CN119405455A - Zoned microlens for cornea implantation and application thereof - Google Patents
Zoned microlens for cornea implantation and application thereof Download PDFInfo
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- CN119405455A CN119405455A CN202411628041.5A CN202411628041A CN119405455A CN 119405455 A CN119405455 A CN 119405455A CN 202411628041 A CN202411628041 A CN 202411628041A CN 119405455 A CN119405455 A CN 119405455A
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Abstract
The invention belongs to the technical field of regenerative medicine, and provides a circular partitioned cornea implantation microlens, which comprises two areas, namely a first correction area and a flattening area, preferably three areas, namely two vision correction areas and one flattening area, wherein the two vision correction areas respectively have the effect of correcting vision, the diopter of the flattening area is 0D, the flattening area is provided with a through hole, and the applicant has found through a great deal of experiments that the through hole is arranged at the central position of the partitioned cornea implantation microlens, so that the phenomenon of cloud nebula and turbidity of a cornea after operation can be reduced. The micro lens for partitioned cornea implantation provided by the invention is implanted to enable the near object to be clear and the far object to be clear after the operation, so that the full-resolution vision is realized. The invention also provides an application of the zoned cornea implantation microlens in correcting vision.
Description
Technical Field
The invention belongs to the technical field of regenerative medicine, in particular to a zoned microlens for cornea implantation, and a second aspect of the invention relates to application of a microlens product in vision deterioration correction products.
Background
With age, or due to poor eye habits, vision is impaired. Presbyopia is a common vision problem, and as the age increases, the lens elasticity of the human eye gradually decreases after 40 years, and the accommodation capacity also gradually decreases, which is a main cause of presbyopia, so that people can see near objects with blurred vision. The presbyopic symptoms mainly include 1, difficulty in seeing very fine fonts in environments with weaker light, 2, longer reading distance when reading books or newspapers, more comfortable eyes, 3, incapability of lasting when writing, reading and doing manual fine work, 4, more comfortable when reading newspapers when taking off myopia glasses, 5, easiness in misplacing and price when buying things, and 6, higher brightness requirement on light when reading books or newspapers compared with young people.
In addition to vision loss caused by unhealthy status of the lens, ametropia can also result in vision loss, for example, when the eye is in a accommodative relaxed state, parallel light rays enter the eye before it is focused on the retina, which results in the inability to form a clear image on the retina, known as a myopic eye. At this time, the inspection optometry prompts the degree of myopia, and when the eye is in a relaxed state, external parallel light enters the eye, and the focus of the parallel light just falls on the retina to form a clear image, which is called emmetropia, and when the focus cannot fall on the retina, the eye is called ametropia, so that the myopia is a symptom of ametropia.
Typically correcting unhealthy conditions of the lens results in vision loss using intraocular lenses, which are typically used for insertion in the eye's chamber, in the capsular bag of the eye, or between the iris and the lens. US 2004/0085111 A1 discloses an intraocular lens for insertion into the posterior chamber of an eye.
Typically correction of ametropia results in vision loss using an intracorneal lens for insertion into the cornea, rather than the eye's room, so such a lens is typically smaller than an intraocular lens. Because the intracorneal lens and the intraocular lens differ in their positions relative to the crystalline lens, the intracorneal lens and the intraocular lens must have different optical structures in order to be able to correct vision loss. Chinese patent document CN101896853a discloses an intracorneal lens with a central aperture.
In the prior art, no technique has been retrieved that has a lens embedded in the cornea to correct both vision loss and ametropia with simultaneous vision loss due to unhealthy status of the lens.
Disclosure of Invention
To remedy the drawbacks and deficiencies of the prior art, a first aspect of the present invention provides a zoned cornea implant microlens, the microlens being a circular curved surface, the microlens comprising two regions, respectively a first correction region and a flattening region, the flattening region being surrounded by the first correction region, the first correction region and the flattening region being concentric, the first correction region having a corrective vision effect, the diopter of the flattening region being 0D.
The zonal microlens for cornea implantation provided by the invention comprises two areas, wherein the first correction area has the effect of correcting vision, the diopter of the plano area is 0D, and the first correction area does not have the effect of correcting vision. The first correction zone can be used for correcting vision deterioration caused by unhealthy condition of the refractive medium or correcting vision deterioration caused by ametropia, and the flat zone does not have the effect of correcting vision, but can enable light rays to travel into eyes to reach retina when far objects are seen, and clear imaging is carried out, in particular, whether the first correction zone is used for correcting vision deterioration caused by unhealthy condition of the refractive medium or correcting vision deterioration caused by ametropia, the flat zone can enable light rays to travel into eyes to reach retina to achieve clear imaging, and further ensures that the first correction zone plays a role in correcting vision, and meanwhile, the light rays entering the eyes through the flat zone can keep the original vision adjustment capability of a patient, so that far vision loss of the patient or near vision compensation can be avoided. When the zonal cornea implantation microlens provided by the invention is used, the specific shape of the first correction zone and the specific shape of the flat zone and the area ratio between the first correction zone and the flat zone can be changed according to the vision symptoms of a patient, so that the vision decline symptoms of the patient can be corrected to the greatest extent.
In a preferred embodiment of the invention, the flat area is provided with a through hole, the through hole has two functions, namely, the first aspect is to facilitate surgical marking, in particular, as the zonal cornea implantation microlens provided by the invention is generally required to have the center of the microlens on the visual axis in clinical application, otherwise, the clinical use effect of correcting vision is affected, the through hole can provide an accurate reference position for a doctor who performs surgery, so that the center of the microlens is conveniently found, and then the center of the microlens is accurately positioned on the visual axis, and the second aspect is summarized by a large number of experiments, and the applicant can reduce the phenomena of cloud nebula and turbidity of the cornea after surgery by arranging the through hole at the center of the zonal cornea implantation microlens.
