CN115167003B - Non-closed scleral contact lens - Google Patents
Non-closed scleral contact lens Download PDFInfo
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- CN115167003B CN115167003B CN202210837851.6A CN202210837851A CN115167003B CN 115167003 B CN115167003 B CN 115167003B CN 202210837851 A CN202210837851 A CN 202210837851A CN 115167003 B CN115167003 B CN 115167003B
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Classifications
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- 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
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- Health & Medical Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Physics & Mathematics (AREA)
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- General Physics & Mathematics (AREA)
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Abstract
The present invention relates to a scleral contact lens, and more particularly to a non-enclosed scleral contact lens comprising an optical zone disposed in the center of the lens, a transition zone surrounding the optical zone, and a landing zone disposed at the periphery of the lens, the scleral contact lens being configured such that when placed on an eyeball, the optical zone and the rear surface of the transition zone do not contact the front surface of the eyeball, a portion of the rear surface of the landing zone is in contact with the bulbar conjunctiva of the eyeball for providing support to the scleral contact lens, and the scleral contact lens being configured such that during use the degree of movement at the surface of the eyeball is between 0.4 and 1.2 mm. The scleral contact lens is convenient to pick, has good visual effect, can provide dynamic tear exchange, and is beneficial to ocular surface health.
Description
Technical Field
The invention relates to the field of contact lenses, in particular to a non-closed scleral contact lens.
Background
Scleral contact lenses are a large diameter rigid gas permeable contact lens commonly used for daytime wear. In contrast to conventional rigid oxygen permeable keratoscopes (RGPs), scleral contact lenses land on the sclera and arch over the entire cornea and the cornea/scleral junction known as the limbus, thus enabling the formation of a gap between the posterior lens surface and the anterior cornea and limbus surfaces, the posterior lens tear gap (posterior LENS CLEARANCE). The posterior tear gap includes the corneal gap and the cornel limbus gap. The gap is used as a liquid reservoir which can be filled with tears, normal saline or functional solutions such as liquid medicine and the like, can create ideal ocular surface environment, and has incomparable advantages for protecting cornea and corneoscleral tissues, improving eye dryness, correcting irregular astigmatism of cornea, reducing higher-order phase difference and the like.
Scleral contact lenses generally include an optical zone, a transition zone, and a landing zone. The optical zone is positioned in the center of the lens and is mainly used for vision correction. The landing zone is the outermost peripheral zone of the scleral contact lens, and is also the load bearing zone of the entire lens, and in order to enhance comfort, avoid conjunctival compression, and distribute the lens weight as much as possible, it is generally desirable that the posterior surface of the landing zone conform as closely as possible to the corresponding ocular surface shape to provide a larger area contact zone. Therefore, most scleral contact lenses are designed with a posterior surface profile that is tangential, with no or little curvature, so as to conform as closely as possible to the shape of the anterior surface of the sclera for good lens stability and comfort of wear. Even more attempts have been made to divide the scleral contact lens into multiple zones or quadrants to facilitate adjustment of parameters and designs within the various zones of the scleral contact lens based on the topography of the subject's eye surface.
Because of this, most scleral lenses are either closed or semi-closed, with no or only minimal tear exchange and lens mobility. However, closed scleral contact lenses are prone to various complications including, but not limited to, daytime fogging caused by tears Chi Suixie (debris), vision fluctuations caused by lens subsidence, higher order aberrations caused by decentration, high lipid concentrations, inflammatory factor accumulation in the post-lens tear gap, corneal hypoxia stress, and the like.
Thus, there is a need for a scleral contact lens that is beneficial to ocular surface health, simple and easy to wear.
Disclosure of Invention
The invention relates to a scleral contact lens comprising an optical zone arranged in the centre of the lens, a transition zone surrounding the optical zone and a landing zone arranged at the periphery of the lens, wherein the scleral contact lens is configured such that when the scleral contact lens is placed on an eyeball, the optical zone and the rear surface of the transition zone are not in contact with the front surface of the eyeball, a portion of the rear surface of the landing zone is in contact with the bulbar conjunctiva of the eyeball for providing support to the scleral contact lens, and the scleral contact lens is configured such that the scleral contact lens has a mobility at the surface of the eyeball of between 0.4 and 1.2mm during use.
In some embodiments, the scleral contact lens is configured such that, during use, the scleral contact lens has a mobility between 0.5 and 1.0mm at the surface of the eyeball.
In some embodiments, the scleral contact lens is configured such that, during use, an apex gap between the posterior surface of the optical zone and an apex of the eyeball does not exceed 200 microns.
In some embodiments, the point of attachment of the posterior surface of the landing zone to the posterior surface of the transition zone is between 6.0-7.0 mm perpendicular to the lens axis of the scleral contact lens.
In some embodiments, the transition zone is configured to be positioned over a scleral limbus of the eyeball when the scleral contact lens is placed on the eyeball.
