Ophthalmic lenses

Abstract

The present invention relates to an ophthalmic lens such as an intraocular lens, which comprises: a) an ophthalmic lens main body, wherein the main body comprises an optical zone and optionally one or more light absorption zones, wherein the light absorption zone comprises a light absorber; b) optionally, one or more additional parts comprising an active agent, which are located on the ophthalmic lens main body and connected to the ophthalmic lens main body, the additional part having a width of 0.05 to 3.5 mm, preferably 0.1 to 1.5 mm, more preferably 0.2 to 0.8 mm; the additional part having a thickness of 0.01 to 2 mm, preferably 0.01 to 1 mm, more preferably 0.01 to 0.7 mm, wherein the inner edge of the additional part is greater than 2 mm from the center of the ophthalmic lens, wherein the ophthalmic lens comprises at least one of the light absorption zone and the additional part.

Description

Technical Field

[0001] The present invention relates to medical devices, in particular ophthalmic lenses such as intraocular lenses, and more particularly ophthalmic lenses comprising additional moieties such as drugs or active agents and / or light absorbing regions. Background Art

[0002] Various reasons such as aging, heredity, local nutritional disorders, immune and metabolic abnormalities, trauma, poisoning, radiation, etc. can cause lens metabolism disorders, leading to lens protein denaturation and turbidity, called cataracts. With the aging of the global population, the incidence of cataracts and the total number of patients are increasing. Replacing the artificial lens through surgery is currently the most effective way to treat cataracts. However, patients after cataract surgery still face a major problem: posterior capsule opacification (PCO). Posterior capsule opacification is mainly caused by the proliferation, migration, and fibrosis of residual lens epithelial cells (LECs) after cataract surgery along the posterior capsule wall. It is the most common complication that affects vision after cataract surgery. Its incidence rate in adults is 30~50% (within 5 years), of which 20%~30% of patients become blind again due to post-cataract, and 43% of patients undergo reoperation due to post-cataract. The incidence rate of post-cataract in children is 100%. When residual lens epithelial cells after cataract surgery undergo cellular growth along the anterior capsule wall, anterior capsule opacity is produced, known as "ACO".

[0003] In addition, inflammatory reactions may occur after the implantation of artificial lens (IOL), such as infectious endophthalmitis and uveitis. Therefore, for cataract patients who have artificial lenses implanted, spot treatment is performed. Hormonal and non-hormonal anti-inflammatory drugs are used for eye drops to prevent postoperative uveitis and fibrosis, acute iridocyclitis, episcleritis, allergic keratitis and macular edema. At the same time, ofloxacin eye drops are used to inhibit bacterial conjunctivitis, keratitis, dacryocystitis, postoperative infections and other infections. The use of eye drops to treat inflammation has the problem of periodic high concentration of intraocular medicine and large fluctuations, which cannot stably and continuously fight bacteria and inflammation. Since the patient's operation and cooperation are required, it adds inconvenience to the patient's life and increases the burden on the patient. The existing technology uses laser posterior capsulotomy to treat existing PCO. Laser posterior capsulotomy may produce some adverse conditions. Since the incision of the posterior capsule destroys the natural barrier, it may cause surgical complications, including intraocular lens damage, postoperative increased intraocular pressure, macular edema, retinal detachment, and intraocular lens dislocation. Therefore, for PCO, people are trying to find ways and methods to prevent its formation.

[0004] At present, the methods for preventing and / or treating PCO generally start from several aspects: the design of intraocular lenses, the improvement of surgical operation methods, intraocular lens drug loading, laser posterior capsulotomy and other methods.

[0005] In terms of the design of intraocular lenses, the use of sharp right-angled edges in the optical components of intraocular lenses, such as U.S. Patents 6162249 and 6468306, has been proven to be an effective method for reducing posterior capsule opacification, because this design can block the migration of lens epithelial cells to the posterior surface of the intraocular lens and the posterior capsule (see the article by Buehl et al., Journal of Cataract and Refractive Surgery, Vol. 34, 1976-1985. In recent years, there have been many works in the industry for forming IOLs with sharp posterior edges to produce sharp discontinuous bends in the posterior capsule wall, such as Nishi U.S. Patent 5171320, Woffinden U.S. Patent 5693093, CN1310625C, CN1684643, CN102711666A, CN201888856U.

[0006] Similar designs also include patent CN1856281, which discloses an artificial lens with a sharp beveled edge around the optical part, and the sharp beveled edge extends along the arc segment defined by the joint at the connection position between the loop and the optical part; patent CN2626458Y, which discloses an artificial lens characterized in that a raised step is added to the edge of the second surface of the non-optical part of an ordinary artificial lens to block the migration and growth of epithelial cells, thereby preventing the problem of posterior capsule opacity after artificial lens implantation; CN2717403Y designs a Sigma artificial lens, in which the edge of the artificial lens optical lens is designed and processed into an inwardly concave wedge, which is also a sharp beveled edge. When viewed from the side, it is similar to the Greek letter Σ, which prevents posterior capsule opacity and glare at the same time.

[0007] Research in this field also reduces the risk of posterior capsule opacification by changing the lens material design. See Mandle's "Acrylic intraocular lenses cause less posterior capsule opacification than PMMA and silicone IOLs" Ophthalmic News, Vol. 14, No. 15, p. 23 (1996). And Ursell et al.'s "Relationship Between Intraocular Lens Biomaterials and Posterior Capsule Opacification" (J. Cataract. Refract. Surg., 24: 352-360, 1998), and patent CN1188178C reduces the risk of posterior capsule opacification by changing the lens material, including an anterior surface layer and a posterior surface layer different from the anterior surface layer.

[0008] Among the ways of drug loading in artificial lenses, one way of drug loading is to prevent postoperative inflammation and microbial infection, which are various antibiotics, steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs. For example, patent CN2531755Y "sustained-release agent-carrying artificial lens" discloses a sustained-release agent-carrying artificial lens, which has holes punched on the artificial lens loop, and the holes are filled with sustained-release drugs to prevent intraocular inflammation after artificial lens implantation; CN104434811A discloses a drug-slow-release microsphere that can be embedded in the artificial lens loop, which effectively prevents and treats microbial infection after cataract surgery, antagonizes inflammatory response, and prevents and inhibits secondary cataract. Another way is to eliminate LEC or inhibit epithelial cell mitosis by carrying lens epithelial cell target agents, including anti-metabolism drugs and mitosis inhibitors, drug immunotoxins and cytotoxins that inhibit inflammatory response, drugs that inhibit cell adhesion to extracellular matrix, and drugs that induce cell apoptosis. For example, Bretton's US Pat. No. 5,620,013 "Method for destroying residual lens epithelial cells" and US Pat. No. 4,918,165 proposed the use of methotrexate to prevent posterior capsule opacity; US Pat. No. 5,576,345A used paclitaxel to prevent posterior capsule opacity, and also includes the following disclosed patent technologies.

[0009] Patent CN100553692C uses chitosan-polyacrylic acid as a carrier to prepare a fluorouracil nanoparticle preparation, and the mixed coating is applied to the surface of the PMMA intraocular lens to increase the biocompatibility of the intraocular lens and prevent the occurrence of PCO and ACO; CN101053680B uses a polymer coating material to apply anti-cell proliferation drugs on the intraocular lens, which can slowly release the drugs to the capsular bag and equatorial cells, inhibit the growth of lens epithelial cells, and prevent the formation of posterior cataract; Patent CN101269240B discloses a An artificial lens with an anti-transforming growth factor β2 antibody film on its surface; CN200973766 fixes a ring-shaped drug sustained-release carrier on the outer side of the equatorial part of the artificial lens, and after implantation, slowly releases a drug that inhibits the proliferation of lens epithelial cells to prevent the occurrence of posterior cataract; Patent CN103099706 discloses an artificial lens for preventing and / or treating posterior cataract, which fixes trypsin on the surface of the lens and can selectively destroy the lens epithelial cells in the lens capsule when implanted into the lens capsule to prevent the occurrence of posterior capsule opacity.

[0010] Although these methods are theoretically appropriate, the toxicity of the drugs themselves can lead to serious complications, significant intraocular toxicity and side effects, poor specificity, or low efficacy. There is also the possibility of excessively fast drug release and unstable release. At the same time, there is no guarantee that all intraocular lens epithelial cells in the capsular bag will be killed. These technologies are difficult to put into clinical application. Any residual LECs may eventually proliferate and migrate to the intraocular lens after the effect of the drug disappears, eventually leading to PCO.

[0011] In terms of surgical operation techniques, ophthalmologists are aware that residual lens cells cause posterior capsule opacity, so they have been trying to improve the surgical method to reduce the residual epithelial cells as much as possible, and carefully remove all residual lens epithelial cells. They have also developed instruments for removal, for example: Patent CN103099705A discloses a device for preventing and treating post-cataract (PCO), which can selectively remove lens epithelial cells during surgery to prevent the occurrence of posterior capsule opacity. However, despite many efforts, there are usually a considerable number of epithelial cells left on the inner surface of the lens capsule, because epithelial cells are difficult to identify and are often difficult to reach due to their limited position on the inner surface of the lens capsule.