In a preferred embodiment of the present invention, the applanation area of the zonal cornea implantation microlens provided by the present invention includes a second correction area, the applanation area includes a second correction area, the second correction area is circular, a cross section of the second correction area along a circular curvature center direction is a concave lens cross section, and the second correction area is surrounded by the remaining applanation area of the applanation area. In this preferred embodiment, the zoned cornea implantation microlens has three regions, two vision correction regions each having a corrective vision effect, which can be used to correct vision deterioration due to unhealthy condition of refractive medium or vision deterioration due to ametropia, and one plano region each having no corrective vision effect, which can allow light to travel flat into the eye to reach the retina, thereby compensating for the condition of unclear imaging due to the crystalline lens or refractive system's self-adjusting function while relieving the corrective vision effect of the first and second correction regions. It should be noted that the second correction area in the plano-optical area has a through hole, and the through hole has two functions, namely, the first is to facilitate surgical marking, in particular, because the zonal cornea implantation microlens provided by the invention generally requires the center of the microlens to be on the visual axis when in clinical application, otherwise, the clinical use effect of correcting vision is affected, but the through hole can provide an accurate reference position for a doctor who performs surgery, so that the center of the microlens is conveniently found, and then the center of the microlens is accurately positioned on the visual axis.
In a preferred embodiment of the present invention, the first correction zone of the zoned keratoplasty microlens provided by the present invention has the effect of correcting vision loss due to unhealthy conditions of the refractive medium, and the second correction zone has the effect of correcting vision loss due to refractive errors. The applicant has concluded through a number of experiments that, while the first correction zone and the second correction zone may have both the effect of correcting vision loss due to the unhealthy condition of the refractive medium and also the effect of correcting vision loss due to refractive errors, when the first correction zone has the effect of correcting vision loss due to the unhealthy condition of the refractive medium and the second correction zone has the effect of correcting vision loss due to refractive errors, the zoned corneal implant microlens provided by the invention can simultaneously correct vision loss due to the unhealthy condition of the refractive medium and vision loss due to refractive errors, and can enable a patient to realize full-resolution vision after operation. Specifically, when the vision object is in near vision, the cornea at the periphery of the first correction area is properly blocked due to shrinkage of the pupil of the iris, at the moment, light rays transmitted through the first correction area are corrected, so that the vision object of a patient in near vision after operation becomes clearer due to the fact that the vision object is in near vision, when the vision object is in near vision, the second correction area and the smooth zone play a role simultaneously, so that the vision object of the patient becomes clearer due to expansion of the pupil of the iris, and when the vision object is in near vision, part of light rays can enter the eye through the cornea area outside the edge of the first correction area of the zonal cornea implantation microlens, so that the vision object is in clear vision object, and the vision object of the patient becomes clear after operation, and the vision object is in near vision object is retained.
In a preferred embodiment of the present invention, the number of through holes of the zoned cornea implantation microlens provided by the present invention is 1, the through holes are circular and concentric with the second correction zone, and the second correction zone is concentric with the flattening zone. The applicant has found through a great deal of experiments that the number of through holes in the second correction area and the number of through holes and the number of 1 through holes are not significantly different for reducing the phenomena of nebula and turbidity of the cornea after operation, and when the arrangement sequence of the three areas of the zoned cornea implantation microlens is that the second correction area, the flattening area and the first correction area are arranged outwards from the circle center of the zoned cornea implantation microlens (namely, the second correction area is surrounded by the flattening area, the flattening area is surrounded by the first correction area), the zoned cornea implantation microlens can simultaneously correct vision loss caused by unhealthy state of refractive media and vision loss caused by ametropia, and the patient can realize full-resolution vision after operation. Specifically, due to the fact that vision is reduced and returned due to the unhealthy state of a refractive medium, a patient can generate a phenomenon that vision is clear and vision is blurred when the vision is reduced and returned due to the ametropia, the vision is imaged in front of retina or behind retina to be blurred when the patient is in operation, after the zonal cornea implantation microlens provided by the invention is implanted, when the vision is near, the first correction area is properly blocked due to shrinkage of the iris and miosis, at the moment, light rays penetrating through the first correction area and the second correction area are corrected, the smooth area is subjected to vision blurring due to the unhealthy state of the refractive medium, the vision is further clear when the vision is far, the iris is extended and miosis is simultaneously exerted when the vision is far, the second correction area and the smooth area are simultaneously exerted to enable the vision is clearer when the vision is far, part of the light rays can penetrate through the area outside the edge of the first correction area of the zonal cornea implantation microlens to enter the eye, at the moment, light rays entering the eye is increased when the vision is far, and the vision is further clear when the vision is far, the vision is completely clear when the vision is far, the vision is also clear when the vision is far, the vision is completely clear when the vision is far, and the vision is clear is far is achieved when the vision is far, and the vision is far is well seen, and the vision is well when the vision is far, and the vision is far is seen. Thus, applicants have concluded from a number of experiments that in this preferred embodiment, vision loss is corrected simultaneously, especially in patients with presbyopia as well as myopia.
In a non-limiting embodiment of the invention, vision deterioration due to unhealthy condition of the refractive medium refers to vision deterioration of the lens due to lack of accommodation, incomplete turbidness, and reduced elasticity, such as presbyopia, etc., and vision deterioration due to refractive error refers to vision deterioration due to parallel rays of light passing through the refractive system of the eye, failing to form a clear object image on the retina, but imaging in front of or behind the retina, such as hyperopia, myopia, astigmatism, etc. Thus, the first correction area and the second correction area of the zoned cornea implantation microlens provided by the invention have the function of correcting the vision loss of the two types, so that the full-resolution vision of a patient after operation is realized.
