convex and. concave surfaces ma overlap, in whole or i part. In some embodiments, the surface feature, or a portion thereof may be designed using a tri- curve methodology. In some embodiments, the surface feature,, or a. portio thereof, may be designed using a spline curve methodology, in other words, the surface feature, or a portion thereof* may be defined by one or more spline curve functions, In some embodiments, the spline curve ihnciion(s) may be Bezier curve f¾nctioo(s),
[ft525| in .embodiments where the surface feature is designed using a td-cnrve methodology (see e.g.., FIGS. T1A - B), the surface feature m y not have fi st and/or second orde continuity, partially at the points where the outer slope and the inner slope meet a. convex or concave surface of a prosthesis, in other words, the points where the outer slope and inner slope meet the convex or concave surface of the prosthesis may not be extremely smooth, in tri -curve embodiments, the smoothness of the outer slope may fee increased by intersecting the outer slope with, the peripheral edge of the prosthesis. Since a peripheral edge (e.g., a manufacture's peripheral edge) is typically sloped itsel this may help to increase the overall smoothness of the surface and the junction points between the outer slope and the concave or convex surface of a prosthesis. But, intersecting the outer slope with the peripheral edge of the prosthesis ma alter tile edge design tor a prosthesi (eg., a manufacture's edge design). While this may be suitable in some circumstances, manufactures generally want to preserve the shape and design of their peripheral edge for the reasons discussed above,
Θ526| i embodiments where the surface feature is designed using a spline curve methodology (see eg,, FIGS. 73 A. - B), at least a. portion of the surface feature is designed using a spline curve function. In some embodiments, the outer slope may be designed using a spline curve function. In such embodiments, the outer slope ma have firs order continuity, including at the points where it meets the convex or concave surface of the prosthesis. In. some embodiments, the outer slope may have first and second order continuity, including at the points where it meets the convex or concave surface of the prosthesis, hi so e embodiments., the inner slope may be designed -using a spline curve function. In some embodiments, the inner slope may have first orde continuity, including at. the points where it meets the convex or concave surface of the prosthesis . In some embodiments, the inner slope may have first and second order continuity, including at the points where it meets the convex or concave surface of the prosthesis. In some embodiments, the entire surface feature may foe designed, using spline curve functions, in some embodiments, the entire surface of the surface feature may have at least first order continuit (and, in some embodiments, first and second order continuity). In some embodiments, the entire surface on which a surface feature is located (i..e., the convex, o - 1.04 - concave surface) may be designed using spline curve fun.etio.ns. In some embodiments, the entire concave o convex, surface may have at least first order continuity (and in some embodiments, second order continuity)* including at any junction point between two adjacent, curve/surface- sections..
j0527j Designing a surface feature, or a portio thereof, using a spline curve ft eiion may provide a high degree of sm othness for the s rface feature, which may turn increase the comfort for a wearer, In particular, since a wearer's eyelids may primarily interact, with the outer slope of a. surface feature to push up (i .e., lift) th upper eyelid, and push down fie,, depress) the lower eyelid, designing the outer slope using a spline eurve function may increase comfort for a wearer. Moreover, designing a surface feature using a spline curve function may help to preserv a manufacture's edge for a specific prosthesis while also preserving the smoothness of the convex or concave surface of the prosthesis, in particular, designing the outer slope of a surface feature using a spline curve function may facilitate a smoot conve or concave surface that does not interfere with a tnanufactexe " s edge .
[0528J FIGS. 70 and 71 A - B sho a prosthesis 7000 having an aperture widening l e
7010 located on a convex surface 7008 according to an embodiment Aperture widening zone 7010 includes a. surface feature havin an outer slope 7014, an inne slope 7020 and a maximum added thickness delta 7012. in. some embodiments; as shown in FIGS. 70 and 71 A - B, aperture widening zone 7010 may include a surface feature in the shape of a continuous ring surrounding a geometric center 7004 of prosthesis 7000,
|¾52?j Prosthesis 7000 may be composed of a sil icon hydrogel (but can be of any known soft contact lens material). The sfiefcries-s (i.e., surface frietion) of the material used to make prosthesis 7000 may affect, the size and shape of aperture widening zone 7010. For example, if a less slick material is selected, the maximum added thickness delta may be reduced in height, compared to a prosthesis made using a more slick material The maximum added thicknes delta may be reduced because it is believed that a less slick material (i.e., a material having higher suriaee friction) will have stronger interaction with a wearer's eyelids,
|0 301 The base thickness of prosthesis 7000 ( .e,5 the thickness between convex surface
7008 and the concave surface 7009 of prosthesis 7000) ma be in the range between 75 microtis and 1.25 microns. In some embodiments, the base thickness of prosthesis 7000 may be approximately 75 microns (the general thickness of a conventional molded or lathe cut soft on act lens). As used herein, base thickness does not account for any added incremental thickness of aperture widening z ne 7 10. In other words, it is the thickness of rosthesis 7000 in th absence of aperture widening zone "010. The base curve for prosthesis 7000 may 'be any known base curve to pro vide appropriate centering and fit for a user. The base curve .for prosthesis 7000 may he, but is net limited to, X 8,4, 8.6, arid 8,8. Prosthesis 7000 may have any suitable front optic diameter, such as, but not limited to 8,5 mm, which is a standard optic diameter for a soil contact lens, in some embodiments, the front optic diameter may be 7.0 or 7.5 mm. An optical zone 7006 of prosthesis 7000 may have any suitable optical power, including no optical power (Le.-, piano),
j«S3! | Prosthesis 7000 may have any suitable overall diameter 7030, such as the overall diameters discussed herein. For example, in some embodiments, overall diameter 7030 of prosthesis 7000 may be 1 ,5 mm or larger,
| 532| Outer slope 7014 may meet convex surface 7008 at an outer slope junction point
7016. Outer slope junction point 7016 may be located at a distance 7018 from a peripheral edge 7002 of prosthesis 7000. in some embodiments, distance 7018 may be i the range of 0,01 mm to 2,0 mm. In some embodiments, distance 7018 may be 0.25 mm or greater, inner slope 7020 may meet convex surface 7008 at an inner slope junction point 7022, inner slope junction point 7022 may be located at a -distance 7024 from optical zone 7006 (or central open aperture in the ease of a scleral ring) of prosthesis 7000. In some embodiments, distance 7024 may be in the range of 0 mm to 3.0 mm. 5331 The width of outer slope 701 may be, but is not limited to 1.0 mm to. 2.0 mm.
Aperture widening zone 7010 may have an suitable aperture widening tone diameter. In some embodiments, the aperture widening zone diameter may be 10.5 mtn or greater. In some•embodiments, th aperiure widening zone diameter may be 1 1,5 mm or greater. In some embodiments, the aperture widening zone diameter may be 12.5 mm or greater. In some embodiments, the aperiure widening z ne diameter may be 13.5 mm or greater. In some embodiments,, the aperture widenin zone diameter may be 13,65 mm. i some embodiments, the aperture widening zone diameter may be 12.5 ram. In some embodiments, the aperture widening zone diameter may be 12,0 mm. $53 1 The slope of outer slope 7014 may be, but is not limited to, greater than.6 degrees.
In some embodiments the slope of outer slope 701 may be approximately 13,15 degrees, fo some embodiments, the slope of outer slope 7014 may be approximately .12 degrees. 'The slope of inner slope 7020 may be, but is riot limited to, less than. 6 degrees. In some embodiments, the slope of hrner, slope 7020 may be 3.25 degrees. In some embodiments, the slope of Inner slope 7020 may b approximately 4 degrees. In some embodiments, the slope of inner slope 7020 may be l ess than or equal to 1 1 degrees . I n some embodiments, the slope of outer slope 701 and/or the slope of inner slope 7620 may be constan t, hi some embodiments, the slope of outer slope 7014 and/or the slope of Inner slope 7020 may be non-constant. As an example, ibr an outer slope 7014 designed using a spline curve function, the slope of outer slope 701 may decrease when approaching the convex or concave surface of a prosthesis to increase the smoothnes of junction point 7016 (see e.g., slope of outer slope 7314 in FIG. 73B). This may be similar at junction point 7022 for an. inner slope 7020 designed using a spline surface function,
;θ53β| aximum added thickness delta 7012 may have any suitable added ..thickness as discussed herein, for example, 300 microns or 200 microns. In some embodiments, maximum added thickness delta 7012 may be greater than or equal to 1 50 microns. In some embodiments, maximum added thickness delta 7 12 may be located on an arc that defines the uppermost (i.e., thickest) part of aperture widening zone 7010, The are may have any suitable shape, including, but not limited to, a spherical shape, an elliptical shape, or an ovoid shape. In some embodiments, the are ma be a spherical are having a radius in. the range of 0 rn.ro to 5.0 mro. In a some embodiments, the arc may be a spherical are having a radius of 2,0 mm.
8S36J Maximum added thickness delt 7012 may be located at any suitable location as discussed herein. In some embodiments, the maximum added thickness delta 7012 ma be located in the range of 0,25 mm to 0,75 mm from peripheral, edge 7002. The slope of an outer slope 7014 and/or the slope of an inner slope 7020 may be opiimisied based on the thickness and location of maximum added thickness delta 7012. for example, outer slope 7014 may be increased as the location of maximum, added thickness delta 7012 is moved closer to peripheral edge 7002. In some embodiments,. designing outer slope 7014 using a spline curve function facilitate the optimization of outer slope 7014: without interfering with a manufacture's edge design. In som embodiments, the slope o (niter slope 7014 is within the range of 5 degrees to 45 degrees, of greater.
1 5371 Any portion of prosthesis 7000 may be designed using one or more spline curve functions. For example, aperture widening zone 7010, or a portion thereof, may be designed using one or more spline curve functions as discu sed- below in reference to. FIGS, 7 and 75.
j0538| In some embodiments, a prosthesis, such as prostheses 7000, may be fitted on an individual using the following method.. A prosthesis including an aperture widening zone diameter that is at least 1 rn.ro or larger in vertical dimension compared to the vertical dimension, of the palpebral fissure of the wearer's eye when the wearer's eye is at its normal/natural aperture size (meaning not squinting or excessive opening the patient} may be provided to an individual Th vertical dimension of the palpebral fissure of a wearer's eye may be measured using at least one of the following methods: taking a photograph of the individual's eye and measuring the ertical dimension of the individual's palpebral fissure in the photograph, physically measuring the vertical dimension of the individual's palpebral fissure, visually estimating the vertical dimension of the individual's palpebral fissure, fitting a trial prosthesis having markings that indicate one or more vertical dimensions on the individual's ey * and fitting a trail prosthesis having a known diameter on the individual's eye,
{05391 in some embodiments, the optimal maximum added thickness delta 7012 for an individual may be determined by starting with a 300 micro maximum added thickness delta. During fitting, prostheses having different base curves may be fitted to determine which base curv provides optimal centering of the prosthesis in an individuals eye and appropriate movement upon blink hut maintains good, centering (e.g., re-centers) when an individual blinks (generally a A base curve is a good starting point).
