Corneal-embedded microlens, and preparation method therefor and application thereof

Abstract

A circular corneal-embedded microlens, comprising two zones, namely, a first correction zone and a plano zone, preferably comprising three zones, namely, two vision correction zones and one plano zone, wherein the two vision correction zones each have the function of correcting vision, the diopter of the plano zone is 0D, and the plano zone has a through hole. Providing the through hole in the center of the corneal-embedded microlens can reduce the occurrence of post-operative corneal clouding and opacity. After the corneal-embedded microlens is implanted, the patient will have clear vision for both near and distant objects, achieving full-range vision clarity. Further provided are a preparation method for and the use of the corneal-embedded microlens.

Description

A corneal embedded microlens, its fabrication method and application

[0001] This application is based on and claims priority to Chinese Patent Application No. 202411628043.4, filed on November 14, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application belongs to the field of regenerative medicine technology. Specifically, the first aspect of this application relates to a corneal embedded microlens product, the second aspect relates to a method for preparing the corneal embedded microlens product, and the third aspect relates to the application of the corneal embedded microlens in a product for correcting vision loss. Background Technology

[0003] As we age, or due to poor eye habits, vision declines. Presbyopia is a common vision problem. After age 40, the elasticity of the lens in the eye gradually weakens, and the eye's accommodative ability also gradually diminishes. This is the main cause of presbyopia, resulting in blurred vision when looking at close objects. Symptoms of presbyopia include: 1. Difficulty seeing very small print in low light; 2. Maintaining a greater reading distance when reading books or newspapers makes the eyes feel more comfortable; 3. Inability to sustain prolonged writing, reading, or fine motor work; 4. Greater comfort when reading newspapers without glasses; 5. Easily misreading prices when shopping; 6. Greater requirement for brighter light when reading books or newspapers compared to when younger.

[0004] Besides an unhealthy lens causing vision loss, refractive errors can also lead to decreased vision. For example, when the eye is in a relaxed state, parallel light rays entering the eye focus in front of the retina, preventing a clear image from forming on the retina, a condition known as myopia (nearsightedness). An eye exam in this case will indicate the degree of myopia. When the eye is relaxed, parallel light rays entering the eye focus precisely on the retina, forming a clear image; this is called emmetropia (normal vision). If the focus does not fall on the retina, it is called ametropia (non-emmetropia), or refractive error. Therefore, myopia is a symptom of refractive error.

[0005] Intraocular lenses are typically used to correct vision loss caused by unhealthy lens conditions. These lenses are usually inserted into the eye chamber, the eye capsule, 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.

[0006] Intracorneal lenses are typically used to correct vision loss caused by refractive errors. These lenses are inserted into the cornea, not the eye chamber, and are therefore usually smaller than intraocular lenses. Because intracorneal and intraocular lenses are positioned differently relative to the lens, they must have different optical structures to correct vision loss. Chinese patent document CN101896853A discloses an intracorneal lens with a central aperture.

[0007] In the existing technology, no technology has been found that embeds a lens into the cornea to simultaneously correct vision loss caused by unhealthy lens conditions and vision loss caused by refractive errors. Summary of the Invention

[0008] To provide a basic understanding of some aspects of the disclosed embodiments, a brief summary is given below. This summary is not intended as a general commentary, nor is it intended to identify key / important components or describe the scope of protection of these embodiments, but rather as a prelude to the detailed description that follows.

[0009] The first aspect of this application provides a corneal embedded microlens, the microlens being circular and comprising two regions: a first correction region and a plano region. The plano region is surrounded by the first correction region, and the first correction region and the plano region are concentric. The first correction region has the function of correcting visual acuity. The plano region has a refractive power of 0D and has a through-hole.

[0010] The corneal embedded microlens provided in this application includes two regions: a first correction region that corrects visual acuity, and a plano region with a refractive power of 0D that does not correct visual acuity. The first correction region can be used to correct visual acuity loss caused by an unhealthy state of the refractive media or by refractive errors. While the plano region does not correct visual acuity, it allows light to enter the eye parallel to the retina for clear imaging when viewing distant objects. Specifically, regardless of whether the first correction region is used to correct visual acuity loss caused by an unhealthy state of the refractive media or by refractive errors, the plano region allows light to enter the eye parallel to the retina for clear imaging. This ensures that while the first correction region corrects visual acuity, the light entering the eye through the plano region maintains the patient's original visual accommodation ability, thus preventing distance vision loss or compensating for near vision loss. The corneal embedded microlens provided in this application, when used, can modify the specific shape and area ratio between the first corrective zone and the plano zone according to the patient's visual symptoms, thereby maximizing the correction of the patient's visual impairment. It should be noted that the plano zone has a through-hole, which serves two purposes. First, it facilitates surgical marking. Specifically, in clinical application, the corneal embedded microlens provided in this application typically requires the center of the microlens to be on the visual axis; otherwise, the clinical effect of visual correction will be affected. The through-hole provides the surgeon with an accurate reference position, making it easier to find the center of the microlens and accurately position it on the visual axis. Second, after extensive experimentation, the applicant has found that setting a through-hole at the center of the corneal embedded microlens can reduce postoperative corneal clouding and opacity.

[0011] In a preferred embodiment of this application, the plano region of the corneal embedded microlens provided in this application includes a second correction region. The second correction region is circular and surrounded by the plano region, and the through-hole is located within the second correction region. In this preferred embodiment, the corneal embedded microlens has three regions: two vision correction regions and one plano region. The two vision correction regions each have the function of correcting vision, and can be used to correct vision loss caused by an unhealthy state of the refractive media, or to correct vision loss caused by refractive errors. The two vision correction regions can also respectively correct vision loss caused by the above two reasons. Although the plano region does not have the function of correcting vision, it allows light to enter the eye parallel to the retina, thereby alleviating the vision correction function of the first and second correction regions, and also compensating for unclear imaging caused by the self-accommodation function of the lens or refractive system. It should be noted that the second correction area has a through hole, which serves two purposes. First, it facilitates surgical marking. Specifically, since the corneal embedded microlens provided in this application is typically required to have its center on the visual axis during clinical application, otherwise it will affect the clinical effectiveness of visual correction. The through hole can provide the surgeon with an accurate reference position, making it easier to find the center of the microlens and accurately position it on the visual axis. Second, after extensive experimentation, the applicant has found that setting a through hole at the center of the corneal embedded microlens can reduce postoperative corneal clouding and opacity.

[0012] In a preferred embodiment of this application, the first correction zone of the corneal embedded microlens provided by this application has the function of correcting vision loss caused by an unhealthy state of the refractive media, and the second correction zone has the function of correcting vision loss caused by refractive errors. Through extensive experimentation, the applicant has learned that although both the first and second correction zones can simultaneously correct vision loss caused by an unhealthy state of the refractive media, and simultaneously correct vision loss caused by refractive errors, when both the first and second correction zones have the function of correcting vision loss caused by an unhealthy state of the refractive media, the corneal embedded microlens provided by this application can simultaneously correct vision loss caused by both an unhealthy state of the refractive media and vision loss caused by refractive errors, enabling patients to achieve full visual clarity post-surgery. Specifically, vision loss due to an unhealthy state of the refractive media causes patients to see distant objects clearly but near objects blurry. Vision loss due to refractive errors can cause images to focus in front of or behind the retina, resulting in blurred vision. Therefore, after surgical implantation of the corneal in-vessel microlens provided in this application, when viewing near objects, the iris constricts and the pupil narrows, appropriately blocking the cornea surrounding the first correction zone. At this time, all light passing through the first correction zone is corrected, thus compensating for the blurred vision in the plano and second correction zones caused by an unhealthy state of the refractive media and refractive errors, thereby improving postoperative vision. The patient's near vision becomes clearer; when viewing distant objects, the pupil dilates due to iris expansion, and the second correction zone and plano zone work simultaneously, making the patient's distant vision even clearer. Furthermore, due to the stretching of the ciliary muscle when viewing distant objects, some light can enter the eye through the corneal region outside the edge of the first correction zone of the corneal in-eye microlens, increasing the amount of light entering the eye. At the same time, the presence of the plano zone preserves intermediate vision when viewing distant objects. Through these two aspects, the patient's distant vision becomes clearer after surgery. Thus, the patient has clear vision for both near and distant objects after surgery, ultimately achieving full visual clarity.