After a great deal of experiments, the applicant has concluded that when the cross section of the first correction area along the circular curvature center direction is a convex lens cross section, vision deterioration caused by the unhealthy state of the refractive medium can be effectively corrected, because after the zonal microlens for cornea implantation provided by the invention is implanted by a patient in operation, especially when the patient looks near, the first correction area is properly blocked due to shrinkage of the iris and pupil, at the moment, light rays passing through the first correction area and the second correction area are corrected, at the moment, the convex lens function of the first correction area compensates for vision blurring caused by the unhealthy state of the refractive medium of the plano-optical area and the second correction area, and further the near object looking of the patient becomes clearer.
In a further preferred embodiment of the present invention, the cross section of the first correction zone along the circular curvature center direction is a convex lens cross section, and the cross section of the second correction zone along the circular curvature center direction is a concave lens cross section, in this embodiment, the zonal keratoplasty microlens provided by the present invention can effectively correct myopia with blurred vision due to ametropia, because, after the zonal keratoplasty microlens provided by the present invention is surgically implanted into a patient, especially when the patient looks at distant objects after surgery, the first correction zone, the second correction zone, the plano-optic zone and the first correction zone simultaneously play a role due to expansion of the iris pupil, and, because the ciliary muscle stretches during the viewing at distant objects, part of light can enter into the eye through the corneal region outside the edge of the first correction zone of the zonal keratoplasty microlens, and thus the light entering the eye increases, and the second correction zone retains the original vision due to the unhealthy condition of refractive medium, thereby compensating vision and the eye with the total amount of vision due to the focal condition, and the total amount of the vision entering the eye due to the plano-optic medium, and the fact that the second correction zone has a certain thickness is more than the concave lens has a certain effect due to the fact that the focal region is generated by the second correction zone, thus the concave lens has a better effect on the cross section, and the focal region is prevented from generating a refractive vision phenomenon due to the focal region.
After a lot of experiments, the applicant finds that when the cross section of the first correction area along the circular curvature center direction is a convex lens cross section, the cross section of the second correction area along the circular curvature center direction is a concave lens cross section, and the through hole is circular and concentric with the second correction area, the split type cornea implantation micro lens is particularly suitable for presbyopia caused by unhealthy state of refractive media and myopia patients caused by ametropia, because the presbyopia can cause the phenomena that the patients generate clear near objects and the near objects are blurred, and the myopia can cause the patients generate clear near objects and the blurred near objects, so that after the patients are surgically implanted into the split type cornea implantation micro lens provided by the invention, when the near objects are seen, the iris is contracted, the outer part of the first correction area is properly shielded, and at the moment, the convex lens function of the first correction area can compensate the clear vision blur caused by presbyopia of the plano area and the second correction area, and the near objects of the postoperative patients become clearer after the operation; when a far object is seen, the concave lens of the second correcting zone, the plano zone and the convex lens of the first correcting zone simultaneously play roles to enable the far object to be seen more clearly, part of light rays can enter the eye through the area outside the edge of the first correcting zone of the zoned cornea implantation micro lens when the far object is seen, so that the light rays entering the eye are increased, meanwhile, due to the existence of the plano zone, the vision of the middle distance which is relatively clear when the far object is seen by presbyopia is reserved, the zoned cornea implantation micro lens provided by the invention can enable the far object to be seen more clearly for a patient after operation through the two aspects, thus, the near object is seen clearly for the patient after operation, the far objects are also clear, and finally, the full clear vision of the patient after operation is realized.
In a preferred embodiment of the present invention, the number of the through holes is 1, and the optical center position of the concave lens where the through holes are located, that is, the thinnest part of the concave lens in the second correction area is 0mm. The applicant has found through a large number of experiments that the diameter size of the through hole is related to the phenomenon that the cornea of a patient is clouded and turbid after operation, the center of the zonal cornea implantation microlens (namely the center of the second correction area) is positioned and placed on the visual axis when a doctor performs operation, and the zonal cornea implantation microlens is positioned on the visual axis when the diameter of the through hole is 0.01-0.6 mm, so that the phenomenon that the cornea of the patient is clouded and turbid after operation can be reduced.
In a preferred embodiment of the present invention, the diameter of the zoned cornea implantation microlens is 2.5-5.5 mm, which is related to the cornea size of an individual patient, and the applicant has found through a great deal of experiments that the size of an insert suitable for being embedded in the cornea of a human body is 2.5-5.5 mm and the thickness is 25-63 μm, and according to the correction principle of the zoned cornea implantation microlens provided by the present invention, when the diameter is 3.0-4.0 mm and the thickness is 25-55 μm, full-transparent vision is easier to realize.
In a non-limiting preferred embodiment of the present invention, in order to extend the useful life of the zonal cornea implant microlens and reduce the damage of ultraviolet rays to other tissues in the eye, the applicant has incorporated azo-phenyl methacrylate into the zonal cornea implant microlens. In a non-limiting preferred embodiment of the present invention, 4-propenoxy-2-hydroxybenzophenone is added to the preparation material of the segmented cornea implant microlens. In a non-limiting preferred embodiment of the present invention, the material for preparing the zoned cornea implant microlens is added with azo phenyl methacrylate and 4-propenoxy-2-hydroxybenzophenone simultaneously. The applicant has found through a plurality of experiments that when the preparation materials of the micro lens for the partitioned cornea implantation are selected from hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocking agent is selected from 4-propenoxy-2-hydroxybenzophenone, the transparency, the biocompatibility and the antibiotic sustained release effect after the transplantation of the micro lens for the partitioned cornea implantation are better, and the service life is longer.