1 5401 For each base curve tried, the individual (wearer) may be allowed to perience the prosthesis for 2 ·■■· 3 minutes before observing centering, movement, and/or the comfort level for the wearer,, if the initial base curve, or any subsequent base curve, does not provide optimum centering and appropriate movement on blink., the base curve may be altered until the optimum, base curve is determined, Once the appropriate base curve is provided for the individual, the individual may he asked about comfort. If the individual complains of discomfort upon blink, the maximum added thickness delta may be reduced in 50 microns step until comfort is achieved and the appropriate palpebral fissure widening is maintained, if the patient does not complain of disconrii , die maximum added thickness delta may be increased in 50 micron steps until appropriate palpebral fissure widening is maintained and/or "until, the earer complains of discomfort
{0541 FIGS. 72A - B show a prosthesis 7200 having a convex surface 7208, a concave surface 7209,. and an aperture widening zone 7.210 having a surface feature located on convex surface 7208 and designed using a cri -curve methodology according to an embodiment. Aperture widening zone 7210 includes a. surface feature having an outer slope 7214, an. inner slope 7220-, and a maximum added thickness, delta 721.2. n some embodiments, aperture widening zone 7210 may nclude a surface- feature in the shape of a continuous circumferential ring surrounding a geometric center 7204 (and optic stone 7206) of prosthesis 7200. But,, the surface feature(s} of aperture widening zone 7210 may have any size, shape, and/or eon figuration as described herein.
{0542] The uppermost (i.e., thickest) part of aperture widening mm 7.210 may be defined by an arc 721 1 having a height different from a normalized convex surface 723 of prosthesis 7200. While arc 721 1 is shown as a broken line in FIGS. 72 A. ~ 13, the broken line i for illustration purposes only and does not denote any structural and/or surface characteristics of arc 721 1. Maximum added thickness delta 7212 ma be located at. the peak of arc 7.21 1 between an outside edge 7213 and an inside edge 7215 of arc 7211. Outside edge 7.213 may be located at a height between normalized convex surface 7230 and maximum added thickness delta 7.212, Inside edge 721.5- may be located at a height between normalized convex surface 7230 and maximum added thickness delta 721 .
{0543.1 As shown in FIGS, 72A - B, outer slope 7214 extends from: outside edge 7213 towards a peripheral edge 7202 of prosthesis 7200, And inner slope 7220 extends from inside edge 7215 towards optic- zone 72.06. In. some embodiments, outer slope 7214 ma meet convex surface 7208 at -an outer slope function point But, in some .-embodiments, as shown in FIGS. 72A. - B, outer slope 7014 may meet convex surface 7208 at peripheral edge 7202, In such embodiments, the shape of peripheral edge 7202 may be influenced by outer slope 7214, which, as discussed, above, may be undesirable in some eases. Inner slope 7220 meets convex surface 7208 at inner slope junction point 7222, Inner slope junction point 7222 may be located at a distance in the range of 0 innt to 3.0 mm from Optic z ne 7206:, $544} In some embodiments, arc 72 ! I may have a constant radius. In some embodiments, the radius of are 721 1. may be in the range of 0 mm to 5.0 mm. In some embodiments, the radius of arc 7211 may be in the range of 0.5 ram to 3.0 ram. In some: embodiments, the radius of are 7:2.1.1 may be in the rang of 1.0 mm to 2.0 rnm. While FIGS, 72A - B show a cross-sectional view of arc 7 1 L are 7211 is a three-dimensional shape, such as, but not limited to, a spherical, shape, an elliptical shape, a ovoid shape, a continuous cireumierentiai ring shape with a spherical, elliptical, conical, or ovoid exterior surface, or a non-condnuoMS circumferential ring shape with spherical, elliptical, conical, or ovoid exterior surfaces.
[0545 j As shown in FIG. 7.2B, the iri-ciirve design of aperture widening zone 7 results in. a dlseontimiity at inner slope junction point 7222. Angle 7240 illustrates this discontinuity. Angle 7240 is the angle between a line 7242 tangent to normalized convex surface 7230 of prosthesis 7200 at inner slope junction point 7222 and a. line 7244 tangent to inner slope 7220 at inner slope junction point 7222,. Accordingly, angle 7240 i dictated by the slope of inne slope 7220 at inner slope junction point 7222, In embodiments where inner slope is designed using a tri-enrve methodology, angle 7240 i greater than 0 degrees, thus creating a .discontinuity at inner sk pe juncti n point 7222, j0546| Similar to angel 7240, an angle 7250 of peripheral edge 7202 may be dictated by the slope of outer slope 7214. Angle 7250 is die angle between line 725 tangent to the normalized convex, surface 7.230 of prosthesis 7200 at peripheral edge 7202 and a line 7254 tangent to outer slope 7214 at peripheral edge 7202, In embodiments where outer slope 7214 is designed using a tr -curve methodology, angle 7250 is greater than 0 degrees. Accordingly, angle 7250 is dictated by ihe slope of outer slope 7 1 . In contrast, a manufacture's edge may not be influenced by such an outer slope because their edges have been designed in the absence of an aperture widening zone 'and/or surface feature: being located at or near the edge of the prosthesis,
ί&547| Prosthesis 7200 may have any suitable overall diameters as discussed herein. In some embodiments, the overall diameter of prosthesis 7200 may be in the range of 15.5 mm to 1.4.5 mm. in a preferred embodiment, the overall, diameter of prosthesis 7200 may be 1.4.5 mm. Maximum added thickness delta 7.212 may have any suitable thickness as described herein. In some embodiments, maximum added thickness delta 7212 may be in the range of 0.25 mm to 035 mm. in a preferred- em'bodi.nient, maximum added thickness delta 7212 may foe 030 mm. Hie slope of outer slope 7214 m¾y have -any -suitable angl as discussed, herein, in some embodiments, the slope of ooter slope 7214 may be in the range of 5 degrees to IS degrees. In a preferred embodiment the slope of outer slop 725 may be .1.0 degrees.. The slop of inner slops 7220 may ve aiiy suH&hte angle as discussed herein, fa some embodiments, the slope of inner slope 7220 may be in the range of 3 to 7 degrees,. In a preferred embodiment', th slops of inner slope 7220 may h 5 degrees. Aperture widening zone 721.0 may have any suitable aperture widenin zone diameter as discussed herein,, in some embodiments, aperture widening zone 7210 may have an aperture widening zone diameter m the range of 12,0 trim to 1 ,0 mm. In a- preferred embodiment aperture widening zone 72 0 may have an aperture widening ¾cme diameter of 2.70 t.nm. In a preferred embodiment, the front' optic diameter of prosthesis 7200 may be 8,5 mm.
jOS48{ FIG. 78 shows a contact lens 7800 having an aperture widening zone 7808 designed using a tri-eurve methodology according to an embodiment showing the dimensions of contact lens 7800. Contact lens 7800 includes a peripheral edge 7802, geometric center 7804,. and an optic zone 7806.. Aperture widening zone 7808 has an aperture widening zone outer diameter 7810 measured from an outer edge of aperture widening zone 7808 {ie,, where an outer slope 7822 of aperture widening zone 7808 meets the convex surface of contact lens 7800} across contact lens 7800 and through geometrical center 7804 to the opposing outer edge of aperture widening zone 7808. In some embodiments, as shown for example in FIG, 78, aperture- widening zone outer diameter 7 10 may be equal to an overall otter diameter 7 12 of contact lens 7800, In some embodiments, aperture widening zone outer diameter 7810 may be less than overall ■outer diameter 7812. In some embodiments, aperture widening zone outer diameter 7810 may be 0,02 mm or less than overall outer diameter 7812. In some embodiments, aperture widening zon outer diameter 7810 may b 0,02 nun to 2,0 mm less tha overall outer diameter 7812, in some embodiments, aperture widening zone outer diameter 7810 ma be 0.02 mm to 4,0 ram less than overall outer diameter 7832. Overall outer diameter 7812 m y have any overall outer diameter discussed herein, including, but not limited to, 14,0 mm, 1 .5 .mm, 1 , mm, and 1.5,0 mm.
i8549'| As shown in FIG. 78, aperture widening zone 7808 may include maximum added thickness delta 7816, an outer slope 7822, and an. inner slope 7820. The thicknes - i l l -
7817 of maximum added thickness, delta 7816 may be measured from normalised convex surface of contact lens 7800 to maximum added thickness delta 7816, Maximum added thickness delta 7816 amy have any suitable thickness discussed herein. Contact Sens 7800 may also include an aperture widening; zone diameter 7814 measured from a first point of maximum, added thickness delta across contact leas 7800 and through geometrical center 7804 to a second (opposi ng) point of maximum added thi ckness del ta . Aperture widening zone diameter 7814 may have an diameter discussed herein. Additionally, inner slope 7820 and outer slope 7822 may have any suitable angle discussed herein. Inner slope 7820 extends from a location on the convex suriace of contact lens 7800 to an edge of an are of aperture widening zone 7808 (see e.g., inner slope 7220 in FIGS. 72A - B). Similarly, outer slope 7822 extends from a location on the convex surface of contact lens 7800 (which may at or interior to peripheral edge 7802} to an edge of an are of aperture widening zone 7808 (see e.g., outer slope 7214 hi FIGS. 72A --B).
S8| FIG. 78 also shows inner slope angle 7821 and outer slope angle 7823. In a incurve design, inner slope angle 7821 and. outer slope angle 78.23 may be constant:. In other words, the slope of inner slope 7820 and the slope of outer slope 7822 may be constant across the width, of inner slope 7820 and outer slope 7822, respectively, in some tri-curve embodiments, inner slope angle 7821 and oute slope angle 7823 may be non-constant. FIG, 78 also shows the distance 781.8 between peripheral edge 7802 and maximum added thickness delta 7816. Irs some embodiments, distance 7818 may be in the range of 0,25 mm to 3.0 mm, in some embodiments, distance 781.8 may Be in the range of 0.5 mm to 3.0 mm. In some embodiments, distance 7818 may be in the range of 0,25 ram to 0.75 mm. It should, be appreciated that if thickness 7817 of maximum added thickness delta 781.6 is held constant and distance 7818 is decreased, outer slope angle 7823 will increase.