[0013] In a preferred embodiment of this application, the corneal embedded microlens provided in this application has one through-hole, which is circular and concentric with the second correction zone, and the second correction zone is concentric with the plano zone. Through extensive experimentation, the applicant has concluded that, for the number of through-holes located in the second correction zone, multiple through-holes and one through-hole do not significantly differ in reducing postoperative corneal opacity and cloudiness. Furthermore, when the three regions of the corneal embedded microlens are arranged in the order of "from the center of the corneal embedded microlens outward: second correction zone, plano zone, first correction zone" (i.e., the second correction zone is surrounded by the plano zone, and the plano zone is surrounded by the first correction zone), the corneal embedded microlens can simultaneously correct visual impairment caused by an unhealthy state of the refractive media and visual impairment caused by refractive errors, enabling patients to achieve full visual clarity postoperatively. Specifically, vision loss due to an unhealthy state of the refractive media causes patients to see distant objects clearly but near objects blurry. Vision loss due to refractive errors can cause images to focus in front of or behind the retina, resulting in blurred vision. Therefore, after surgical implantation of the corneal in-vessel microlens provided in this application, when viewing near objects, the iris constricts and the pupil narrows, appropriately blocking light outside the first correction zone. At this time, light passing through both the first and second correction zones is corrected, compensating for the blurred vision in the plano area caused by the unhealthy state of the refractive media, thus improving postoperative vision for the patient. The vision becomes clearer when viewing near objects; when viewing distant objects, due to iris dilation and pupil expansion, the second correction zone and the plano zone work simultaneously, making the patient's vision clearer when viewing distant objects. Furthermore, due to ciliary muscle stretching when viewing distant objects, some light can pass through the area outside the edge of the first correction zone of the corneal inset microlens and enter the eye, increasing the amount of light entering the eye. Simultaneously, the presence of the plano zone preserves intermediate-distance vision when viewing distant objects. Through these two aspects, the patient's vision becomes clearer when viewing distant objects post-surgery. Thus, the patient has clear vision for both near and distant objects post-surgery, ultimately achieving full visual clarity. Therefore, after extensive testing, the applicant concluded that this preferred embodiment is particularly effective in correcting vision loss in patients with both presbyopia and myopia.

[0014] In a non-limiting embodiment of this application, the vision loss caused by the unhealthy state of the refractive medium refers to vision loss caused by the lens due to lack of accommodation, incomplete opacity, or weakened elasticity, such as presbyopia; the vision loss caused by refractive error refers to the inability of parallel light rays to form a clear image on the retina after passing through the eye's refractive system, but instead forming an image in front of or behind the retina, such as hyperopia, myopia, and astigmatism. Thus, the first and second correction zones of the corneal embedded microlens provided in this application respectively have the function of correcting the above two types of vision loss, thereby enabling patients to achieve full vision after surgery.

[0015] After extensive testing, the applicant concluded that when the cross-section of the first correction zone along the direction of the annular curvature center is a convex lens cross-section, it can effectively correct vision loss caused by the unhealthy state of the refractive media. This is because after the patient undergoes surgery to implant the corneal in-vitro lenticule provided in this application, especially when the patient is viewing near objects after surgery, the pupil constricts due to iris contraction, causing the area outside the first correction zone to be appropriately blocked. At this time, the light passing through the first correction zone and the second correction zone will be corrected. The convex lens function of the first correction zone will compensate for the blurred vision in the plano and second correction zones caused by the unhealthy state of the refractive media, thereby making the patient's near vision clearer after surgery.

[0016] In a further preferred embodiment of this application, the cross-section of the first correction zone along the direction of the annular curvature center is a convex lens cross-section, and the cross-section of the second correction zone along the direction of the circular curvature center is a concave lens cross-section. In this embodiment, the corneal embedded microlens provided by this application can effectively correct myopia caused by refractive errors, resulting in clear near vision but blurred distance vision. This is because, after the patient undergoes surgery to implant the corneal embedded microlens provided by this application, especially when the patient is viewing distant objects post-surgery, firstly, due to iris dilation and pupil expansion, the second correction zone, the plano zone, and the first correction zone will all function simultaneously. Furthermore, due to ciliary muscle stretching when viewing distant objects, some light can pass through the corneal embedded microlens. First, the corneal region outside the edge of the second correction zone enters the eye, thus increasing the amount of light entering the eye. Second, due to the presence of the plano zone, the original visual accommodation ability caused by the unhealthy state of the refractive media is preserved, thereby compensating for intermediate-distance vision and the total amount of light entering the eye. Third, since the cross-section of the second correction zone along the center of the circular curvature is a concave lens cross-section, it plays the role of a concave lens in correcting myopia, and the aperture is concentric with the second correction zone, which means that the optical center of the second correction zone (i.e., the concave lens) is the aperture. This avoids light reflection caused by the thickness of the cross-section, thereby avoiding glare. Due to these three factors, the patient's vision of distant objects becomes clearer after surgery.

[0017] After extensive experimentation, the applicant concluded that when the cross-section of the first correction zone along the center of the annular curvature is a convex lens cross-section, the cross-section of the second correction zone along the center 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 an unhealthy refractive medium and myopia caused by refractive errors. This is because presbyopia causes patients to see distant objects clearly but near objects are blurry, while myopia causes patients to see near objects clearly but distant objects are blurry. Therefore, after the patient undergoes surgery to implant the corneal inset microlens provided in this application, when viewing near objects, due to iris contraction and pupil constriction, the area outside the first correction zone is appropriately blocked. At this time, the light passing through both the first and second correction zones will be corrected, and the convex lens function of the first correction zone is restored. This will compensate for the blurred vision caused by presbyopia in the plano and second correction zones, thus making near vision clearer for postoperative patients. When viewing distant objects, due to iris dilation and pupil expansion, the concave lens in the second correction zone, the plano zone, and the convex lens in the first correction zone will all work simultaneously, making distant vision clearer. Furthermore, due to ciliary muscle stretching when viewing distant objects, some light can enter the eye through the area outside the edge of the first correction zone of the corneal embedded microlens, increasing the amount of light entering the eye. At the same time, the presence of the plano zone preserves the relatively clear intermediate-distance vision originally present in presbyopic patients. Through these two aspects, the corneal embedded microlens provided in this application can make distant vision clearer for postoperative patients. In this way, postoperative patients have clear near vision and clear distance vision, ultimately achieving full-clear vision after surgery.

[0018] In a preferred embodiment of this application, the diameter of the corneal embedded microlens is 2.5–5.5 mm, which is related to the individual corneal size of the patient. The applicant has concluded through extensive experiments that the appropriate size of the embedded object 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 partitioned corneal implantation microlens provided in this application, when the diameter is 3.0–4.0 mm and the thickness is 25–55 μm, it is easier to achieve full-clear vision.

[0019] In a preferred embodiment of this application, the number of through holes is one, and the through hole is located at the optical center of the concave lens, i.e., the thinnest part of the concave lens in the second correction zone is 0 mm. Through extensive experimentation, the applicant has found that the diameter of the through hole is related to the occurrence of corneal opacity and cloudiness after surgery. When the surgeon positions the center of the corneal inset microlens (i.e., the center of the second correction zone) on the visual axis, and the through hole diameter is 0.01–0.6 mm, it facilitates the positioning of the corneal inset microlens on the visual axis during clinical transplantation, while also reducing the occurrence of corneal opacity and cloudiness after surgery.

[0020] In a non-limiting embodiment of this application, the applicant selected the preparation material for the corneal inset microlens from the following aspects: first, transparency and biocompatibility; second, corrective effect after transplantation; third, suitable hardness (brittleness) for cutting before transplantation; fourth, hydration rate, i.e., the time required for the adsorbed solute in the hydration solution to reach a stable equilibrium concentration; and fifth, the release duration after binding with postoperative antibiotics. Through extensive experimentation, the applicant concluded that when the preparation material is one or more copolymers of 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, styrene acrylate, and hydroxyethyl methacrylate, the first to fourth conditions can be met; and when the preparation material is hydroxyethyl methacrylate and methyl methacrylate, all five conditions can be met.