In a second aspect, the present invention provides the use of a zoned corneal implant microlens in the manufacture of a product for correcting vision loss caused by an unhealthy condition of a refractive medium. The present invention also provides in a second aspect the use of a zoned keratotic microlens for correcting vision loss products due to ametropia.
The zoned cornea implantation microlens provided by the invention comprises two areas and through holes, and the first correction area has the function of correcting vision deterioration caused by the unhealthy state of a refractive medium, or has the function of correcting vision deterioration caused by refractive error, and the diopter of the plano area is 0D, so that after a patient implants the zoned cornea implantation microlens, no matter whether the first correction area is used for correcting the vision deterioration caused by the unhealthy state of the refractive medium or correcting the vision deterioration caused by refractive error, the plano area can enable light to travel into eyes in a plane manner to reach retina, clear imaging is realized, and the original vision regulation of the patient can be kept by the light entering the eyes through the plano area while the first correction area has the function of correcting vision. The applicant has found through a great deal of experiments that by arranging the through hole in the center of the zonal cornea implantation microlens, the surgical mark is convenient, and the phenomena of clouds and turbidity of the cornea after surgery can be reduced.
In a preferred embodiment of the present invention, the applanation zone of the zoned cornea implantation microlens further comprises a second correction zone, wherein the zoned cornea implantation microlens has three zones, namely two vision correction zones and one applanation zone, and the second correction zone, the applanation zone and the first correction zone are arranged outwards from the center of the zoned cornea implantation microlens in sequence, namely, the second correction zone is surrounded by the applanation zone, the applanation zone is surrounded by the first correction zone, and the applanation zone between the two correction zones has no effect of correcting vision, but can enable light to travel into the eye flatly to reach the retina, so that the situation of unclear imaging caused by the self-adjusting function of the crystalline lens or the diopter system can be compensated while the vision correction effect of the first correction zone is relieved. In particular, when the eye is not dominant, the first correction area is properly shielded when the eye is near due to the shrinkage of the iris and the pupil, so that the light rays passing through the first correction area are corrected, the vision blur caused by the unhealthy state and ametropia of the dioptric medium is compensated for in the plano-optic area and the second correction area, so that the eye is more clear when the eye is near to the operation patient, when the eye is far away due to the expansion of the iris and the pupil, the second correction area and the plano-optic area act simultaneously, part of the light rays can pass through the area outside the edge of the first correction area of the zonal cornea implantation micro lens to enter the eye, so that the light rays entering the eye are increased, and meanwhile, due to the existence of the plano-optic area, the vision of the distance vision in the eye is reserved, the eye is clear when the eye is not dominant, in addition, when the eye is far away from the operation patient, the eye is far away from the eye is seen clearly, the eye is seen clearly (the eye is dominant eye is seen clearly, the eye is not dominant eye is imaged relatively), and the eye is imaged clearly when the eye is near to the eye is imaged properly, and the eye is imaged clearly is not dominant, and the eye is imaged properly. See fig. 5 for a view of the simulation of the effect of the object.
Drawings
FIG. 1 is an enlarged schematic view of a zoned cornea implant microlens according to the present invention
FIG. 2 is a vertical sectional view through the optical center of a zoned corneal implant microlens (three microlenses are examples) according to the present invention
FIG. 3 is a schematic diagram showing the operation of the zonal keratolytic microlens according to embodiment 10 of the present invention when implanted in a patient's retrokeratology
FIG. 4 is a schematic diagram showing the operation of the zonal keratolytic microlens according to embodiment 10 of the present invention when it is used to implant a distance object behind a patient's cornea
FIG. 5A simulation of the effect of binocular vision after a zonal keratology lens according to example 11 of the present invention is implanted into the cornea of a patient
Detailed Description
In order to accurately express and describe the technical scheme provided by the invention, technical terms used by the invention are explained as follows before the content of the invention.
The invention relates to a zonal cornea implantation microlens which can be embedded into a cornea stroma layer and can play a role in correcting vision.
The curved surface refers to a surface generated by a motion track of a straight line or a curve under a certain constraint condition. The curved surface comprises a spherical surface, a cylindrical surface and a conical surface.
"Concentric" as used herein refers to the situation where the centers of gravity or centers of circles (e.g., circles) of two or more regions coincide.
The optical center refers to an optical center in a physical sense, for example, the optical center of a concave lens is a point where the centers of two refraction surfaces coincide, and the optical center is characterized in that the propagation direction of light passing through the point is unchanged.
The term "curvature" as used herein refers to the curvature of a curve in an exponential sense, and is a numerical value that indicates the degree of curvature of the curve at a certain point. The larger the curvature, the greater the degree of curvature of the curve.
The concave lens is a concave lens in the optical term meaning that the middle of the lens is thin and the edge is thick, and the concave lens is concave. The concave lens comprises a plane surface and a concave surface on one surface, and also comprises concave surfaces on both surfaces.
The convex lens is a convex lens in the meaning of optical terms, namely, the middle of the lens is thick, the edge of the lens is thin, and the convex lens is convex. The convex lens comprises a plane surface and a convex surface, and also comprises a convex surface on both sides. The convex lens is a complete convex lens along the direction vertical to the main optical axis, and also comprises an incomplete convex lens along the direction vertical to the main optical axis, wherein the incomplete convex lens comprises a half convex lens along the direction vertical to the main optical axis, and the thickest part of the convex lens is the same as the thickness of the flat light area.
The "refractive medium" refers to a refractive medium in the medical sense of crystalline lens, vitreous body and the like.
The term "unhealthy state of the refractive medium" as used herein refers to a reduced vision, such as presbyopia, of the lens due to lack of accommodation, incomplete turbidness, and reduced elasticity.