SI § As shown in F G; 78, inner slope angle 7821 may be the angle between a line tangential, to the convex surface of contact lens 7800 and. a line tangential to the surface of inner slope 7820 at the junction point of the convex surface of contact lens 7800 and inner slope 7820. And outer slope angle 7823 may be the angle between a line tangential to the normalized convex surface of contact lens 7800 at peripheral, edge 7802 and a line tangential to outer slope 7822 at peripheral edge 7802, |05S2| An aperture widening zone (e.g., aperture widening zone 7808) designed using a iri-eurve methodology may fee designed by selecting a suitable arc 721 1 , a suitable base prosthesis profile (e.g., normalized convex surface), and selecting suitable values for th various dimensions of the prosthesis.
jOSSSf FIGS. 73 A - B show a prosthesis 7300 having a convex surface 7308, a concave surface 7309,. and an aperture widening zone 7310 having a surface feature located cm convex surface 7308 and designed using a spline curve methodology according to an embodiment. Aperture widening zone 7310 includes a surface feature having an outer slope 7314, an. inne slope 7320, and a- maximum added thickness delta 731.2. In some embodiments, aperture widening zone 7310 may nclude a surface feature in the shape of a continuous circumferential ring surrounding a geometric center 7304 (and an optic zone 7306) of prosthesis 7300. But, the surface feature(s} of aperture widening zone 731.0 may have any size, shape, and/or configuration as described herein.
j05S4J The uppermost (i.e., thickest) part of aperture widening zone 7310 may he defined by an arc 731 1 having a height different from a normalized -convex: surface 7330 of prosthesis 7300. While are 7 1 1. is shown as a broken line in FIGS,. 73 A. ~ B, the broken l ne is for illustration purposes only and does not denote any structural and/or surface characteristics of arc 73.1 1. Maximum added thickness delta 7312 ma be located at. the peak of arc 731 1 between an outside edge 7313 and an inside edge 73 15 or arc 731 1. Outside edge 73.13 may be located at height between normalized convex suria.ee 7330 and maximum added thickness delta 7312, Inside edge 73 1.5 may be located at -a height between, normalized convex surface 7330 and .maximum added thickness delta 7.312. jOSSSj As shown in FIGS. 73 A - B, outer slope 7 14 extends rom outside edg 7 13 towards a peripheral edge 7302 of prosthesis 7300. And inner slope 7320 extends from inside edge 7315 towards optic zone 7306. In. some embodiments, outer slope 731 ma be designed using- a spline curve function, in such embodiments, outer slope 7314 ma have first order continuity, particularly at a junction point 7316 where it meets convex surface 7308 and/or wher it. meet outside edge 7313. In some embodiments, outer slope 731.4 may have first and second order continuity,, particularly at a junction point 7316 where it meets convex surface 7308 and/or where it meets outside edge 7 13. Junction point 7316 may be located at a distance 73-18 'from peripheral edge 7302:. Distance 7318 may in the range of 0.01 mm to 2.0 ram. j$5S6J In some embodiments, inner slope 7320 may be designed using a splin curve function. In. such embodiments, inner slope 7320 may have 'first order continuity, •pa ticularly at a junction, point 7322 where it meets con vex -surface 730S and/or where it meets inside edge 7315. in. some embodiments, outer slop 731.4 may have first and second order continui * particularly at junction point 7322 where it meets convex, surface 7308 and/or where it meets inside edge 7315. Junction point 7322 may be located, at a distance 7324 from optic zone 73-06. Distance 7.324 may in the range of 0 mm to 3,0 mm, hi some embodiments,,, the entire surface feature may be designed using a spline carve function., in some embodiments, the entire surface of the surface feature may have first order continuity, including outer slope 7314, inner slope 7320, are 7311*. and at all intersection points between the slopes 7314/7320, arc 7 1 1, and convex surface 7308. In some embodiments, the entire surface of the surface feature may have first and second order continuity, including outer slope 7314, inner slope 7320, arc 731 1, and. at all intersection points between the slopes 7314/7320, arc 731 1, and convex surface 7308. In some embodiments, the entire convex surface 7308 may be designed using, spline curve functions, in some embodiments, the entire convex surface 7308 may have first order continuity, in some embodiments, the entire convex surface 7308 ma have first and second order continuity.
J 055 1 In some embodiments arc 73.1 1 may have a constant radius, in some embodiments, the radius of arc 731 1, may be in the range of 0 mm to- 5.0 mm. in some embodiments, the radius of arc 73 I t may be in the range of 0.5 mm. to 3.0 n l In some eiBbodimenis, the radius of are 731 1 may be in the range of 1.0 m to 2,0 mm, While
FIGS. 73 A B show a cross-sectional, view of arc 731 1 , are 731 i is a three-dimensional shape, such as, but. not limited, to, a. spherical, shape, an elliptical shape, an ovoid shape, a continuous circumferential ring shape with a spherical, elliptical, conical, or ovoid exterior surface, or a non-coHiinoous circumferential ring shape with spherical, elliptical, conical, or ovoid exterior surfaces.
[0558} As shown in FIG. 73B, when inner slope 7320 is designed, using a spline curve, function, the angle 7340 at junction point 7322 (where ie spline curve meets convex surface 7308) is zero or substantially equal to zero. In oilier words, the spline curve and convex, surface 7308 are tangential at junction point 7322. The slope of inner slope 7320 may decrease as if approache convex surface 7308 to create a smooth j unci ion point 7322 having at least first order continuity (and, in some embodiments, second order eoTUiiiitityJ . inner slope 7.320 joins to inside edge 7315 of are 731 1 at a position that forms a predeterniined spline inner angle 7370.. Spline inner angle 7370 is the angl between a line 7372 tatigent to the n rmalize convex surface 7330 of prosthesis 7300 at maximum added thickness delta 731.2 and a line 7.374 tangent to inside edge 7315 of arc 731 1. Spline inner angle 7370 may be in the range of 5 to 25 degrees. In some embodiments, spline inner angle 7370 is in the range between 10 to 20 degrees. Spline inner angle 7370 ma b used to describe the slope of Inner slope 7320. Also, angle 7370 may be used to manipulate the spline function for inner slope 7320.
§59{ Also, as shown in FIG. 73B, when outer slope 7314 is designed using a spline curve function, the angle 7350 at junction point 731 (where the spline curve meets th edge geometry of convex surface 7308) is zero or substantially equal to ze o. In other words, the spline curve and the portion of convex surface 7308 adjacent to peripheral edge 73 2 are tangential, at junction point 731.6. Since angle 7350 is zero or substantially equal to zero, the surface feature, and specifically outer slope 731 , does not. aifeci the edge design for peripheral edge 7302, therefore allowing manufacture's own edge design to be -utilized. As shown in FIG, 73 B, the slope of outer slope 7314 may decrease as tt approaches convex surface 7308 to create a smooth junction point 7316 having at least first order continuity (and, in some embodiments, second order continuity)- Outer slope 7314 joins to outside edge 7313 of arc 731 1 at a position that forms a predetermined spline outer angle 7360. Spline outer angle 7360 is the angle between .a line 7362 tan en to the norraalked convex surface 72.30 of prosthesis at maxirtuirn added, thickness delta 7312 and a. line 7364 tangent to outside edge 7313 of arc 731 1 , Spline outer angle 7360 may be n the range of 5 t 45 degrees, or greater, in some enibodinieuts, spline outer angle 7360 may be in the range of 1.0 to 20 degrees. Spline outer angle 7360 -m y be used to describe the slope of outer slope 7 14, Also, angle 7360 may be used to manipulate the spline function for outer slope 7 14, In some embodiments, angles 7360 and 7370 may he the same, in some embodiments, angles 7360 and 7370 may be different
f(}$6 | The use of a spline curve allows for spline outer angle 7360 and the spline inner angle 7370 to be independent from other geometrical elements. For example, when utilizing a trt-cutve design including: an arc that is on axis to the optical axis of the lens (see e.g., FIGS. 72 - B and 78} the corresponding angles at which an inner slope and outer slope -meet the convex surface .are dependent on the increase in thickness. This may not be true for an toner or outer slope designed using a spline curve function. The spline curve also allows for a multitude of paths from the tangential/start point to- the tangential end point. Moreover, the spline curve can be manipulated by selecting various control points (e.g., control points 7440, 7442, 7444, 7446, 7448, 7450, 7452, and/or 7454), which allows fo a spline central angle {i.e*, the slope of a center portion of outer slope 7314 or toner slope 7320) to be altered. This may be altered to accommodate different sized surface features on a convex or concave surface of a prosthesis. For example, the slope of center portion for any portion) of outer slope 731.4 may be increased in orde to fit a surface feature- on a smaller diameter prosthesis without having to change the size/shape of the arc and or the location of the maximum added thickness delta. As other example, the slope of a center portion (or any portion) of Outer slope 73 ! 4 m y be increased in orde to locate a maximum added thickness delta, close (e.g., in the range between 0.75 mm to 0.25 mm) to the peripheral edge of a prosthesis without' interfering with a manufacture's edge. In some embodiments, the spline curve may be replaced with other forms of curves that can be mathematicall defined such as series of sub-arcs- linked tarsgesitiaOy, curves defined using polynomial equations and other algorithms, and curves defined by a series of points.
Prosthesis 7300 may have any suitable overall, diameter as discussed herein. In some embodiments, the overall, diameter of prosthesis 7300 may be in the range o 15.5 mm to 14.5 mm. In a preferred embodiment, the overall diameter of prosthesis 7300 may¬ be .1 .5 mm. Maximum, added thickness delta 7312 may have any suitable thickness as described herein, in some embodiments, maximum added thickness delta 7312 may be in the range of 0.20 mm to 0.40 ram. In. a preferred embodiment, maximum added thickness delta 731.2 may be 0,30 mm. The slope of outer slope 7 14 may have any suitable angle: •as -discussed herein. In some embodiments, the slope of outer slope 7314 may be in. the range of 5 degrees to 45 degrees, or greater, in some embodiments, the slope of outer slope 7314 may be in the range of 5 degrees to 25 degrees, for example, 1 degrees. The slope of inner slope 7320 may have any suitable angle as discussed herein , in some embodiments, the slope of inner slope 7320 ma be in. the range of 5 to 25 degrees, for example, 10 degrees. 0562J Aperture widening zone 7310 may have any suitable aperture widening zone diameter as discussed herein. In some embodiments, aperture widening zone 7310 may have an. aperture widening mm diameter in the range of 1 1 ,0 mm to 14.0 mm. in a preferred embodiment, aperture widening zone 7310 may have an aperture w denin zone diameter of 12.70 mm In a preferred embodiment, the fron optic diameter of prosthesis 7300 may be 8.5 mm,
eS63J FIG, 7 shows a contact lens 7900 having an aperture widening zone 7908 des gned si g a id-curve, methodology according to an embodiment showioe the dimensions of prosthesis 7900, Prosthesis 7900 includes a peripheral edge 7902, a geometric center 7904, and an optic zone 7906. Aperture widening zone 7908 has an aperture widening zone outer diameter 7910 measured from the outer edge of .aperture widening zone 7908 (i.e., where an outer slope 79.2.2 of aperture widening zone 7908 meets the convex surface of contact Jens 7900} across contact iesis 7900 and throug geometrical center 7904 to the opposing outer edge of aperture widening zone 7908;. Aperture widening zone outer diameter 7910 may he less than an overall outer diameter 7 1.2 of contact lens 7900. In some embodiments, aperture widening zone outer diameter 7910 may be 0.02 mm or less than overall outer diamete 7 12, In such embodiments, a manufacturer's peripheral edge may he maintained since the slope of outer slope 7922 will not affect the shape and curvature of the manufacturer's, edge. In some embodiments, aperture widening zone outer diameter 7910 may be 0.02 mm to 2,0 mm less than overall outer diameter 7912, in some embodtraeats-, aperture widening zone outer diameter 7910 may be 0.02 mm to 4,0 mm less than, overall, outer diameter 7912. Overall outer diameter 7912 may have any overall outer diameter discussed herein, including, but not. limited to, 14.0 mm, 14.5 mm, 1 ,8 mm, and ! 5,0 mm,
0564f As shown in FIG. 79, aperture widening zone 7908 may include a maximum added thickness delta 7916, an outer slope 7922, and an inner slope 7920. The thickness 7917 of maximum added thickness delta 7916 may be measured from normalized convex surface of contact lens 7900 to maximum added thickness delta 7 16, Maximum added thickness delta 7916 may have any suitable thickness discussed herein. Contact lens 7900 may also include an aperture widenin zone diameter 791 measured from a first point of maximum added thickness delta across contact Sens 7900 and through geometrical center 7904 to a second (opposing) point of maximum added thickness delta. Aperture widening zone diameter 7914 ma have any diameter discussed herein. Additionally, inner slope 7920 and outer slope 7922 may have any suitable angle- discussed herein, inner slope 7920 extends from a location on the convex surface of contact lens 7900 to an edge of a c of aperture widening zone 7908 (see e.g. , inner slope 7320 in FIGS. 73 A - ). Similarly, outer slope 7922 exten s from a location on die convex Surface of contact lens 7900 (which is i nterior to peripheral edge 7902} to art edge of an arc of aperture widening z ne 7908 (see e.g., outer slope 7314 in FIGS. 73 A - B).