[0021] In a non-limiting preferred embodiment of this application, to reduce the damage of ultraviolet light to other intraocular tissues, the applicant added azophenyl methacrylate to the material used to prepare the corneal inset microlens. In a non-limiting preferred embodiment of this application, 4-propenoxy-2-hydroxybenzophenone was added to the material used to prepare the corneal inset microlens. In a non-limiting preferred embodiment of this application, both azophenyl methacrylate and 4-propenoxy-2-hydroxybenzophenone were added to the material used to prepare the corneal inset microlens. Through extensive experimentation, the applicant concluded that adding either azophenyl methacrylate or 4-propenoxy-2-hydroxybenzophenone alone, compared to adding a mixture of both, resulted in better outcomes for the transparency, biocompatibility, sustained antibiotic release, and post-transplantation efficacy of the corneal inset microlens.

[0022] The second aspect of this application provides a method for preparing a corneal embedded microlens, comprising: Step A. Weighing one or more of hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, styrene acrylate, and hydroxyethyl methacrylate to prepare a mixture; Step B. Weighing azophenyl methacrylate and / or 4-propenoxy-2-hydroxybenzophenone and adding them to the solution prepared in Step A; stirring evenly and then adding the mixture to a mold; Step C. Drying at 80-120℃ for 4-8 hours to obtain a clipping material; Step D. Cutting, polishing, and hydrating the clipping material to obtain a corneal embedded microlens.

[0023] In a non-limiting embodiment of this application, the hydration solution used for hydration is a saline solution containing antibiotics. Among numerous materials for preparing corneal in-vitro lenticules, the applicant, in selecting the materials and ultraviolet blocking agents, also considered the strength of the adsorption and binding of these materials to antibiotics and the release rate of the antibiotics, while ensuring postoperative safety.

[0024] Through extensive experimentation, the applicant discovered that when hydroxyethyl methacrylate and methyl methacrylate are selected as the preparation materials, and 4-propenoxy-2-hydroxybenzophenone is chosen as the UV blocker, the negative impact of ultraviolet radiation on the unhealthy state of the refractive media and refractive errors of the refractive system can be effectively reduced, thereby reducing the rate and degree of visual decline in patients, thus satisfying all five conditions mentioned above. Further experimentation revealed that when the mass percentage of hydroxyethyl methacrylate to methyl methacrylate is 3:1 and 4-propenoxy-2-hydroxybenzophenone is selected as the UV blocker, the antibiotic release time can exceed 18 hours, and no corneal opacity or microlenticule opacity was observed postoperatively.

[0025] Through extensive experimentation, the applicant discovered that when hydroxyethyl methacrylate and methyl methacrylate are selected as the preparation materials and 4-propenoxy-2-hydroxybenzophenone is selected as the UV blocker, the two materials are relatively stable when fused together, with no premature aging observed. Furthermore, the softness after hydration is suitable, and the antibiotic release time can exceed 18 hours, which can promote the recovery of corneal transparency and nerve plexus after surgery.

[0026] In a non-limiting embodiment of this application, the mold has a cylinder so that the material for preparing the corneal embedded microlens has a through hole after being formed in the mold. The cylinder of the mold corresponds to the through hole. After a large number of experiments, the applicant concluded that setting the through hole at the center of the corneal embedded microlens can reduce the occurrence of corneal opacity and cloudiness in patients after surgery.

[0027] In a non-limiting preferred embodiment of this application, the cylinder is perpendicular to the mold surface, and the connection between the cylinder and the mold has a circular curvature on a cross-section along the cylinder's axial direction, so that the cross-section of the second correction area after the solution is formed in the mold, along the center of the circular curvature, is a concave lens cross-section. In this case, the second correction area of ​​the corneal embedded microlens prepared using the above mold is a concave lens, and the optical center of the concave lens is a through-hole.

[0028] In a non-limiting preferred embodiment of this application, the mold has a planar outer ring surrounding the second correction area, so that the mixture has a planar region after being formed in the mold. In this case, the second correction area of ​​the corneal embedded microlens prepared with the above mold is surrounded by the planar region.

[0029] In a non-limiting preferred embodiment of this application, the mold has a circular curvature on the cross-section along the cylindrical axis of the outer ring surrounding the plano region, so that the cross-section of the first correction region after the mixture is formed in the mold, along the center of the circular curvature, is a convex lens cross-section. In this case, the plano region of the corneal embedded microlens prepared using the above mold is surrounded by the first correction region, and the first correction region is a convex lens.

[0030] In a non-limiting embodiment of this application, in the above-described method for preparing corneal embedded microlenses, the hydration solution used in the hydration step is a saline solution containing antibiotics. Hydration refers to placing the shaped and polished microlens into a saline solution, allowing the microlens to absorb water and recover in an isotonic environment similar to that of the human cornea, thereby making the corneal embedded microlens soft and similar in water content to that of the human cornea. Through extensive experimentation, the applicant has concluded that using a saline solution containing antibiotics in the hydration process allows the antibiotics to bind with the materials used in preparing the corneal embedded microlens in a saline environment. Furthermore, after the microlens is implanted into the patient's cornea, it can continuously release antibiotics for more than 18 hours, thus reducing the amount of antibiotics the patient needs post-surgery and avoiding the overall impact of antibiotic use on the patient's health.

[0031] After extensive testing, the applicant concluded that, in addition to antibiotics, when the hydration solution also contains one or more of the following components: chondroitin sulfate, dextran 70, or hydroxypropyl methylcellulose E4M, and simultaneously contains one or more of the following components: bFGF, VB6, and VB12, rabbit eye transplantation experiments have shown that the rabbit eye can always remain completely transparent, and the nerve plexus morphology is similar to that of the preoperative nerve morphology 3 months after the rabbit eye surgery.

[0032] In a preferred embodiment of this application, the concentration of the hydrated solution is 3 mg / ml when it contains tobramycin, 1 mg / ml when it contains chondroitin sulfate, 1 mg / ml when it contains dextran 70, 3 mg / ml when it contains hydroxypropyl methylcellulose E4M, 4000 IU / ml when it contains bFGF, 50 mg / ml when it contains VB6, and 0.2 mg / ml when it contains VB12.

[0033] In a non-limiting preferred embodiment of this application, after a corneal in-vitro lenticule is prepared using the method provided in this application, the cornea is preferably placed in a solution containing all the components of the hydration solution during subsequent storage and transportation of the corneal in-vitro lenticule. That is, the cornea is placed in a solution containing all the components of the hydration solution used in the preparation of the corneal in-vitro lenticule during storage and transportation. The applicant has found that this ensures that the antibiotics and other components adsorbed on the cornea are not diluted during use, thereby ensuring that these components function effectively after surgery.

[0034] In a non-limiting preferred embodiment of this application, the mold is circular, with a diameter of 10-18 mm and a thickness of 3-8 mm. Since the larger the size of the material made using the mold, the more material needs to be cut away during the cutting step to produce the corneal embedded microlens, this not only results in material waste but also reduces cutting efficiency, thus affecting the production efficiency of the corneal embedded microlens product. However, through extensive experimentation, the applicant has concluded that when the mold diameter is 10-18 mm and the mold thickness is 3-8 mm, material waste can be reduced while maintaining production efficiency.

[0035] The third aspect of this application provides the use of corneal-embedded microlenses in products for correcting vision loss caused by unhealthy conditions of the refractive media. The third aspect of this application also provides the use of corneal-embedded microlenses in products for correcting vision loss due to refractive errors.

[0036] The corneal embedded microlens provided in this application includes two regions and a through-hole. Since the first correction region corrects vision loss caused by an unhealthy refractive media or by refractive errors, and the plano region has a refractive power of 0D, after implantation of this corneal embedded microlens, regardless of whether the first correction region is used to correct vision loss caused by an unhealthy refractive media or by refractive errors, the plano region allows light to enter the eye parallel to the retina, achieving clear imaging. This ensures that while the first correction region corrects vision, light entering the eye through the plano region can maintain the patient's original visual accommodation. The applicant, after extensive experimentation, found that placing a through-hole at the center of the corneal embedded microlens not only facilitates surgical marking but also reduces postoperative corneal clouding and opacity.

