Partitioned micro lens for cornea implantation and application thereof
By designing a microlens for partitioned corneal implantation, including correction areas for correcting non-healthy states and refractive errors of the lens, and flat light areas for maintaining vision regulation capabilities, the existing technology cannot simultaneously correct non-healthy lenses because of non-healthy lenses. The problem of visual loss caused by state and refractive errors achieves a clear visual effect.
Patent Information
- Application Number
- CN202411628041.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-14
- Publication Date
- 2025-02-11
AI Technical Summary
The prior art fails to simultaneously correct vision loss due to non-healthy state of the lens and refractive error.
A partitioned corneal implantation microlens was designed, including two correction areas and a flat light area. The first correction area is used to correct vision loss due to non-healthy state of the refractive medium or refractive error. The diopter of the flat light area is 0D, which is used to make light enter the eye in parallel and ensure vision adjustment ability.
It achieves the simultaneous correction of vision loss caused by non-healthy lens state and refractive error, avoids far vision loss or compensates for myopia, and ensures that both the patient's vision of near objects and the distant objects are clear.
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Figure CN119405455A_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of regenerative medicine. Specifically, the first aspect of the present invention relates to a microlens for partitioned corneal implantation, and the second aspect of the present invention relates to the application of the microlens product in a product for correcting visual impairment. Background Art
[0002] As we age, or due to bad eye habits, our vision will deteriorate. Presbyopia is a common vision problem. As we age, the elasticity of the lens of the human eye will gradually weaken after the age of 40, and the ability to adjust will also gradually weaken. This is the main cause of presbyopia, so people will have blurred vision when looking at close objects. The main symptoms of presbyopia are: 1. It is difficult to see very small fonts in a low-light environment; 2. When reading books or newspapers, keep a longer reading distance, and the eyes will feel more comfortable; 3. You cannot persist when writing, reading, and doing fine manual work; 4. When reading newspapers, it will be more comfortable to take off myopic glasses; 5. When buying things, it is easy to misread the price; 6. Compared with when you were young, you have higher requirements for the brightness of light when reading books or newspapers.
[0003] In addition to vision loss caused by an unhealthy lens, refractive error can also cause vision loss. For example, when the eye is in a relaxed state, parallel light enters the eye and focuses in front of the retina, which results in a clear image not being formed on the retina, which is called myopia. At this time, an eye examination will indicate the degree of myopia; when the eye is in a relaxed state, parallel light from the outside world enters the eye and its focus falls on the retina, forming a clear image, which is called emmetropia; if the focus cannot fall on the retina, it is called non-emmetropia, which is a refractive error. Therefore, myopia is a symptom of refractive error.
[0004] Intraocular lenses are usually used to correct vision loss caused by unhealthy lens conditions. Intraocular lenses are usually inserted into the eye chamber, the capsular bag of the eye, or between the iris and the lens. US Patent Document US2004 / 0085511A1 discloses an intraocular lens for insertion into the posterior chamber of the eye.
[0005] Usually, an intracorneal lens is used to correct vision loss caused by refractive error. The intracorneal lens is inserted into the cornea instead of the eye chamber, so this lens is usually smaller than the intraocular lens. Because the positions of the intracorneal lens and the intraocular lens relative to the lens are different, the intracorneal lens and the intraocular lens must have different optical structures to correct vision loss. Chinese patent document CN101896853A discloses an intracorneal lens with a central hole.
[0006] In the prior art, there is no technology that uses a lens embedded in the cornea to simultaneously correct vision loss caused by an unhealthy state of the lens and vision loss caused by refractive errors. Summary of the invention
[0007] In order to make up for the shortcomings and deficiencies of the prior art, the first aspect of the present invention provides a partitioned corneal implant microlens, the microlens is a circular curved surface, the microlens includes two areas, namely a first correction area and a plano area, the plano area is surrounded by the first correction area, the first correction area and the plano area are concentric, the first correction area has the function of correcting vision, and the refractive power of the plano area is 0D.
[0008] The partitioned corneal implant microlens provided by the present invention includes two areas, wherein the first correction area has the function of correcting vision, and the refractive power of the plano area is 0D, which does not have the function of correcting vision. The first correction area can be used to correct the vision loss caused by the unhealthy state of the refractive medium, or to correct the vision loss caused by refractive error. Although the plano area does not have the function of correcting vision, when looking at distant objects, it can make the light enter the eye in parallel, and then reach the retina, and form a clear image. Specifically, whether the first correction area is used to correct the vision loss caused by the unhealthy state of the refractive medium, or to correct the vision loss caused by refractive error, the plano area can make the light enter the eye in parallel, and then reach the retina, and form a clear image, thereby ensuring that the first correction area plays a role in correcting vision, and the light entering the eye through the plano area can maintain the patient's original visual adjustment ability, so that the patient's distance vision loss or near vision compensation can be avoided. When used, the zoned corneal implant microlens provided by the present invention can change the specific shapes of the first correction zone and the planophotographic zone and the area ratio between the two according to the patient's vision symptoms, thereby correcting the patient's vision loss symptoms to the greatest extent.
[0009] In a preferred embodiment of the present invention, the plano area has a through hole, and the through hole has two functions. The first is to facilitate surgical marking. Specifically, since the center of the partitioned corneal implant microlens provided by the present invention is usually required to be on the visual axis during clinical application, otherwise it will affect the clinical use effect of correcting vision, and the through hole can provide an accurate reference position for the doctor performing the operation, which is convenient for finding the center of the microlens, and then accurately positioning the center of the microlens on the visual axis; secondly, the applicant has concluded and found after a large number of experiments that setting a through hole at the center position of the partitioned corneal implant microlens can reduce the phenomenon of corneal clouding and turbidity after surgery.
[0010] In a preferred embodiment of the present invention, the plano area of the partitioned corneal implant microlens provided by the present invention includes a second correction area, the plano area includes a second correction area, the second correction area is circular, the cross section of the second correction area along the center of the circular curvature is a concave lens cross section, and the second correction area is surrounded by the remaining plano area of the plano area. In this preferred embodiment, the partitioned corneal implant microlens has three areas, namely two vision correction areas and one plano area, the two vision correction areas have the function of correcting vision respectively, and can be used to correct vision loss caused by the unhealthy state of the refractive medium, or to correct vision loss caused by refractive error, and the two vision correction areas can also respectively correct vision loss caused by the above two reasons, although the plano area does not have the function of correcting vision, it can make the light enter the eye in parallel and reach the retina, thereby alleviating the first correction area and the second correction area from playing the role of correcting vision, and can also compensate for the unclear imaging caused by the self-adjustment function of the lens or the refractive system. It should be noted that the second correction zone in the plano zone has a through hole, and the through hole has two functions. The first is to facilitate surgical marking. Specifically, since the partitioned corneal implant microlens provided by the present invention is usually required to have the center of the microlens on the visual axis during clinical application, otherwise it will affect the clinical use effect of correcting vision, and the through hole can provide an accurate reference position for the doctor performing the operation, which is convenient for finding the center of the microlens, and then accurately positioning the center of the microlens on the visual axis; secondly, after a large number of experiments, the applicant concluded that setting a through hole at the center position of the partitioned corneal implant microlens can reduce the phenomenon of corneal clouding and turbidity after surgery.