[0012] In recent years, research on photodynamic therapy or photothermal therapy in the field of ophthalmology has also attracted attention. Patent WO2013 / 027222 reported a chlorophyll photosensitizer for treating eye diseases; Patent CN103083133 reported a laser photothermal therapy system for fundus diseases based on gold nanorods; Patent WO97 / 33619 reported a method for improving vision through photodynamic therapy of the eye; Patent WO98 / 25648 reported a photosensitive compound for preparing photodynamic therapy drugs for eye diseases; WO98 / 25610 reported a green porphyrin photosensitizer drug for treating after-cataracts; in the treatment of after-cataracts, US Patent 5733276 disclosed a preventive laser therapy method. According to this method, a laser is used to irradiate the artificial lens capsule to destroy the remaining lens epithelial cells; Patent CN100455276C coats a titanium dioxide nanofilm on the surface of the artificial lens to inhibit the growth of lens epithelial cells through the inhibition and oxidation of cell proliferation by titanium dioxide photocatalysts.

[0013] However, both traditional photodynamic therapy and photothermal therapy are limited by photosensitizers and cannot be widely used in the treatment of intraocular lens posterior capsule opacity. The photosensitizers used in traditional photodynamic therapy and photothermal therapy, including photodynamic photosensitizers and photothermal photosensitizers, ultimately need to be made into liquid medicines, enter the blood and enter the diseased tissues through intravenous injection or other methods, or directly injected into the diseased tissues. When the treatment is over, the photosensitizers need to be excreted from the body through degradation or metabolism. Traditional photodynamic therapy and photothermal therapy need to consider the safety and metabolism of photosensitizers, which greatly limits the range and types of photosensitizer selection. Although the toxic and side effects of photodynamic therapy are very small, the photosensitizers used eventually enter the human body and have certain toxicity. In addition, photosensitizers generally cannot be used alone, and need to act together with other drugs or compounds to enter the human body in the form of solutions, suspensions or emulsions. These compounds that interact with photosensitizers will also have certain toxicity, increasing the risk of treatment. In addition, since the photosensitizer needs to be injected into the body through the vein, and the injection speed and clearance speed are required to be very fast, the patient's heart, blood vessels and other organ tissues need to endure the discomfort caused by the rapid injection of the photosensitizer during the treatment process; and only when the photosensitizer passes through the diseased tissue can the laser irradiation be turned on for effective treatment, so high requirements are placed on the timing of drug administration and maintenance time, which brings difficulties to the treatment process.

[0014] The existing technology prevents epithelial cell migration by designing artificial lenses, thereby achieving the purpose of preventing cataracts, but the effect is limited. Removing the lens epithelium as much as possible during the surgical operation can also reduce the incidence of post-op cataracts, but in fact it is difficult to completely remove the epithelium by physical methods. These operations require extra time and may increase eye tissue damage, leading to increased destruction of the blood-aqueous barrier, which in turn stimulates the proliferation of residual epithelial cells. Although sharp-edged IOLs have been shown to inhibit PCO, there is still the possibility that LECs will migrate along the posterior capsule and on the surface of the IOL. This situation is particularly prone to occur when there is uneven contact and force between the periphery of the intraocular lens and the capsular bag, such as when the intraocular lens rotates and moves in the capsular bag after surgery. Drugs and chemical methods are very effective in removing or destroying the proliferation and migration of residual lens epithelial cells, but drugs and chemical methods have the problem of toxic side effects on other tissues. While damaging epithelial cells, they will also cause toxic damage to other tissues in the eye, which is still a problem that has not been well solved. In addition, there is also the problem of short duration of effective drug concentration and the need for continuous administration. Traditional photodynamic therapy and photothermal therapy are both limited by photosensitizers and cannot be widely used in the treatment of posterior capsule opacities of intraocular lenses. Currently, laser posterior capsulotomy is still the main method for treating secondary cataract, but it also brings a series of complications, including IOL damage, increased intraocular pressure after surgery, cystoid macular edema, retinal detachment, and IOL dislocation.

[0015] Therefore, the existing technology cannot effectively prevent the occurrence of post-syndrome, and there is currently no effective method for preventing and treating post-syndrome in clinical practice.

[0016] In addition, in ophthalmic applications, artificial lenses are generally made of transparent materials and are divided into an optical zone and a support zone. The optical zone is located in the center of the artificial lens and is used to change the refractive state of the human eye to achieve the purpose of optical imaging. The support part is also called a support loop, which can be plate-shaped, L-shaped, C-shaped, etc., and is used to support and fix the artificial lens in the human eye. The optical zone and the support zone can be made of the same material or different materials. An artificial lens made of soft materials can be implanted in the eye through a smaller incision in a folded or curled state. This folded or curled artificial lens can automatically unfold after entering the human eye.

[0017] In the field of ophthalmology, the optical zone of an ophthalmic lens (such as an intraocular lens) generally includes two curved surfaces, the front and the back. Since the refractive index of the material is different from that of the aqueous humor in the eye, the refractive and refracting effects are produced. The optical zone of an ophthalmic lens (such as an intraocular lens) generally includes an optical lens, which is located in the center of the ophthalmic lens (such as an intraocular lens). It is the core part of the ophthalmic lens (such as an intraocular lens) to achieve the refractive function. Some ophthalmic lenses (such as intraocular lenses) have structures connected to the supporting part on the periphery of the optical zone. After the ophthalmic lens (such as an intraocular lens) is implanted in the eye, the optical zone is centered, and the ophthalmic lens (such as an intraocular lens) and the eye's own optical structure together form an optical system. The optical zone of an ophthalmic lens (such as an intraocular lens) includes the optical imaging part, which is generally not allowed to be blocked or interfered with.

[0018] Any optical system, due to various reasons, has some unintended light that is finally projected onto the imaging surface. These lights are collectively referred to as stray light, which is an interfering light beam that affects the normal imaging of the optical system. Most stray light does not form an image on the image plane, but instead creates a bright background on the image plane, which reduces the image contrast and affects the imaging quality. Some high-brightness targets will form ghost images (also called secondary images) on the image plane. The presence of interfering light can cause patients to experience adverse optical phenomena such as ghost images, glare, and abnormal bright spots after implanting an artificial lens.

[0019] There are two main sources of interference light and ghost images in the optical system of the eye for ophthalmic lenses (such as intraocular lenses): one is the additional image generated near the focal plane of the optical system due to multiple reflections on the lens surface. This ghost image is mainly solved or alleviated by reasonable optical surface design of the front and back surfaces of the lens. The other is that the light is incident on the edge of the lens and is reflected or refracted by the edge cut surface to form harmful light. This harmful light has a greater impact on the visual effect. In clinical practice, patients often report "tear sensation under the eye", "bright ring / bright edge", "edge glare" and other phenomena after surgery are all caused by this type of interference light. In particular, the refractive index of the material of ophthalmic lenses (such as intraocular lenses) is generally greater than the refractive index of the surrounding aqueous humor. The light is incident from a light-dense medium with a higher refractive index to a light-sparse medium with a lower refractive index, and the light is incident at an oblique angle. The incident angle is generally very large, which is very easy to produce total reflection. After incident on the edge of the intraocular lens, all the light is reflected to the human eye, which will seriously interfere with the visual quality. For intraocular lens materials with higher refractive index, this phenomenon is more serious. It is well known to those skilled in the art that total internal reflection refers to the phenomenon that when light is incident from a denser medium to a less dense medium and the incident angle is greater than the Brewster angle, all the light will be reflected.

[0020] At present, the main way to solve the interference light of the edge of artificial lenses is to alleviate it through edge shape design and surface treatment. For example, U.S. Patent No. 6884262 uses an edge shape with a special slope to try to reduce the reflection of edge interference light, and U.S. Patent No. 8012203 uses a frosted edge to change the mirror reflection of the edge into diffuse reflection, reducing interference light and ghost images. These methods have a mitigating effect on edge light reflection, but they cannot completely eliminate it. The method used in US6884262 has a single bevel angle and can only eliminate part of the interference light; the local frosting treatment of US8012203 is very difficult to implement in terms of process, and diffuse reflection will still form a certain amount of interference light, and only the brightness of the interference light is reduced and alleviated.

[0021] The inventors of the present invention have discovered that by providing a medical device (such as a lens) with a specific structure, the above-mentioned various problems can be solved, such as reducing adverse optical phenomena, reducing edge interference light and local treatment (such as preventing after-cataracts, etc.), and can be used in devices related to optical medical devices, such as ophthalmic lenses (for example, artificial lenses), frame glasses, corneal contact lenses (contact lenses), corneal intraocular lenses, phakic intraocular lenses (implantable contact lenses) and other ophthalmic lenses. Summary of the invention

[0022] The present invention provides an ophthalmic lens (especially, an intraocular lens) having an additional portion containing an active agent. Specifically, the additional portion can be combined with one or more treatment methods such as sharp right-angled ophthalmic lens design, ophthalmic lens drug loading, photodynamic therapy, etc., to solve the problem that epithelial cells in the ophthalmic lens are not easy to be completely removed and various optical problems (such as edge interference light). In addition, adding a light absorption area to the edge of an ophthalmic lens (such as an intraocular lens) has other unexpected effects, such as improving biocompatibility and safety, and having certain light therapy, prevention of after-effects, drug therapy, etc.

[0023] The present invention relates to an ophthalmic lens, such as an intraocular lens, comprising:

[0024] a) an ophthalmic lens body portion, wherein the body portion comprises an optical zone and optionally one or more light absorbing zones, wherein the light absorbing zones comprise a light absorbing agent;

[0025] b) optionally, one or more additional parts containing active agents, which are located on and connected to the main part of the ophthalmic lens, the additional part width is 0.05 to 3.5 mm, preferably 0.1 to 1.5 mm, more preferably 0.2 to 0.8 mm; the additional part thickness is 0.01 to 2 mm, preferably 0.01 to 1 mm, more preferably 0.01 to 0.7 mm, wherein the inner edge of the additional part is greater than 2 mm from the center of the ophthalmic lens,

[0026] Wherein, the ophthalmic lens includes at least one of a light absorbing region and an additional portion.