In some embodiments, a scleral margin gap between the posterior surface of the transition zone and the scleral margin is between 75 to 150 microns.
In some embodiments, the posterior surface of the scleral contact lens is rotationally symmetric.
In some embodiments, the posterior surface of the landing zone is a rotationally symmetric aspheric surface.
In some embodiments, the scleral contact lens further comprises a through hole and/or a pocket disposed in the optical zone and/or the transition zone of the scleral contact lens.
In some embodiments, the scleral contact lens has a diameter of 14.0 to 25.0mm, preferably 14.0 to 18.0mm.
Drawings
Fig. 1 schematically illustrates a cross-sectional view of a scleral contact lens in accordance with the present invention disposed on a human eye.
Fig. 2 is a schematic diagram of a scleral contact lens according to one embodiment of the invention. The left image is a bottom view of the scleral contact lens and the right image is a cross-sectional view of the left image along line A-A.
FIG. 3 is a photograph of a fluorescein obtained from an assessment of diffuse light source under cobalt blue light of a slit lamp.
FIG. 4 is a schematic illustration of landing zone edge lift assessment.
Fig. 5 is a flow chart of a scleral contact lens challenge method in accordance with the present invention.
Reference numerals:
OZ optical zone, TZ transition zone, LZ landing zone, TD lens total diameter, AC apex gap, LSH lens sagittal height, ESH eye sagittal height, EL edge warp, J1 optical zone and transition zone posterior surface connection point, J2 transition zone and landing zone posterior surface connection point, 1 cornea, 2 bulbar conjunctiva.
Detailed Description
The following detailed description of the embodiments of the application refers to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough and complete disclosure of the present application, and to fully convey the concept of the application to those skilled in the art. With respect to the drawings, the relative proportions and proportions of features in the drawings may be exaggerated or reduced in size, for the sake of clarity and convenience. Such arbitrary proportions are merely illustrative and do not limit the application in any way. Unless defined otherwise, terms used in the present application have meanings commonly understood by those skilled in the art.
In the present description, when used in connection with contact lenses, "anterior surface" refers to the surface that is closest to the inner surface of the eyelid, or convex surface of the lens, when worn, and "posterior surface" refers to the surface of the lens that faces the cornea, or concave surface of the lens, when worn.
1. Lens moving (movement)
The present invention relates to a scleral contact lens, as shown in fig. 1, comprising an Optical Zone (OZ), a Transition Zone (TZ) and a Landing Zone (LZ). The optical zone is centered on the lens and is typically larger in diameter than the horizontally visible iris diameter, primarily for vision correction. The landing zone is the outermost peripheral region of the scleral contact lens, which is the region where the scleral contact lens contacts or lands on the ocular surface. The transition region connects the optical zone and the landing zone, and is generally arched above the scleral edge. The scleral contact lens is configured such that when the scleral contact lens is placed on an eyeball, the optical zone and the posterior surface of the transition zone do not contact the anterior surface of the eyeball, and a portion of the posterior surface of the landing zone contacts the bulbar conjunctiva of the eyeball for providing support to the scleral contact lens.
The landing zone is the outermost peripheral zone of the scleral contact lens, and is also the load bearing zone of the entire lens, and in order to enhance comfort, avoid conjunctival compression, and distribute the lens weight as much as possible, it is generally desirable that the posterior surface of the landing zone conform as closely as possible to the corresponding ocular surface shape to provide a larger area contact zone. Studies have shown that the shape of the anterior surface of the sclera (between 15.0mm and 20.0mm in diameter) is tangential in most subjects, exhibiting a convex shape in only less than one third of subjects, and rarely in a concave shape in some subjects. Moreover, it is known in the art that the shape of the anterior surface of the sclera gradually increases in areas other than 13.0mm in diameter. Therefore, to achieve good fit and lens stability, most of the posterior surface topography of the landing zone of the scleral contact lens is designed to be tangential with no or little curvature, and many more attempts have been made to divide the scleral contact lens into multiple zones or quadrants in order to adjust the parameters and design within each zone of the scleral contact lens according to the subject's ocular topography.
Because of this, most scleral lenses are either closed or semi-closed, with no or only minimal tear exchange and lens mobility. In most cases, a conventional scleral contact lens that is ideally suited does not exhibit any clinically significant tear exchange without mechanical manipulation. Complications that can easily arise from closed scleral contact lenses include, but are not limited to, daytime fogging caused by tear pool debris, vision fluctuations caused by lens subsidence, higher order aberrations caused by decentration, high lipid concentrations, inflammatory factor accumulation, corneal hypoxia stress, and the like. In addition, since conventional scleral lenses have no or only a very small amount of tear fluid exchange, the reservoir behind the lens cannot be filled, air bubbles can form, etc. after wearing, the wearer is required to add a suitable liquid to the concave surface of the lens in advance, keep the low head substantially parallel to the ground, and then insert the scleral lens with the liquid into the eye with one hand. If the amount of liquid added is insufficient or the wearer is not skilled, air bubbles may be present between the lens and the ocular surface, and therefore the lens needs to be removed and re-worn, because air bubbles can cause discomfort to the eye, blurred vision, and staining of the cornea, which is to be avoided both during and during the lens application.