[0011] In a preferred embodiment of the present invention, the first correction zone of the microlens for zoned corneal implantation provided by the present invention has the function of correcting vision loss caused by the unhealthy state of the refractive medium, and the second correction zone has the function of correcting vision loss caused by refractive error. The applicant has learned through a large number of experiments that although the first correction zone and the second correction zone can simultaneously have the function of correcting vision loss caused by the unhealthy state of the refractive medium, and can also simultaneously have the function of correcting vision loss caused by refractive error, when the first correction zone has the function of correcting vision loss caused by the unhealthy state of the refractive medium and the second correction zone has the function of correcting vision loss caused by refractive error, the microlens for zoned corneal implantation provided by the present invention can simultaneously correct vision loss caused by the unhealthy state of the refractive medium and vision loss caused by refractive error, so that the patient can achieve full vision after surgery. Specifically, the vision loss caused by the unhealthy state of the refractive medium will cause the patient to see distant objects clearly but near objects blurred, while the vision loss caused by refractive error will cause the patient to image objects in front of or behind the retina, resulting in blurred vision. Therefore, after the patient is surgically implanted with the partitioned corneal implant microlens provided by the present invention, when looking at near objects, the cornea outside the first correction zone is properly blocked due to the contraction of the iris and the reduction of the pupil. At this time, all light passing through the first correction zone will be corrected, thereby compensating for the blurred vision caused by the unhealthy state of the refractive medium and the refractive error in the plano zone and the second correction zone, thereby making the patient's vision blurred after surgery. The patient's vision becomes clearer when seeing near objects; when seeing distant objects, due to the expansion of the iris and the pupil, the second correction zone and the plano zone will work simultaneously, making it clearer for the patient to see distant objects; and, due to the stretching of the ciliary muscle when seeing distant objects, part of the light can enter the eye through the corneal area outside the edge of the first correction zone of the partitioned corneal implant microlens, thereby increasing the amount of light entering the eye. At the same time, due to the existence of the plano zone, the vision of medium-distance vision when seeing distant objects is retained. Through the above two aspects, the patient's vision of distant objects becomes clearer after surgery. In this way, the patient can see near objects clearly and distant objects clearly after surgery, and ultimately achieves full clear vision.
[0012] In a preferred embodiment of the present invention, the number of through holes of the partitioned corneal implant microlens provided by the present invention is 1, the through hole is circular and concentric with the second correction zone, and the second correction zone is concentric with the plano zone. The applicant has learned through a large number of experiments that there is no significant difference between multiple through holes and 1 through hole in reducing the phenomenon of postoperative corneal clouding and turbidity in terms of the number of through holes located in the second correction zone; and when the arrangement order of the three areas of the partitioned corneal implant microlens is "from the center of the partitioned corneal implant microlens outward: the second correction zone, the plano zone, the first correction zone" (that is, the second correction zone is surrounded by the plano zone, and the plano zone is surrounded by the first correction zone), the partitioned corneal implant microlens can simultaneously correct the vision loss caused by the unhealthy state of the refractive medium and the vision loss caused by refractive error, so that the patient can achieve full vision after surgery. Specifically, the vision loss caused by the unhealthy state of the refractive medium will cause the patient to see distant objects clearly but near objects blurred, while the vision loss caused by refractive error will cause the patient to image objects in front of or behind the retina, resulting in blurred vision. Therefore, after the patient is surgically implanted with the partitioned corneal implant microlens provided by the present invention, when looking at near objects, the first correction zone is properly blocked due to the contraction of the iris and the shrinkage of the pupil. At this time, the light passing through the first correction zone and the second correction zone will be corrected, compensating for the blurred vision of the plano area caused by the unhealthy state of the refractive medium, thereby making the patient's vision blurred after surgery. When looking at near objects, it becomes clearer; when looking at far objects, due to the expansion of the iris and pupil, the second correction zone and the plano-light zone will work at the same time, making the patient's vision of far objects clearer; and, due to the stretching of the ciliary muscle when looking at far objects, part of the light can enter the eye through the area outside the edge of the first correction zone of the microlens for partitioned corneal implantation, thereby increasing the light entering the eye. At the same time, due to the existence of the plano-light zone, the vision of the middle distance when looking at far objects is retained. Through the above two aspects, the patient's vision of far objects becomes clearer after surgery; in this way, the patient can see near objects clearly and far objects clearly after surgery, and finally achieve full vision. Therefore, after a large number of experiments, the applicant concluded that in this preferred embodiment, it plays a corrective role at the same time, especially for patients with both presbyopia and myopia.
[0013] In a non-limiting embodiment of the present invention, the vision loss caused by the unhealthy state of the refractive medium refers to the vision loss caused by the lack of accommodation power, incomplete turbidity and weakened elasticity of the lens, such as presbyopia, etc.; the vision loss caused by refractive error refers to the fact that parallel light rays cannot form a clear image on the retina after passing through the refractive system of the eye, but form an image in front of or behind the retina, such as hyperopia, myopia, astigmatism, etc. In this way, the first correction area and the second correction area of the partitioned corneal implant microlens provided by the present invention respectively have the function of correcting the above two types of vision loss, thereby enabling the patient to achieve full vision after surgery.
[0014] After a large number of experiments, the applicant concluded that when the cross-section of the first correction zone along the center direction of the annular curvature is a convex lens cross-section, it can effectively correct the vision loss caused by the unhealthy state of the refractive medium. This is because after the patient is surgically implanted with the partitioned corneal implant microlens provided by the present invention, especially when the patient looks at near objects after the operation, the iris contracts and the pupil shrinks, causing the outside of the first correction zone to be properly blocked. At this time, the light passing through the first correction zone and the second correction zone will be corrected. At this time, the convex lens function of the first correction zone will compensate for the blurred vision caused by the unhealthy state of the refractive medium in the plano zone and the second correction zone, thereby making the patient's near objects clearer after the operation.