[0027] According to another specific embodiment of the present invention, the main part of the ophthalmic lens is combined with the additional part by physical means or chemical means.

[0028] According to another specific embodiment of the present invention, the physical method is selected from the group consisting of inlaying, bonding, spraying, printing, and evaporation.

[0029] According to another specific embodiment of the present invention, the chemical method is selected from step-by-step copolymerization and grafting modification.

[0030] According to another specific embodiment of the present invention, the additional portion is located on the rear surface of the main body of the ophthalmic lens.

[0031] According to another specific embodiment of the present invention, the main part of the ophthalmic lens has one or more grooves, and the additional part is embedded in the groove of the main part of the intraocular lens.

[0032] According to another embodiment of the present invention, the additional part comprises an active agent. In the present invention, the active agent can be any type of active agent that can be used in the ophthalmic lens of the present invention, which can be selected according to the final use of the product.

[0033] According to another embodiment of the present invention, the ophthalmic lens body portion has at least two sharp edges.

[0034] According to another specific embodiment of the present invention, the ophthalmic lens is an artificial lens, in the main part of which the support loop forms a certain angle with the optical plane of the ophthalmic lens; the proximal end of the rear surface of the support loop has a right-angle edge stepped structure; the distal end of the rear surface of the support loop has a right-angle edge stepped structure, wherein the thickness of the proximal end of the step structure of the rear surface of the support loop is greater than the thickness at the distal end.

[0035] According to another specific embodiment of the present invention, the ophthalmic lens is an artificial lens, and the step height of the right-angle edge stepped structure at the distal end of the posterior surface of the supporting haptic is 0.1-5 mm, preferably 0.1-1 mm, and more preferably 0.2-0.5 mm, wherein the thickness of the stepped structure at the proximal end of the posterior surface of the supporting haptic is greater than the thickness at the distal end.

[0036] According to another specific embodiment of the present invention, the ophthalmic lens is an intraocular lens, and the step height of the right-angle edge stepped structure at the proximal end of the posterior surface of the supporting haptic is 0.1-5 mm, preferably 0.3-3 mm, and more preferably 0.5-2 mm, wherein the thickness of the stepped structure at the proximal end of the posterior surface of the supporting haptic is greater than the thickness at the distal end.

[0037] According to another specific embodiment of the present invention, the rear surface of the optical portion of the ophthalmic lens main body is a convex spherical surface and its radius of curvature is in the range of 6.6 mm to 80.0 mm.

[0038] According to another specific embodiment of the present invention, the radius of curvature of the rear surface of the optical portion of the main body of the ophthalmic lens is 17.8% to 60.0% of the radius of curvature of the front surface of the optical portion.

[0039] According to another specific embodiment of the present invention, the ophthalmic lens is prepared from the following material, the material includes a copolymer prepared by copolymerizing a polymerizable monomer containing acrylates, wherein the polymerizable monomer containing acrylates includes a hydrophilic acrylate monomer and a hydrophobic acrylate monomer, wherein the molar ratio of the hydrophilic acrylate monomer to the hydrophobic acrylate monomer is 20:80-80:20, preferably 30:70-70:30, more preferably 40:60-60:40, and the material has the following properties:

[0040] a. The moisture content at 35°C is 5-15wt%, preferably 6-13wt%, more preferably 7-12wt%;

[0041] b. The refractive index (wet state) at 35°C is 1.49-1.54, preferably 1.49-1.53, and more preferably 1.50-1.52.

[0042] According to another specific embodiment of the present invention, the hydrophilic acrylate monomer is selected from acrylate monomers having a hydrophilic group, which conforms to the following formula:

[0043]

[0044] Where R1 is H or C 1-6 Alkyl, preferably H or CH3;

[0045] R2 is a linear or branched, saturated or unsaturated C 1-20 Alkyl or C 6-20 Arylalkyl, either straight chain or C 6-20 heteroarylalkyl;

[0046] X can be O, S or NR4, wherein R4 is H, linear or branched, saturated or unsaturated C 1-20 Alkyl or C 6-20 Arylalkyl, or C 6-20 Heteroarylalkyl, or C 3-20 heterocyclylalkyl;

[0047] R3 is C n H 2n+1 O m , where m or n is equal to 0 or is selected from an integer greater than 1, and m ≤ n, or C 3-20 Heterocyclylalkyl or C 3-20 Cycloalkyl.

[0048] According to another specific embodiment of the present invention, the hydrophobic acrylate monomer is selected from acrylate monomers having a hydrophobic group, which conforms to the following formula:

[0049]

[0050] Where R1 is H or C 1-6 Alkyl, preferably H or CH3;

[0051] R5 is a linear or branched, saturated or unsaturated C 1-20 Alkyl or C 6-20 Arylalkyl, or C 6-20 Heteroarylalkyl, or C 6-20 Heterocyclylalkyl or C 3-20 Cycloalkyl;

[0052] Y may be H, or Z-R6, wherein Z may be present or absent and may be selected from heteroatoms such as O or S,

[0053] R6 is C6-20 Arylalkyl, or C 6-20 Heteroarylalkyl.

[0054] According to another specific embodiment of the present invention, the hydrophilic acrylic acid ester monomer is selected from: hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, ethoxyethoxyethyl methacrylate, ethoxyethoxyethyl acrylate, ethoxyethyl methacrylate, ethoxyethyl acrylate, methoxyethyl methacrylate, methoxyethyl acrylate, dimethacrylate (1,3-butylene glycol), ethylene glycol dimethacrylate, polyethylene glycol methacrylate, polyethylene glycol 200 dimethacrylate (such as AGEFLEX™ PEG200DMA), polyethylene glycol acrylate, polyethylene glycol methyl ether methacrylate, polyethylene glycol methyl ether acrylate, glycidyl methacrylate, glycidyl acrylate, acrylic acid, methacrylic acid, 2-(trifluoromethyl)acrylic acid, phenyl acrylic acid, acrylamide, methacrylamide, N-hydroxymethyl acrylamide, N-hydroxymethyl methacrylamide, or derivatives of the above substances, or mixtures of the above substances, preferably hydroxyethyl methacrylate.

[0055] According to another specific embodiment of the present invention, the hydrophobic acrylic acid ester monomer is selected from methyl methacrylate, ethyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, hexyl acrylate, isopropyl methacrylate, isopropyl acrylate, isobutyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl acrylate, isodecyl methacrylate, lauryl methacrylate, lauryl acrylate, octadecyl methacrylate, octadecyl acrylate, 9-anthracenemethyl methacrylate, 9-anthracenemethyl olefinate, cyclohexyl methacrylate, cyclohexyl acrylate, dimethylaminoethyl acrylate, dimethylaminoethyl methacrylate, N,N-dimethylmethacrylamide, N,N-dimethylacrylamide, N,N-diethylaminoethyl acrylate, N,N-diethylaminoethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropyl The invention can be selected from the group consisting of 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 41, 42, 43, 44, 45, 46, 47, 48, 49, 51, 52, 53, 54, 55, 56, 57, 58, 59, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 101, 102, 114, 125, 134, 135, 146, 159, 119, 129, 136, 147, 159, 15

[0056] According to another specific embodiment of the present invention, the glass transition temperature (dry state, obtained by DSC test) of the material for preparing the ophthalmic lens of the present invention is 10-35°C, preferably 15-30°C, more preferably 20-25°C.

[0057] According to another specific embodiment of the present invention, the elongation at break (wet state) of the material for preparing the ophthalmic lens of the present invention is greater than 180%, and the breaking strength (wet state) thereof is greater than 2.5 MPa.

[0058] According to another specific embodiment of the present invention, in an ophthalmic lens for reducing adverse optical phenomena, the optical zone is used for imaging, and the light absorption zone is used for shielding adverse optical phenomena such as ghosting, glare, bright spots, etc. caused by edge interference light. Therefore, the ophthalmic lens has a light absorption zone, which contains a light absorber, such as a light absorber for shielding adverse optical phenomena such as ghosting, glare, bright spots, etc. caused by edge interference light.

[0059] According to another specific embodiment of the present invention, the light absorbing region comprising the light absorber is located at the edge of the optical zone and / or the equatorial region of the optical part.

[0060] According to another specific embodiment of the present invention, the ophthalmic lens is an artificial lens, which includes a main body and a supporting haptic, the main body includes an optical zone and a light absorption zone, the optical zone is located at the center of the artificial lens, the light absorption zone is located at the edge of the optical zone and is closely connected to the optical zone, and the light absorption zone contains a light absorber component.

[0061] According to another specific embodiment of the present invention, the distance between the inner edge of the light absorption zone and the center of the optical zone is ≥1.0 mm, preferably ≥2.1 mm, and more preferably ≥2.25 mm.

[0062] According to another specific embodiment of the present invention, the light absorption region is in a circular ring shape with a width of 0.05 to 3.5 mm, preferably 0.1 to 1.5 mm, and more preferably 0.2 to 0.8 mm.

[0063] According to another specific embodiment of the present invention, the light absorption region is in a circular ring shape with a thickness of 0.01 to 2 mm, preferably 0.01 to 1 mm, and more preferably 0.01 to 0.7 mm.

[0064] According to another specific embodiment of the present invention, the light absorber contained in the light absorption region absorbs light within the wavelength range of 300 to 1100 nm, preferably visible light within the wavelength range of 400 to 700 nm.