Accordingly, in embodiments of the present invention, the inventors have addressed the problems associated with conventional closed/semi-closed scleral contact lenses by providing a non-closed or open scleral contact lens. As used herein, "non-closed" or "open" scleral contact lens means that the posterior surface of the landing zone of the scleral contact lens is not designed or tailored to be fully or as complementary or conforming as possible to the corresponding ocular surface topography of its wearer.
Because perfect fit to the topography of the ocular surface is not pursued, the scleral contact lens of the present invention has a higher degree of ocular surface mobility than similar products. The higher the lens mobility, the higher the tear exchange rate. The scleral contact lens of the present invention has been demonstrated to provide sustained dynamic tear exchange as evidenced by, for example, the ability to observe that fluorescein fills behind the lens after 5-10 blinks after the lens has been added dropwise. However, too high or too low a mobility may reduce comfort, and thus in some embodiments, the scleral contact lens of the present invention is configured to have a mobility at the surface of the eyeball of between 0.4mm and 1.2mm, preferably between 0.5mm and 1.0mm, such as about 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1mm, and any value therebetween, preferably less than 1.0mm, more preferably equal to about 0.5mm (e.g., 0.5±0.05 mm) during use. The degree of movement is measured by slit lamp illumination (0.5-2.0 mm width) and a scale line of known length of the slit lamp or slit lamp illumination beam width, and the lens movement is assessed using a direct focus method.
In some embodiments, the posterior surface of the landing zone of the scleral contact lens of the present invention is rotationally symmetric about the optical axis of the scleral contact lens so that when the lens is placed on the sclera with an asymmetric anterior surface topography, it will not fit perfectly therewith, but will likely have only a few points or locations of contact, thus providing a higher degree of mobility that is more conducive to under-lens tear exchange. In still other embodiments, the posterior surface of the landing zone is rotationally symmetric aspheric. In still other embodiments, the eccentricity of the rear surface of the landing zone is between 0.05 and 1.00, preferably between 0.05 and 0.60.
In still other embodiments, the point of attachment of the posterior surface of the landing zone to the posterior surface of the transition zone (i.e., the starting point of the landing zone, J2) is between 6.0mm and 7.0mm, preferably between 6.0mm and 6.8mm, such as 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7mm, and any value therebetween, from the lens axis of the scleral contact lens to take advantage of the asymmetry of the anterior surface of the sclera with a diameter outside 13.0 mm.
Without wishing to be bound by any theory, the inventors believe that the scleral contact lens of the present invention effectively avoids accumulation of proteins, lipids, mucins, and inflammatory factors within the tear layer between the cornea and the posterior surface of the lens by achieving adequate exchange of tear fluid under the scleral contact lens with tear fluid outside the lens, thereby solving the problems of the prior art.
As mentioned above, conventional scleral lenses are typically designed as closed or semi-closed reservoirs, and thus are also particularly suitable for dry eye patients. However, the biggest problem with closed or semi-closed scleral contact lenses is the accumulation of various chemicals and debris in the subocular layer, a most representative of which is daytime fogging (midday fogging), which has to be cleaned by lens removal during the day of wear to maintain good vision. The scleral contact lens is not perfectly attached to the ocular surface in the landing area, has relatively high mobility, can realize filling of a posterior tear pool of the lens and continuous exchange and updating of tears by means of blinking actions of a subject, is beneficial to cornea health, and enables the lens to be worn comfortably for a whole day without any problem.
Therefore, the scleral contact lens disclosed by the invention is not only easy to wear without instilling normal saline before wearing, but also is safe and convenient to pick up, and has no fogging phenomenon in daytime.
2. Corneal gap
When the scleral contact lens of the present invention is placed on the eyeball, the rear surface of the optical zone and the transition zone thereof are not in contact with the front surface of the eyeball of the subject, thereby forming a liquid storage space. The gap between the posterior surface of the optical zone and the anterior surface of the cornea is called the corneal gap, and the gap between the posterior surface of the transition zone and the anterior surface of the limbus is called the limbus gap. The corneal gap may be characterized by a central or apex gap (AC (apical clearance)). The central gap refers to the distance between the center of the posterior surface of the scleral contact lens and the anterior surface of the cornea, and the apex gap refers to the distance between the highest point of the anterior surface of the cornea and the posterior surface of the scleral contact lens. Because anterior corneal surface morphology is generally irregular, particularly in keratoconus patients, corneal trauma or post-operative patients, the use of the apex gap in the present invention determines whether the curvature of the scleral contact lens over the cornea is appropriate. The apex gap is related to the Lens Sagittal Height (LSH) (i.e., the perpendicular distance of the lens posterior surface geometric center from the lens edge plane).