[0015] In a further preferred embodiment of the present invention, the cross section of the first correction zone along the center direction of the annular curvature is a convex lens cross section, and the cross section of the second correction zone along the center direction of the circular curvature is a concave lens cross section. In this embodiment, the partitioned corneal implant microlens provided by the present invention can effectively correct myopia caused by refractive error, in which near objects are clear and far objects are blurred. This is because, after the patient is surgically implanted with the partitioned corneal implant microlens provided by the present invention, especially when the patient looks at far objects after the operation, first: due to the expansion of the iris and the dilation of the pupil, the second correction zone, the plano zone and the first correction zone will work at the same time, and due to the stretching of the ciliary muscle when looking at far objects, part of the light can pass through the partitioned corneal implant microlens The corneal area outside the edge of the first correction zone of the lens enters the eye, so more light enters the eye; second: due to the existence of the plano zone, the original visual adjustment ability caused by the unhealthy state of the refractive medium is retained, thereby compensating for the mid-distance vision and the total amount of light entering the eye; third: because the cross-section of the second correction zone along the center of the circular curvature is a concave lens cross-section, the concave lens plays the role of correcting myopia, and the through hole is concentric with the second correction zone, which is equivalent to the optical center of the second correction zone (i.e., the concave lens) being the through hole, which can avoid the light reflection phenomenon caused by the thickness of the section, and thus avoid glare; due to the above three factors, the patient's vision of distant objects becomes clearer after surgery.
[0016] The applicant has concluded and found after a large number of experiments that when the cross section of the first correction zone along the center direction of the annular curvature is a convex lens cross section, the cross section of the second correction zone along the center direction of the circular curvature is a concave lens cross section, and the through hole is circular and concentric with the second correction zone, it is particularly suitable for patients with presbyopia caused by the unhealthy state of the refractive medium and myopia caused by refractive error. This is because presbyopia can make patients see distant objects clearly but near objects blurred, while myopia can make patients see near objects clearly but distant objects blurred. Therefore, after the patient is surgically implanted with the partitioned corneal implant microlens provided by the present invention, when looking at near objects, the iris contracts and the pupil shrinks, causing the outside of the first correction zone to be appropriately blocked. At this time, the convex lens function of the first correction zone will compensate for the flat light zone and the second correction zone. The blurred vision caused by presbyopia makes the postoperative patient see near objects more clearly; when seeing distant objects, the iris stretches and the pupil expands, and the concave lens in the second correction zone, the plano zone and the convex lens in the first correction zone will work simultaneously, making the patient see distant objects more clearly; and, since the ciliary muscle stretches when seeing distant objects, part of the light can enter the eye through the area outside the edge of the first correction zone of the partitioned corneal implant microlens, thereby increasing the light entering the eye, and at the same time, due to the existence of the plano zone, the originally relatively clear middle-distance vision of the presbyopic eye when seeing distant objects is retained. Through the above two aspects, the partitioned corneal implant microlens provided by the present invention can make the postoperative patient see distant objects more clearly; in this way, the postoperative patient can see near objects clearly and distant objects clearly, and finally the patient can achieve full vision after surgery.
[0017] In a preferred embodiment of the present invention, the number of the through holes is 1, and the through hole is located at the optical center of the concave lens, that is, the thinnest part of the concave lens in the second correction zone is 0 mm. The applicant has concluded through a large number of experiments that the diameter of the through hole is related to the phenomenon of corneal clouding and turbidity after surgery. When the doctor positions the center of the microlens for partitioned corneal implantation (that is, the center of the second correction zone) on the visual axis during surgery, and when the through hole diameter is 0.01-0.6 mm, it is convenient to position the microlens for partitioned corneal implantation on the visual axis during clinical transplantation, and at the same time, it can reduce the phenomenon of corneal clouding and turbidity after surgery.
[0018] In a preferred embodiment of the present invention, the diameter of the microlens for partitioned corneal implantation is 2.5-5.5 mm, which is related to the size of the cornea of the individual patient. The applicant has learned through a large number of experiments that the size of the embedding suitable for embedding in the human cornea is 2.5-5.5 mm in diameter and 25-63 μm in thickness. According to the correction principle of the microlens for partitioned corneal implantation provided by the present invention, when the diameter is 3.0-4.0 mm and the thickness is 25-55 μm, it is easier to achieve full vision.
[0019] In a non-limiting preferred embodiment of the present invention, in order to extend the service life of the microlens for partitioned corneal implantation and reduce the damage of ultraviolet rays to other intraocular tissues, the applicant added azophenyl methacrylate to the microlens for partitioned corneal implantation. In a non-limiting preferred embodiment of the present invention, 4-propyleneoxy-2-hydroxybenzophenone was added to the preparation material of the microlens for partitioned corneal implantation. In a non-limiting preferred embodiment of the present invention, azophenyl methacrylate and 4-propyleneoxy-2-hydroxybenzophenone were added to the preparation material of the microlens for partitioned corneal implantation. The applicant concluded after a large number of experiments that when the preparation material of the microlens for partitioned corneal implantation is selected from "hydroxyethyl methacrylate, methyl methacrylate" and the ultraviolet blocker is selected from "4-propyleneoxy-2-hydroxybenzophenone", the transparency, biocompatibility, sustained release effect of antibiotics and service life of the microlens for partitioned corneal implantation after transplantation are better.
[0020] The second aspect of the present invention provides the use of a microlens for a partitioned corneal implant in a product for correcting vision loss caused by an unhealthy state of a refractive medium. The second aspect of the present invention also provides the use of a microlens for a partitioned corneal implant in a product for correcting vision loss caused by ametropia.
[0021] The partitioned corneal implant microlens provided by the present invention includes two areas and a through hole. Since the first correction area has the function of correcting the visual impairment caused by the unhealthy state of the refractive medium, or has the function of correcting the visual impairment caused by refractive error, and the refractive power of the plano area is 0D, after the patient implants the partitioned corneal implant microlens, no matter whether the first correction area is used to correct the visual impairment caused by the unhealthy state of the refractive medium or to correct the visual impairment caused by refractive error, the plano area can make the light enter the eye in parallel, reach the retina, and form a clear image, thereby ensuring that the first correction area plays a role in correcting vision, and the light entering the eye through the plano area can maintain the patient's original visual adjustment. After a large number of experiments, the applicant concluded that setting a through hole at the center of the partitioned corneal implant microlens can not only facilitate surgical marking, but also reduce the phenomenon of corneal clouding and turbidity after surgery.