[0037] In a preferred embodiment of this application, the plano zone of the corneal embedded microlens further includes a second correction zone. In this case, the corneal embedded microlens has three regions: two vision correction zones and one plano zone. From the center of the corneal embedded microlens outward, 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, which is located between the two correction zones, does not have the function of correcting vision, it can allow light to enter the eye parallel to the retina. Thus, while alleviating the vision correction function of the first correction zone, it can also compensate for the unclear imaging caused by the self-accommodation function of the lens or refractive system. In particular, after implantation in the patient's non-dominant eye, when viewing near objects, due to iris contraction and pupil constriction, the area outside the first correction zone is appropriately blocked. At this time, all light passing through the first correction zone is corrected, thus compensating for the blurred vision in the plano and second correction zones caused by unhealthy refractive media and refractive errors, resulting in clearer near vision post-surgery. When viewing distant objects, due to iris dilation and pupil expansion, both the second correction zone and the plano zone function simultaneously. Due to ciliary muscle stretching, some light can pass through the area outside the edge of the first correction zone of the corneal inset microlens into the eye, increasing the amount of light entering the eye. Simultaneously, the light from the plano and pupil dilates. The presence of the plano-vision zone preserves intermediate-distance vision when viewing distant objects. Through these two aspects, the non-dominant eye becomes clearer when viewing distant objects after surgery. In addition, when the human body sees objects with both eyes, if the clarity of the two eyes differs (the eye with the clear image is the dominant eye, and the eye with the relatively unclear image is the non-dominant eye), the human body will actively select the clear image as the dominant image and appropriately ignore the visual experience of the unclear image. Therefore, after the corneal in-set microlens provided in this application is implanted into the non-dominant eye of the patient, the patient can see near objects clearly and also see distant objects clearly after surgery, ultimately achieving full-clear vision. Please see the attached figure 5 for a simulation illustration of the visual effect.

[0038] The above general description and the description below are exemplary and illustrative only and are not intended to limit this application. Attached Figure Description

[0039] One or more embodiments are illustrated by way of example with reference to the accompanying drawings. These illustrations and drawings do not constitute a limitation on the embodiments, and wherein:

[0040] Figure 1 is an enlarged schematic diagram of the corneal embedded microlens provided in this application.

[0041] Figure 2: A perpendicular cross-section through the optical center of the corneal embedded microlens provided in this application (four examples). Figure 3: Schematic diagram of the working principle of the corneal embedded microlens provided in Example 10 of this application when implanted into the patient's cornea for near vision. Figure 4: Schematic diagram of the working principle of the corneal embedded microlens provided in Example 10 of this application when implanted into the patient's cornea for distance vision. Figure 5: Simulation diagram of the binocular vision effect after the corneal embedded microlens provided in Example 11 of this application is implanted into the patient's cornea. Figure 6: Flowchart of the fabrication method of the corneal embedded microlens provided in this application. Detailed Implementation

[0042] To provide a more detailed understanding of the features and technical content of the embodiments of this disclosure, the implementation of the embodiments of this disclosure will be described in detail below with reference to the accompanying drawings. The accompanying drawings are for illustrative purposes only and are not intended to limit the embodiments of this disclosure. In the following technical description, for ease of explanation, several details are used to provide a full understanding of the disclosed embodiments. However, one or more embodiments may still be implemented without these details.

[0043] Any reference to prior art in the specification is not and should not be construed as an admission or in any way an implication that such prior art constitutes part of the general common knowledge in the application region or any other jurisdiction, or that such prior art could be reasonably understood and regarded as relevant by a person skilled in the art.

[0044] The term "corneal embedded microlens" in the specification, claims, and accompanying drawings of this disclosure refers to a membrane that can be embedded in the corneal stroma and can correct vision.

[0045] In this embodiment of the disclosure, "concentric" refers to the situation where the centroids or centers of two or more regions (such as circles) coincide.

[0046] The "optical center" mentioned in the embodiments of this disclosure 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 refracting surfaces coincide. The characteristic of the optical center is that the direction of light propagation through this point remains unchanged.

[0047] The term "curvature" in this disclosure refers to the curvature of a curve in a mathematical sense, used to indicate the degree of bending of the curve at a certain point. The greater the curvature, the greater the degree of bending of the curve.

[0048] The "concave lens" described in this disclosure refers to a concave lens in the optical sense, meaning a lens that is thinner in the middle and thicker at the edges, forming a concave shape. The concave lens described in this disclosure includes lenses with one flat surface and one concave surface, and lenses with both concave surfaces.

[0049] The "convex lens" described in this disclosure refers to a convex lens in the optical sense, meaning a lens that is thicker in the middle and thinner at the edges, exhibiting a convex shape. The convex lens described in this disclosure includes lenses with one flat surface and another convex surface, as well as lenses with both surfaces being convex. The convex lens is a complete convex lens along the direction perpendicular to the principal optical axis, and also includes incomplete convex lenses along the same direction, including lenses that are half-convex lenses along the same direction, where the thickest part of the convex lens is the same as the thickness of the flat optical region.

[0050] The "refractive media" mentioned in the embodiments of this disclosure refers to medically significant refractive media such as the lens and vitreous body.

[0051] The "unhealthy state of the refractive media" mentioned in this disclosure refers to vision loss caused by a lack of accommodation, incomplete opacity, and reduced elasticity of the lens, such as presbyopia.

[0052] The "refractive error" described in this disclosure refers to the inability of parallel light rays to form a clear image on the retina after passing through the eye's refractive power, instead forming an image in front of or behind the retina.

[0053] The "decreased vision" described in this disclosure refers to the phenomenon where, compared to normal vision of 1.0, vision testing shows that the vision is less than 1.0, resulting in blurred vision and difficulty in distinguishing small or distant objects.

[0054] The "mold" mentioned in this disclosure refers to the mold and tool used in industrial production to make shaped articles, that is, the tool that makes the blank into a part with a specific shape and size under the action of external force.

[0055] In this embodiment of the disclosure, "VB12" refers to vitamin B12.

[0056] The “bFGF” mentioned in this disclosure refers to basic fibroblast growth factor.

[0057] It should be noted that, unless otherwise specified, the embodiments and features described in the present disclosure can be combined with each other.

[0058] The following description, in conjunction with the accompanying drawings, further illustrates non-limiting embodiments of this application, using experimental rabbits instead of human patients to explain the specific steps of the parameters and preparation method of the corneal embedded microlens provided by this application. It should be noted that the specific embodiments described below are merely illustrative and should not be construed as limiting the technical solution of this application.

[0059] Example 1

[0060] This embodiment illustrates a corneal embedded microlens. The microlens is circular and includes two regions: a first corrective region and a plano region. The plano region is surrounded by the first corrective region, and the first corrective region and the plano region are concentric. The first corrective region has the function of correcting visual acuity, and the plano region has a refractive power of 0D. The plano region has a through-hole. The first corrective region can be used to correct visual acuity loss caused by an unhealthy state of the refractive media or by refractive errors. The plano region does not have the function of correcting visual acuity. When using the corneal embedded microlens provided in this embodiment, the specific shape of the first corrective region and the plano region, as well as their area ratio, can be changed according to the patient's visual symptoms, thereby maximizing the correction of the patient's visual acuity loss symptoms.

[0061] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0062] Example 2

[0063] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, the microlens includes two regions: a "first correction zone" and a "plano zone." The first correction zone corrects vision loss caused by an unhealthy state of the refractive media, while the plano zone does not correct vision. The plano zone is a circle with a diameter of 2 mm and a thickness of 25 μm. Outside the plano zone is an annular first correction zone. The inner circumference of the first correction zone has the same thickness as the plano zone, and the outer diameter of the first correction zone is 4 mm (i.e., the diameter of the corneal embedded microlens). The maximum thickness of this corneal embedded microlens is 54 μm.

[0064] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0065] Example 3

[0066] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outwards: second correction zone, plano zone, and first correction zone. The first correction zone corrects vision loss caused by an unhealthy state of the refractive media, the plano zone does not correct vision, and the second correction zone corrects vision loss caused by refractive errors. The corneal embedded microlens is circular. The second correction zone is a circle with a diameter of 1.5 mm and a maximum thickness of 30 μm. Outside the second correction zone is a ring-shaped plano zone with an outer diameter of 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 a ring-shaped first correction zone with an outer diameter of 4.5 mm (i.e., the diameter of the corneal embedded microlens). The thickness of the inner circumference of the first correction zone is the same as the thickness of the plano zone.