[0065] According to another specific embodiment of the present invention, the light absorber contained in the light absorption zone includes but is not limited to various organic dyes, for example, the light absorber includes but is not limited to various organic dyes, such as chlorophyll derivatives (such as rhodochrome 18), azo series, anthraquinone series, aromatic methane series, indigo series, porphyrin series, phthalocyanine series, nitro and nitroso series, methine and polymethine series, heterocyclic compounds and their derivatives; various organic or inorganic pigments, such as carbon black, graphite, graphene, metal particles, metal oxides, metal salt compounds, metal alkali compounds, metal sulfides, etc. Preferred light absorbers include various dyes or pigments used for colored contact lenses, such as compounds disclosed in U.S. Pat. Nos. 4,668,240, 4,857,072, 5,272,010, and 8,915,590 and Chinese Patent No. CN200580017745.8, and any colorant licensed and approved by the FDA for use in medical devices, such as D&C Blue 6, D&C Green 6, D&C Violet 2, carbazole violet, a copper complex, a chromium complex, various iron oxides, phthalocyanine green, phthalocyanine blue, etc.; preferred pigments include blue phthalocyanine blue (Pigment Blue 15, CI 74160), cobalt blue (Pigment Blue 15, CI 77343), green phthalocyanine green (Pigment Green 7, CI 74260) and chromium trioxide, various iron oxides in yellow, red, brown and black, purple carbazole violet, black Monolith black C-K (Ciba), etc. More preferred light absorbers include carbon black, chlorophyll derivatives (eg, rhodopsin 18).

[0066] According to another specific embodiment of the present invention, the refractive index (wet state) of the optical zone material and the light absorption zone material of the ophthalmic lens at 35° C. is 1.43-1.56, preferably 1.47-1.53, and more preferably 1.50-1.52.

[0067] According to another specific embodiment of the present invention, the refractive index of the material in the absorption zone is greater than or equal to the refractive index of the material in the optical zone.

[0068] According to another specific embodiment of the present invention, the light absorber is added to the material surface of the light absorption region by coating, surface grafting, etc.

[0069] According to another specific embodiment of the present invention, the light absorber is added into the material of the light absorption zone by chemical synthesis, physical mixing, etc.

[0070] According to another specific embodiment of the present invention, the materials of the optical zone and the light absorption zone are integrated and combined by chemical means.

[0071] According to another specific embodiment of the present invention, the materials of the optical zone and the light absorption zone are not integrated, but are combined by physical means.

[0072] According to another specific embodiment of the present invention, the edge of the optical zone has one or more grooves, and the light absorption zone is embedded in the grooves as an additional part.

[0073] According to another specific embodiment of the present invention, the groove may be penetrating, preferably, to better fix the additional part. Optionally, the groove may also be non-penetrating.

[0074] According to another specific embodiment of the present invention, the opening of the groove is located on the rear surface of the lens (the position facing the fundus is the rear, and the position facing the viewed object is the front).

[0075] According to another specific embodiment of the present invention, the groove is frosted or made into a rough surface.

[0076] According to another specific embodiment of the present invention, the main view shape of the absorption zone can be circular, polygonal, or any shape that can form a light absorption closed loop around the optical zone.

[0077] According to another specific embodiment of the present invention, the main view shape of the optical zone can be circular, polygonal, or any shape that can form a light absorption closed loop around the optical zone.

[0078] According to another specific embodiment of the present invention, the optical zone, light absorption zone and support haptic are made of different materials, and the three zones are combined by physical or chemical means.

[0079] According to another specific embodiment of the present invention, the optical zone is integrated with the supporting haptic, and the absorption zone is an additional part, which is combined with the optical zone by physical or chemical means.

[0080] According to another specific embodiment of the present invention, the light absorbing region and the supporting haptic are integrated, both are added with light absorbers, and the optical zone is an additional part, which is combined with the light absorbing region by physical or chemical means.

[0081] According to another specific embodiment of the present invention, the refractive power of the intraocular lens in aqueous humor is -25.0D~+36.0D, preferably, -10.0D~+36.0D, and more preferably, +6.0D~+30.0D.

[0082] According to another specific embodiment of the present invention, the edge of the main body portion has a thickness of 0.08-0.6 mm, preferably, 0.1-0.5 mm, and more preferably, 0.15-0.3 mm.

[0083] According to another specific embodiment of the present invention, the shape of the junction between the light absorption zone and the optical zone matches the surface shape of the artificial lens, and the additional part is slightly higher than the main body of the artificial lens at the distal end of the optical zone, forming a right-angle edge step structure with a step height of 0.001~1.0mm, preferably 0.005~0.4mm, and more preferably 0.01~0.3mm.

[0084] According to another specific embodiment of the present invention, the light absorbing region is located at the edge of the main body portion.

[0085] According to another specific embodiment of the present invention, the light absorbing region may include at least one other component in addition to the light absorber, such as a drug, a light absorber, a fluorescent agent and / or a photosensitizer.

[0086] According to another specific embodiment of the present invention, the additional part further comprises at least one drug, light absorber, fluorescent agent and / or photosensitizer.

[0087] According to another specific embodiment of the present invention, the combination of the drug, light absorber, fluorescent agent and / or photosensitizer contained in the light absorbing region and / or the additional part with the material (e.g., copolymer) of the light absorbing region and / or the additional part is selected from:

[0088] - The drug, light absorber, fluorescent agent and / or photosensitizer participates in the polymerization during the molding process of the light absorbing area and / or the additional part material;

[0089] - drugs, light absorbers, fluorescent agents and / or photosensitizers are added to the copolymer material by physical dispersion during the molding process of the light absorbing region and / or the additional part material;

[0090] - drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the light absorption area and / or the additional material by surface grafting or surface modification; and / or

[0091] - The drug, light absorber, fluorescent agent and / or photosensitizer are fixed on the surface of the light absorption area and / or the additional part material by surface coating.

[0092] Specifically, when the light absorbing region and / or the additional portion material is a copolymer,

[0093] - drugs, light absorbers, fluorescent agents and / or photosensitizers participate in the polymerization during the copolymer formation process;

[0094] - drugs, light absorbers, fluorescent agents and / or photosensitizers are added to the copolymer material by physical dispersion during the copolymer molding process;

[0095] - drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the copolymer by surface grafting or surface modification; and / or

[0096] - Drugs, light absorbers, fluorescent agents and / or photosensitizers are immobilized on the surface of the copolymer by surface coating.

[0097] The present invention also relates to the use of the ophthalmic lens in preventing the migration and proliferation of epithelial cells, preventing the occurrence of posterior capsule opacity, preventing posterior cataract and reducing the occurrence of adverse optical phenomena.

[0098] The present invention also relates to a medical device comprising the ophthalmic lens.

[0099] The present invention also relates to the use of the ophthalmic lens in a medical device for treating eye diseases, in particular, the medical device is used to prevent epithelial cell migration, epithelial cell proliferation, prevent the occurrence of posterior capsule opacity, prevent post-ocular cataract and reduce the occurrence of adverse optical phenomena. DETAILED DESCRIPTION OF THE INVENTION

[0101] The main body of the ophthalmic lens (such as an intraocular lens) of the present invention can be the main body of any form of ophthalmic lens (such as an intraocular lens) known in the art, which includes an optical component and at least one support loop, wherein the optical component and the support loop are made of different materials and then formed in steps or are made of the same material as a whole. The optical component is divided into a front surface and a rear surface. The front surface and / or the rear surface can include any optical device according to the user's situation and / or requirements, for example, selected from aspheric devices, multifocal devices, complex curved devices, dispersion-free devices, variable focus devices, light filtering devices, or various conventional and suitable devices in the art.

[0102] According to a specific embodiment of the present invention, the ophthalmic lens can be an artificial lens, such as a phakic artificial lens, an aphakic artificial lens, or other suitable ophthalmic lenses.

[0103] According to a specific embodiment of the present invention, the rear surface of the main part of the ophthalmic lens (such as an intraocular lens) is composed of a central area and a peripheral area, wherein the peripheral area may be at least 0.2 mm thicker than the edge of the central area, so that a right-angle edge step structure is provided on the rear surface of the support haptic near the optical component. The step height of the right-angle edge step structure is 0.1-5 mm, preferably 0.3-3 mm, and most preferably 0.5-2 mm. This right-angle edge step structure is conducive to blocking the proliferation and migration of lens epithelial cells to the rear surface of the optical component, thereby reducing the probability of posterior capsule opacification.

[0104] According to a specific embodiment of the present invention, the support loop of the main part of the ophthalmic lens (such as an intraocular lens) forms a certain angle with the optical plane (optical plane is perpendicular to the optical axis) of the ophthalmic lens (such as an intraocular lens), generally any suitable angle can be used, preferably 1-20 degrees, most preferably 5-10 degrees. The support loop with the above angle can ensure that the ophthalmic lens (such as an intraocular lens) protrudes or moves toward the back of the eye when the (eye) capsule squeezes the force. An open groove is provided at the proximal end of the support loop (that is, the end of the support loop close to the optical component) to serve as a force transmission fulcrum. When the support loop is squeezed by the peripheral capsule, it will rotate axially with the open groove as the fulcrum, and will not transmit stress to the optical component, thereby ensuring the stability of the optical component in the eye. At the distal end of the rear surface of the support loop (that is, the end of the support loop away from the optical component), at least 1.5 mm away from the right-angle edge structure at the proximal end, a right-angle edge stepped structure is also provided. The step height of the right-angle edge step structure is 0.1-5 mm, preferably 0.1-1 mm, and most preferably 0.2-0.5 mm. The right-angle edge step structure can further block the proliferation and migration of lens epithelial cells to the posterior surface, and can create a support point between the support loop and the posterior capsule, thereby improving the stability of the ophthalmic lens (such as an intraocular lens) in the (eye) capsule. In addition, when the ophthalmic lens device is folded, this step structure can create a certain space between its optical components and the support loop, thereby reducing the adhesion between them, which is conducive to the automatic opening of the support loop after the ophthalmic lens is implanted.