The corneal gap cannot be too large nor too small. When the corneal gap is too large, the tear layer thickness therein increases, affecting the transfer of oxygen from the outer surface of the lens to the cornea, which is prone to hypoxia of the cornea and to accumulation of various ocular debris (e.g., mucosal debris (mucus debris), meibomian gland debris (meibomian debris), lacrimal sac debris). In cases where the corneal gap is insufficient, contact between the posterior surface of the scleral contact lens and the anterior surface of the cornea may occur after the subject wears the lens for several hours due to the sedimentation effect of the scleral contact lens, causing damage to the corneal epithelium. In addition, the thin (100 μm or less) tear layer is considered by the scholars to be disadvantageous even if no cornea load bearing occurs, because the film adhesion force generated in the closed space increases the adsorption between the scleral contact lens and the ocular surface, resulting in difficulty in taking off the lens, especially after long-term lens wearing, ocular surface secretions, metabolites, and the like, resulting in more viscous tears therein. Of course, there is no certainty in the art as to how much corneal clearance is desired, but it is currently generally accepted that at least 250 microns of corneal clearance should be ensured at the time of initial lens fitting.
The inventors have found that in the closed scleral contact lens of the present invention, setting the proper apex gap of the scleral contact lens to be no more than 200 microns not only does not present the problem of difficulty in lens removal, but also unexpectedly reduces the extent of lens settlement even when the apex gap is as low as 40 microns, and does not present corneal weight bearing and damage after extended wear of the subject. As used herein, the term "initial apex gap" refers to the distance between the highest point of the anterior surface of the cornea and the posterior surface of the scleral contact lens as measured by Optical Coherence Tomography (OCT) or fluorescein stain after 20 to 30 minutes of lens wear by the subject. The initial apex gap according to the present invention is also one of the important parameters for the optician to determine whether the selected test piece is fit during the scleral contact lens of the present invention.
Thus, the initial vertex gap between the posterior surface of the optical zone of a scleral contact lens according to the present invention and the vertex of the eyeball is below 200 microns, e.g., less than 200 μm, less than 190 μm, less than 180 μm, less than 170 μm, less than 160 μm, less than 150 μm, less than 140 μm, less than 130 μm, less than 120 μm, less than 110 μm, less than 100 μm, less than 90 μm, less than 80 μm, less than 70 μm. An apex gap of greater than 200 microns is undesirable because in the non-closed scleral contact lens of the present invention, an excessive apex gap tends to cause air bubbles to move from the landing zone without the contact surface and tear fluid into the post lens space during wear.
In preferred embodiments, the initial apex gap is above 40 microns, e.g., greater than 40 μm, greater than 50 μm, greater than 60 μm, greater than 70 μm, e.g., the initial apex gap is 55, 65, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 160, 165, 170, 175, 180, 185, 190, 195 μm or any value therebetween. The apex gap below 40 microns is disadvantageous because irregular morphology of the sclera, rotation of the eyeball in different gaze directions, all have the potential to cause the lens to approach the cornea during movement, risking potential damage.
Since the scleral contact lens according to the present invention has a thin post-lens tear gap where tear formation is thin under ideal fitting conditions, even if the lens mobility is high, the change in tear lens thickness resulting therefrom is almost negligible and does not lead to vision fluctuations in the subject.
In some embodiments of the invention, the transition region of the scleral contact lens is configured to be positioned over the corneoscleral edge of the eyeball when the scleral contact lens is placed on the eyeball. Corneoscleral limbus is the cornea-scleral junction, which contains stem cells that play a critical role in eye health. If the scleral contact lens contacts the scleral limbus, damage to the stem cells therein may occur, and if the scleral contact lens is too arched over this area, oxygenation of the scleral limbus stem cells may be affected. Thus, in some embodiments of the invention, the scleral contact lens is further configured to provide an angular scleral gap between 75 and 150 microns.
The post-lens vertex gap and scleral edge gap can be quantitatively measured by Optical Coherence Tomography (OCT) or assessed using fluorescein staining, both in static and dynamic states.
3. Edge-curling
In some embodiments, the landing zone tip is provided with an edge-lift. As used herein, "edge lift" refers to the fact that the end of the land is not in contact with the ocular surface, edge lift is sometimes referred to as edge lift or edge lift, and "edge lift height" refers to the distance of the end of the land from the bulbar conjunctiva where the chordal length of the eyeball is equal to the diameter of the scleral contact lens (fig. 1).