|β565| FIG, 79 shows inner slope angle 7921 and. outer slope angle 7923. In embodiments including an outer slope and/or inner slope designed using a spline curve, inner slope angle 7921 and outer slope angle 7923 are nan-constant due to the spline curve function used to design inner slope 7920 and/or outer slope 7922. In some embodiments, the slope of inner slope 7920 and/or the slope of outer slope 7922 may start at 0° (i.e., tangential to the convex surftee contact lens 7900), increase until reaching an inflection point, and then begin to decrease until intersecting with an inner or outer edge, respectively, of an are of aperture widening zone 7908 (seee.g.< outer slope 7 14 in FIG. 74). The angle of inner slope 7920 and outer slope 7922 designed using a spline curve function ma be measured based on the angle of the slope at the intersection with inner edge or outer edge or the arc of aperture widenin zone 7908.
{0566| As shown in FIG. 79, inner slope angle 7921 may be the angle between line tangential to the normalized convex surface of contact lens 7900 at maximum added thickness delta 7916 and a line tangential to an inside edge of an arc of aperture widening n 7908. Similarly, outer slope angle 7923 may the angle between, a line tangential to the normalized convex surface of contact lens 7900 at maximum added thickness- delta 7 1,6 and a line tangent to art outside edge of an. arc of aperture widening ¾one 7008.
f0567j FIG. 79 also shows the distance 7918 between peripheral edge 7902 and maximum added thickness delta 7916. In some embodiments, distance 7918 may be in the range of 0.25 mm to 3.. mm. In some embodiments, distance 7918 may be in me range of 0.5 mm to 3.0 mm. In some embodiments, distance 7918 may be in the range of 0.25 mm to 0.75 mm. It should be appreciated that if thickness 7 17 of max mum, added thickness delta 7916 is held constant and distance 7918 is decreased, outer slope angle 7923 may increase. Alternatively or additionally, die slope of a center portion of outer slope 7922 may increase. Θ568| A surface feature of an aperture widening zone may be designed using a spline curve function and one or more control points. The control points may be used to control the location the surface feature, the characteristics of the inner slope of the surface feature, the characteristics of the outer slope of the surface features, -ete.
056.9| FIG. 74 shows an aperture widening mm 7410 located a convex surface 7408 of a prosthesis 74(30 according to an embodiment. Aperture widening zone 7410 may be placed on a base prosthesis profile 7430 (i.e., normalized convex surface). Similar to aperture widening ¾one 7310, aperture idening z ne 741.0 includes a surface feature having an outer slope 7 14, an inner slope 7420, and a .maximum added thickness delta 741 , FIG. 74 also illustrates the location of control points used in conjunction- with a sptme curve function to design the surface feature.
0576] The uppermost .(i.e., thickest) part of aperture widening zone 7410 may be .defined by an arc 741 1. Arc 7 1 1 may be the ame as or similar to are 731 1. While are 7411 is shown as a broken line in FIG. 74, the broken line is fo illustration purposes only and does not denote any structural and/or surface characteristics of arc 741 1, A maximum- added thickness delta 7412 may be located at the peak: of arc 741 1 . As- shown in f 1(1 74, outer slope 7414 extends from arc 741 1 towards a peripheral edge 7402 of prosthesis 7400. And inner slope 7420 extends fern arc 741 1 towards an optic zone 7406 of prosthesis 7400.
05711 FIG. 74 shows the location of eight control points, each of which may b used in conjunction wit one o more spline curve functions to design the surface feature of aperture widening zone 7410. I some embodiments, all eight control points may be used to design the surface feature. In some embodiments, a subset of the eight control points may be used to design the surlkee feature. As shown in FIG. 74, each of the control points may be located on a. single eross-seetional plane of base prosthesis profile 7430. lie: single plane illustrated in FIG.. 74 ma intersect a .geometrical cente of the base prosthesis profile 7430 and peripheral edge 74-02.
0572} A first control point 7440 is located on. convex surface 7408 of base prosthesi profile 7430 at a distance 7441 from peripheral edge 7402 of base prosthesis profile 7430. First control point 7440 may be located at the junction point between outer slope 7414 and convex surface 7408. The location of first control point 7440 (i.e., distance 744!) ma be selected based on number of parameters, including, hut not limited to, the: desired location f r the starting point of outer slope 7414 of aperture widening mm 7410, the desired shape/slope (e.g., steepness) of outer slope 7 1 , Hie overall diameter of base prosthesis profile 7430, and .m ximum added thickness delta 7412 of aperture widening zone 7410, Distance 7441 may be in the range of 0.01 ram to 2.0 aim. In some embodiments, distance 7441 may be 0,25 mm or greater,
S73J A second control point 7442 is located' on the outside edge of the arc 7411 , Since second control point 7442 is located cm the outside edge of arc, its location is dictated by the location of arc 7 11 relative to base prosthesis profile 7430 and peripheral edge 7402, A third control point 7444 is located on the inside edge of are 741 1. Si milar to second control point 7442, the location of third control point 7444 is dictated b the location of arc 7411 relative to base prosthesis profile 7430 and peripheral edge 7402.
)0574| A fourth control point 7446 is located on convex surface 7408 of base prosthesis, profile 7430 a a distance 7447 front an edg of an optic zone 7406 of me base prosthesis profile 7430. Fourth control, point 7446 may be located at the junction point between inner sl pe 7420 and convex surface 7408, The location, of fourth control point 7446 (i.e., distance 7447) ma he selected based on a number of parameters, including, but not limited to, the desired location or the starting point of inner slope 7420 of aperture widening zone 7 1.0» the desired slope/shape (e.g., steepness) of inner slope 7420, die overall diameter of base prosthesis profile 7430, and maximum added thickness delta 7412 of aperture widening zone 7410. Distance 7447 may be in ire range of 0 mm to 3,0 mm.
95?5} A fifth control point 7448 is located tangential to convex surface 7408 of base prosthesis profile 7430 at first control point. 7440 and at a distance 7449 front first control poi nt 7448 towards .maxipnitn added thickness del la 7412 (fe., th e peak) o f the arc 741 1 , The location of fifth control point 7448 (fe,, distance 7449} may be selected based on a number of parameters, including, but not limited to, the desired location ibr the starting point of outer slope 7414 of aperture widening zone 7410, the desired slope/shape (e.g., steepness) of outer slope 7434, the overall diameter of base prosthesis profile 7430, and maximum, added thickness delt 7412 of aperture widening zone 7410, Distance 7449 may he in the range of 0 mm to 2,0 mm.
1 576} A sixth control point 7450 is located tangential to the outside edge of arc 741 1 at second control poin 7442 and at a distance 7451 from second control point 7442 towards eripheral edge 7402 of base prosthesis profile 7430. The location of sixth control point 745 (i.e., distance 7451} .may be selected based on a number of parameters, including, but not limited to, the desired location for the starting point Of outer slope 7414 of •aperture widening zone 7410, the desired slope/shape (e.g., steepness) of otuer slope 7414, the overall diameter of base prosthesis profile 7430, aid maximum added thickness delt 7412 of aperture widening zone 7410. Distance 7451 may be in the range of 0 rani to 2.0 mm.
|0577 j A seventh control point 7452 is located tangential to the inside edge of are 741 1 at third control point 7444 and at a distance 7453 from third control- point 7444 towards optic zone 7406 of base prosthesis profile 7430. The location of seventh control point 7452 tie,, distance 7453) may be selected based oil a number of parameters, including, but not limited to, the desired location for the starting point of inner slope 7420 of aperture widening zo e 7410, die desired slope/shape {©.-g., steepness) of inner slope 7420s the overall diameter of base prosthesis profile 7430, arid maximum added thickness delta 7412 of aperture widening zone 7410. Distance 7453 may fee in the range of 6 mm to 2.0 mm
|'β578| An eighth control point 7454 is located tangential to convex surface 7408 of base prosthesis profile 7430 at fourth control point 7446 and at a distance 7455 from fourth control point 7446 towards maximum added thickness delta 7412 (i.e., the peak) of arc 741 L The location of eig th, control point 7454 (i,e,, distance 7455) may be selected based on number of parameters, including, but not limited to, the desired location for the starting point of inner slope 7420 of aperture widening ¾one 7410:. the desired slope/shape (e.g., steepness) of inner slope 7420, the overall diameter of base prosthesi profile 7430, and maximum added thickness delta 741.2 of aperture widening ¾ojis 7410, Distance 7455 may be in the range of 0 mm to 2.0 mm.
j¾579| The location of control points 7440, 7442, 7444, 7446, 7448, 7450, 7452, and
7454 may be input into a software program on a computer (e.g., computer system 8100) using an interface (e.g., display interface 8102), The software program, may be, but is not limited to* Ultravision Lens Design Application developed by tjlttavision C.LP.L. The resulting prosthesis 7400 may have first and/or second order continuity at one or more of first control point 7440, second control point 7442,. third control point 7444, and fourth control point 7446.. In some embodiments, the resulting prosthesis' 7499 may have first - 12 ! - order and second order continuity at one- or more of first control point 7440. second control point 7442, third control point 7444, and fourth control point 7446.
|0S80 While FIG. 74 shows aperture widening zone 7410 located OH convex surface
7408 o prosthesis 7400, aperture widening zone 7410 may be located cm- the concave surface 7409 of prosthesis 7400, In such embodiment's, the- location of control points will be determined in the same way discussed above, but the locations will be relative t concave surface 7409 rather than convex surface 7408.