[0105] According to a specific embodiment of the present invention, an ophthalmic lens (such as an intraocular lens) includes a main body portion and a supporting portion (such as a support haptic), wherein the main body portion includes an optical zone and a light absorption zone, wherein the optical zone is located at the center of the main body and is the imaging portion of the ophthalmic lens (such as an intraocular lens).

[0106] According to a specific embodiment of the present invention, the light absorption region of the present invention is one of the main functional regions.

[0107] According to a specific embodiment of the present invention, the material used to prepare the light absorption region of the present invention can be the same as or different from the material used to prepare the main body, and can be selected from a main body material containing a polymerizable monomer or any suitable material preferably having good biocompatibility. The polymerizable monomer is selected from a hydrophilic polymerizable monomer or a hydrophobic polymerizable monomer, and can be a homopolymer of the monomer or a copolymer of multiple monomers. It can also be selected from a polymer biodegradable material.

[0108] Preferably, the light absorption region is prepared from a material containing a light absorber. The light absorption region is located at the edge of the optical zone and is in close contact with the optical zone. The light absorption region contains a light absorber component. The light absorption region has an absorption effect on visible light and a spectrum that the human eye is sensitive to. The light absorption region can reduce the reflection of light at the edge of the artificial lens.

[0109] According to a specific embodiment of the present invention, the light absorption zone and the optical zone can be integrally formed (one piece of material) or separately formed (two or more pieces of material). If they are separately formed, the combination between the two can be physical (such as snap-fitting, embedding, etc.) or chemical (such as bonding, molding, etc.). For example, when bonding is required, the connection can be made by an adhesive, and the adhesive is selected from but not limited to α-cyanoacrylate medical adhesives, such as α-cyanoacrylate n-butyl ester, α-cyanoacrylate n-octyl ester, α-cyanoacrylate isobutyl ester and a mixture of two or three components thereof; medical silicone adhesives can be used. Such as Nusil's MED-1131, MED-1137, MED-1511, MED-1540, MED-1555, MED-2000, MED1-4213 and medical silicone adhesives with the same function.

[0110] According to a specific embodiment of the present invention, the light absorber in the light absorption zone may be on the surface of the material or inside the material; and may be combined with the material by copolymerization, blending, coating, injection, etc.

[0111] According to a specific embodiment of the present invention, a light absorber is coated on the edge of the optical zone of an ophthalmic lens (such as an intraocular lens). The advantage of this embodiment is that since the material is coated on the side of the intraocular lens, the optical zone is protected to the greatest extent.

[0112] According to another embodiment of the present invention, a light absorption zone is added to the edge of the optical zone of an ophthalmic lens (such as an intraocular lens), and the light absorption zone has a coating or structure containing a light absorber. The light absorber is added to the light absorption zone matrix by, for example, chemical polymerization, physical blending, and surface treatment, wherein the light absorption zone matrix material can be the same as or different from the optical zone material of the ophthalmic lens (such as an intraocular lens). Preferably, the light absorption zone matrix material of the ophthalmic lens (such as an intraocular lens) is prepared using a silicone-based material. The light absorption zone is combined with the optical zone by chemical or physical means. Preferably, in order to maintain the performance of the ophthalmic lens (such as an intraocular lens), the light absorption zone and the optical zone material of the ophthalmic lens (such as an intraocular lens) maintain basically the same physical properties, such as a soft and foldable intraocular lens, and its light absorption zone material should also be soft and foldable.

[0113] The additional part of the present invention can be prepared from any material known in the art suitable for preparing the ophthalmic lens (such as an intraocular lens) of the present invention; in particular, it can be prepared from an ophthalmic medical material with a suitable water content and a suitable refractive index suitable for manufacturing micro-incision intraocular lenses. The material used to prepare the additional part can be the same as or different from the material used to prepare the main body of the medical device, such as the ophthalmic lens (such as an intraocular lens).

[0114] According to another specific embodiment of the present invention, the additional part is another main functional area. According to the function achieved by the present invention, the shape of the additional part is not limited. The additional part can be any shape such as annular, square, trapezoidal, intermittent or uninterrupted additional parts, triangle, fan-shaped, etc. Any shape of the additional part that may achieve the function of the present invention is within the protection scope of the present invention.

[0115] The additional part of the present invention is preferably prepared from a material containing drugs, light absorbers, photosensitizers and / or fluorescent agents, or can carry drugs, light absorbers and / or photosensitizers and / or filter dyes, and photosensitizers are fixed inside or on the surface of the additional part material. At the same time, the edge of the additional part can form a sharp right angle of 90° with the optical surface of the optical part of the ophthalmic lens, and the additional part can be located on the front surface and / or the back surface of the optical part of the ophthalmic lens (such as an intraocular lens), which can reduce or eliminate harmful reflected light from the edge of the intraocular lens or other ophthalmic lenses, reduce the probability of adverse visual effects such as glare and ghosting after the use of the intraocular lens or other ophthalmic lenses, improve the patient's visual experience, and can prevent and treat anterior capsule opacity, posterior capsule opacity, and postoperative intraocular inflammation. Among them, the light absorber in the additional part can be the same as or different from the light absorber in the light absorption zone.

[0116] According to another specific embodiment of the present invention, the additional part of the present invention comprises therapeutic drugs, wherein the drugs include various antibiotics, steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs to prevent postoperative inflammation and microbial infection. It can also carry anti-metabolism drugs and mitosis inhibitors, immunotoxins and cytotoxins that inhibit inflammatory reactions, drugs that inhibit cell adhesion to extracellular matrix, and drugs that induce cell apoptosis to eliminate LEC or inhibit epithelial cell mitosis, prevent and treat posterior capsule opacity. Such as ofloxacin, ascorbic acid, aspirin, colchicine, lidocaine, nepafenac, ketorolac, bromfenac, recombinant hirudin, methotrexate, 5-fluorouracil, taxol, doxorubicin, daunorubicin, saponin, and other known or unknown drugs or compositions with similar functions.

[0117] According to another specific embodiment of the present invention, the additional part of the present invention comprises a light absorber, wherein the light absorber is selected according to the final use of the medical device (especially ophthalmic lens (such as intraocular lens)). In particular, the light absorber includes but is not limited to various organic dyes, such as azo series, anthraquinone series, aromatic methane series, indigo series, porphyrin series, phthalocyanine series, nitro and nitroso series, methine and polymethine series, heterocyclic compounds and their derivatives; various organic or inorganic pigments, such as carbon black, graphite, graphene, metal particles, metal oxides, metal salt compounds, metal alkali compounds, metal sulfides, etc. Preferred light absorbers include various dyes or pigments used for colored contact lenses, such as compounds disclosed in U.S. Pat. Nos. 4,668,240, 4,857,072, 5,272,010, and 8,915,590 and Chinese Patent No. CN200580017745.8, and any colorant licensed and approved by the FDA for use in medical devices, such as D&C Blue 6, D&C Green 6, D&C Violet 2, carbazole violet, a copper complex, a chromium complex, various iron oxides, phthalocyanine green, phthalocyanine blue, etc.; preferred pigments include blue phthalocyanine blue (Pigment Blue 15, CI 74160), cobalt blue (Pigment Blue 15, CI 77343), green phthalocyanine green (Pigment Green 7, CI 74260) and chromium trioxide, various iron oxides in yellow, red, brown and black, purple carbazole violet, black Monolith black CK (Ciba), etc. According to another preferred embodiment, the light absorber may further include carbon black or a chlorophyll derivative (eg, rhodopsin 18).

[0118] According to another specific embodiment of the present invention, the additional part of the present invention comprises a photosensitizer, wherein the photosensitizer is any photosensitizer dye activated by a wavelength range of 300 to 1100 nanometers, preferably, the activation wavelength range is selected from 500 to 1000 nanometers; in particular, the activation wavelength range is selected from 600 to 900 nanometers; especially, the activation wavelength range is selected from 700 to 900 nanometers or the activation wavelength range is selected from 800 to 1100 nanometers. The photosensitizer is selected from porphyrin, porphin, chlorophyll, rhodamine, fluorescein, phthalocyanine, metal phthalocyanine, indocyanine green, tricarbocyanine, nanogold, metal nanoparticles, metal oxide nanoparticles, metal sulfide nanoparticles, metal carbide nanoparticles, carbon nanotubes, graphene, etc., as well as derivatives of the above compounds, or degradation products of the above compounds, or salt forms of the above compounds, or mixtures thereof.

[0119] According to another specific embodiment of the present invention, the additional part of the present invention may contain any filter dye that can be used in the additional part, and the filter dye is selected from a compound having a filtering function for a specific wavelength range, such as the additional part contains a blue light absorber, wherein the blue light absorber is selected from a compound having a selective filtering function for blue light in the wavelength range of 400 to 500 nm. Yellow dye compounds containing azo groups in the molecular structure are preferred. Yellow dye compounds containing polymerizable groups are more preferred, and the polymerizable groups are selected from vinyl, allyl, butenyl, ethynyl, acryloxy, methacryloxy, acrylamide, methacrylamide, vinyl ether, etc.