[0022] In a preferred embodiment of the present invention, the plano zone of the partitioned corneal implant microlens also includes a second correction zone. In this case, the partitioned corneal implant microlens has three areas, namely, two vision correction zones and one plano zone. From the center of the partitioned corneal implant microlens to the outside, they are: the second correction zone, the plano zone, and the first correction zone, that is, the second correction zone is surrounded by the plano zone, and the plano zone is surrounded by the first correction zone. Although the plano zone between the two correction zones does not have the function of correcting vision, it can allow light to enter the eye in parallel and reach the retina, thereby alleviating the vision correction function of the first correction zone while compensating for the unclear imaging caused by the self-adjustment function of the lens or the refractive system. In particular, after implantation in the patient's non-dominant eye, when viewing near objects, the iris contracts and the pupil shrinks, and the outside of the first correction zone is appropriately blocked. At this time, all light passing through the first correction zone will be corrected, thus compensating for the blurred vision caused by the unhealthy state of the refractive medium and refractive error in the plano zone and the second correction zone, thereby making the patient's near objects clearer after surgery; when viewing distant objects, the iris stretches and the pupil expands, and at this time the second correction zone and the plano zone will work at the same time. Due to the stretching of the ciliary muscle, part of the light can pass through the area outside the edge of the first correction zone of the partitioned corneal implant microlens The light entering the eye increases, and due to the existence of the plano area, the vision of the medium-distance vision when looking at distant objects is retained. Through the above two aspects, the patient's non-dominant eye can see distant objects more clearly after surgery. In addition, when the human body sees objects with binocular vision, when the clarity of the two eyes is different (the eye with clear image is the dominant eye, and the eye with relatively unclear image is the non-dominant eye), the human body will actively choose the clear image as the main image, and will appropriately ignore the visual perception of unclear image. Therefore, after surgery, the patient can see near objects clearly, and also see distant objects clearly, and finally achieve full vision. Please see the attached diagram for the simulation of the visual effect. Figure 5 . BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Attached Figure 1 An enlarged schematic diagram of a microlens for partitioned corneal implantation provided by the present invention
[0024] Attached Figure 2 Vertical section through the optical center of the microlens for partitioned corneal implantation provided by the present invention (three types of microlenses are shown as examples)
[0025] Attached Figure 3 Working principle diagram of the microlens for the partitioned corneal implant provided in Example 10 of the present invention when implanted into the patient's cornea and looking at near objects
[0026] Attached Figure 4 Working principle diagram of the microlens for the partitioned corneal implant provided in Example 10 of the present invention when implanted into the patient's cornea to look at distant objects
[0027] Attached Figure 5 Simulation diagram of binocular vision effect after implantation of microlens for partitioned corneal implantation provided in Example 11 of the present invention into the cornea of a patient DETAILED DESCRIPTION
[0028] In order to accurately describe and illustrate the technical solution provided by the present invention, the technical terms used in the present invention are explained as follows before the content of the invention.
[0029] The "partitioned corneal implantable microlens" described in the present invention refers to a film that can be embedded in the corneal stroma layer and can correct vision.
[0030] The "curved surface" mentioned in the present invention refers to the surface generated by the motion trajectory of a straight line or curve under certain constraints. The curved surface mentioned in the present invention includes a spherical surface, a cylindrical surface and a conical surface.
[0031] The term "concentric" as used in the present invention refers to a situation where the centroids or centers (such as circles) of two or more regions coincide with each other.
[0032] The "optical center" mentioned in the present invention refers to the optical center in the physical sense. For example, the optical center of a concave lens is the point where the centers of the two refractive surfaces coincide. The characteristic of the optical center is that the propagation direction of light passing through this point remains unchanged.
[0033] The "curvature" mentioned in the present invention refers to the curvature of a curve in the mathematical sense, which is a numerical value indicating the degree of curvature of the curve at a certain point. The greater the curvature, the greater the degree of curvature of the curve.
[0034] The "concave lens" described in the present invention is a concave lens in the sense of optical terminology, that is, the lens is thin in the middle and thick at the edge, and is concave. The concave lens described in the present invention includes one side being a flat surface and the other side being a concave surface, and also includes both sides being concave surfaces.
[0035] The "convex lens" described in the present invention is a convex lens in the sense of optical terminology, that is, the lens is thick in the middle and thin at the edge, and is convex. The convex lens described in the present invention includes one side being a flat surface and the other side being a convex surface, and also includes both sides being convex surfaces. The convex lens is a complete convex lens along the direction perpendicular to the main optical axis, and also includes an incomplete convex lens along the direction perpendicular to the main optical axis, including a convex lens along the direction perpendicular to the main optical axis that is a half convex lens and at this time the thickest part of the convex lens is the same as the thickness of the flat optical area.
[0036] The "refractive medium" mentioned in the present invention refers to the refractive medium in the medical sense, such as the lens and vitreous body.
[0037] The "unhealthy state of the refractive medium" mentioned in the present invention refers to the visual impairment caused by the lack of accommodation power, incomplete opacity and weakened elasticity of the lens, such as presbyopia.
[0038] The "refractive error" mentioned in the present invention refers to the fact that after parallel light rays pass through the refractive effect of the eye, they cannot form a clear image on the retina, but form an image in front of or behind the retina.
[0039] The "visual impairment" mentioned in the present invention refers to the phenomenon that compared with the normal visual acuity of 1.0, the visual acuity becomes blurred when the visual acuity is lower than 1.0 as shown in the visual acuity test, making it difficult to distinguish small or distant objects.
[0040] The following non-limiting embodiments of the present invention are further described in conjunction with the accompanying drawings, wherein experimental rabbits are used instead of human patients to illustrate the various parameters of the microlens for partitioned corneal implantation provided by the present invention and the specific steps of the preparation method. It should be stated that the following specific embodiments are only for illustrative purposes and should not be construed as limiting the technical solution of the present invention.
[0041] Example 1
[0042] This embodiment illustrates a partitioned corneal implant microlens, the microlens is a circular curved surface, the microlens includes two areas, namely a first correction area and a plano area, the plano area is surrounded by the first correction area, the first correction area and the plano area are concentric, the first correction area has the function of correcting vision, and the refractive power of the plano area is 0D. The first correction area can be used to correct vision loss caused by the unhealthy state of the refractive medium, or to correct vision loss caused by refractive error, and the plano area does not have the function of correcting vision. When the partitioned corneal implant microlens provided in this embodiment is used, the specific shape of the first correction area and the area ratio between the two can be changed according to the patient's vision symptoms, so as to correct the patient's vision loss symptoms to the greatest extent.