Generally, because of the larger size of the scleral lens, the side-tilt is not favored by the subject, as the side-tilt is more likely to make the subject feel the presence of the lens (foreign body sensation), and the upper side-tilt may also exacerbate Giant Papillary Conjunctivitis (GPC). In the scleral lens fitting procedure, the ideal situation that is generally accepted in the art is that the landing zone is perfectly attached to the sclera (bulbar conjunctiva), without edge-lifting, without compression, and without conjunctival whitening (blanching).
However, the invention utilizes the tear exchange promoting effect brought by edge-curling. The provision of the edge-warps at the landing zone tip makes the posterior tear exchange effect of the scleral contact lens of the present invention more excellent.
In addition, the inventors have found that by setting the radius of curvature r1 at the junction (J2) of the posterior surface of the landing zone and the posterior surface of the transition zone of the scleral contact lens of the present invention and the radius of curvature r2 of the distal end of the posterior surface of the landing zone (fig. 2), and setting the radius of curvature of the portion of the posterior surface of the landing zone between the two points to gradually (continuously or stepwise) increase radially outward, it is possible to individually control the posterior surface profile of the land zone, to construct a gentle raised edge and to reduce the foreign body sensation of the subject. Wherein the radius of curvature r1 at the junction J2 is also called the landing zone radius of curvature LZR. In some embodiments, the radius of curvature r1 at the junction (J2) of the landing zone rear surface and the transition zone rear surface is between 8.5-15.0 mm, such as 9.0, 10.0, 11.0, 12.0, 13.0, 14.0, 15.0mm, or any value therebetween. The radius of curvature r2 of the end of the landing zone rear surface is between 8.65 and 20.0mm, preferably between 10.0 and 15.0 mm. Changing r1 (LZR) can result in a change in the position of the lens to land on the conjunctiva, changing the sagittal height of the lens as a whole and fitting to the anterior surface of the cornea. Part B of fig. 2 shows the landing zone change caused by the r1 change.
In some embodiments, the sagittal height S at J2 is set according to the radius of curvature r1 at J2, S representing the perpendicular distance of the junction J2 from the lens edge plane, with the smaller S being the greater the r 1. Where S (r 1) = (a+b×r1+c×r1 2+D×r13)-1, and a is selected from-2 to-150, B is selected from 0.5 to-5, C is selected from-0.06 to-0.6, d is selected from 0.003 to 0.03, e.g. a is-10, B is 2.5, C is-0.28, d is 0.017, suitable sagittal heights S are selected from 0.6 to 3.2mm, preferably 1.0 to 2.2mm, more preferably 1.2 to 1.7mm, the inventors have found that scleral contact lenses varying in this range provide landing zones with suitable heights to establish a balance between tear exchange and subjective feeling comfort in the subject.
4. Other lens features
In some embodiments, the scleral contact lens of the present invention further comprises a through hole (fenestration) and/or a pocket (pocket) disposed in the optical zone and/or the transition zone of the scleral contact lens (fig. 2). The through holes are small holes drilled in the scleral lens to help improve tear exchange under the lens and/or to provide more available oxygen through the lens. The horizontal cross section of the through hole has a maximum dimension selected from 0.2-1.0 mm. The pocket, unlike the through hole, is a non-penetrating structure having an opening on the rear surface of the lens. The pockets suitable for use in the present invention may have a variety of contours. The pockets may reduce the average thickness of the lens and increase the oxygen permeability of the lens, and thus, in some embodiments, the scleral contact lens of the present invention is provided with a plurality of pockets on the posterior surface. In some embodiments, the pocket is configured to capture and confine bubbles that may enter the back mirror gap through the through hole, such as described in CN112666723 a. Said patent document is incorporated by reference in its entirety into the present invention.
In still other embodiments, the optical zone diameters of the scleral contact lenses of the inventionAnd the thickness is 5.00-12.00 mm. The central thickness of the optical area is between 0.15 and 0.55mm, so that the optical area provides enough lens strength and good lens oxygen permeability. In various embodiments, the rear surface of the optical zone may be spherical, aspherical or toric. In various embodiments, the optical zone posterior surface may have a radius of curvature that is greater or less than the radius of curvature of the cornea. In some embodiments, the radius of curvature r0 of the posterior surface of the optical zone (i.e., the base curve radius of curvature (BCR) of the scleral contact lens) is between 5.0 and 14.0mm, such as between 5.5 and 12.0mm, such as 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, and any value therebetween.
In various embodiments, the width of the transition zone of the scleral contact lens of the present invention (i.e.And (3) withHalf of the difference) is between 0.8 and 1.8mm, preferably between 1.0 and 1.5 mm. In various embodiments, the radius of curvature (also called transition region radius of curvature (TZR)) at the junction (J1) of the rear surface of the transition region with the rear surface of the optical region (i.e., at the starting point of the transition region) is greater than or equal to the base arc radius of curvature, e.g., greater than 0.1-2.0 mm, e.g., greater than 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9mm, and any value therebetween. Thus, in various embodiments of the present invention, the radii of curvature of the optical zone rear surface and the transition zone rear surface are in linkage.