!0581| FKX 75 shows a flowchart Illustrating a method for designing a p osthesis: according to an embodiment. First, in 7502, a base prosthesis profile 7430 having convex surface 7408 and co cave surface 7409 is selected. Base prosthesis profile 7430 may be, but is not limited to, a standard contact lens profile for a commercially available contact tens. For example, an Acuvuei) contact lens manufactured by Vistakon®, a division of Johnson & Johnson Vision Care, in Jacksonville, Florida. Base prosthesis profile 7430 may be for a daily or extended wear contact iens, may have any optical power (including piano), and may be a tone contact lens. Base prosthesis profile 7340 may be selected from a database containing one or more base prosthesis profiles. In some embodiments, the base prosthesis profiles may be generated by a user designing a prosthesis, for example by inputting certain aspects of the profile, such as the base curve, the edge design, the overall diameter, the front optic diameter, and the hack (concave .surface) vertex power, in some embodiments, the base prosthesis profile may be received from a contact lens manufacturer (e.g., Vistakon€5),
$5821 Once base prosthesis profile is selected, in. 7502, an are 7411 may be selected in 7504, And, in 7506, the location of arc 741 1 relative to base prosthesis profile 7430 may be selected. When selecting the location of are 741 1, the location of maximum added thickness delta 7412 (i.e., the peak) of are 741. 1, is also selected. The sfee and shape, as well as the location, of arc 741 1 may dictate, in part, the overall aperture widening !eeis for aperture widening zone 7411) since it defines the thickes portion of aperture widening zone 7 10.. Arc 7411 may have any size and shape as discussed herein. Also, while FIG, 74 shows a cross-sectional view of are 74 I f it will be appreciated that three-dimensional arcs 7411 may he selected. For example, a three-dimensional are 74 ! I having a spherical shape, an elliptical shape, an ovoid shape, a continuous circuroferential ring shape with a spherical, efliptieal. conical, or ovoid exterior surface, or a non«contin:uons circumferential ring shape with spherical, elliptical, conical, or ovoi exterior su faces-, may be selected. This list is not meant to be limiting, in some embodim nts, a two- dimensional arc may be- selected (i.e., a cross-section- of an are), a d software ma be used to -extrapolate the two-dimensional arc into a tkree-diniensional one (e g.,. the cross- sectional view of arc 74 Π m FIG. 74 may foe extrapolated into a continuous ring are surrounding optic zone 74-06),
{0583} in 7508, the location f first control point 7440 may be selected, in 7510, the location of second- control point 7442 may be selected, winch may have already been determined by the location, size, and shape of arc 741 L I 7512, the location of third control point 7444 may be selected, which may have already been determined by the location, size, and shape of arc 7 11 , In 751 , the location- of fourth control point 7446 may he selected, io 7 16, the location of fifth control point 7448 may be selected. In 7518, the location of sixth control point 7450 may be selected In 7520, the location of seventh control point 7452 may be selected, in 7522, the location of eighth control point 745 may be selected. It should be appreciated, that the order of selectin the contro points does not necessarily have to be performed in the order shown: in FIG, 75. Indeed, the location of second control point 7442 and third control point 7444 may, in actuality, he selected when the location, size, and shape of are 741 1 are selected.
f 0584| In 7524, once all, or a portion of, the control points are selected, spline curve function may be applied, using the control points as -reference points, to design the surface feature of aperture widening zone 7410. In some embodiments, a two-dimensional surface tea tore rpay designed (i.e., a cross-section of a surface- feature), and. software may be used to extrapolate the two-dimensional surface feature into a three-dimensional one (e.g., the cross-sectional view of the surface feature- of aperture wi ening. stone- 7410 in FIG, 74 may be extrapolated into a continuous ring surrounding optic zone 7406),
|0S85| It should, be appreciated that not all eight control points need: to he utilised to design a surface feature. For example, a spline curve lor outer slope 7414 may be designed using only control points 7440 and. 7442, And a spline curve- for inner slope 7420 may be designed using only control points 7444 and 7446, As another example, for a surface feature having only an outer slope 741.4 designed using a spline curve function, only control points 7440, 7442, 7448, a 7450 may be used. Software may be used to desig the spline curvets) of aperture widening zone 7410 based on the selected location of the control points. The soft ware may be, but is not limited to, Uftravision Lens Design Application developed b intravision CLP.L
[0S86| Once the surface feature of aperture widening ¾one has been designed, the design may be used to mamdaeiure a prosthesis. In some embodiments, the maniri¾Cturing may include lathe- cutting.. n such embodiments, the design created in 7524 may be used by a lathe cutting machine, including the appropriate software, to lathe cat prosthesis. In some embodiments, the manufacturing may include molding. In such embodiments, the design created in 7524 may be used to create a moid for molding a prosthesis with the design,
|0587j In some embodiments, mold for molding a prosthesis may be designed using on or more control points and a spline carve function. FIGS. 76A ~ B show a mold 7600 used to make a prosthesis including an aperture widening zone according to an embodiment. Mold 7600 ma include an up e mold 7 10 and a: lower mold 7630.
$5881 As shown in PIG. 76A, npper moid 7610 includes a concave surface 7612, a convex surface 7614, and a convex surface edge 7 16, Convex surface 7614 may include the curvatufe(s)/design necessary to mold the concave surface of a prosthesis -(e.g., concave surface 7409 of prosthesis 7400). Convex surface edge 7 16 may include the curva:t«re(s)/des!gn necessary to mold the peripheral edge of a prosthesis (e,g„, peripheral edge 7402). which may include a niani ¾efnre¾ edge design.
[ 589| Similar to upper mold 7610, lower mold 7620 includes a convex surface 7622, concave surface 7624, and a concave surface edge 7626, Concave surface 7624 surface may include the eun?ature(s)/de$ign necessary to mold the convex surface of a prosthesis (e.g., convex surface 7408 of prosthesis 7400} having: an aperture widening zone (e,g,, aperture widening zone 7 10): located thereon. Concave surface edge 7626 may include the cttrvature(s)/design necessary to mold the peripheral edge of a prosthesis (e,g.5 peripheral edge 7402), which may include a. manufacture's edge design. In. orde to form aperture widening zone 7410, concave surface 7624 includes a cavity 7640 (or a pluralit of cavities 7640 dependin on the configuration of aperture widening zone 741 } corresponding to the desired shape, size, and configuration for aperture widening ¾one 7410.
[05901 Cavity 7640 includes a surface fe ture having an outer slope 7644, a inner slope
7646, and a maxim m: change in. thickness 7642. The lowermost (i.e., deepest} pari of cavity 764 may be defined by an are 7641. Are 76 may be the same as or similar to arc 741 1. Maximum, change in thickness 7642 may be locate at the peak of arc 7641 between an outside edge 7643 and an inside edge 7645 of arc 764.1:.
jft591f As shown m FIGS. 76A — B, outer slope 7644 extends from o side edge 7643 towards concave surface edge 7626. And timer slope 7646 extends- from inside edge 7645 towards the center of lower mold 7620. In some embodiments, Outer slope 7644 may he designed using a spline curve function.. In such embodiments, outer slope 7644 may have at least first order continuity (and, in some embodiments, second order continuity}, particularly at a junction poin where it meets concave surface 7624 of lower mold 7620 and/or where it meets outside edge 7643. The location of the junction .point may he the same as or similar to the location of junctio point 731 discussed above in regards to FIGS. 73 A. - B (e.g., 0.0 S. mm. to 2.0 mm from concave surface edge 7626). in some embodiments, tuner slope 7646 ma he designed using a. spline curve function. In such embodiments, inner slope 7646 may have at least first order continuity (arid, in some -embodiments, second order continuity), particularly at a junction point where it meets concave surface 7624 of lower mold 76.20 and/Or where it meets inside edge 7645. The location of the j unction point may he the same as or similar to the location of junct ion point. 7322 discussed, above in regards to FIGS. 73 A ~- B {e.-g., 0 mm to 3.0 mm from the part: of lower mold 7620 used to mold an optical zone). In some embodiments, the entire cavity 7640 may be designed using a spline curve function, in some embodiments, the entire surface of cavity 7640 may have at least first order continuity (and, in some embodiments, second order continuity), including outer slope 7644. inner slope 7646, are 764 ! , and at all intersection points between the slopes 7644/7646,. are 7641 , and concave surface 7624. In some embodiments, the entire concave surface 7624 may he designed using spline curve functions..
jf 5921 FIG. 76B shows the location of eight mold control point (7650, 7652, 7654,
7656, 7658, 7660, 7662, and 7664), each of which ma be used in conjunction with one or more spline curve functions to design cavity 7640. In some embodiments, all eight mold control points may be used t design, cavity 7640. In some embodiments, a subset of the eight, mold control points may be used t design cavity 7640.
jf 59 { The location the eight mold control points, relative to a base mold profile 7630 may be selected in the same fashion as discussed above id regard to the: eight control points (7440, 7443, 7444, 7446, 7448, 7450, 7452, and 7454) for prosthesis 7400... Also, the .location, of arc 7641 relative to base mold profile 7630 may selected in the same .fashion, discussed above In regards to are 741 1.
j0594J FIG. 77 shows a flowchart illustrating a method tor designing a lower mold 7S20 according to an embodiment First, in 7702, a base mold profile 7630 havin convex Surface 7608 and concave surface 7409 is selected. Base mold profile 7630 may be, but is not limited to, a standard, contact lens mold profile tor a commercially available contact tens. For example, an Acuvue® contact Sens manufactured by Vistakon®, a division of Johnson & Johnson Vision Care, in Jacksonville, Florida. Base mold profile 7630 may be for molding a dail or extended wear contact ism,, may be for molding a contact lens having an optical power (including piano), and ma be for molding a tone contact lens. Base mold profile 7340 may be selected from a database containing one or more base moid, profiles, In some embodiments* a base mold profile may be generated by a user designing a lower mold, for example by inputting certain aspects of the profile, such as the base curve, the edge design, the overall diameter, and the front optic diameter for a desired prosthesis. In some embodiments, the base mold profile may be received from a contact lens manufacturer (e.g., Vistakon®),
|0595| Once base mold profile is selected in 7702, a arc 7641 may be selected, in 7704.
And, i 7706, the location of are 7641 relative to base mold profile 7630 may be selected. When selecting the location of arc 7641, the location of maximum change In thickness 7642 (i.e., the peak) of arc 7641 is also selected. The size and shape, as well a the location, of arc 7641 may dictate, in. part, the overall aperture widening afreets, for an aperture widening zone {e.g., aperture widening zone 7410) since it will mold the thickest part of the aperture widening zone. Arc 7641 may have any size and shape as discussed above in regards to arc 741 1. Also, while FIG. 76B shows a eross-seetional view of are 7641, it will be appreciated that a three-dimensional arc may be seiecied, as discussed above in regards; to are 741 1.
18596.) in. 7708, the location, of first mold control point 7650 may be selected, in 771 , the location of second mold control point 7652 may be selected, which may have alread been determined by the location, size, and shape of arc 76 1. In 7712, the location: of third mold control point 7654 may be selected, winc may have already been determined b the location, size, and shape of arc 7641. In 7714, the locatio of fourth mold control point 7656 may be selected In 7716, the location of fifth moid control point 7658 may be selected. In 7718, tire location of sixth mold control point 7660 may be selected, in 7720» the location of seventh, mold control point 7662 may be selected. In 7722, the location of eighth mold control point 7664 may be selected, it should e appreciated that the order of selecting the mold control points does not necessarily have to be perforated in the order shown in FIG. 77. indeed, the location of second mold control point 7652 and third mold control point 7654 may, m actuality, be selected when the location, size, and shape of arc 7641 are selected.