[0043] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0044] Example 2
[0045] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the microlens includes two areas, "a first correction area and a plano area", wherein the first correction area has the function of correcting vision loss caused by the unhealthy state of the refractive medium, and the plano area does not have the function of correcting vision. The plano area is a circle with a diameter of 2 mm, and the thickness of the plano area is 25 μm; outside the plano area is an annular first correction area, the thickness of the annular inner circumference of the first correction area is the same as the thickness of the plano area, and the outer diameter of the first correction area is 4 mm (i.e., the diameter of the partitioned corneal implant microlens). The maximum thickness of the partitioned corneal implant microlens is 54 μm.
[0046] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0047] Example 3
[0048] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the plano area further includes a second correction area. At this time, the partitioned corneal implant microlens has three areas, namely, "two correction areas and one plano area". The three areas are arranged in the following order from the center of the partitioned corneal implant microlens to the outside: the second correction area, the plano area, and the first correction area. Among them, the first correction area has the function of correcting vision loss caused by the unhealthy state of the refractive medium, the plano area does not have the function of correcting vision, and the second correction area has the function of correcting vision loss caused by refractive error. The microlens for the zoned corneal implant is circular, wherein the second correction zone is a circle with a diameter of 1.5 mm, and the thickest part of the second correction zone is 30 μm; outside the second correction zone is an annular plano zone, and the outer diameter of the plano zone is 2.5 mm; the thickness of the plano zone is the same as the thickness of the edge of the second correction zone; outside the plano zone is an annular first correction zone, and the outer diameter of the first correction zone is 3.5 mm (i.e., the diameter of the microlens for the zoned corneal implant), and the thickest part of the inner circumference of the annular first correction zone is the same as the thickness of the plano zone.
[0049] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0050] Example 4
[0051] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the partitioned corneal implant microlens has three regions, namely, "two correction regions and one plano region". The three regions are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction region, the plano region, and the first correction region. The first correction region has the function of correcting vision loss caused by the unhealthy state of the refractive medium, the plano region does not have the function of correcting vision, and the second correction region also has the function of correcting vision loss caused by the unhealthy state of the refractive medium. The microlens for the zoned corneal implant is circular, wherein the second correction zone is a circle with a diameter of 2 mm, and the thickest part of the second correction zone is 42 μm; outside the second correction zone is an annular plano zone, and the outer diameter of the plano zone is 2.5 mm; the thickness of the plano zone is the same as the thickness of the edge of the second correction zone; outside the plano zone is an annular first correction zone, and the outer diameter of the first correction zone is 3.2 mm (i.e., the diameter of the microlens for the zoned corneal implant), and the cross-sectional thickness of the inner circumference of the annular first correction zone is the same as the thickness of the plano zone.
[0052] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0053] Example 5
[0054] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the partitioned corneal implant microlens has three regions, namely, "two correction regions and one plano region". The three regions are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction region, the plano region, and the first correction region. The first correction region has the function of correcting vision loss caused by the unhealthy state of the refractive medium, the plano region does not have the function of correcting vision, and the second correction region has the function of correcting vision loss caused by ametropia. The microlens for the zoned corneal implant is circular, wherein the second correction zone is a circle with a diameter of 1.5 mm, and the thickest part of the second correction zone is 54 μm; outside the second correction zone is an annular plano zone, the outer diameter of the plano zone is 2 mm, and the thickness of the plano zone is the same as the thickness of the edge of the second correction zone; outside the plano zone is an annular first correction zone, the outer diameter of the first correction zone is 4.5 mm (i.e., the diameter of the microlens for the zoned corneal implant), and the cross-sectional thickness of the inner circumference of the annular first correction zone is the same as the thickness of the plano zone.
[0055] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0056] Example 6
[0057] This embodiment illustrates a partitioned corneal implant microlens. Figure 1 For example, the partitioned corneal implant microlens has three areas in total: "two correction areas and one plano area". The three areas are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction area S3, the plano area S2, and the first correction area S1. The partitioned corneal implant microlens is circular, wherein the second correction area S3 is a circle with a diameter of 1.5 mm, and the second correction area S3 is a concave lens, the thickness of the edge of the concave lens is 45 μm, the thickness at the optical center of the concave lens is 0, and then expands outward from the optical center to a circular hole with a diameter of 0.4 mm, and the entire circular hole is a through hole SH, that is, the thickness is 0; the thickness from the edge of the through hole SH to the second correction area gradually thickens from 0; outside the second correction area S3 is an annular plano area S2, the outer diameter of the plano area is 2.5 mm, and the plano area The thickness of S2 is the same as the thickness of the edge of the concave lens of the second correction zone S3; the outside of the plano zone S2 is the annular first correction zone S1, the cross section of the first correction zone S1 along the center direction of the annular curvature is a convex lens cross section, the convex lens of the first correction zone S1 is the same thickness as the plano zone S2 at the junction with the plano zone S2, the outer diameter of the first correction zone S1 is 4.0 mm (i.e., the diameter of the microlens for the partitioned corneal implant), and the optical center thickness of the convex lens of the first correction zone S1 is 54 μm (i.e., the thickness of the thickest part of the microlens for the partitioned corneal implant).
[0058] It should be noted that, in the three regions of the cornea-embedded microlens in this embodiment, the concave lens and the convex lens respectively include attached Figure 2 The four situations include the situation that one of the two surfaces of the concave lens (or convex lens) is a plane and the other is a concave surface (or convex surface), and the situation that both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction perpendicular to the main optical axis, and also includes an incomplete convex lens along the direction perpendicular to the main optical axis, including a convex lens along the direction perpendicular to the main optical axis is a half convex lens and the thickest part of the convex lens is the same as the thickness of the flat light area.