[0120] Since the additional part of the present invention contains drugs, light absorbers, photosensitizers and / or fluorescent agents or drugs, light absorbers, photosensitizers and / or fluorescent agents are fixed on the additional part, the medical device (especially ophthalmic lenses (such as artificial lenses)) can reduce optical problems (such as light interference, etc.) and can play a preventive role after implantation. On the other hand, once the tissue or part is diseased, it does not need to undergo surgery again to receive laser treatment, and the optical problems are solved. More specifically, the material provided by the present invention has a repeatable effect. After one laser treatment is completed, since the photosensitizer is not eliminated and still exists in the lesion site, when the site develops secondary lesions again or multiple times, it does not need to inject photosensitizers multiple times to receive laser treatment again or multiple times, and the treatment has repeatability. Specifically, the present invention provides an ophthalmic lens (such as an intraocular lens) for preventing and / or treating after-cataracts, which contains a photosensitizer. After the ophthalmic lens (such as an intraocular lens) is implanted in the patient's eye during cataract surgery, under the conditions of selected laser extraocular irradiation, the photosensitizer is activated, and by generating cytotoxic active oxygen or high-temperature heat, the lens epithelial cells in the lens capsule can be killed, thereby achieving the effect of preventing or treating after-cataracts. Specifically, the additional part of the ophthalmic lens of the present invention contains a photosensitizer and has a photothermal effect. The additional part with a photothermal effect is combined with the main part of the lens by a physical method or a chemical method, wherein the physical method is selected from casting, inlaying, bonding, spraying, printing, and evaporation; the chemical method is selected from step-by-step copolymerization and grafting modification. Under the irradiation of a laser of a selected wavelength (for example, 300-1100 nanometers), the ophthalmic lens can kill the posterior capsule lens epithelial cells, thereby achieving the effect of preventing and / or treating after-cataracts. In particular, since the lens epithelial cells are generated around the optical zone to cause aftereffects, and the photosensitizer area is also located around the optical zone of the lens, when the ophthalmic lens is subjected to photothermal therapy, it can kill the residual lens epithelial cells while not damaging normal cells in other tissues, and the side effects are small. More particularly, since the photosensitizer area is located around the optical zone and does not touch the optical imaging area of ​​the lens, the lens has a visible light transmittance consistent with that of a normal ophthalmic lens, there is no light energy loss, and the patient's visual perception in any scene state is not affected, and there is no glare.

[0121] The main part and / or the additional part of the medical device of the present invention (especially the ophthalmic lens (such as an intraocular lens)) can be prepared from any material known in the art that is suitable for preparing the medical device of the present invention (especially the ophthalmic medical device, such as an ophthalmic lens). Particularly preferably, it is prepared from an ophthalmic medical material with a suitable water content and a suitable refractive index suitable for manufacturing micro-incision ophthalmic lenses, which is prepared by copolymerization of acrylate monomers, wherein the acrylate monomers include hydrophilic acrylate monomers and hydrophobic acrylate monomers, wherein the molar ratio of the hydrophilic monomer to the hydrophobic monomer is 20:80-80:20, preferably 30:70-70:30, and more preferably 40:60-60:40, and the material has the following specific properties:

[0122] a. The moisture content at 35°C is 5-15wt%, preferably 6-13wt%, more preferably 7-12wt%, even 8-11wt%, especially 9-11wt%;

[0123] b. The refractive index (wet state) at 35°C is 1.49-1.54, preferably 1.49-1.53, and more preferably 1.50-1.52.

[0124] The hydrophilic acrylate monomers described in the present invention are selected from acrylate monomers having a hydrophilic group and conform to the following formula:

[0125]

[0126] R1 is H or C 1-6 Alkyl, preferably H or CH3;

[0127] R2 is a linear or branched, saturated or unsaturated C 1-20 Alkyl or C 6-20 Arylalkyl, either straight chain or C 6-20 heteroarylalkyl;

[0128] X can be O, S or NR4, wherein R4 is H, linear or branched, saturated or unsaturated C 1-20 Alkyl or C 6-20 Arylalkyl, or C 6-20 Heteroarylalkyl, or C 3-20 heterocyclylalkyl;

[0129] R3 is C n H 2n+1 O m , where m or n is equal to 0 or is selected from an integer greater than 1, and m ≤ n, or C 3-20 Heterocyclylalkyl or C 3-20 Cycloalkyl.

[0130] In the present invention, the hydrophilic acrylate is an acrylate having a hydrophilic group, which is selected from, for example, hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, ethoxyethoxyethyl methacrylate, ethoxyethoxyethyl acrylate, ethoxyethyl methacrylate, ethoxyethyl acrylate, methoxyethyl methacrylate, methoxyethyl acrylate, dimethacrylate (1,3-butylene glycol), ethylene glycol dimethacrylate, polyethylene glycol methacrylate, polyethylene glycol 200 dimethacrylate (e.g., AGEFLEX™PEG200DMA), polyethylene glycol acrylate, polyethylene glycol methyl ether methacrylate, polyethylene glycol methyl ether acrylate, glycidyl methacrylate, glycidyl acrylate, acrylic acid, methacrylic acid, 2-(trifluoromethyl)acrylic acid, phenyl acrylic acid, acrylamide, methacrylamide, N-hydroxymethyl acrylamide, N-hydroxymethyl methacrylamide, or derivatives thereof, or mixtures thereof. Hydroxyethyl methacrylate is preferred.

[0131] The hydrophobic acrylate monomer in the present invention is selected from acrylate monomers having a hydrophobic group, which conforms to the following formula:

[0132]

[0133] R1 is H or C 1-6 Alkyl, preferably H or CH3;

[0134] R5 is a linear or branched, saturated or unsaturated C 1-20 Alkyl or C 6-20 Arylalkyl, or C 6-20 Heteroarylalkyl, or C 6-20 Heterocyclylalkyl or C 3-20 Cycloalkyl;

[0135] Y may be H, or Z-R6, wherein Z may be present or absent and may be selected from heteroatoms such as O or S,

[0136] R6 is C 6-20 Arylalkyl, or C 6-20 Heteroarylalkyl.

[0137] The hydrophobic acrylate described in the present invention is an acrylate having a hydrophobic group, which is selected from, for example, methyl methacrylate, ethyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, hexyl acrylate, isopropyl methacrylate, isopropyl acrylate, isobutyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl acrylate, isodecyl methacrylate, lauryl methacrylate, lauryl acrylate, octadecyl methacrylate, octadecyl acrylate, 9-anthracenemethyl methacrylate, 9-anthracenemethyl olefinate, cyclohexyl methacrylate, cyclohexyl acrylate, dimethylaminoethyl acrylate, dimethylaminoethyl methacrylate, N,N-dimethylmethacrylamide, N,N-dimethylacrylamide, N,N-diethylaminoethyl acrylate, N,N-diethylaminoethyl methacrylate, N-tert-butylacrylamide, N-tert-butyl 2-(perfluorooctyl)ethyl methacrylate, 2-(perfluorooctyl)ethyl methacrylate, 2-(perfluorooctyl)ethyl acrylate, glyceryl methacrylate, glyceryl acetonate, tetrahydrofuranyl acrylate, tetrahydrofuranyl methacrylate, phenyl methacrylate, phenyl acrylate, phenyl ethyl methacrylate, phenyl ethyl acrylate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, benzyl acrylate, ethyl acetoacetate methacrylate, ethyl acetoacetate acrylate, diacetone acrylamide, diacetone methacrylamide, allyl methacrylate, phenoxyethyl acrylate, or derivatives thereof, or mixtures thereof. Ethyl acrylate and / or phenoxyethyl acrylate are preferred.

[0138] The material used for preparing ophthalmic lenses (such as intraocular lenses) of the present invention should also contain one or more additives, such as a cross-linking agent, an ultraviolet absorber, a blue light absorber, etc., if necessary.

[0139] The material for ophthalmic lenses (such as intraocular lenses) of the present invention may contain a crosslinking agent, wherein the crosslinking agent is selected from polymerizable monomers having two or more functionalities, including: ethylene glycol dimethacrylate, ethylene glycol diacrylate, butylene glycol dimethacrylate, butylene glycol diacrylate, hexanediol dimethacrylate, hexanediol diacrylate, diethylene glycol dimethacrylate, diethylene glycol diacrylate, triethylene glycol dimethacrylate, triethylene glycol diacrylate, polyethylene glycol dimethacrylate, Polyethylene glycol acrylate, trimethylolpropane triacrylate, trimethylolpropane trimethacrylate, triethylolpropane triacrylate, triethylolpropane trimethacrylate, bisphenol A glycerol dimethacrylate, bisphenol A glycerol diacrylate, pentanediol diacrylate, pentanediol dimethacrylate, methacrylic anhydride, acrylic anhydride, N,N'-methylenebisacrylamide, N,N'-methylenebismethacrylamide, divinylbenzene, or derivatives thereof, or mixtures thereof. Ethylene glycol dimethacrylate is preferred.

[0140] The material used for preparing ophthalmic lenses (such as intraocular lenses) of the present invention may contain an ultraviolet absorber, wherein the ultraviolet absorber is selected from compounds having a high efficiency absorption function for ultraviolet rays with a wavelength range below 380 nm. Benzophenone compounds and / or benzotriazole compounds with high safety are preferred. Benzophenone compounds and / or benzotriazole compounds containing polymerizable groups are more preferred, and the polymerizable groups are selected from vinyl, allyl, butenyl, ethynyl, acryloyloxy, methacryloyloxy, acrylamide, methacrylamide, vinyl ether, etc.