In various embodiments, the radius of curvature of the landing zone of the scleral contact lens of the present invention is not dependent on BCR settings, but rather on the desired edge-to-edge height, so long as it is greater than BCR.
In various embodiments, the scleral contact lens of the present invention has a diameter of 14.0 to 25.0mm, preferably 14.0 to 18.0mm.
Table 1 exemplary scleral contact lens of the invention
5. Verification of scleral contact lenses
The fitting of scleral contact lenses includes pre-fitting inspections, fitting assessments, parameter adjustments, and ordering of custom lenses.
Pre-dose examinations include medical history collection, eye health examination, eye parameter measurement, subjective refraction, and the like. Wherein the eye parameter measurement comprises cornea curvature, cornea morphological parameter, cornea diameter, pupil diameter measurement, etc. Knowledge of cornea morphology is the basis for selecting a pilot patch base curve. Corneal curvature can be measured using a keratometer and a corneal topography. The cornea topography is more widely used in practice because it can more fully reflect the full view of the cornea.
Based on the results of the pre-dose examination, the optician will select the first test piece for the subject to evaluate for fit. Good scleral contact lens fit includes three basic aspects, proper corneal gap, limbal gap, and scleral fit. Thus, the fit assessment includes an assessment check of the optical zone, transition zone, and landing zone, such as a pen or slit lamp to generally assess whether the central zone has corneal contact or air bubbles, whether the landing zone has lift, vascular compression, etc., after 5 minutes of wear, while inquiring about the subject's comfort. If the first sheet is positioned centrally, has no contact, no big bubble and no obvious discomfort, the first sheet is continuously worn for 20 minutes and then is evaluated by adopting the slit lamp fluorescein, otherwise, the first sheet is replaced and the first sheet is re-evaluated. The conventional scleral contact lens is usually evaluated at 20-30 minutes, 2 hours and 4 hours of lens wear, which is time-consuming. Criteria for successful scleral contact lens fit include good dynamic-static assessment (bubble-free, contact-free, including contact-free both at the cornea and at the limbal portion), improved on-chip vision correction, and good subject comfort.
If the fitting of the fitting sheet is not good, the fitter needs to select fitting sheets of other parameters for the subject according to the situation until a good fitting is obtained, and then the fitter can order corresponding products for the subject according to the parameters of the fitting sheets. Scleral lenses designed by different manufacturers typically require the lens operator to adjust various lens parameters and provide corresponding guidelines for adaptation. Some scleral contact lenses are complex in design, many in adjustable parameters and complex in test and fit.
The scleral contact lens according to the present invention is simple in design and so the fitting is relatively simple. Accordingly, in some embodiments, the present invention also provides a method of testing a scleral contact lens. As shown in FIG. 5, the method includes measuring a corneal morphology of a subject, for example, using a corneal topography, to obtain a flat K value (FK) of the cornea of the subject and a corneal eccentricity e value corresponding to FK (step 110), and selecting a first test piece of a scleral contact lens for the subject based on the FK value and the e value, the optical zone of the first test piece having a first base radius of curvature BCR 1 and the landing zone thereof having a first landing zone radius of curvature LZR 1 (step 120).
The first fitting piece selecting step comprises the steps of calculating a proper lens rise according to FK, an e value and a target initial vertex gap (40-200 mu m), calculating a base arc curvature radius according to the lens rise and a base arc eccentricity (0.30-1.10, preferably 0.5-0.99), and subtracting a correction parameter C in a range of 0.2-0.5 from the calculated base arc curvature radius to obtain the base arc curvature radius of the first fitting piece. The calculation formulas required for the various steps are well known in the art, for example, see Contact lens optics AND LENS DESIGN, those described in ISBN978-0-7506-8879-6,Chapter 4aspherical surfaces (contact lens optics and lens design, ISBN978-0-7506-8879-6, chapter 4 asphere). In a preferred embodiment, the correction parameter is 0.3.