[0059] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0060] Example 7
[0061] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the partitioned corneal implant microlens has three areas in total, namely, "two correction areas and one plano area". The three areas are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction area, the plano area, and the first correction area. The partitioned corneal implant microlens is circular, wherein the second correction area is a circle with a diameter of 1.5 mm, and the second correction area is a concave lens, the thickness of the edge of the concave lens is 47 μm, the thickness at the optical center of the concave lens is 0, and then expands outward from the optical center to a circular hole with a diameter of 0.35 mm. The entire circular hole is a through hole, that is, the thickness is 0; the thickness from the edge of the through hole to the second correction area gradually increases from 0; outside the second correction area is an annular plano area, and the outer diameter of the plano area is 2.0 mm , the thickness of the plano area is the same as the thickness of the edge of the concave lens of the second correction area; the first correction area is annular outside the plano area, the cross section of the first correction area along the center direction of the annular curvature is a convex lens cross section, the convex lens of the first correction area is the same thickness as the plano area at the junction with the plano area, the outer diameter of the first correction area is 3.3mm (i.e. the diameter of the microlens for the partitioned corneal implant), and the optical center thickness of the convex lens of the first correction area is 63μm (i.e. the thickness of the thickest part of the microlens for the partitioned corneal implant). The preparation material of the microlens for the partitioned corneal implant is one or more of hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, and styrene acrylate.
[0062] It should be noted that, in the three regions of the cornea-embedded microlens in this embodiment, the concave lens and the convex lens respectively include attached Figure 2 The four situations include the situation that one of the two surfaces of the concave lens (or convex lens) is a plane and the other is a concave surface (or convex surface), and the situation that both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction perpendicular to the main optical axis, and also includes an incomplete convex lens along the direction perpendicular to the main optical axis, including a convex lens along the direction perpendicular to the main optical axis is a half convex lens and the thickest part of the convex lens is the same as the thickness of the flat light area.
[0063] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0064] Example 8
[0065] This embodiment illustrates a partitioned corneal implant microlens. Based on Embodiment 1, the partitioned corneal implant microlens has three areas in total, namely "two correction areas and one plano area". The three areas are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction area, the plano area, and the first correction area. The microlens for the partitioned corneal implant is circular, wherein the second correction zone is a circle with a diameter of 2 mm, and the second correction zone is a concave lens, the edge thickness of the concave lens is 48 μm, the thickness at the optical center of the concave lens is 0, and then it expands outward from the optical center to a circular hole with a diameter of 0.6 mm, and the entire circular hole is a through hole, that is, the thickness is 0; the thickness from the edge of the through hole to the second correction zone gradually increases from 0; the outside of the second correction zone is an annular plano zone, the outer diameter of the plano zone is 2.5 mm, and the thickness of the plano zone is the same as the thickness of the edge of the concave lens of the second correction zone; the outside of the plano zone is an annular first correction zone, the cross section of the first correction zone along the center direction of the annular curvature is a convex lens cross section, the convex lens of the first correction zone is connected to the plano zone at the same thickness as the plano zone, the outer diameter of the first correction zone is 4 mm (that is, the diameter of the microlens for the partitioned corneal implant), and the optical center thickness of the convex lens of the first correction zone is 62 μm (that is, the thickness of the thickest part of the microlens for the partitioned corneal implant). The preparation material of the microlens for partitioned corneal implantation is one or more of hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, and styrene acrylate, and the ultraviolet blocker of the microlens for partitioned corneal implantation is azophenyl methacrylate and / or 4-propyleneoxy-2-hydroxybenzophenone.
[0066] It should be noted that, among the three regions of the cornea-embedded microlens in this embodiment, the concave lens in the second correction region and the convex lens in the first correction region respectively include attached Figure 2 The four situations include the situation that one of the two sides of the concave lens (or convex lens) is a plane and the other side is a concave (or convex) surface, and the situation that both sides are concave (or convex) surfaces. The convex lens is a complete convex lens along the direction perpendicular to the main optical axis, and also includes an incomplete convex lens along the direction perpendicular to the main optical axis, including a convex lens along the direction perpendicular to the main optical axis. The convex lens is half a convex lens and the thickest part of the convex lens is the same as the thickness of the planoscopic area. The materials, conditions and parameters not described in this embodiment can be selected by those skilled in the art with creative labor. Reagents, materials, parameters and specific settings can be implemented to obtain a partitioned corneal implantable microlens with the effect of correcting vision.
[0067] Example 9
[0068] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the partitioned corneal implant microlens has three areas in total, namely, "two correction areas and one plano area". The three areas are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction area, the plano area, and the first correction area. The partitioned corneal implant microlens is circular, wherein the second correction area is a circle with a diameter of 1.5 mm, and the second correction area is a concave lens, the thickness of the edge of the concave lens is 34 μm, the thickness at the optical center of the concave lens is 0, and then expands outward from the optical center to a circular hole with a diameter of 0.3 mm, and the entire circular hole is a through hole, that is, the thickness is 0; the thickness from the edge of the through hole to the second correction area gradually increases from 0; outside the second correction area is an annular plano area, and the outer diameter of the plano area is 2.3 mm The thickness of the plano area is the same as the thickness of the edge of the concave lens of the second correction area; the first correction area is an annular first correction area, the cross section of the first correction area along the center direction of the annular curvature is a convex lens cross section, the convex lens of the first correction area is the same thickness as the plano area at the junction with the plano area, the outer diameter of the first correction area is 3.5mm (i.e. the diameter of the partitioned corneal implant microlens), and the optical center thickness of the convex lens of the first correction area is 52μm (i.e. the thickness of the thickest part of the partitioned corneal implant microlens). The preparation material of the partitioned corneal implant microlens is a combination of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocker of the partitioned corneal implant microlens is 4-propyleneoxy-2-hydroxybenzophenone.
[0069] For materials, conditions and parameters not described in this embodiment, those skilled in the art can select reagents, materials, parameters and specific settings for implementation with creative efforts, thereby obtaining a partitioned corneal implantable microlens with the effect of correcting vision.
[0070] Example 10
[0071] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the partitioned corneal implant microlens has three areas in total, namely, "two correction areas and one plano area". The three areas are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction area, the plano area, and the first correction area. The partitioned corneal implant microlens is circular, wherein the second correction area is a circle with a diameter of 1.6 mm, and the second correction area is a concave lens, the thickness of the edge of the concave lens is 48 μm, the thickness at the optical center of the concave lens is 0, and then expands outward from the optical center to a circular hole with a diameter of 0.2 mm. The entire circular hole is a through hole, that is, the thickness is 0; the thickness from the edge of the through hole to the second correction area gradually increases from 0; outside the second correction area is an annular plano area, and the outer diameter of the plano area is 2.2 mm The thickness of the plano area is the same as the thickness of the edge of the concave lens of the second correction area; the first correction area is annular outside the plano area, the cross section of the first correction area along the center of the annular curvature is a convex lens cross section, the convex lens of the first correction area is the same thickness as the plano area at the junction with the plano area, the outer diameter of the first correction area is 3.4mm (i.e. the diameter of the microlens for the partitioned corneal implant), and the optical center thickness of the convex lens of the first correction area is 67μm (i.e. the thickness of the thickest part of the microlens for the partitioned corneal implant). The preparation material of the microlens for the partitioned corneal implant is a combination of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocker is azophenyl methacrylate.