[0067] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0068] Example 4

[0069] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outward: second correction zone, plano zone, and first correction zone. The first correction zone corrects vision loss caused by an unhealthy state of the refractive media. The plano zone does not correct vision. The second correction zone also corrects vision loss caused by an unhealthy state of the refractive media. The corneal embedded microlens is circular. The second correction zone is a circle with a diameter of 2 mm and a maximum thickness of 42 μm. Outside the second correction zone is a ring-shaped plano zone with an outer diameter of 3 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 a ring-shaped first correction zone with an outer diameter of 4.2 mm (i.e., the diameter of the corneal embedded microlens). The thickness of the inner circumference of the first correction zone is the same as the thickness of the plano zone.

[0070] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0071] Example 5

[0072] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outwards: second correction zone, plano zone, and first correction zone. The first correction zone corrects vision loss caused by an unhealthy state of the refractive media, the plano zone does not correct vision, and the second correction zone corrects vision loss caused by refractive errors. The corneal embedded microlens is circular. The second correction zone is a circle with a diameter of 1.5 mm and a maximum thickness of 54 μm. Outside the second correction zone is a ring-shaped plano zone with an outer diameter of 2 mm and a thickness equal to the edge thickness of the second correction zone. Outside the plano zone is a ring-shaped first correction zone with an outer diameter of 3.8 mm (i.e., the diameter of the corneal embedded microlens). The inner circumference thickness of the first correction zone is the same as the thickness of the plano zone.

[0073] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0074] Example 6

[0075] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, and taking Figure 1 as an example, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outwards: second correction zone S3, plano zone S2, and first correction zone S1. The corneal embedded microlens is circular. The second correction zone S3 is a circle with a diameter of 1.5 mm and is a concave lens with an edge thickness of 45 μm. The thickness at the optical center of the concave lens is 0 μm. Extending outwards from the optical center, a circular hole with a diameter of 0.4 mm is formed. This entire circular hole is a through-hole SH, meaning its thickness is 0 μm. The thickness of the through-hole SH gradually increases from 0 μm to the second correction zone. Outside the second correction zone S3 is the annular plano zone S2, with an outer diameter of 2.5 mm. The thickness of the plano zone S2 is the same as the thickness of the edge of the concave lens in the second correction zone S3; outside the plano zone S2 is the annular first correction zone S1, and the cross section of the first correction zone S1 along the direction of the center of the annular curvature is the cross section of a convex lens. The thickness of the convex lens in the first correction zone S1 at the junction with the plano zone S2 is the same as that of the plano zone S2. The outer diameter of the first correction zone S1 is 4.0 mm (i.e., the diameter of the corneal embedded microlens), and the optical center thickness of the convex lens in the first correction zone S1 is 54 μm (i.e., the thickness of the thickest part of the corneal embedded microlens).

[0076] It should be noted that in the three regions of the corneal embedded microlens in this embodiment, the concave lens and the convex lens respectively include the four cases shown in Figure 2, that is, one of the two sides of the concave lens (or convex lens) is a plane and the other side is a concave surface (or a convex surface), and also includes the case where both sides are concave surfaces (or convex surfaces).

[0077] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0078] Example 7

[0079] This embodiment illustrates a corneal embedded microlens. Based on embodiment 1, the corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outward: second correction zone, plano zone, and first correction zone. The corneal embedded microlens is circular. The second correction zone is a 1.5mm diameter circle and is a concave lens with an edge thickness of 47μm and a zero thickness at the optical center. Extending outwards from the optical center, it forms a 0.35mm diameter circular aperture, which is a through-hole with a thickness of zero. The thickness of the second correction zone gradually increases from zero at the edge of the through-hole. Outside the second correction zone is a ring-shaped plano zone with an outer diameter of 2.5mm and a thickness equal to that of the concave lens edge. Outside the plano zone is a ring-shaped first correction zone. The cross-section of the first correction zone along the direction of the ring's curvature is a convex lens cross-section. The junction of the convex lens in the first correction zone with the plano zone has the same thickness as the plano zone. The outer diameter of the first correction zone is 4.5mm (the diameter of the corneal embedded microlens), and the optical center thickness of the convex lens in the first correction zone is 63μm (the thickness at the thickest point of the corneal embedded microlens). The corneal embedded microlens is made of one or more of the following materials: hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, and styrene acrylate.

[0080] It should be noted that in the three regions of the corneal embedded microlens in this embodiment, the concave lens and the convex lens respectively include the four cases shown in Figure 2, that is, one of the two sides of the concave lens (or convex lens) is a plane and the other side is a concave surface (or a convex surface), and also includes the case where both sides are concave surfaces (or convex surfaces).

[0081] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0082] Example 8

[0083] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outwards: second correction zone, plano zone, and first correction zone. The corneal embedded microlens is circular. The second correction zone is a 2mm diameter circle and is a concave lens with an edge thickness of 48μm. The thickness at the optical center of the concave lens is 0. Extending outwards from the optical center, it extends to a 0.6mm diameter circular aperture. This aperture is entirely through-hole, meaning its thickness is 0. The thickness from the edge of the through-hole to the second correction zone gradually increases from 0. Outside the second correction zone is a ring-shaped plano zone. The first corrective lens has a diameter of 2.5 mm and a thickness in the plano zone that is the same as the thickness of the concave lens edge in the second corrective zone. Outside the plano zone is a ring-shaped first corrective zone. The cross-section of the first corrective zone along the center of the ring's curvature is a convex lens cross-section. The thickness of the convex lens in the first corrective zone at its junction with the plano zone is the same as that of the plano zone. The outer diameter of the first corrective zone is 3.8 mm (i.e., the diameter of the corneal embedded microlens), and the optical center thickness of the convex lens in the first corrective zone is 62 μm (i.e., the thickness at the thickest point of the corneal embedded microlens). The corneal embedded microlens is made of one or more of the following materials: hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, and styrene acrylate. The ultraviolet blocking agent for the corneal embedded microlens is azophenyl methacrylate and / or 4-acryloxy-2-hydroxybenzophenone.

[0084] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0085] Example 9

[0086] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outwards: second correction zone, plano zone, and first correction zone. The corneal embedded microlens is circular. The second correction zone is a circle with a diameter of 1.5 mm and is a concave lens. The thickness of the concave lens edge is 34 μm, and the thickness at the optical center is 0 μm. Extending outwards from the optical center, a circular aperture with a diameter of 0.3 mm is formed. This entire aperture is a through-hole, meaning its thickness is 0 μm. The thickness from the edge of the through-hole to the second correction zone gradually increases from 0 μm. Outside the second correction zone is a ring-shaped plano zone. The diameter of the circular area is 2.0 mm. The thickness of the plano area is the same as the thickness of the edge of the concave lens in the second correction area. Outside the plano area is the annular first correction area. The cross-section of the first correction area along the center of the annular curvature is the cross-section of a convex lens. The thickness of the convex lens in the first correction area at the junction with the plano area is the same as that of the plano area. The outer diameter of the first correction area is 3.3 mm (i.e., the diameter of the corneal embedded microlens). The optical center thickness of the convex lens in the first correction area is 52 μm (i.e., the thickness at the thickest point of the corneal embedded microlens). The corneal embedded microlens is made of a combination of hydroxyethyl methacrylate and methyl methacrylate, and the ultraviolet blocking agent is 4-propenoxy-2-hydroxybenzophenone.

[0087] It should be noted that in the three regions of the corneal embedded microlens in this embodiment, the concave lens in the second correction region and the convex lens in the first correction region respectively include the four cases shown in Figure 2, that is, one of the two sides of the concave lens (or convex lens) is a plane and the other side is a concave surface (or a convex surface), and also includes the case where both sides are concave surfaces (or convex surfaces).

[0088] Materials, conditions, and parameters not described in this embodiment can be selected by those skilled in the art through creative effort to implement the invention, thereby obtaining corneal embedded microlenses with vision-correcting effects.