[0141] The material used for preparing ophthalmic lenses (such as intraocular lenses) of the present invention may contain a blue light absorber, wherein the blue light absorber is selected from compounds having a selective filtering function for blue light within a wavelength range of 400 to 500 nm. Yellow dye compounds containing azo groups in the molecular structure are preferred. Yellow dye compounds containing polymerizable groups are more preferred, and the polymerizable groups are selected from vinyl, allyl, butenyl, ethynyl, acryloyloxy, methacryloyloxy, acrylamide, methacrylamide, vinyl ether, etc.

[0142] According to another specific embodiment of the present invention, the material for preparing an ophthalmic lens (such as an intraocular lens) of the present invention is obtained by polymerization of a hydrophobic acrylate monomer and a hydrophilic acrylate monomer, and optional additives such as a crosslinking agent, an ultraviolet absorber, a blue light absorber, etc. The polymerization method is selected from bulk polymerization, preferably free radical bulk polymerization. The free radical polymerization initiator can be selected from the free radical polymerization initiators commonly used in the art, for example, selected from azo initiators and / or peroxide initiators, preferably dilauroyl peroxide, bis(4-tert-butylcyclohexyl) peroxydicarbonate, di(hexadecyl) peroxydicarbonate, ditetradecyl peroxydicarbonate, azobisisobutyronitrile, azobisisovaleronitrile, azobisisoheptonitrile, diisopropylbenzene peroxide, benzoyl peroxide, 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane, tert-butylperoxycarbonic acid-2-ethylhexyl ester, tert-amyl peroxide-2-ethylhexanoate, tert-amyl peroxide (2-ethylhexyl) carbonate, 2,5-dimethyl-2,5-bis(2-ethylhexanoic acid peroxy)hexane, 2,5-dimethyl-2,5-di-tert-butylperoxy-3-hexyne, tert-butyl peroxide (2-ethylhexanoic acid) Ester, 1,1-di-tert-butyl peroxycyclohexane, tert-butyl neodecane peroxyester, tert-butyl peroxypivalate, tert-butyl 2-ethylbutane peroxycarboxylate, 1,1-di-tert-butylperoxy-3,3,5-trimethylcyclohexane, 3,6,9-triethyl-3,6,9-trimethyl-1,4,7-triperoxynonane, bis(3,5,5-trimethylhexanoyl) peroxide, 1,1,3,3-tetramethylbutyl peroxy-2-ethylhexanoate, tert-butylperoxy-3,5,5-trimethylhexanoate, tert-butyl hydroperoxide, di-tert-butyl peroxide, tert-butyl peroxybenzoate, tert-butyl peroxyisopropyl formate, di(2-ethylhexyl) dicarbonate, tert-butyl peroxyacetate, hydroxyisopropylbenzene peroxide, diisopropylbenzene hydroperoxide, tert-butylisopropyl peroxide, tert-amyl hydroperoxide, or a mixture thereof. Azobisisobutyronitrile is preferred.

[0143] The material for preparing ophthalmic lenses (such as intraocular lenses) of the present invention has a moderate water content, which provides the necessary lubricity and flexibility for the ophthalmic lenses (such as intraocular lenses) to be suitable for micro-incision surgery, while at the same time not causing serious negative effects on the refractive index and mechanical properties of medical devices (especially ophthalmic lenses (such as intraocular lenses)). Therefore, the material of the present invention (such as the material for preparing medical devices (especially ophthalmic lenses (such as intraocular lenses)) has a saturated water content selected from 5 to 15% by weight, preferably 6 to 13% by weight, more preferably 7 to 12% by weight, even 8-11% by weight, and especially 9-11% by weight) under the simulated human intraocular state (35°C physiological saline).

[0144] The material used for preparing ophthalmic lenses (such as intraocular lenses) of the present invention has a moderate refractive index, and can be processed into a medical device (especially an ophthalmic lens (such as an intraocular lens)) of the same refractive power, which can be relatively thin, and thus more suitable for micro-incision implantation surgery; while at the same time, the dispersion effect caused by the excessively high refractive index is overcome, thereby avoiding glare after the medical device (especially an ophthalmic lens (such as an intraocular lens)) is implanted. Therefore, the material of the present invention (for example, the material for preparing a medical device (especially an ophthalmic lens (such as an intraocular lens)) has a refractive index selected from 1.49 to 1.54, preferably 1.49 to 1.53, and more preferably 1.50 to 1.52 under a simulated human intraocular state (35°C physiological saline).

[0145] The material used for preparing ophthalmic lenses (such as intraocular lenses) of the present invention has special mechanical properties. It is a hard material in a dry state at room temperature or below room temperature and can be processed into a medical device (especially an ophthalmic lens (such as an intraocular lens)); while it is a soft material in a wet state (after full hydration) at room temperature or in an environment simulating a human eye (35°C), and can be folded to enter the capsular bag of the human eye through a narrow channel, and then can automatically and slowly recover to the original shape of the medical device (especially an ophthalmic lens (such as an intraocular lens)), and can maintain a stable working state in the capsular bag. Therefore, the material of the present invention (for example, the material for preparing medical devices (especially ophthalmic lenses (such as artificial lenses))) has a dry glass transition temperature selected from 10 to 35°C, preferably 15 to 30°C, and more preferably 20 to 25°C; the material of the present invention (for example, the material for preparing medical devices (especially ophthalmic lenses (such as artificial lenses))) has moderate mechanical strength, and its elongation at break in a wet state (after complete hydration) at room temperature is at least 180%, and its breaking strength is at least 2.5 MPa, which can meet the requirements of micro-incision surgical implantation and avoid the occurrence of folding, fracture, etc. of the medical device (especially ophthalmic lenses (such as artificial lenses)) during the implantation process, thereby ensuring safety during the operation.

[0146] The inventors of the present invention have found that the material for preparing ophthalmic lenses (such as intraocular lenses) of the present invention can have the above-mentioned comprehensive properties by selecting and mixing monomers, such as having the following properties at the same time:

[0147] a. The moisture content at 35°C is 5-15wt%, preferably 6-13wt%, more preferably 7-12wt%;

[0148] b. The refractive index (wet state) at 35°C is 1.49-1.54, preferably 1.49-1.53, and more preferably 1.50-1.52. In the material of the present invention (e.g., a material for preparing a medical device (especially an ophthalmic lens (such as an intraocular lens))), the molar ratio of the hydrophilic monomer to the hydrophobic monomer is 20:80-80:20, preferably 25:75-75:25, preferably 30:70-70:30, preferably 35:65-65:35, preferably 40:60-60:40, more preferably 45:55-55:45, or even about 50:50.

[0149] The material for preparing an ophthalmic lens (such as an intraocular lens) of the present invention (especially the material for preparing an additional part) may further include at least one drug, a fluorescent agent and / or at least one photosensitizer.

[0150] According to another specific embodiment of the present invention, when the material used to prepare a medical device (especially an ophthalmic lens (such as an intraocular lens)) of the present invention contains a fluorescent agent, the fluorescent agent is fixed inside or on the surface of the final material. The fluorescent agent is stably combined in the final material. At this time, the fluorescence of the material of the present invention can be used to perform, for example, medical testing. Specifically, the material is made to fluoresce under a slit lamp light source or a Pentero microscope, and an ophthalmologist can clearly and clearly judge the compatibility of the material with the cornea. Since the material does not stain the cornea when it contacts the cornea, it completely gets rid of exogenous corneal fluorescent stains, so that the material of the present invention can be used for medical testing without adding any additional reagents (including fluorescent agents).

[0151] According to another specific embodiment of the present invention, when the material for preparing ophthalmic lenses (such as intraocular lenses) of the present invention contains a photosensitizer, the photosensitizer is fixed inside or on the surface of the final material, and the material is implanted into the lesion site through surgery. When the lesion site needs to be treated, it is irradiated with a laser of a selected wavelength; when the treatment is over, only the laser needs to be removed. Since the photosensitizer is bound inside or on the surface of the material and cannot freely enter other tissues of the human body through blood or other body fluids, the toxicity of the photosensitizer itself can be ignored, and the range of photosensitizer selection is no longer limited. In particular, the material provided by the present invention can be pre-implanted into tissues or parts that may become ill along with other eye surgeries. On the one hand, it can play a preventive role, and on the other hand, once the tissue or part becomes ill, it can receive laser treatment without undergoing surgery again; more particularly, the material provided by the present invention has a repeating effect. After one laser treatment is completed, since the photosensitizer is not eliminated and still exists in the lesion site, when the site recurs or recurs with secondary lesions again or multiple times, it can receive laser treatment again or multiple times without multiple injections of photosensitizer, and has the repeatability of treatment.

[0152] In the material for preparing ophthalmic lenses (such as intraocular lenses) of the present invention, when the copolymer prepared by copolymerization of acrylate monomers is used as the copolymer material, and further comprises at least one drug, a fluorescent agent and / or at least one photosensitizer, the combination mode of the drug, the light absorber, the fluorescent agent and / or the photosensitizer with the copolymer material is selected from:

[0153] - Drugs, light absorbers, fluorescent agents and / or photosensitizers participate in the polymerization during the formation of copolymer materials;

[0154] - The drug, light absorber, fluorescent agent and / or photosensitizer are added to the copolymer material by physical dispersion during the copolymer material molding process;

[0155] - Drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the copolymer material by surface grafting or surface modification; and / or

[0156] - Drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the copolymer material by surface coating.