[05971 In 7724, once all or a portion oil the mold control points are selected, a spline curve function may be applied, using the mold control points as reference points, to design the cavity 7640. Similar to the surface feature in FIG. 74, FIGS- 76A - B show a cross-sectional view of cavity 7640. In some embodiments, a twp-dimenskmal cavity may designed (i.e.., a cross-section of a . cavit )„ and software may be used, to extrapolate tire two-dimensional cavity into a three-dimensional one (e.g., the cross-sectional view of cavity 7604 in FIGS. 76 A - B may be extrapolated into a continuous cavity in the shape of a ring).
\i)S9$t It should he appreciated that not all eight moid control points need to be utilized to design cavity 7640, For exam le, a spline carve for outer slope 764 may be designed using only mold control points 7650 and 7652, And a spline curve for inner slope 7646 may be designed using only mold control points 7654 and 7656. As another example, for a cavit having onl an outer slope 7644 designed using a spline curve function, only mold control points 7650, 7652, 7658, a. 7660 may be used. Software may be used to design the spline curvets) of cavity 7640 based, on the selected location of the mold control points,. The software way be, but. is not limited to, Ultravision Lens Design Application, developed by Ultravision CLFL.
j¾699j Upper mold 7610 may be a. standard mold used to mold the concave surface of a prosthesis (e.g., concave surface 7409). Upper mold 7610 may be based on a standard mold profile for a commercially available contact lens. For exam le.: an Acuvue® contact lens manufactured by Visiakon®, a. division of Johnson & Johnson Vision. Care in Jacksonville, Florida, in some embodiments, the design of upper mold 7630 may be generated by a user designing an upper moid, for example by inputting certain aspects of the mold, such as the base curve, the edge design, and the overall diameter for a desired prosthesis, it should be appreciated that a mold for a prosthesi having an surface feature located on its concave surface may e designed in the same way as mold 7600. I such an embodiment, the cavity(ies} may be designed on convex surface 7614 of upper mold 7610 rather than on concave surface 7624 of lower mold 7620.
tlilf Once caviiy(ies 7640, and the siirfaces of upper meld 761.0 and lower mold 7620 have been designed, the designs ma be .aed to manufacture a mold 7600, In some embodiments, the manufacturing may include lathe cutting. In such embodiments, the design created in 7724 and the design of upper mold 7610 may be used by a lathe cutting machine, including the appropriate software, to lathe cut upper mold 7610 and lower mold 7620. in. some embodiments, the mamdaeturirig may include moldin e.g., injection molding). In such embodiments, th design created in 7724 and the design of upper mold 7610 may be used to create a mold for molding a prosthesis. I some embodiments, mold 7600 may be a mater template mold (e.g., a metal mold) Used to make disposable molds (e.g., one time use plastic molds}., in some embodiments-, mold 7600 may be a disposable mold.
0601 { Table 3 shows a comparison of the widenin effects of various contact lenses: having different apertur widening zones. Table- 3 shows the overall diameter and the aperture widening zone (AWZ) outer diameter for various contact lenses. The AWZ oute diameter is the diameter measured from die outer edge of the AWZ across the contact lens through the geometrical center to the opposing A WZ outer edge, in one or more rotational positions, the AWZ outer diameter may be the minimum vertical dimensi n- of the AWZ,
0602J Each contact lens in Table 3 includes an AWZ having an outer slope, and inne slope, and a maximum added, thickness delta, located between- the outer .slope- -and the inner slope. Table .3 shows the maximum added delta thickness ("Max, Delta T' , the slope of die outer slope and the slope of the inner slope for each contact lens. Table 3 als shows the aperture widening ¾>ne diameter ("Delta T Diarrv" for each contact lens,, in Table 3, contact lens versions starting with a (e.g., BE VI .1 and BE VI, 2} have an AWZ designed using a iri-eurve methodology. And contact lens versions starting with a "2" (e,g., BE V2.1 and BE V2.2) have an AWZ designed using a spline curve .methodology. The dimensions in Table 3 for tri-curve lens designs and spline curve lens designs are illustrated and described in reference to FIOS-, 78 and 79, respectively.
Figure imgf000129_0001
Figure imgf000130_0001
6Θ3| The contact lenses shown in Table 3 were fitted, at least oaee, on six different patients ΟΉΟί,, SP02. B03, A 04 O 05, and AS06). In each case, a single contact leas was fitted on one of the patien s eye, while the other eye was left in its natural, state {i.e., contact lens fitted on the other eye).. 0R0S pulled out of the trial for reasons unrelated t the trial Accordingly O 05 will not be discussed in regards to die widening capabilities of the lenses tested. The vertical dimension of each patient's palpebral fissure tor the eye on which lenses were fitted, was measured before fitting a respective contact lens on the patient* eye and after the lens was fitted on the eye.
j¾h604j The vertical dimensions of each patient's palpebral fissure without contact lens in his/her eye and after fitting each contact, lens having: a A WZ were measured using the following method. Patients were positioned chin, op with their forehead against a forehead rest of a Momieroscope. A camera was positioned 12 inches from the patients and video of eac patient's, palpebral fissure was recorded. Still images from the video were captured and analyzed to determine the vertical dimensions of each patient's palpebral fissure. The vertical dim nsi n of each patient's palpebral sure was measured using Inkscape 0..4H {m open source vector graphics drawing program that can draw dimensioned lines on an image). The measurements made using Infcscape 0.48 were calibrated by incorporating a ruler into the image by placing the■.ruler on the iorebead rest of the head restraint, on which each patient placed their head.
|06(l5j The percentage difference between the vertical dimension of each patient's eye before and alte fitting is receded in Table 3 as the percent increase in VPA ("%ln VPA"). Additionally, while wearing each respective contact lens, each patient was asked to rate the comfort level of lens on a scale from 1 ~ 5 (5 being very comfortable and I being, very uncomfortable). The eom.tb.rt score fo each contact lens in also recorded in Table 3. Versions of lenses label with a "PVP" were made with a contact lens materia! embedded with PVP (polyvinylpyrrolidone), which may improve the surface wettability and comfort of a contact lens. But otherwise there arc no differences from the corresponding versions not. labeled w th "PVP."
|β666) Table 3 shows that aperture widening can be achieved using each of the contact lens designs, with th exception of BE V 2.3, BE V 2.3 would not center on the eye and was so uncomfortable that it was onl tested on patient SP0.2. Analysis of the results In Table show thai lenses having: an AWZ designed using a spline curve methodology are more effective at widening the palpebral fissure of a patient's e e.
β6β?| Table 4 below shows the average percentage increase in VPA for each contact fens version fitted on each patient. It should be noted that some of the values are not actually "averages" because there is only a single data point for the percentage increase in VPA f r some lenses hi Table 3, While each lens version was capable of widening the palpebral fissure of a patient's eye, when comparing similar Sense it: can be seen that a contact lens having an AWZ. designed using a. spline curve methodology is more effective than a lens designed using a tri-carve methodology.
j¾608| As shown in Table 3 above, BE 1.3 and BE 2,1 have essentially the same AWZ design, but BE VI .3 includes tri-eurve design and BE 2.1 includes a spline carve design. While BE VI .3 has a smaller inner and outer slope than BE V2.1, this difference results from, the different design methodologie for the lens, Practically, the AWZ of BE VI .3 is the same as the AWZ of BE V2..1, except for the differences in the topography of the inner and outer slopes due to the differences between a tri-cnrve desig and a spline curve design. 06(I9| "fable 4 shows that BE. V2.1 produced an average percent increase i VPA that was 2.7% greater than thai for BE VI..3. While tins percentage is not a large number, it is significant because the maximum average percentage increase achieved using the lenses tested was 10,6%, and 2.7 is 25.5% of 10.6. Accordingly, iii the cont t of th se tests, BE V2,I perfor ed approximately 25% better than. BE VI, 3.
Average Average
Version %l VFA Cnmfert
BE V 1.1 5.8 4.8
BE VI .2 8.2 3.4
BE I .3 6.2 .3.2
BE V2.J 8.9 3.5
BE V2.2 10.6
BE V2.3 N/A 0.0
BE V2.4 6.7 2.4
BE V2.5 4.9 4.2
BE V2.6 7.7 2.4
Table 4: Average Percent Increase in VFA and Comfort for Each Contact Lens Desig
Tested in Table 3
f06Jfi| Table 4 also shows the average comfort for each contact lens tested. The average comfort level deviated between the different versions of contact lenses, with BE. V I J. being the most comfortable and BE V2.4 being the least eomfbrtable. Of note, the comfort level for BE V2.1. was slightly higher than the comfort level for BE V 3 ,3..
ffKillj Table 5 shows the average percent increase in VPA for each lens design fitted on each patient The designation of "N/A" means mat a. specific lens design was not fitted on a particular patient. BE V2.3 has all "N/A" designations because, as discussed above, it was highly uncomfortable and. incapable of centeri g on a patient's eye.
Figure imgf000132_0001
| 6I2| A shown in 'table 5, the average percent increase in VPA for BE V2.1 was higher than the average percent increase in VPA for BE V 1.3 for each patient fitted with both lenses, In other wo ds, BE V2J showed Improved widening capabilities compared to its tri-curve counter-part in each patient fitted with both liaises. Again, while the changes in the percentages are small, the relative changes are large. For example, for patient A 04, BE V2J showed an average percent increase iri VPA 2,!% higher than BE VI .3. This is a 22.3% relative increase in average percent increase in VPA.
6131 Table 5 illustrates that without changing th : characteristics of an AWE (e.g., location and amount of max mum, delta thickness) the widening capabilities of an A.WZ can fee improved fey designing the AWZ using a spline curve methodology rather than a tri-curve methodology; This does not mean thai AWZs designed using a. tri-curve methodology are never preferable. Indeed, for example, manufacturing, considerations (e.g., equipment and. techniques available) may result in a iri-enrve design being more preferable, regardless of whether or not it shows a lesser capability of widening a wearer's palpebral fissure,
|iI6I | Table 6 shows the aperture widening effects of various other lenses designed using a spline curve methodology for various patients. The vertical dimensions of each patient's palpebral fissure without a contact lens in his/her eye and after fitting each lens having an AWZ were measured using the following procedure. Patients were positioned chin up with their forehead against a forehead rest of a biomieroscope. A camer was positioned 1.2 inches from the patie ts and video of each patient's palpebral fissure was recorded. Still images torn the video were captured and analyzed to determine the vertical dimensions of each patient's palpebral: fissure. The vertical dimensions were measured using Microsoft 'PowerPoint and PixelStick, PiselStiek is a software tool for measuring distances and angles on an. image displayed on a computer screen, A. circular sticker measuring 19 mm m diameter was placed between each patient's eyes k serve as a reference measurement for the PixelStick. software.
im$ The dimensions of BE V2.1 are shown in Table 3 above. BE Y .8 has an. overall outer diameter of 14.5 m , an aperture widening zone outer diameter of 14,4 mm, an •aperture widening zone diameter of 1.2.7 mm, a maximum added thickness delta of 350 microns, an outer slope of 14 degrees, and an inner slope of 9 degrees. BE ¥2.9 has a overall outer diameter of 14.5 lira, an aperture widening one outer diameter of 14.4 mm. an aperture widening zone diameter of 13.0 mm, a maximum added thickness delta of 300 microns, an turter slope of 14 degrees, and an inner slope of 9 degrees. And BE V2J0 has •an overall outer diameter of 14,5 mm, an aperture widening nc outer diameter of 14.4 mm, an aperture widening zone diameter of 13.5 mm, a maximum added thickness delta of 300 microns, art outer slope of 14 degrees, and an inner slope of degrees.