By "ametropia" as used herein is meant that parallel rays of light, after passing through the refractive effect of the eye, do not form a clear object image on the retina, but are imaged either anterior or posterior to the retina.
The 'vision deterioration' refers to the phenomenon that the vision with the vision lower than 1.0 is blurred after vision detection compared with the normal vision of 1.0, and fine or remote objects are difficult to distinguish.
The following describes a non-limiting embodiment of the present invention with reference to the accompanying drawings, wherein test rabbits are used to replace patients to describe various parameters of the segmented microlens for cornea implantation and specific steps of the preparation method. It should be noted that the following detailed description is merely illustrative, and should not be construed as limiting the technical solution of the present invention.
Example 1
This embodiment exemplifies a zoned microlens for cornea implantation, the microlens is a circular curved surface, the microlens includes two regions, which are a first correction region and a flattening region, the flattening region is surrounded by the first correction region, the first correction region and the flattening region are concentric, the first correction region has a function of correcting vision, and diopter of the flattening region is 0D. Wherein the first correction zone may be used to correct vision loss due to an unhealthy condition of the refractive medium or to correct vision loss due to refractive error, and the plano zone has no corrective vision effect. When the zonal cornea implantation microlens provided by the embodiment is used, the specific shape of the first correction zone and the specific shape of the flattening zone and the area ratio between the two can be changed according to the vision symptoms of a patient, so that the vision decline symptoms of the patient can be corrected to the greatest extent.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 2
This example illustrates a zoned microlens for corneal implantation, which includes, on the basis of example 1, two regions of a "first correction region having the effect of correcting vision deterioration due to an unhealthy state of refractive medium and a plano region having no effect of correcting vision. The flattening area is round with the diameter of 2mm, the thickness of the flattening area is 25 mu m, the outer part of the flattening area is an annular first correcting area, the annular inner circumference of the first correcting area is the same as the thickness of the flattening area, and the outer diameter of the first correcting area is 4mm (namely the diameter of the zonal cornea implantation microlens). The thickness of the zoned microlens for cornea implantation is 54 μm at the maximum.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 3
The embodiment illustrates a zoned cornea implantation microlens, wherein the zoned cornea implantation microlens further comprises a second correction zone in the flattening zone based on embodiment 1, and the zoned cornea implantation microlens has three zones, namely, two correction zones and one flattening zone, wherein the arrangement sequence of the three zones is that the second correction zone, the flattening zone and the first correction zone are sequentially arranged outwards from the center of the zoned cornea implantation microlens. Wherein the first correction zone has the effect of correcting vision loss due to unhealthy conditions of the refractive medium, the plano zone does not have the effect of correcting vision, and the second correction zone has the effect of correcting vision loss due to refractive errors. The zoned cornea implantation microlens is circular, wherein the second correction area is circular with the diameter of 1.5mm, the thickest part of the second correction area is 30 mu m, the outer circle of the second correction area is an annular flattening area, the diameter of the outer circle of the flattening area is 2.5mm, the thickness of the flattening area is the same as the thickness of the edge of the second correction area, the outer circle of the flattening area is an annular first correction area, the diameter of the outer circle of the first correction area is 3.5mm (namely the diameter of the zoned cornea implantation microlens), and the thickest part of the inner circle of the annular first correction area is the same as the thickness of the flattening area.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 4
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. Wherein the first correction zone has the effect of correcting vision loss due to an unhealthy condition of the refractive medium and the plano zone does not have the effect of correcting vision loss due to an unhealthy condition of the refractive medium and the second correction zone also has the effect of correcting vision loss due to an unhealthy condition of the refractive medium. The zoned cornea implantation microlens is circular, wherein the second correction area is circular with the diameter of 2mm, the thickest part of the thickness of the second correction area is 42 mu m, the outer circle of the second correction area is an annular flattening area, the diameter of the outer circle of the flattening area is 2.5mm, the thickness of the flattening area is the same as the thickness of the edge of the second correction area, the outer circle of the flattening area is an annular first correction area, the diameter of the outer circle of the first correction area is 3.2mm (namely the diameter of the zoned cornea implantation microlens), and the thickness of the section of the inner circumference of the annular first correction area is the same as the thickness of the flattening area.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 5
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. Wherein the first correction zone has the effect of correcting vision loss due to unhealthy conditions of the refractive medium, the plano zone does not have the effect of correcting vision, and the second correction zone has the effect of correcting vision loss due to refractive errors. The zoned cornea implantation microlens is circular, wherein the second correction area is circular with the diameter of 1.5mm, the thickest part of the thickness of the second correction area is 54 mu m, the outer circle diameter of the second correction area is an annular flattening area, the thickness of the flattening area is 2mm, the thickness of the flattening area is the same as that of the edge of the second correction area, the outer circle diameter of the flattening area is an annular first correction area, the diameter of the outer circle of the first correction area is 4.5mm (namely the diameter of the zoned cornea implantation microlens), and the section thickness of the annular inner circumference of the first correction area is the same as that of the flattening area.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 6
The present embodiment exemplifies a zoned cornea implantation microlens, which has three areas of two correction areas and one flattening area, based on embodiment 1, and is exemplified in fig. 1, wherein the arrangement order of the three areas is that a second correction area S3, a flattening area S2 and a first correction area S1 are arranged in order from the center of the zoned cornea implantation microlens to the outside. The zoned cornea implantation microlens is circular, wherein the second correction zone S3 is circular with the diameter of 1.5mm, the second correction zone S3 is a concave lens, the edge thickness of the concave lens is 45 mu m, the thickness of the optical center of the concave lens is 0, the optical center is taken as a circle center to be outwards expanded to a round hole with the diameter of 0.4mm, the whole round hole is a through hole SH, namely the thickness is 0, the thickness from the edge of the through hole SH to the second correction zone is gradually thickened, the second correction zone S3 is an annular flat area S2, the outer circle diameter of the flat area is 2.5mm, the thickness of the flat area S2 is the same as the thickness of the concave lens edge of the second correction zone S3, the flat area S2 is an annular first correction zone S1, the cross section of the first correction zone S1 along the annular curvature circle center direction is a convex lens cross section, the thickness of the convex lens of the first correction zone S1 is the flat area S2, the diameter of the first correction zone S1 is 4.0mm (namely the thickness of the zoned cornea implantation microlens is 54 mu m), and the thickness of the first correction zone S1 is the thickness of the zoned cornea implantation microlens).