The method of the invention further comprises the step of carrying out fit evaluation (step 130) after 20-30 minutes of wearing the lens, wherein the evaluation comprises the steps of whether the lens is positioned centrally, the degree of mobility, whether the center is provided with large bubbles, whether the center is provided with contact, whether the periphery (transition zone) of the lens is provided with bubbles and compression, and whether the periphery (landing zone) of the lens is provided with bubbles and compression. Fig. 3 shows several cases where a lens fit may occur, where a flat fit is manifested as too thin a gap behind the lens or a contact in the center, a steep fit is manifested as a large bubble in the center, and a perfect fit sees a uniform distribution of the phosphor layer behind the lens. In both flat and steep fitting cases, it is necessary to adjust parameters of the tab, such as BC radius of curvature or edge lift. In the field of contact lenses, particularly hard lenses (such as RGP, cornea shaping lenses and scleral contact lenses), corresponding lens parameters are adjusted according to the fitting evaluation results of the fitting lenses, which belongs to the conventional technical means in the field. By way of simple example, in the method of the present invention, BC (smaller BCR) may be steeped if compression of the optical zone is observed, or the apex gap is less than 40 μm, increasing the sagittal height of the lens away from the cornea, and replaced with a patch with larger BCR if the optical zone has larger bubbles, or the apex gap is greater than 200 μm, and/or the limbal gap is too large or has bubbles. If the landing zone is pressed, the edge-lift can be relaxed, a larger r1 (namely LZR) is selected, and if the landing zone is bubble, a smaller r1 is selected, so that the edge-lift is reduced. Fig. 4 shows several cases of poor edge-to-edge fit of the lens.
In some embodiments, the methods of the invention further comprise measuring the apex gap and/or the corneoscleral limbus gap, for example by OCT.
Further, the method of the present invention further comprises customizing or ordering a scleral contact lens having the parameters for the subject based on the ideal BCR and edge-lift height (characterized by LZR) obtained from the fitting assessment and the diopter of the subject (step 140). Those skilled in the art will appreciate that the parameters listed may also include other specific instructions, such as adjusting the lens diameter, polishing the lens well, etc. In various embodiments, however, none of the methods include the step of measuring the scleral surface morphology of the subject, nor do the underlying parameters include scleral morphology-related parameters.
In still other embodiments, the methods of the present invention further comprise making multiple corneal topography measurements to ensure consistency and accuracy of the data.
Because the scleral contact lens has dynamic tear exchange and no or only slight sedimentation, the evaluation time of 4 hours is not required to be waited when the lens is matched, and an ideal lens can be found by adjusting BC and edge tilting of the lens, so that the lens matching process is greatly shortened and simplified.
Thus, according to yet another embodiment, the present invention also provides a set of test strips for scleral contact lens fitting that provides different combinations of lenses BCR and LZR for selection by the dispenser. The test wearing piece group comprises a high-side warping subgroup comprising a plurality of first test wearing pieces and a low-side warping subgroup comprising a plurality of second test wearing pieces, wherein the curvature radius of a landing zone of each first test wearing piece is LZR1, the curvature radius of a landing zone of each second test wearing piece is LZR2, the LZR1 is larger than LZR2 and is respectively and independently selected from 8.5-15.0 mm, and the first test wearing pieces respectively have different curvature radii of a base arc, the curvature radii of the base arc of each first test wearing piece and the base arc of each second test wearing piece are respectively selected from the same set of curvature radii of the base arc, and the set of curvature radii of the base arc comprises a plurality of equal steps (for example, steps selected from 0.2-1.0 mm, for example, steps selected from 0.5 mm) distributed preset curvature radii selected from 5.0-14.0 mm.
In some embodiments, the number of first tabs is the same as the number of second tabs. In still other embodiments, the number of preset base curve radii of curvature is the same as the number of first tabs and/or the number of second tabs. In some embodiments, the set of test strips further comprises other subgroups having LZR different from LZR 1 and LZR 2, the other subgroups also comprising a plurality of test strips. For example, the set of tabs further includes a mid-edge-to-edge sub-set including a plurality of third tabs, each of the plurality of third tabs having a landing zone radius of curvature of LZR3 and LZR1> LZR3> LZR2.
By way of example, the present invention provides a scleral contact lens tab set comprising (1) a high-side-tip sub-set having 14 first tabs with LZR1 of 13.0mm, (2) a low-side-tip sub-set having 14 second tabs with LZR2 of 10.0mm, and (3) a mid-side-tip sub-set having 14 third tabs with LZR3 of 11.5mm, wherein the base curve radius of curvature set comprises the following 14 preset base curve radii of curvature 6.0, 6.2, 6.4, 6.6, 6.8, 7.0, 7.2, 7.4, 7.6, 7.8, 8.0, 8.2, 8.4, 8.6mm.
6. Indication of the scleral contact lens of the invention
The scleral contact lens according to the present invention is suitable for (1) patients with irregular astigmatism of the cornea, such as keratoconus, limbal degeneration disease, and astigmatism after cornea implantation, etc., (2) treatment of ocular surface diseases, such as dry eye, corneal neuralgia, GVHD graft versus host reaction, severe ocular surface diseases (such as persistent epithelial defect disunion (PED)), and combination treatment with drugs (such as lubricants, snacks, cyclosporine eye drops) and other ophthalmic procedures (such as amniotic membrane transplantation, blepharo-surgery), and (3) non-emmetropic eyes, such as ametropia, presbyopia.