Figure imgf000134_0001
j¾l6f As shown in Table 6, various contact Sens designs may have different palpebral widening effects on difference patients. But, Table 6 shows the effectiveness of aperture widening zones designed using a spline corve function, For a maj it of the patients, ie vertical dimension of their palpebral fissure increased significantl (i.e., more than 10%) when wearing one or more of lens designs. Patient 7CJ has a congenital lid abnormality that affected the ability of the contacts lenses to widen the palpebral fissure of his eye. Pat tents 2 .B and 6VP are affected by ptosis, hut the various lens designs showed an ability to increase the width of their palpebral, fissures. If patients 7G, 2 , and 6VP are removed from the results, it can be seen tort BE V2.1Q was optimal for the patients having youth fill eyes unaffected by a lid abnormality or ptosis. This indicates that, for at least some individuals or groups of individuals, a larger aperture widening zone (e.g., an aperture widening zone having a large aperture widening zone diameter, such as 1.3.5 mm or bigger) may be more effective at widening the palpebral fissure. Moreover, each patient stated that BE V2J0 was just as comfortable, if not more comfortable, when compared to BE V2.1, BE V2.8, and BE V2,9. This is unexpected because usually when an object having larger sur fhce 'features i placed on a patien 's eye, he/she will generally complain about discomfort,
|06!7| FIX! 80 shows a prosthesis 8000 having a conve surface 8008, a concave surface
8009. and a aperture widening zone 801 having a surfac feature located on concave:: - 1.34 - surface 8009 according to an embo iment Aperture widening zone 8010 ma be designed using a tti-eurve methodology or a spline curve methodology. Similar to. •aperture widening zones 7210 and 731 , aperture widening m SO S O includes a surface feature having an outer slope 8 1 , an inner slope 8020, and a maximum added thickness delta SO 1.2. In some embodiments, aperture widening zone 8010 may include surface feature in the shape of a continuous eireumterentia! ring surrounding, a eometric center S004 (and an optic ssone 8006} of prosthesis 8000. But, the surface featnrefs} of aperture widening zone 8010 may have any size, shape, and/or configuration as described herein. The size, shape, location, etc. of the surface feature of aperture widening zone 8010 may be designed using the sizes, shapes, and dimensions discussed herein with regards to suriace features located on a convex surface of a prosthesis/contact lens, it should be appreciated that in embodiments where prosthesis 8000 is a scleral ring, optic zone 8 06 would be replaced with an open central aperture.
|96l8j Aspects of the design and ni&nu&euiring of prostheses and molds discussed herein, or any part(s) or functk)n(s) thereof, may be im l mented- using hardware, software modules, firmware, tangible computer readable media having instructions stored thereon., or a combination thereof and may be implemented in one or more computer systems or other processing: systems.
Figure 81 illustrates an exemplary computer system 8100 in which embodiments, or portions thereof; may be implemented as computer-readable code. For example, the design, of a prosthesis and/or a mold may he implemented in computer-system 8000 using hardware, software, firmware, tangible computer readable media having instructions stored thereon, or a combination thereof and ma be implemented in one or more ■computer systems or other processing systems.
| ϊ620| If programmable logic is used, such logic may execute on a commerciall available processing platform or a special purpose device. One of ordinary skill in the art: may appreciate that embodiments of the disclosed subject matter can be practiced with various computer system configurations, including multi-core multiprocessor systems, minicomputers, and mainframe computers, computer linked or clustered with distributed functions, as well as pervasive or miniature computers that may be embedded into virtuall any device. 62ί | For instance, at least one processor device and a m mory ma be used to implement the above described embodiments. A processor device may b a single processor, a plurality of processors, .or combinations thereof. Processor devices may have one r more processor "cores."
|0622f Various em odimeiits of the mventions are described in. terms of this example computer system 8100, After reading this description, it will become apparent to a. person skilled In the relevant art how to implement the inventions) using other computer systems and/or computer architectures.. Although operations may he described as a sequential process, some of the operations -may in feet he performed in parallel, concurrently, and/or in a distributed environment, and with program code stored locally or .remotely for access by single o multi-processor machines, in addition,
Figure imgf000136_0001
embodiments the order of operations may be rearranged without departing; .from the spirit of the disclosed subject matter.
p62S\ Processor device 8104 may be a special purpose or a general purpose processor device. As will be appreciated by persons skilled, in the relevant art, processor device 8104 may also he a single processor in a muki-cofe/muitiprocessor system, such system operating alone, of in a cluster of com uting devices operating in a cluster or server farm. Processor device 81 4 is connected to a communication infrastructure 8106, for example, a bus, message queue, network, or multi-core message-passing scheme.
[ 6241 Computer system 8100 also includes a. main memory 81 OS, for example, random access, memory (RAM), and may also include a secondary memory 81 10, Secondar memory 81 10 may include, for example, a hard disk drive 8112:, or removable storage drive 81 14, Removable storage drive 81 14 may include floppy disk, drive, a magnetic tape dri ve, an optical disk dri ve, a flash memory, or the like. The removable storage drive. 81. 14 reads from and/or writes to a removable storage unit 8118 in a well-known mapner.. Removable storage unit 81 18 may include a floppy disk, magnetic tape, optical disk, etc. which is read by and written to by removable storage drive S I 14. As will be appreciated by persons skilled in the relevant art, removable stora.ge unit 81 18 includes a computer usable storage medium having stored therein computer software and/or data.
|'062S| Computer stem: 8100 (optionally) includes a display interface 8102 (which can include Input and output devices such as keyboards, mice, etc,) that forwards graphics. text, and other data from communication infrastructure 8106 (or from a frame buffer not shown) for display on display unit 81.30.
j 0626 J in alternative implementati ns, secondary memory §1 10 ma include other similar me ns for allowing com uter program or other nstructi ns to be loaded into compu er system S lOiK Such, means may include, for example, a removable storage unit 8 22 and an interface 8120, Examples of such means may include a program cartridge and cartridge interlace (such as that found in video game devices), a removable memory chi (such as an EPRQM, or PROM) and associated socket, and other removable storage units 8122 and interlaces 812 which allow software and data to be transferred from the .removable storage unit 8122 to computer system 8100.
I (1627 Computer system 8100 may also include a communication interface 8124,
Communication interface 81.24 allows software and data to be transferred between computer system 8100 and external devices. Communication interface 8124 may .include a modem,, a network interface {such as an Ethernet card), a communication port, a PCMCIA slot and card, or the like. Software and data transferred vi communication interface 8124 may be in the form of signals, which may be electronic, electromagnetic, optical, or other signals capable of being received by communication interlace 8124, These signals may be provided to communication interface 8124 via a communication path 8126. Communication pat 1.26 carries signals and may be implemented using wire or ca le:, fiber optics, a phone line, a cellular phone link, an E.P link or other common i cation channels .
628} In this document, the terms "comparer program medium" and "computer usable medium'* are used to generally refer to media such as removable storage unit 81 18, removable storage unit 8122, and a hard disk installed in hard disk drive 81 12. Computer program medium and computer usable medium, may also refer to .memories, such as main memory 8108 and secondary memory 81 10, which may be memory semiconductors (e.g.. ORAM'S, etc,}.
f0629{ Computer programs (also called computer control logic) are stored, in main memor 81 8 and/or secondary memory 8.1 10, Computer ro rams may also be received via communication interface 8124, Such computer programs, when executed, enable computer system 8100 to implement the embodiments as discussed herein, in particular, the computer programs, when executed, enable processor device: 81.04 to implement the: processes of the embodiments discussed here. Accordingly, such computer program •represent controllers of the computer system 8100. Where the embodiments are implemented using software, the software may be stored in a computer program product and loaded into computer system 8.100 using removable storage drive 8. Li 4, Interface S320, and hard disk drive 81.1.2, or communication interface 8124.
[8630] Embodiments of the invention(s) also may be directed to computer program products comprising software stored on any computer useable medium. Such software, when executed in one or more data processing device, causes a data processing deviec(s) to operate as described herein. Embodiments of the inve tion's) ma employ any computer useable or readable medium.. Examples of computer useable mediums include, but ate not limited to, primary storage devices (e.g., any type of random access memory), secondary storage devices (e.g,, hard drives. Soppy disks, CD iOMS, ZIP disks, tapes, .magnetic- -storage devices, and optical storage devices, MEMS, nanoteehnologieal storage device, etc.).
|θ 311 it is to be appreciated that the Detailed. Description: section, and not the Summary and Abstract sections (if any), is intended to be used to interpret the claims, lire Summar and Abstract sections (if any) may set forth one or more but not all exemplary embo iments of the inventions- as contemplated by the inventoris), and thus, are not intended to limit the inventions or the appended claims in any way.
[8632| While the inventions have been described herein with reference to exemplary embodiments for exemplary fields and applications, it should' be understood that the inventions are not limited, thereto. Other embodiments and modification thereto are possible, and are within the scope and spirit, of the inventions. For example, and without limiting the generality of this paragraph, embodiments are not limited to the, hardware, methods and/or entities illustrated in the figures and/or described herein. Further, embodiments (whether or not explicitly described herein) have significant utility to fields and applications beyond the examples described herein,
[8633.1 .Embodiments have been described herein with the aid of functional buildin blocks illustrating the implementation, of specified function and relationships thereof The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined as long as ie specified functions and relationships (or equivalents thereof) are appropriately performed. Also, alternative embodiments may perform functional .blocks, steps, operations, methods, etc. using orderings different than those described herein.
References herein to "one embodiment'' an embodiment," "an example embodiment," or similar phrases, indicate that the embodiment described may incl de a .particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessaril referring to the same embodiment Further, when a particular feature, structure, or characteristic is described m connection with an embodiment, ii would be within the knowledge of persons skilled in the relevant art(s): to incorporate such feature, structure, or characteristic into other embodiments whether or not explicitly mentioned -or described herein,
The breadth and scope of the inventions should not fee limited by any of the above-described ex mplar embodiments, but should be defined: only i accordance with the i liowing claims and their equivalents.

Claims

WHAT IS CLAIMED IS:
1 . A prosthesis capable of being wont cm the eye of a wearer, comprising:.
a convex surface;
a concave surface;
an aperture widening zone comprising a surface feature that is located on th convex o -concave surface of the prosthesis* the surface feature comprising an outer sl pe, art inner slope, and a itjaximum added thickness delta located between the outer slope arid the inner slope;
wherein the aperture widening zone has a niininiiini vertical dimension of greater than or equal to 10.5 mm:
wherein the aperture widening zone is configured to widen the natural palpebral fissure of a wearer's eye; and
wherein the surface topography of at least one of the outer slope a d the iurser slope is defined by a s line curve !imction..