It should be noted that, in the three regions of the cornea-embedded microlens illustrated in this embodiment, the concave lens and the convex lens respectively include four cases in fig. 2, that is, a case in which one of two surfaces of the concave lens (or the convex lens) is a plane, and the other surface is a concave surface (or a convex surface), and further includes a case in which both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction vertical to the main optical axis, and also comprises an incomplete convex lens along the direction vertical to the main optical axis, wherein the incomplete convex lens comprises a half convex lens along the direction vertical to the main optical axis, and the thickest part of the convex lens is the same as the thickness of the flat light area.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 7
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. The zoned cornea implantation microlens is circular, wherein the second correction zone is circular with the diameter of 1.5mm, the second correction zone is a concave lens, the edge thickness of the concave lens is 47 mu m, the thickness of the optical center of the concave lens is 0, the optical center is taken as the center of the circle to be outwards expanded to a round hole with the diameter of 0.35mm, the whole round hole is a through hole, namely the thickness is 0, the thickness from the edge of the through hole to the second correction zone is gradually thickened from 0, the second correction zone is an annular flat zone, the outer circle diameter of the flat zone is 2.0mm, the thickness of the flat zone is the same as the thickness of the edge of the concave lens of the second correction zone, the flat zone is an annular first correction zone, the cross section of the convex lens of the first correction zone along the direction of the center of the annular curvature is the convex lens, the junction of the convex lens of the first correction zone and the flat zone is the same as the thickness of the flat zone, the outer circle diameter of the first correction zone is 3.3mm (namely the diameter of the zoned cornea implantation microlens), and the thickness of the convex lens of the first correction zone is 63 mu m (namely the thickness of the zoned cornea implantation microlens is the most thick). The preparation material of the micro lens for the partitioned cornea implantation is one or more of hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate and styrene acrylate.
It should be noted that, in the three regions of the cornea-embedded microlens illustrated in this embodiment, the concave lens and the convex lens respectively include four cases in fig. 2, that is, a case in which one of two surfaces of the concave lens (or the convex lens) is a plane, and the other surface is a concave surface (or a convex surface), and further includes a case in which both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction vertical to the main optical axis, and also comprises an incomplete convex lens along the direction vertical to the main optical axis, wherein the incomplete convex lens comprises a half convex lens along the direction vertical to the main optical axis, and the thickest part of the convex lens is the same as the thickness of the flat light area.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 8
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. The zoned cornea implantation microlens is circular, wherein the second correction zone is circular with the diameter of 2mm, the second correction zone is a concave lens, the edge thickness of the concave lens is 48 mu m, the thickness of the optical center of the concave lens is 0, the optical center is taken as the center of the circle to be expanded outwards to a round hole with the diameter of 0.6mm, the whole round hole is a through hole, namely the thickness is 0, the thickness from the edge of the through hole to the second correction zone is gradually thickened from 0, the second correction zone is an annular flat area, the outer circle diameter of the flat area is 2.5mm, the thickness of the flat area is the same as the thickness of the edge of the concave lens of the second correction zone, the flat area is an annular first correction zone, the cross section of the convex lens of the first correction zone along the direction of the center of the annular curvature is the thickness of the flat area, the junction of the convex lens of the first correction zone and the flat area is the same, the outer circle diameter of the first correction zone is 4mm (namely the diameter of the zoned cornea implantation microlens), and the thickness of the convex lens of the first correction zone is 62 mu m (namely the thickness of the zoned cornea implantation microlens is the most thick). The preparation material of the micro lens for the partitioned cornea implantation is one or more of hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate and styrene acrylate, and the ultraviolet blocking agent of the micro lens for the partitioned cornea implantation is azo phenyl methacrylate and/or 4-propenoxy-2-hydroxybenzophenone.
It should be noted that, in the three areas of the cornea embedded microlens illustrated in this embodiment, the concave lens of the second correction area and the convex lens of the first correction area respectively include four cases in fig. 2, that is, one of two surfaces of the concave lens (or convex lens) is a plane, and the other surface is a concave surface (or convex surface), and also includes a case that both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction vertical to the main optical axis, and also comprises an incomplete convex lens along the direction vertical to the main optical axis, wherein the incomplete convex lens comprises a half convex lens along the direction vertical to the main optical axis, and the thickest part of the convex lens is the same as the thickness of the flat light area. The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 9
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. The zoned cornea implantation microlens is circular, wherein the second correction zone is circular with the diameter of 1.5mm, the second correction zone is a concave lens, the edge thickness of the concave lens is 34 mu m, the thickness of the optical center of the concave lens is 0, the optical center is taken as the center of the circle to be expanded outwards to a round hole with the diameter of 0.3mm, the whole round hole is a through hole, namely the thickness is 0, the thickness from the edge of the through hole to the second correction zone is gradually thickened from 0, the second correction zone is an annular flat zone, the outer circle diameter of the flat zone is 2.3mm, the thickness of the flat zone is the same as the thickness of the edge of the concave lens of the second correction zone, the flat zone is an annular first correction zone, the cross section of the convex lens of the first correction zone along the direction of the center of the annular curvature is the convex lens, the junction of the convex lens of the first correction zone and the flat zone is the same as the thickness of the flat zone, the outer circle diameter of the convex lens of the first correction zone is 3.5mm (namely the diameter of the zoned cornea implantation microlens), and the thickness of the convex lens of the first correction zone is 52 mu m (namely the zoned cornea implantation microlens is the most thick). The preparation material of the microlens for zonal cornea implantation is a composition of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocking agent of the microlens for zonal cornea implantation is 4-propenoxy-2-hydroxybenzophenone.