[0089] Example 10

[0090] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, this corneal embedded microlens has three regions: two correction zones and one plano zone. The three regions are arranged in the following order from the center of the corneal embedded microlens outwards: second correction zone, plano zone, and first correction zone. The corneal embedded microlens is circular. The second correction zone is a circle with a diameter of 1.6 mm and is a concave lens with an edge thickness of 48 μm. The thickness at the optical center of the concave lens is 0 μm. Extending outwards from the optical center, a circular aperture with a diameter of 0.2 mm is formed. This aperture is entirely through-hole, meaning its thickness is 0 μm. The thickness from the edge of the through-hole to the second correction zone gradually increases from 0 μm. Outside the second correction zone is a ring-shaped plano zone. The first corrective lens has a diameter of 2.2 mm and a thickness in the plano zone that is the same as the thickness of the concave lens edge in the second corrective zone. Outside the plano zone is a ring-shaped first corrective zone. The cross-section of the first corrective zone along the center of the ring's curvature is a convex lens cross-section. The thickness of the convex lens in the first corrective zone at its junction with the plano zone is the same as the plano zone. The outer diameter of the first corrective zone is 3.4 mm (i.e., the diameter of the corneal embedded microlens), and the optical center thickness of the convex lens in the first corrective zone is 67 μm (i.e., the thickness at the thickest point of the corneal embedded microlens). The corneal embedded microlens is made of a combination of hydroxyethyl methacrylate and methyl methacrylate in a mass ratio of 3:1, and 4-propenoxy-2-hydroxybenzophenone is added as an ultraviolet blocking agent.

[0091] It should be noted that in the three regions of the corneal embedded microlens in this embodiment, the concave lens in the second correction region and the convex lens in the first correction region respectively include the four cases shown in Figure 2, that is, one of the two sides of the concave lens (or convex lens) is a plane and the other side is a concave surface (or a convex surface), and also includes the case where both sides are concave surfaces (or convex surfaces).

[0092] Example 11

[0093] This embodiment illustrates a corneal embedded microlens. Based on Embodiment 1, the corneal embedded microlens is prepared using one or more of the following materials: hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, styrene acrylate, and hydroxyethyl methacrylate. Furthermore, the ultraviolet blocking agent azophenyl methacrylate and / or 4-acryloxy-2-hydroxybenzophenone are added to the prepared material. This corneal embedded microlens has three regions: two correction zones and one plano zone. The arrangement of the three regions, from the center of the corneal embedded microlens outwards, is: second correction zone, plano zone, and first correction zone. The corneal embedded microlens is circular. The second correction zone is a 1.4mm diameter circle and is a concave lens with an edge thickness of 37μm. The thickness at the optical center of the concave lens is 0μm. Extending outwards from the optical center, a 0.3mm diameter circular aperture is formed. This aperture is entirely through-hole, meaning its thickness is 0μm. The thickness gradually increases from the edge of the through-hole to the second correction zone. Outside the second correction zone is a ring-shaped plano zone. The diameter of the circular area is 2.0 mm. The thickness of the plano zone is the same as the thickness of the edge of the concave lens in the second correction zone. Outside the plano zone is the annular first correction zone. The cross-section of the first correction zone along the center of the annular curvature is the cross-section of a convex lens. The thickness of the convex lens in the first correction zone is the same as that of the plano zone at the junction with the plano zone. The outer diameter of the first correction zone is 3.5 mm (i.e., the diameter of the corneal embedded microlens). The optical center thickness of the convex lens in the first correction zone is 55 μm (i.e., the thickness at the thickest point of the corneal embedded microlens). The corneal embedded microlens is made of a combination of hydroxyethyl methacrylate and methyl methacrylate in a mass ratio of 3:1. The ultraviolet blocking agent of the corneal embedded microlens is 4-propenoxy-2-hydroxybenzophenone.

[0094] The corneal embedded microlens prepared in this embodiment is shown in Figure 2-B of Figure 2. The simulation diagram of its full-clear visual imaging effect is shown in Figure 5.

[0095] Example 12

[0096] This embodiment illustrates a method for preparing a corneal embedded microlens, specifically as follows: Step A. Weigh 75g of hydroxyethyl methacrylate, 5g of 2-phenoxyethyl acrylate, and 22g of ethylene glycol dimethacrylate; Step B. Weigh 0.9g of 4-propenoxy-2-hydroxybenzophenone and add it to the solution prepared in Step A; stir evenly and pour into a mold; Step C. Dry at 80-120℃ for 4-8 hours to obtain a clipping material; Step D. Cut and polish the clipping material using a machine tool to obtain a circular corneal embedded microlens with a diameter of 4.2mm. The second correction area of ​​the corneal embedded microlens is a circle with a diameter of 1.6 mm, and the second correction area is a concave lens with an edge thickness of 47 μm. The optical center of the concave lens is a through hole. Since the above mold has a cylinder with a diameter of 0.5 mm, the corneal embedded microlens prepared in this embodiment has a circular through hole of the same diameter after molding. Outside the second correction area is an annular plano area with an outer diameter of 2.4 mm. The inner circle of the annular plano area is the circumferential edge of the second correction area, and the thickness of the plano area is the same as the thickness of the edge of the concave lens in the second correction area. Outside the plano area is an annular first correction area. The cross-section of the first correction area along the direction of the annular curvature center is a convex lens cross-section. The thickness of the convex lens in the first correction area at the junction with the plano area is the same as the thickness of the plano area. The outer diameter of the first correction area is the diameter of the corneal embedded microlens, and the optical center thickness of the convex lens in the first correction area is 57 μm (i.e., the thickness of the thickest part of the corneal embedded microlens). The prepared corneal in-situ microlens was hydrated in a saline solution containing 3 mg / ml tobramycin. The microlens was then placed in the hydration solution. Step E: Packaging, storage, and transportation, during which the cornea was placed in a solution containing all the components of the hydration solution. The microlens was removed from the packaging and used directly before clinical use.

[0097] Materials, conditions, and parameters not described in this embodiment can be implemented by those skilled in the art through creative effort by selecting reagents, materials, parameters, and specific settings. For example, the size and surface smoothness of the corneal embedded microlens after molding can be changed by adjusting the diameter and thickness of the mold, the diameter of the cylinder in the mold, and the smoothness of the mold surface, thereby obtaining corneal embedded microlenses with vision-correcting effects suitable for different patients.

[0098] Example 13

[0099] This embodiment illustrates a method for preparing a corneal embedded microlens, specifically as follows: Step A. Weigh 60g of hydroxyethyl methacrylate, 15g of 2-phenoxyethyl acrylate, and 5g each of ethylene glycol dimethacrylate; Step B. Weigh 0.35g of azophenyl methacrylate and 0.35g of 4-propenoxy-2-hydroxybenzophenone and add them to the mixture prepared in Step A; stir evenly and pour into a mold; Step C. Dry at 80-120℃ for 4-8 hours to obtain a clipping material; Step D. Cut and polish the clipping material using a machine tool to obtain a circular corneal embedded microlens with a diameter of 3.8mm. The second correction area of ​​the corneal embedded microlens is a circle with a diameter of 1.4 mm, and the second correction area is a concave lens with an edge thickness of 44 μm. The optical center of the concave lens is a through hole. Since the above mold has a cylinder with a diameter of 0.3 mm, the corneal embedded microlens prepared in this embodiment has a circular through hole of the same diameter after molding. Outside the second correction area is an annular plano area with an outer diameter of 2.4 mm. The inner circle of the annular plano area is the circumferential edge of the second correction area, and the thickness of the plano area is the same as the thickness of the edge of the concave lens in the second correction area. Outside the plano area is an annular first correction area. The cross-section of the first correction area along the direction of the annular curvature center is a convex lens cross-section. The thickness of the convex lens in the first correction area at the junction with the plano area is the same as the thickness of the plano area. The outer diameter of the first correction area is the diameter of the corneal embedded microlens, and the optical center thickness of the convex lens in the first correction area is 54 μm (i.e., the thickness of the thickest part of the corneal embedded microlens). The prepared corneal in-situ microlens was hydrated in a saline solution containing 3 mg / ml tobramycin. The microlens was then placed in the hydration solution. Step E: Packaging, storage, and transportation, during which the cornea was placed in a solution containing all the components of the hydration solution. The microlens was removed from the packaging and used directly before clinical use.