[0072] It should be noted that, among the three regions of the cornea-embedded microlens in this embodiment, the concave lens in the second correction region and the convex lens in the first correction region respectively include attached Figure 2 The four situations include the situation that one of the two surfaces of the concave lens (or convex lens) is a plane and the other is a concave surface (or convex surface), and the situation that both surfaces are concave surfaces (or convex surfaces). The convex lens is a complete convex lens along the direction perpendicular to the main optical axis, and also includes an incomplete convex lens along the direction perpendicular to the main optical axis, including a convex lens along the direction perpendicular to the main optical axis is a half convex lens and the thickest part of the convex lens is the same as the thickness of the flat light area. Example 11
[0073] This embodiment illustrates a partitioned corneal implant microlens. On the basis of Embodiment 1, the partitioned corneal implant microlens has three areas in total, namely, "two correction areas and one plano area". The three areas are arranged in the following order, from the center of the partitioned corneal implant microlens to the outside: the second correction area, the plano area, and the first correction area. The partitioned corneal implant microlens is circular, wherein the second correction area is a circle with a diameter of 1.4 mm, and the second correction area is a concave lens, the thickness of the edge of the concave lens is 37 μm, the thickness at the optical center of the concave lens is 0, and then expands outward from the optical center to a circular hole with a diameter of 0.3 mm. The entire circular hole is a through hole, that is, the thickness is 0; the thickness from the edge of the through hole to the second correction area gradually increases from 0; outside the second correction area is an annular plano area, and the outer diameter of the plano area is 2.0 mm , the thickness of the plano zone is the same as the thickness of the edge of the concave lens of the second correction zone; the outside of the plano zone is the annular first correction zone, the cross section of the first correction zone along the center direction of the annular curvature is the cross section of a convex lens, the thickness of the convex lens of the first correction zone at the junction with the plano zone is the same as that of the plano zone, the outer diameter of the first correction zone is 3.6 mm (i.e., the diameter of the partitioned corneal implant microlens), and the optical center thickness of the convex lens of the first correction zone is 55 μm (i.e., the thickness of the thickest part of the partitioned corneal implant microlens). The preparation material of the partitioned corneal implant microlens is a combination of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocker is 4-propyleneoxy-2-hydroxybenzophenone. The corneal embedded microlens prepared in this embodiment is as shown in the attached Figure 2 middle Figure 2 -B, please see the attached diagram for a simulated diagram of the full-definition visual imaging effect. Figure 5 .
[0074] Example 12
[0075] This embodiment illustrates the incidence of clouding or turbidity after the microlens for partitioned corneal implantation provided in Embodiment 11 is implanted into the cornea of an animal. The details are as follows:
[0076] 1. Test materials and equipment:
[0077] 1. 12 experimental rabbits;
[0078] 2. Test materials: 6 microlenses for partitioned corneal implantation provided in Example 11;
[0079] 3. Comparative material: 6 pieces of partitioned corneal implantable microlenses having the same size as that of the partitioned corneal implantable microlenses provided in Example 11 but without a central hole;
[0080] 4. Normal saline, lidocaine hydrochloride, etc.
[0081] 5. Main equipment: surgical microscope, face opener, ophthalmic separator, implanter, sleeve, surgical instruments, slit lamp, ophthalmic B-ultrasound, etc.
[0082] 2. Test process
[0083] 1. Experimental groups: 6 rabbits in the control group were numbered and implanted with a comparison material (a microlens for partitioned corneal implantation without a central hole); 6 rabbits in the experimental group were numbered and implanted with a test material (a microlens for partitioned corneal implantation with a central hole provided in Example 11).
[0084] 2. Experimental process: The rabbit's eye was cleaned before surgery, and then the corneal stroma pocket was prepared with a scalpel. After the pocket was separated with a separator, the microlens was pushed into the pocket with a surgical implanter. After surgery, the tobramycin dexamethasone eye drops were administered according to the instructions. The rabbit was observed for 12 months after surgery.
[0085] 3. Scoring Criteria
[0086]
[0087] 4. Test results
[0088] The scores were recorded at 3 months, 6 months, and 12 months after surgery as follows:
[0089]
[0090] V. Test Conclusion
[0091] The test results showed that the test rabbits implanted with the partitioned corneal implant microlens with a central hole were completely transparent for 12 consecutive months, and no clouding or corneal opacity occurred. The control group had 3 cases of corneal opacity and clouding at 6 months, and there was a trend of further aggravation at 12 months. Test conclusion The partitioned corneal implant microlens with a central hole provided in Example 11 did not show clouding or corneal opacity for 12 consecutive months.
[0092] Example 13
[0093] This embodiment illustrates a partitioned corneal implantable microlens with ultraviolet blocking function, and evaluates the application effects of the partitioned corneal implantable microlens provided in Embodiments 10 and 11 through aging, transparency, biocompatibility and sustained antibiotic release tests. The details are as follows:
[0094] Test group 1: the partitioned corneal implantable microlens provided in Example 10;
[0095] Test group 2: the partitioned corneal implantable microlens provided in Example 11;
[0096] According to the microlenses for partitioned corneal implantation provided in the corresponding embodiments, each test group is numbered respectively.
[0097] 1. Aging test
[0098] The corneal lenticules were aged at 60°C at an accelerated rate, and samples were taken at 1, 3, 5, 8 and 12 months. The content of UV blockers was measured by spectral analysis to evaluate the aging of the lenticules.
[0099] 2. Transparency, biocompatibility and sustained release of antibiotics
[0100] The antibiotic release duration and transparency of the microlens were investigated.
[0101] 1. Test materials:
[0102] 1) 16 experimental rabbits;
[0103] 2) Normal saline, lidocaine hydrochloride, surgical instruments, slit lamp, ophthalmic B-ultrasound, etc.
[0104] 3) Main equipment: surgical microscope, face opener, ophthalmic separator, implanter, sleeve, etc.
[0105] 2. Test process
[0106] Before surgery, the rabbit's eye was cleaned, a corneal stroma pocket was prepared with a scalpel, the pocket was separated with a separator, and then the microlens was pushed into the pocket with a surgical implanter and centered. Dexamethasone eye drops were applied after surgery.