The materials, conditions and parameters not described in this example can be selected and implemented by those skilled in the art with the inventive effort, by selecting the reagents, materials, parameters and specific settings, thereby obtaining the zoned microlens for cornea implantation having the effect of correcting vision.
Example 10
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. The zoned cornea implantation microlens is circular, wherein the second correction zone is circular with the diameter of 1.6mm, the second correction zone is a concave lens, the edge thickness of the concave lens is 48 mu m, the thickness of the optical center of the concave lens is 0, the optical center is taken as the center of the circle to be expanded outwards to a round hole with the diameter of 0.2mm, the whole round hole is a through hole, namely the thickness is 0, the thickness from the edge of the through hole to the second correction zone is gradually thickened from 0, the second correction zone is an annular flat zone, the outer circle diameter of the flat zone is 2.2mm, the thickness of the flat zone is the same as the thickness of the edge of the concave lens of the second correction zone, the flat zone is an annular first correction zone, the cross section of the convex lens of the first correction zone along the direction of the center of the annular curvature is the convex lens, the junction of the convex lens of the first correction zone and the flat zone is the same as the thickness of the flat zone, the outer circle diameter of the first correction zone is 3.4mm (namely the diameter of the zoned cornea implantation microlens), and the thickness of the convex lens of the first correction zone is 67 mu m (namely the thickness of the zoned cornea implantation microlens is the most thick). The preparation material of the micro lens for the partitioned cornea implantation is a composition of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocker is azo phenyl methacrylate.
It should be noted that, in the three areas of the cornea embedded microlens illustrated in this embodiment, the concave lens of the second correction area and the convex lens of the first correction area respectively include four cases in fig. 2, that is, one of two surfaces of the concave lens (or convex lens) is a plane, and the other surface is a concave surface (or convex surface), and also includes a case that both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction vertical to the main optical axis, and also comprises an incomplete convex lens along the direction vertical to the main optical axis, wherein the incomplete convex lens comprises a half convex lens along the direction vertical to the main optical axis, and the thickest part of the convex lens is the same as the thickness of the flat light area. Example 11
This example illustrates a zoned cornea implantation microlens having three regions, namely, two correction regions and one flattening region, arranged in this order from the center of the zoned cornea implantation microlens to the outside in this order, a second correction region, a flattening region, and a first correction region, based on example 1. The zoned cornea implantation microlens is circular, wherein the second correction zone is circular with the diameter of 1.4mm, the second correction zone is a concave lens, the edge thickness of the concave lens is 37 mu m, the thickness of the optical center of the concave lens is 0, the optical center is taken as the center of the circle to be outwards expanded to a round hole with the diameter of 0.3mm, the whole round hole is a through hole, namely the thickness is 0, the thickness from the edge of the through hole to the second correction zone is gradually thickened from 0, the second correction zone is an annular flat zone, the outer circle diameter of the flat zone is 2.0mm, the thickness of the flat zone is the same as the thickness of the edge of the concave lens of the second correction zone, the flat zone is an annular first correction zone, the cross section of the convex lens of the first correction zone along the circular curvature center direction is the same as the thickness of the flat zone, the outer circle diameter of the convex lens of the first correction zone is 3.6mm (namely the diameter of the zoned cornea implantation microlens), and the thickness of the convex lens of the first correction zone is 55 mu m (namely the thickness of the zoned cornea implantation microlens). The preparation material of the micro lens for the partitioned cornea implantation is a composition of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocker is 4-propenoxy-2-hydroxybenzophenone. The cornea embedded microlens prepared in this embodiment is shown in fig. 2-B of fig. 2, and the full-resolution visual imaging effect simulation diagram is shown in fig. 5.
Example 12
This example illustrates the incidence of pannus or haze after implantation of the zonal keratoplasty microlens provided in example 11 into an animal cornea. The method comprises the following steps:
1. Test materials and apparatus:
1.12 test rabbits;
2. test materials 6 pieces of zonal cornea implantation microlenses provided in example 11;
3. Comparative material a zoned cornea implant microlens 6 sheet having exactly the same size as the zoned cornea implant microlens provided in example 11, but having no central hole;
4. Normal saline, lidocaine hydrochloride, and the like.
5. The main equipment comprises a surgical microscope, a face opener, an ophthalmic separator, an implanter, a surgical instrument, a slit lamp, an ophthalmic B ultrasonic and the like.
2. Test procedure
1. Test group test rabbits 6 were individually numbered and were implanted with a comparative material (zonal cornea implantation microlens without a center hole), and test group test rabbits 6 were individually numbered and were implanted with a test material (zonal cornea implantation microlens with a center hole provided in example 11).
2. Test procedure preoperatively cleaning the test rabbit's eye, then preparing the corneal stroma capsular bag with a scalpel, separating the capsular bag with a separator, and pushing the microlens into the capsular bag with a surgical implanter. The drug is administrated according to the instruction book of tobramycin dexamethasone eye drops after operation. The post-operative observation was for 12 months.