[0100] Materials, conditions, and parameters not described in this embodiment can be implemented by those skilled in the art through creative effort by selecting reagents, materials, parameters, and specific settings. For example, the size and surface smoothness of the corneal embedded microlens after molding can be changed by adjusting the diameter and thickness of the mold, the diameter of the cylinder in the mold, and the smoothness of the mold surface, thereby obtaining corneal embedded microlenses with vision-correcting effects suitable for different patients.

[0101] Example 14

[0102] This embodiment illustrates a method for preparing a corneal embedded microlens, specifically as follows: Step A. Weigh 90 grams of hydroxyethyl methacrylate and 30 grams of methyl methacrylate; Step B. Weigh 1.2 grams of 4-propenoxy-2-hydroxybenzophenone and add it to the mixture prepared in Step A; stir evenly and pour into a mold; Step C. Dry at 80-120℃ for 4-8 hours to obtain a clipping material; Step D. Cut and polish the clipping material using a machine tool to obtain a circular corneal embedded microlens with a diameter of 3.5 mm. The second correction area of ​​the corneal embedded microlens is a circle with a diameter of 1.6 mm, and the second correction area is a concave lens with an edge thickness of 36 μm. The optical center of the concave lens is a through hole. Since the above mold has a cylinder with a diameter of 0.5 mm, the corneal embedded microlens prepared in this embodiment has a circular through hole of the same diameter after molding. Outside the second correction area is an annular plano area with an outer diameter of 2.1 mm. The inner circle of the annular plano area is the circumferential edge of the second correction area, and the thickness of the plano area is the same as the thickness of the edge of the concave lens in the second correction area. Outside the plano area is an annular first correction area. The cross-section of the first correction area along the direction of the annular curvature center is a convex lens cross-section. The thickness of the convex lens in the first correction area at the junction with the plano area is the same as the thickness of the plano area. The outer diameter of the first correction area is the diameter of the corneal embedded microlens, and the optical center thickness of the convex lens in the first correction area is 56 μm (i.e., the thickness of the thickest part of the corneal embedded microlens). The prepared corneal in-situ microlens was hydrated in a saline solution containing 3 mg / ml tobramycin. The microlens was then placed in the hydration solution. Step E: Packaging, storage, and transportation, during which the cornea was placed in a solution containing all the components of the hydration solution. The microlens was removed from the packaging and used directly before clinical use.

[0103] Materials, conditions, and parameters not described in this embodiment can be implemented by those skilled in the art through creative effort by selecting reagents, materials, parameters, and specific settings. For example, the size and surface smoothness of the corneal embedded microlens after molding can be changed by adjusting the diameter and thickness of the mold, the diameter of the cylinder in the mold, and the smoothness of the mold surface, thereby obtaining corneal embedded microlenses with vision-correcting effects suitable for different patients.

[0104] Example 15

[0105] This embodiment illustrates the incidence of corneal opacity or cloudiness after implantation of the corneal-embedded microlens prepared by the method provided in Example 14 into the cornea of ​​an animal. Details are as follows:

[0106] I. Experimental Materials and Equipment:

[0107] 1. Twelve rabbits were used in the experiment;

[0108] 2. Experimental materials: Six corneal embedded microlenses prepared by the method in Example 14;

[0109] 3. Comparative materials: Six corneal embedded microlenses with the same dimensions as those prepared in Example 14 but without a central hole;

[0110] 4. Physiological saline, lidocaine hydrochloride, etc.

[0111] 5. Main equipment: surgical microscope, facial incision device, ophthalmic separator, implanter, sling, surgical instruments, slit lamp, ophthalmic B-ultrasound, etc.

[0112] II. Experimental Procedure

[0113] 1. Experimental groups: 6 rabbits in the control group were numbered and implanted with the control material (corneal embedded microlens without a central hole); 6 rabbits in the experimental group were numbered and implanted with the experimental material (corneal embedded microlens with a central hole prepared by the method in Example 14).

[0114] 2. Experimental Procedure: The operated eyes of the rabbits were cleaned before surgery. A corneal stromal capsule was then prepared using a scalpel. After separating the capsule with a separator, a microlens was inserted into the capsule using a surgical implanter. Postoperatively, tobramycin-dexamethasone eye drops were administered according to the instructions. The rabbits were observed for 12 months postoperatively.

[0115] III. Scoring Criteria

[0116] IV. Test Results

[0117] The scores were recorded at 3 months, 6 months, and 12 months post-surgery, as follows:

[0118] V. Experimental Conclusions

[0119] The experimental results showed that the rabbits implanted with the corneal inset microlens with a central hole remained completely transparent for 12 consecutive months, without any corneal opacity or clouding. In the control group, three cases of corneal opacity and clouding occurred at 6 months, and these conditions tended to worsen further at 12 months. The experimental conclusion is that the corneal inset microlens with a central hole prepared in Example 14 did not exhibit corneal opacity or clouding for 12 consecutive months.

[0120] Example 16

[0121] This embodiment illustrates a method for fabricating a corneal embedded microlens with ultraviolet blocking function, and evaluates the fabrication materials and method of the corneal embedded microlens through aging, hydration, transparency, biocompatibility, and sustained antibiotic release tests. Details are as follows:

[0122] Experimental Group 1: The materials used for preparation were a combination of "2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, and 4-propenoxy-2-hydroxybenzophenone";

[0123] Experimental Group 2: The materials used for preparation were a combination of "hydroxyethyl methacrylate, methyl methacrylate, and 4-propenoxy-2-hydroxybenzophenone";

[0124] Experimental Group 3: The materials used for preparation were a combination of methyl methacrylate, styrene acrylate, and 4-propenoxy-2-hydroxybenzophenone;

[0125] Experimental Group 4: The materials used for preparation were a combination of "polymethyl methacrylate, ethylene glycol dimethacrylate, and azophenyl methacrylate";

[0126] Experimental Group 5: The materials used for preparation were a combination of "styrene acrylate, 2-phenoxyethyl acrylate, and azophenyl methacrylate";

[0127] Following the preparation method provided in Example 14, the materials for preparing corneal embedded microlenses and the ultraviolet blocking agent were replaced with the corresponding materials of the above-mentioned experimental groups. The materials and parameters not recorded in each experimental group were prepared according to the description in Example 14, and corneal embedded microlenses with the corresponding experimental group numbers were obtained.

[0128] I. Experimental Methods

[0129] 1. Aging test

[0130] Corneal embedded microlenses were aged at 60°C, and samples were taken at 1, 3, 5, 8 and 12 months. The content of ultraviolet blocking agent was measured by spectral analysis to evaluate the aging of the microlenses.

[0131] 2. Softness test

[0132] Compare the results after testing the softness.

[0133] 3. Transparency, biocompatibility, and sustained antibiotic release tests

[0134] The duration of antibiotic release and the transparency of the microlenses were investigated.

[0135] 3.1 Test Materials:

[0136] 1) Forty rabbits were used in the experiment;

[0137] 2) Physiological saline, lidocaine hydrochloride, surgical instruments, slit lamp, ophthalmic B-ultrasound, etc.

[0138] 3) Main equipment: surgical microscope, facial opening device, ophthalmic separator, implanter, sling, etc.

[0139] 3.2 Experimental Procedure:

[0140] The operated eyes of the experimental rabbits were cleaned before surgery. Then, a corneal stromal capsule was prepared using a scalpel. After separating the capsule with a separator, a microlens was pushed into the capsule and centered using a surgical implanter. Dexamethasone eye drops were applied postoperatively.

[0141] Postoperative observation was continued, and antibiotic test results were recorded at 8, 12, 18 and 24 hours postoperatively. Transparency was finally recorded at 12 months postoperatively.

[0142] 3.3 Transparency Scoring Criteria

[0143] II. Test Results

[0144] 1. Record of microlens aging

[0145] The results of this experiment show that the above material combinations are stable and no premature aging of the materials was observed.

[0146] 2. Softness test record

[0147] The results of this experiment show that material softness test group 2 is softer than the other groups.

[0148] 3. Transparency and antibiotic release records

[0149] (1) The corneal transparency score at 12 months post-surgery is as follows:

[0150] The results of this experiment show that the corneal transparency of each group was basically the same 12 months after surgery.