2. The prosthesis of claim 1 , wlierei the spline curve ftinctio.il is a Bessier curve function.
3. The prosthesis of any one of claims J or 2, wherein the maximum added thickness delta is located a least 5.25 mm from a geometrical, center of the leas,
4. The prosthesis of any one of claims I - 3, wlierein the raaximyni added thleteess- delta is located a t least 5 ,5 m from a geometrical, center of the lens..
5. The prosthesis of any one of claims 1 -4, wherein the- maxiittunt added thiei Dess delta is located at or exterior to the corneal !inibus of the wearer's eye when the prosthesis i worn oo tile eye.
6. The prosthesis of any one of claims I. ·- 5, wherein the aperture widening ¾one begins at least 0.01 mm from a peripheral edge of the prosthesis.
7. The prosthesis of any one of claims I. --- 6, wherein the outer slope begins at least ilM mm from a -peripheral, edge of the prosthesis ,
8. The- prosthesis of any owe of claims 1 - 7, wherein the aperture widening ¾one has minimum vertical dimension of greater than or equal to 12.0 mm,
9. The prosthesis of any one of claims 1 8. wherein the prosthesis is a corneoscleral lens.
10. The prosthesis of claim 9, wherein a peripheral edge of the corneoscleral lens is not altered from that which is commercially available for a specific brand and type of corneoscleral contact lens,
1 1. The prosthesis of any one of claims 1 ~ 10, wherein the outer slope intersects the convex or concave surface at a first junction point and the inner slope intersects the convex or concave surface at a second junction point and wherein the first junction point has first and second order continuity,
12. The prosthesis of claim I L wherein the second junction point has first and second order continuity.
13. The prosthesis of any one of claims ί - 12, wherein the entire surface of the surface feature has first and second order continuity.
14. The prosthesis of any one of claim f - 13, wherein the entire surface having the surface feature located thereo has first and second order continuity.
15. The prosthesis of any one of claims 1 - 14, wherein the maximum added thickness delta is located within a range of 0.25 mm to 0.75 mm fro a peripheral edge of the prosthesis.
16. The prosthesis of any one of claim 1 ~ IS, wherein the prosthesis is configured to be capab le of rotation w hen worn, on the eye. 17, A method of designing a prosthesis capable of being wo/nron the eye of a wearer, the method comprising:
selecting a base prosthesis profile having a convex, surface and a concave surface; selecting ari are tor a sur ace feature located On the convex surface or the concave surface of the base prosthesis profi le, the arc comprising:
a height different from a normalized convex surface of the base prosthesis profile or a norniah¾ed concave surface of the base prosthesis profile,
a peak located ai a. maximum height of the are, and
ari outside edge and an inside edge;
selecting the location of the peak: relative a peripheral edge of the base prosthesis profile;
selecting a first control point located on the base pH>sihesis profile at a distance A from a peripheral edge of the base prosthesis profile;
selecting a second control point located on the outside edge of the arc; sel ecting a thi rd control poin located on the inside edge of the are; selecting a fourth control point located on the base prosthesis profile at a distance B from an edge of an optical. zon of the base prosthesis profile; and
designing the prosthesis having the surface feature on the base prosthesis profile using the control points and a spline curve function.
I S, The method of claim 17 wherein the surface feature begins at the first control point and ends at the fourth control point
19. The method of any one f claims .17 or ! 8 , further comprising:
selecting a fifth control point located tangential to the surface of the base prosthesis profile at the first control point and at a distance C from the first control point towards the peak: of the are;
selecting a sixth control point located tangential to the outside edge of the arc at the second control point and a a distance D from the second control point towards the peripheral edge of the base prosthesis profile; selecting a seventh control point located tangential to the inside edge of the arc at the third control point and at a d stance E from the third control point towards the peripheral edge of the base prosthesis profile;
selecting m eighth control point located tangential t tlie surface of the bas prosthesis profile at the fourth, control point and at a distance F from the fourth .control point towards the peak of the are; and
designing tlie surface feature using the control points and a spline curve function. , The method of any one of claims 17 - 1 , where o the are has a constant radius, , The method of any one of claims 1 ? - 20, wherein the inside edge of the arc is located at a height between the normalized convex surface or normal i¾d concave snrfce of the base prosthesis profile arid the peak of the arc, , The method of any one of claims 17 ·-- 2.1, wherein the outside edge of the arc is located at a height between the normalized convex, surface of .normalized concave su face; of the base prosthesis profile and the peak of the are. , The method of any one of claims 17·— 22, wherein A in the range of 0.01 mm to 2.0 num. , The method ° any one of claims 17 - 23 s wherein B is in the range of 0 mm to 3,0 mm. , The method of any one of claims 19 - 24, wherein C t§ in the range of 0 mm to .2.0 mm. , The method of an one of claims 1.9 - 25, wherein D is in. the range of 0 mm to 2.0 mm. , The method of any one of claims 1 - 26, wherein E is in the range of 0 mm to 2,0 mm, , The method of any one of claims 19 - 27, wherein F is in the range of 0 mm to 2,1) mm.
29. The method of any one of claims 1 ? - 28, wherein the spline curv functio is a Bezie curve function,
30. The method of any one of claims 17 - 29, wherein the first, second, third, and fourth control points are located on a single cross-sectional plane -of the base prosthesis profile that interests a- eometrical, center of the base prosthesis profile and the peripheral edge of the base prosthesis profile.
31. The method of any one of claims 17■·■■ 30, wherein the convex or concave .surface of the prosthesis has first order continuity at the first control, point.
32. The method of any one of claims 17 - 3L wherein the convex or concave surface of the prosthesis has first order and second order continuity at the first control point.
33. The method of an one of claims 17 - 32, wherein the convex or conca ve surface of the prosthesis ha first order and second order continuity at the outside edge of the arc
34. The method of any one of claims 1 ~ 33, wherein the convex or concave surface of the prosthesis ha first order and second order continuity at the fourth control point.
35. The method, of any one f claims 17 - 34, wherein the c nv x: or concave, surface of the prosthesis has first order and second order continuit at the inside edge of the are.
36. The method of any one of claims 17 - 35, wherein the entire surface feature has first and second, order continuity, including at the first and fourth control points,
37. The method of any one of claims- 17 - 36, wherein the entire surface- aving the surface feature located thereon has first and second order continuity.
38. The method of any one of claims 17 - 37, wherein the prosthesis is eorneo-scleral lens. 39', The method of any one of claims 17 - 38, wherein the prosthesis is a scleral ring.
40. The method of any one of claims 17 - 39, wherein the prosthesis is configured to wide the natural palpebral fissure of the wearer's eye,
41. The method of any one of claims 17 - 40, wherein th first control point is located at least 0.01 im from the peripheral, edge of the base prosthesis profile.
42. A method of maauiketwttig a prosthesis capable of being worn on the eye of a wearer, the method comprising:
designing a prosthesis according to claim 13; and
forming the prosthesis using the design.
43. The method of claim 42, wherein forming the prosthesis comprises molding.
44. The method of claim 42, wherein form ng die prosthesis comprises lathe cutting.
45. A method of making a mold for prosthesis capable of being worn on the eye of a wearer, the method comprising;
selecting a base mold profile having a convex surface, and a concave surface; selecting as arc for a surface feature located- on the convex surface or th concave surface of the base mold profile:, the arc comprising;
a height different from a normal rmd conve surface of the base old profile or the normalised concave surface of the base mold profile,
peak located at. a maximum height of the are, and:
an outside edge and an inside edge;
selecting the location o the peak relative a peripheral edge of the base mold profile;
seiccorsg a first control point located on the base mold profile at a distance A from a peripheral, edge of the base mold profile
selecting a second control point located on. the outside edge of the arc;
selecting a third control point located on the inside edg -Of the arc - 1.45 - selecting a fourth control point located on the base mold profile at a distance B from an edge o f opt cal zone of the base m id profile;
designing t e mold having the surface feature using the control points and a spline curve fonciiou; and
forming the mold.
The method of claim 45, wherein forming the mold comprises injection . molding,
A. prosthesis capable of being worn OH the eye of a wearer, comprisi g:
a convex surface;
a concave surface;
an aperture widening zone comprising a surface feature that is located n the convex or concave surface of the prosthesis, the surface feature comprising:
an arc located at a height different from the convex surface the prosthesis or the concave surface of the prosthesis, the arc comprising a radius, an outside edge, and an. Inside edge, and
a peak, located, at a maximum added thickness delta of the arc, an. outer slope extending from the outside edge of the arc towards a peripheral region of the prosthesis ; and
an inner slope extending from the inside edge of the are towards a central region of the prosthesis;
wherein the surface topography of at least one of the outer slop and the inner slope is defined by a spline curve function; and
wherein, aperture widening zone has . a min mum vertical dimension of greater than or equal to 10.5 mm.
The prosthesis of claim 47, wherein the outer slope intersects the peripheral region at a first junctio point, and wherein the first junction point: has first and second order continuity. The prosthesis of any one of claims 47 or 48, wherein the Inner slope intersects the central regson at a second junction point and wherei the second junction point has first and second order continuity.
The prosthesis of any one of claims 4? ~ 49, wherein the radius is in the range of 0 mm to 5 nun. he prosthesis of any one of claims 47 -50, wherein the radius is in the range of 0.5 mm to 3 ram.
The prosthesis of any one of claims 47 - 51» wherein the maximum added d ckness delta is greater than or equal to 25 microns.
The prosthesis of any one of claims 47 ~ 52, wherein the maximum added thickness delta is greater than or equal to 200 microns.
The prosthesis of any one of claims 47 -- 53, wherein, the maximum added thickness delta is in the range of 25 microns to 1000 microns.
The prosthesis of any one of claims 47 - 54, wherein the- sp!ipe curve::fun.c'ti0n s a Beisier curve function.
The prosthesis of an one of claims 47 - 55, wherein, the maximum added thickness delta is located at least" 5.25 mm from a geometrical center of the prosthesis.
The prosthesis of any one of claims 47 ·■■· 56, wherein the maximum added thickness delta is located at least 5.5 ram from a geometrical center of the prosthesis.
The prosthesis of any one of claims 47 - 57, wherein the arc is a circumferential, a e disposed around an optica! zone of the prosthesis. 59, The prosthesis of c laim. 58, wherein the circumferential are is eoistlmioiis.
60. The prosthesis of claim 58, wherein the ctrcBjnf fential arc is non-coTiiirsuoiis,
61 , The prosthesis of any one of claims 47 - 60, wherein the prosthesis is configured to e capable of rotation when worn on the eye.
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US62/073,403 2014-10-31
US14/624,269 2015-02-17
US14/624,269 US9995947B2 (en) 2012-09-07 2015-02-17 Prosthesis and method for widening the palpebral fissure of an individual's eye
US201562133109P 2015-03-13 2015-03-13
US62/133,109 2015-03-13
US14/680,854 2015-04-07
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