3. Scoring criteria
4. Test results
Scoring at 3 months, 6 months, 12 months after surgery, respectively, was recorded as follows:
5. Conclusion of the test
The test results showed that the test rabbits implanted with the zonal cornea implantation microlens having the central hole were completely transparent for 12 months, were free from clouds and clouds, and had a tendency to be further aggravated at 12 months, with 3 cases of clouds and clouds occurring at 6 months. Conclusion the zonal corneal implant microlens with central aperture provided in example 11 was free of clouds and corneal haze for 12 consecutive months.
Example 13
This example illustrates a zoned microlens for cornea implantation having an ultraviolet blocking function, and the application effects of the zoned microlens for cornea implantation provided in examples 10 and 11 were evaluated by aging, transparency, biocompatibility, and antibiotic sustained release test. The method comprises the following steps:
test group 1 zonal keratoplasty microlenses provided in example 10;
test group 2 zonal keratoplasty microlenses provided in example 11;
The zoned microlenses for corneal implantation provided according to the respective embodiments were each numbered.
1. Ageing test
The cornea microlenses were accelerated aged at 60 ℃, sampled at 1, 3, 5, 8 and 12 months, and the content of ultraviolet blocker was measured by spectroscopic analysis to evaluate the aging of the microlenses.
2. Transparency, biocompatibility and antibiotic sustained release test
The duration of antibiotic release of the microlens and the transparency of the microlens were examined.
1. Test materials:
1) Test rabbits 16;
2) Normal saline, lidocaine hydrochloride, surgical instruments, slit lamps, ophthalmic B ultrasonic and the like.
3) The main equipment is a surgical microscope, a face opening device, an ophthalmic separator, an implanter, a surgical sleeve and the like.
2. Test procedure
The test rabbits were preoperatively cleaned for eye surgery, the corneal stroma capsular bag was prepared with a scalpel, the capsular bag was separated with a separator, and the microlenses were pushed into the capsular bag with a surgical implanter and centered. Dexamethasone eye drops are spotted after operation.
And continuously observing after the operation, recording antibiotic detection results at 8-12-18-24 hours after the operation, and finally recording and observing transparency at 12 months after the operation.
3. Transparency scoring criteria
4. Test results
4.1 Ageing Condition recording
From the test results, the early aging of the materials does not occur in both test group 1 and test group 2.
4.2 Transparency and antibiotic Release Condition recording
(1) The cornea clarity scores at 12 months post-surgery were as follows:
| Group of | Test group 1 | Test group 2 |
| Transparency of the film | 0 | 0 |
From the results of this test, the corneal transparency was substantially the same for each group at 12 months post-surgery.
(2) Antibiotic release assay results:
From the test results, it was found that tobramycin was detected at 2-8-12 hours in both test group 1 and test group 2, that tobramycin was not detected at 18 hours after surgery in test group 1, and that tobramycin was still detected in test group 2.
5. Conclusion of the test
As can be seen from the test results of the group, the test group 2 has no early aging phenomenon and good biocompatibility, and the antibiotic release test results show that when the preparation materials of the test group 2, namely, the hydroxyethyl methacrylate, the methyl methacrylate and the 4-propenoxy-2-hydroxybenzophenone, are adopted, the tobramycin release time of the micro lens can exceed 18 hours. Therefore, test group 2 materials are preferred.
Example 14
This example illustrates a method for preparing a zonal corneal implant microlens with antibiotics in which several components of the hydration solution and/or preservation solution are selected and a preferred hydration solution is selected by comparison. The method comprises the following steps:
the components of the hydration solution and/or the preservation solution described in this example were prepared and tested in the following test groups.
Test group 1, containing tobramycin;
test group 2 contains tobramycin, bFGF and VB2;
test group 3, without any additives (blank).
The following evaluation of the postoperative recovery effect was performed by implanting the zoned keratoplasty microlenses (9 pieces in total) provided in example 11 on the cornea of an animal in accordance with the components contained in the hydration solution shown above. The method comprises the following steps:
The components of the zoned keratology lenses provided in example 11 in the hydration solution were replaced with the corresponding components of the test groups described above, and the parameters not described in each test group were as described in example 11.
1. Test materials and apparatus
1. Test rabbits 9;
2. The reagent is physiological saline, lidocaine hydrochloride and the like.
3. The main equipment is a surgical microscope, a face opener, an ophthalmic separator, an implanter, a surgical sleeve, an ophthalmic B ultrasonic, a slit lamp and the like.
2. Test procedure
The test rabbits were cleaned preoperatively, then corneal stroma bags were prepared with a scalpel, the bags were separated with a separator, and the microlenses were pushed into the bags with a surgical implanter. The administration is carried out according to instructions of dexamethasone eye drops after operation. The post-operative observation was for 3 months. And the nerve growth condition is observed by taking histological sections 3 months after operation.
Corneal clarity score criteria:
3. Test results
1. Corneal transparency observation record
The results showed that each test group remained completely transparent at all times after rabbit eye surgery, indicating that the addition of the corresponding ingredients of test groups 1 and 2 did not affect the post-operative transparency of rabbit eyes.
2. Nerve fiber growth observation record
The sections showed a slightly reduced number of distorted and increased reflectivity nerves in the plexus image at 1 month, a significantly reduced number of nerves in the plexus image at 3 months post-surgery, and the plexus tended to have preoperative neuromorphic characteristics, while test groups 1 and 2 were not significantly different, while test group 3 had slightly lower neurological recovery than the other test groups. It can be seen that the post-operative effect of the microlenses with tobramycin added or with tobramycin, bFGF and VB2 added simultaneously in the hydration step is better.
It should be noted that the foregoing description is only a preferred embodiment of the present invention, and is not intended to limit the technical scope of the present invention, and any person skilled in the art should be able to equally substitute or change the inventive concept of the technical scope of the present invention within the scope of the technical scope of the present invention.
Claims (10)
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