[0107] Continuous observation was performed after surgery, and antibiotic test results were recorded at 8-12-18-24 hours after surgery, and finally transparency was recorded and observed at 12 months after surgery.
[0108] 3. Transparency Scoring Criteria
[0109]
[0110] 4. Test results
[0111] 4.1 Aging Record
[0112]
[0113] From the test results, it can be seen that there is no premature aging of materials in both test group 1 and test group 2.
[0114] 4.2 Transparency and antibiotic release records
[0115] (1) The corneal transparency scores at 12 months after surgery were as follows:
[0116] Group Experimental Group 1 Experimental Group 2 transparency 0 0
[0117] From the results of this experiment, it can be seen that the corneal transparency of each group was basically the same 12 months after surgery.
[0118] (2) Antibiotic release test results:
[0119]
[0120] From the results of this experiment, we can see that tobramycin was detected in both test group 1 and test group 2 at 2-8-12 hours. Tobramycin was not detected in test group 1 from 18 hours after surgery, but it was still detectable in test group 2.
[0121] 5. Test conclusion
[0122] The test results of this group show that there is no premature aging phenomenon in test group 2, and the biocompatibility is good; the antibiotic release test results show that when the preparation material is selected from test group 2, i.e. "hydroxyethyl methacrylate, methyl methacrylate, 4-propyleneoxy-2-hydroxybenzophenone" as described in Example 11, the tobramycin release time of the microlens can exceed 18 hours. Therefore, the material of test group 2 is better.
[0123] Embodiment 14
[0124] This embodiment illustrates several components of the hydration solution and / or storage solution in a method for preparing a microlens for partitioned corneal implantation with antibiotics, and selects a better hydration solution through comparison. The details are as follows:
[0125] The components of the hydration solution and / or preservation solution exemplified in this embodiment were prepared and tested according to the following test groups.
[0126] Test group 1: containing tobramycin;
[0127] Experimental group 2: containing tobramycin, bFGF, and VB2;
[0128] Test group 3: without any additives (blank control).
[0129] According to the components of the hydration solution shown above, the microlenses for partitioned corneal implantation provided in Example 11 (9 pieces in total) were implanted on the cornea of animals to evaluate the postoperative recovery effect. The details are as follows:
[0130] The components of the microlens for partitioned corneal implantation provided in Example 11 in the hydration solution are replaced with the corresponding components of the above-mentioned test groups. For parameters not recorded in each test group, please refer to Example 11.
[0131] 1. Test materials and equipment
[0132] 1. 9 experimental rabbits;
[0133] 2. Reagents: physiological saline, lidocaine hydrochloride, etc.
[0134] 3. Main equipment: surgical microscope, face opener, ophthalmic separator, implanter, ophthalmic B-ultrasound, slit lamp, etc.
[0135] 2. Test process
[0136] The rabbit's eye was cleaned before surgery, and then a corneal stroma bag was prepared with a scalpel. After the bag was separated with a separator, the microlens was pushed into the bag with a surgical implant. Dexamethasone eye drops were administered according to the instructions. The rabbit was observed for 3 months after surgery. Histological sections were taken at 3 months after surgery to observe the nerve growth.
[0137] Corneal transparency scoring criteria:
[0138]
[0139] 3. Test results
[0140] 1. Corneal transparency observation and record
[0141]
[0142] The results showed that the rabbit eyes of each test group remained completely transparent after surgery, indicating that the corresponding ingredients added to test groups 1 and 2 did not affect the transparency of the rabbit eyes after surgery.
[0143] 2. Observation and recording of nerve fiber growth
[0144] The slices showed that at 1 month, the number of nerves with distortion and increased reflectivity in the plexus images decreased slightly, and this phenomenon decreased significantly at 3 months after surgery, and the plexus tended to the preoperative nerve morphology characteristics; at the same time, there was little difference between experimental groups 1 and 2, and the nerve recovery state of experimental group 3 was slightly lower than that of other experimental groups. It can be seen that the microlens with tobramycin added in the hydration step or tobramycin, bFGF and VB2 added at the same time has a better postoperative effect.
[0145] It should be noted that the above is only a preferred embodiment of the specific implementation of the present invention, and is not a limitation of the technical solution protected by the present invention. Any technician familiar with the technical field, within the scope of the technical solution disclosed by the present invention, who makes equivalent substitutions or changes to the inventive concept of the technical solution of the present invention, should be covered by the protection scope of the present invention.
Claims
1. A microlens for a zoned corneal implant, the microlens being a circular curved surface, the microlens comprising two zones, characterized in that: The two areas are respectively a first correction area and a plano area, the plano area is surrounded by the first correction area, the first correction area and the plano area are concentric, the first correction area has a function of correcting vision, and the refractive power of the plano area is 0D.
2. The microlens for partitioned corneal implantation according to claim 1, characterized in that: The flat light area has a through hole.
3. The microlens for partitioned corneal implantation according to claim 2, characterized in that: The plano zone includes a second correction zone, the second correction zone is circular, a cross section of the second correction zone along the center of the circular curvature is a concave lens cross section, and the second correction zone is surrounded by the remaining plano area of the plano zone.
4. The microlens for partitioned corneal implantation according to claim 2, characterized in that: The first correction zone has a function of correcting vision loss caused by an unhealthy state of the refractive medium, and the second correction zone has a function of correcting vision loss caused by refractive error.
5. The microlens for partitioned corneal implantation according to claim 3, characterized in that: The number of the through hole is 1, the through hole is circular and concentric with the second correction area, and the second correction area is concentric with the flat light area.
6. The microlens for partitioned corneal implantation according to claim 3, characterized in that: The cross section of the first correction zone along the center direction of the annular curvature circle is a convex lens cross section.
7. The microlens for partitioned corneal implantation according to claim 6, characterized in that: The optical center of the concave lens is a through hole, and the diameter of the through hole is 0.01-0.6 mm.
8. The microlens for partitioned corneal implantation according to claim 1, characterized in that: The diameter of the microlens is 2.5-5.5 mm; the thickness of the microlens is 25-63 μm.
9. The microlens for partitioned corneal implantation according to claim 1, characterized in that: The microlens for partitioned corneal implantation has the function of preventing ultraviolet rays from penetrating.
10. Use of the microlens for partitioned corneal implantation according to any one of claims 1 to 9 in a product for correcting vision loss caused by an unhealthy state of a refractive medium and / or in a product for correcting vision loss caused by ametropia.
Citation Information
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