[0151] (2) Antibiotic test results:

[0152] The results of this experiment show that tobramycin was detected in all experimental groups at 8-12 hours post-operation. Tobramycin was not detected in experimental group 5 starting at 12 hours post-operation, while it was detected in all other groups. Tobramycin was still detectable in experimental group 2 at 18 hours post-operation, but was not detected at 24 hours post-operation.

[0153] III. Experimental Conclusions

[0154] The results of this group of experiments show that when one or more copolymers of 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, and styrene acrylate are used as the preparation materials, the material processing is stable, the integration with the UV blocker is relatively stable, and no premature aging phenomenon was observed, indicating good biocompatibility. The results of the flexibility and antibiotic release tests show that when the preparation materials of test group 2 (hydroxyethyl methacrylate, methyl methacrylate, and 4-propenoxy-2-hydroxybenzophenone) are used, the microlenses exhibit better flexibility, and the tobramycin release time can exceed 18 hours. Therefore, the materials selected in test group 2 are superior.

[0155] Example 17

[0156] This embodiment illustrates several components of the hydration solution and / or preservation solution in a method for preparing a corneal embedded microlens containing antibiotics, and selects a preferred hydration solution through comparison. Details are as follows:

[0157] The components of the hydration solution and / or preservation solution in this embodiment were prepared and tested according to the following test groups.

[0158] Experimental group 1: Contains only tobramycin;

[0159] Experimental group 2: Contains tobramycin, bFGF, and vitamin B2;

[0160] Experimental group 3: No additives (blank control).

[0161] Nine corneal-embedded microlenses (in total) prepared using the method described in Example 14, based on the composition of the hydrated solution shown above, were implanted into the corneas of animals to evaluate postoperative recovery. Details are as follows:

[0162] The components in the hydrated solution in the preparation method provided in Example 14 were replaced with the corresponding components of the above-mentioned test groups. The materials and parameters not recorded in each test group were prepared according to the description in Example 14, and corneal embedded microlenses with the corresponding test group numbers were prepared.

[0163] I. Experimental Materials and Equipment

[0164] 1. Nine rabbits were used in the experiment;

[0165] 2. Reagents: physiological saline, lidocaine hydrochloride, etc.

[0166] 3. Main equipment: surgical microscope, facial opening device, ophthalmic separator, implanter, sling, ophthalmic B-ultrasound, slit lamp, etc.

[0167] II. Experimental Procedure

[0168] The operated eyes of the experimental rabbits were cleaned before surgery. A corneal stromal capsule was then prepared using a scalpel. After separating the capsule with a separator, a microlens was inserted into the capsule using a surgical implanter. Postoperatively, tobramycin and dexamethasone eye drops were administered according to the instructions. The rabbits were observed for 3 months postoperatively. Histological sections were taken at 3 months postoperatively to observe nerve growth.

[0169] III. Criteria for Judging Corneal Transparency:

[0170] IV. Test Results

[0171] 1. Corneal transparency observation record

[0172] The results showed that the rabbit eyes remained transparent after surgery in all experimental groups, indicating that the corresponding components added to experimental groups 1-5 did not affect the transparency of the rabbit eyes after surgery.

[0173] 2. Observation and recording of nerve fiber growth

[0174] One month post-surgery, slice images showed a slight decrease in the number of nerves exhibiting tortuosity and increased reflexivity in the nerve plexus images. This phenomenon diminished further at three months post-surgery, with the nerve plexus reverting to its pre-operative morphological characteristics. However, the nerve recovery in experimental group 6 was slightly lower than in the other experimental groups. This suggests that microlenses with surface modifications resulted in better post-operative outcomes.

[0175] It should be noted that the above description is only a preferred embodiment in the specific implementation of this application, and is not a limitation on the technical solution protected by this application. Any equivalent substitution or modification of the inventive concept of the technical solution of this application by those skilled in the art within the scope of the technical solution disclosed in this application should be covered within the protection scope of this application.

[0176] .

Claims

1. A corneal inlay micro-lens, the micro-lens being circular, the micro-lens comprising two regions, characterized in that: The two regions are a first correction zone and a plano zone, respectively. The plano zone is surrounded by the first correction zone and is concentric with the plano zone. The first correction zone has the function of correcting vision. The plano zone has a refractive power of 0D and has a through-hole. The corneal embedded microlens has the function of blocking ultraviolet rays from passing through.

2. The corneal inlay micro-lens of claim 1, wherein: The flat area includes a second correction area, which is circular and surrounded by the flat area, and the through hole is located within the second correction area.

3. The corneal inlay micro-lens of claim 2, wherein: The first correction zone has the function of correcting vision loss caused by an unhealthy state of the refractive media, and the second correction zone has the function of correcting vision loss caused by refractive error.

4. The corneal inlay micro-lens of claim 2, wherein: The number of through holes is one, the through hole is circular and concentric with the second correction area, and the second correction area is concentric with the flat area.

5. The corneal inlay micro-lens of claim 3, wherein: The cross section of the first correction area along the direction of the center of the annular curvature is a convex lens cross section, and the cross section of the second correction area along the direction of the center of the circular curvature is a concave lens cross section.

6. The corneal inlay micro-lens of claim 3, wherein: The cross section of the first correction area along the direction of the center of the annular curvature is a convex lens cross section, or the cross section of the second correction area along the direction of the center of the circular curvature is a concave lens cross section.

7. The corneal inlay micro-lens of claim 5, wherein: The optical center of the concave lens is a through hole, and the diameter of the through hole is 0.01 to 0.6 mm.

8. The corneal inlay micro-lens of claim 1, wherein: The diameter of the microlens is 2.5–5.5 mm; the thickness of the microlens is 25–63 μm.

9. The method of claim 1 to 8, wherein the corneal inlay micro-lens is prepared by, Includes the following steps: Step A. Weigh one or more of the following: hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, styrene acrylate, and hydroxyethyl methacrylate to prepare a mixture. Step B. Weigh azophenyl methacrylate or 4-propenoxy-2-hydroxybenzophenone and add it to the mixture prepared in Step A; stir evenly and then add it to a mold; the mold is cylindrical so that the solution has the through hole after being formed in the mold; Step C. Dry at 80-120℃ for 4-8 hours to prepare the material. Step D. Cut, polish, and hydrate the material to prepare a corneal embedded microlens; The hydration solution used for hydration is a saline solution containing antibiotics.

10. The method of claim 1 to 8, wherein the corneal inlay micro-lens is prepared by, Includes the following steps: Step A. Weigh one or more of the following: hydroxyethyl methacrylate, 2-phenoxyethyl acrylate, ethylene glycol dimethacrylate, methyl methacrylate, polymethyl methacrylate, styrene acrylate, and hydroxyethyl methacrylate to prepare a mixture. Step B. Weigh azophenyl methacrylate and 4-propenoxy-2-hydroxybenzophenone, add them to the mixture prepared in Step A; stir evenly and then pour the mixture into a mold; the mold is cylindrical so that the solution has the through holes after being formed in the mold; Step C. Dry at 80-120℃ for 4-8 hours to prepare the material. Step D. Cut, polish, and hydrate the material to prepare a corneal embedded microlens; The hydration solution used for hydration is a saline solution containing antibiotics.

11. The method of claim 9, wherein: The cylinder is perpendicular to the mold surface, and the connection between the cylinder and the mold has a circular curvature on the tangent along the cylinder axis, so that the cross-section of the second correction zone after the mixture is formed in the mold, along the center of the circular curvature, is a concave lens cross-section; the outer ring of the mold surrounding the second correction zone is flat, so that the mixture has a flat area after being formed in the mold; the outer ring of the mold surrounding the flat area has a circular curvature on the tangent along the cylinder axis, so that the cross-section of the first correction zone after the mixture is formed in the mold, along the center of the circular curvature, is a convex lens cross-section.

12. The use of any one of claims 1 to 8 in products for correcting vision loss caused by unhealthy refractive media and in products for correcting vision loss caused by refractive errors.

13. The use of any one of claims 1 to 8 in a product for correcting vision loss caused by an unhealthy state of the refractive medium or in a product for correcting vision loss caused by refractive error.

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