Examples
Example 1
Patient A30 years old, male, 3 years vision decline after left eye chemical injury
Eye basic information is that the naked eye vision is 0.05, the subjective refraction OS-0.75/-2.25 x 150, and the optimal corrected vision is 0.4
Measurement of the patient's corneal flatness K value by corneal topography 8.46, e value 0.94
The first test piece is BC 8.6mm, medium edge warp (the sagittal height of the joint S=1.47 mm), after 20 minutes of wearing the lens, the first test piece is checked by a slit lamp, the central keratoscope is thin in tear layer, the thickness is about 20 mu m, the peripheral keratoscope is thin in tear layer, the thickness is about 40 mu m, the nasal side conjunctiva is whitened, the lens is well centered, and the lens mobility is not generated in a natural blinking state.
The lens is adjusted to be high in edge lift (the sagittal height S of the joint=1.40 mm), a test wearing piece with the steep BC of 8.2mm is selected, after the lens is worn for 20 minutes, the central and peripheral keratoscopes are checked by a slit lamp, the tear layer is full of 100 mu m, the landing area is well adapted, conjunctiva blood flow is not blocked in dynamic and static evaluation, the centering of the lens is well positioned, and the lens has small mobility under a natural blinking state of about 0.5mm. The main complaints have no foreign body sensation.
One month after the mirror is worn, dai Jingzhu are subjected to vision inspection, namely-0.75/-0.50 x 180, and the mirror wearing vision is 0.8.
Example 2
Patient B, 22 years old, male, left eye keratoconus 2 years after keratoconus procedure
Eye basic information is that the naked eye vision is 0.15, the subjective refraction OS-4.00/-3.75 x 80, and the optimal corrected vision is 0.3
Measurement of the patient's corneal flatness K value by corneal topography 8.39, e value 0.21
The first test piece is BC 7.2mm, medium edge warping (S=1.47 mm at the connecting position), central cornea contact is checked by a slit lamp after 20 minutes of lens wearing, bubbles are generated after peripheral lenses are worn, a landing area is well adapted, conjunctiva blood flow is not blocked in dynamic and static evaluation, the centering of the lens is well positioned, and the lens has tiny mobility under a natural blinking state of about 1.0mm.
The lens is adjusted to be steeper BC 7.0mm, mid-equilateral warp (S=1.47 mm at the connecting position) is detected by a slit lamp after 20 minutes of wearing the lens, the central cornea is not contacted, the thickness of tear liquid layer after the lens is 100 mu m, small movable bubbles after the peripheral lens, a landing area is well adapted, conjunctiva blood flow is not blocked in dynamic and static evaluation, the lens is well centered, and the lens has small mobility under a natural blinking state of about 0.5mm. The main complaints have no foreign body sensation.
One month after wearing the glasses, checking the main angle of wearing the glasses to be-0.50/-0.50 x 145, and the eyesight of wearing the glasses is 0.8.
Example 3
Patient C is 31 years old, female, double eye high myopia 20+ years
Eye basic information is that the naked eye vision is 0.01, the subjective refraction OD-10.75/-3.25 x 5, and the optimal corrected vision is 0.8
Measurement of the patient's corneal flatness K value by corneal topography 8.11, e value 0.78
The first test piece is BC 8.0mm, medium edge warpage (junction sagittal height S=1.47 mm), after 20 minutes of wearing the lens, the lens is inspected by a slit lamp, namely, the central keratoscope is thin in tear layer with the thickness of less than 20 mu m, the peripheral lens is full of tear layer with the thickness of about 100 mu m, the nasal conjunctiva is whitened, the lens is well centered, and the degree of movement of the lens under a natural blink is less than 0.5mm.
BC 7.6mm test piece which is adjusted to be high in edge warping and steeper is inspected by a slit lamp after 20 minutes of lens wearing, the tear layer is moderate and is about 50 mu m after the central keratoscope is worn, small mobile bubbles are generated after the peripheral keratoscope is worn, the landing area is well adapted, conjunctival blood flow is not blocked in dynamic and static evaluation, the lens is well centered, and the lens has tiny mobility of about 0.5mm in a natural blinking state. The main complaints have no foreign body sensation.
One month after wearing the glasses, checking the main angle of wearing the glasses, namely-0.25/-0.50 x 34, and the eyesight of wearing the glasses is 1.0.
Although certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is, therefore, to be understood that the invention is intended to cover all such modifications and changes as fall within the true spirit of the invention.
Claims (15)
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| CN214751154U (en) * | 2021-06-29 | 2021-11-16 | 珠海维视艾康特医药科技有限公司 | Scleral mirror designed by annular curved surface |
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| CN214751154U (en) * | 2021-06-29 | 2021-11-16 | 珠海维视艾康特医药科技有限公司 | Scleral mirror designed by annular curved surface |
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