[0157] When (1) the drug, light absorber, fluorescent agent and / or photosensitizer are combined with the copolymer material in such a way that the drug, light absorber, fluorescent agent and / or photosensitizer participate in polymerization during the molding process of the copolymer material, the drug, light absorber, fluorescent agent and / or photosensitizer contains a material with a polymerizable monomer.

[0158] When (2) the drug, light absorber, fluorescent agent and / or photosensitizer are combined with the copolymer material in such a way that the drug, light absorber, fluorescent agent and / or photosensitizer are added to the copolymer material by physical dispersion during the molding process of the copolymer material, the drug, light absorber, fluorescent agent and / or photosensitizer can be any suitable drug, light absorber, fluorescent agent and / or photosensitizer, optionally containing a polymerizable monomer.

[0159] When (3) the drug, light absorber, fluorescent agent and / or photosensitizer are combined with the copolymer material in such a way that the drug, light absorber, fluorescent agent and / or photosensitizer are fixed on the surface of the formed copolymer material by surface grafting or surface modification, the copolymer material is a formed material, but contains polymerizable groups on the surface of the copolymer material.

[0160] The polymerizable group herein may be, for example, a vinyl group, an allyl group, a butyl group, an acryloyloxy group, a methacryloyloxy group, an acrylamide group, a methacrylamide group, a vinyl ether group, an alkynyl group, a hydroxyl group, a mercapto group, an amino group, an imino group, a carboxyl group, an acid anhydride group, an aldehyde group, an isocyanate group, a siloxane group, an epoxy group, a cyclic nitrogen group, and the like.

[0161] When (4) the drug, light absorber, fluorescent agent and / or photosensitizer are combined with the copolymer material in such a way that the drug, light absorber, fluorescent agent and / or photosensitizer are fixed on the surface of the formed copolymer material by surface coating, the copolymer material is a formed material.

[0162] According to another embodiment of the present invention, a light absorber is coated on the edge of the optical zone of an ophthalmic lens (such as an intraocular lens). The advantage of this embodiment is that since the material is coated on the side of the intraocular lens, the optical zone is protected to the greatest extent.

[0163] In another embodiment of the present invention, the fluorescent agent of the present invention is selected from: fluorescein (sodium), cyanine fluorescent dyes, fluorescein isothiocyanate, rhodamine substances with fluorescent properties, lanthanide chelates with fluorescent properties, phycoerythrin (P-phycoerythrin, PE), substances that produce fluorescence after enzyme action such as peridinium chlorophyll protein (PerCP), propidium iodide and other derivatives with emission wavelengths in the range of 300-850 nanometers, or fluorescent agents formed by reasonably loading the above compounds into nanomaterials, or mixtures thereof.

[0164] In another embodiment of the present invention, the light absorber and the ophthalmic lens (such as an intraocular lens) can be combined by copolymerization, blending, inlaying, bonding, spraying, printing, and evaporation.

[0165] In another embodiment of the present invention, the edge light absorbing material or structure is contained in other non-intraocular lens ophthalmic lenses, such as frame glasses, corneal contact lenses (contact lenses), intracorneal lenses, etc.

[0166] In another embodiment of the present invention, the shape of the light absorption zone in the main view may be a ring, a polygon, or any shape that can form a light absorption closed loop around the optical zone.

[0167] In another embodiment of the present invention, the light absorption region may contain other components such as photosensitizers and sustained-release drugs in addition to the light absorber.

[0168] In another embodiment of the present invention, the edge of the optical zone of the intraocular lens is made of a material with a light absorber, the optical zone and the haptic are made of different materials, and the three areas are combined by physical or chemical synthesis.

[0169] According to a preferred embodiment of the present invention, the refractive index of the material of the light absorption zone of the artificial lens is greater than or equal to the refractive index of the material of the optical zone. In this case, light incident on the boundary between the optical zone and the absorption zone of the artificial lens will not cause total reflection, and the incident angle of light from the absorption zone to the aqueous humor is reduced to avoid secondary total reflection.

[0170] In another embodiment of the present invention, the main body of an ophthalmic lens (such as an intraocular lens) has a groove, and the ophthalmic lens (such as an intraocular lens) has the following characteristics:

[0171] Refractive index (tested in 35°C water): 1.43-1.56, preferably 1.47~1.53, more preferably 1.50~1.52

[0172] Optical power: -25.0D~+36.0D, preferably, -10.0D~+36.0D, more preferably, +6.0D~+30.0D

[0173] Optical zone diameter: ≥2.0 mm, preferably ≥4.2 mm, more preferably ≥4.5 mm

[0174] Center thickness: 0.1mm~1.5mm, preferably, 0.2mm~1.0mm, more preferably, 0.5~0.9mm

[0175] Body edge thickness: 0.08~0.6mm, preferably 0.1-0.5mm, more preferably 0.15~0.3mm

[0176] Groove depth: 0.01 to 2 mm, preferably 0.01 to 1 mm, more preferably 0.01 to 0.7 mm

[0177] Groove width: 0.05 to 3.5 mm, preferably 0.1 to 1.5 mm, more preferably 0.2 to 0.8 mm

[0178] The distance between the inner edge of the groove and the center of the lens is: ≥1.0 mm, preferably ≥2.1 mm, more preferably ≥2.25 mm.

[0179] The grooves may be one or more; may be penetrating, preferably non-penetrating; the opening of the grooves may be located on the front surface or the back surface of the intraocular lens, preferably the back surface. Preferably, the grooves are frosted or made into a rough surface.

[0180] In one embodiment of the present invention, the photosensitizer of the present invention is selected from a photodynamic photosensitizer or a photothermal photosensitizer. The photosensitizer of the present invention is any photosensitizer whose wavelength range of the activated laser light source is 300 to 1100 nanometers. Preferably, the wavelength range of the laser light source is selected from 500 to 1000 nanometers; preferably, the wavelength range of the laser light source is selected from 600 to 900 nanometers; preferably, the wavelength range of the laser light source is selected from 700 to 900 nanometers or the wavelength range of the laser light source is selected from 800 to 1100 nanometers.

[0181] In one embodiment of the present invention, when the material containing the photodynamic photosensitizer is irradiated with a laser of a selected wavelength (e.g., 300 to 1100 nanometers), the photosensitizer in the material is excited to generate cytotoxic reactive oxygen species that can kill cells in the diseased area and achieve a therapeutic effect.

[0182] In another embodiment of the present invention, when the material containing the photothermal photosensitizer of the present invention is irradiated with a laser of a selected wavelength (e.g., 300 to 1100 nanometers), the photosensitizer in the material is excited, and the light energy is converted into heat, so that the temperature of the surrounding environment is increased to kill the diseased tissue cells. When the temperature of the diseased tissue area reaches 43°C, the synthesis of DNA, RNA and protein can be inhibited, and the safety limit of normal cells is 45°C. Therefore, in a preferred embodiment, the material containing the photothermal photosensitizer can generate heat under laser irradiation, so that the temperature increases by 4 to 20°C; in a more preferred embodiment, the material containing the photothermal photosensitizer can generate heat under laser irradiation, so that the ambient temperature increases by 6 to 12°C; in a more preferred embodiment, the material containing the photothermal photosensitizer can generate heat under laser irradiation, so that the ambient temperature increases by 8 to 10°C. For example, the elevated temperature is greater than 38°C, greater than 39°C, preferably greater than 40°C, preferably greater than 41°C, preferably greater than 42°C, preferably greater than 43°C, preferably greater than 44°C, preferably greater than 45°C, preferably greater than 46°C, preferably greater than 47°C, preferably greater than 50°C, and less than 55°C, preferably greater than 56°C, preferably greater than 57°C, preferably greater than 58°C, preferably greater than 59°C, preferably greater than 60°C, preferably greater than 61°C, preferably greater than 62°C, preferably greater than 63°C, preferably greater than 64°C, preferably greater than 65°C, but preferably less than 66°C, preferably less than 65°C, preferably less than 64°C, preferably less than 63°C, preferably less than 62°C, preferably less than 61°C, preferably less than 60°C, preferably less than 59°C, preferably less than 58°C, preferably less than 57°C, preferably less than 56°C, preferably less than 55°C, preferably less than 54°C, preferably less than 53°C, preferably less than 52°C, preferably less than 51°C, preferably less than 50°C, preferably less than 49°C, preferably less than 48°C, preferably less than 47°C, preferably less than 46°C.

[0183] In another embodiment of the present invention, the photosensitizer suitable for the present invention is selected from porphyrin, metalloporphyrin, porphin, chlorophyll, rhodocyanine, fluorescein, phthalocyanine, metal phthalocyanine, indocyanine green, tricarbocyanine, nanogold particles, metal nanoparticles, metal oxide nanoparticles, metal sulfide nanoparticles, metal carbide nanoparticles, carbon nanotubes, graphene, etc., as well as derivatives of the above compounds, or degradation products of the above compounds, or salt forms of the above compounds. In a preferred embodiment, the photosensitizer is selected from indole monocyanine (monomethylcyanine), indole carbocyanine (trimethylcyanine), indole dicarbocyanine (pentamethylcyanine), indole tricarbocyanine (heptamethylcyanine), tricarbonyl cyanine dyes, benzindole semicyanine dyes, indole squaryl cyanine dyes, phthalocyanines, chlorophyll derivatives, pheophytin, pheophorbide a and its derivatives, dihydrochlorin e6 and its derivatives, purpurin 18, dihydrochlorin p6 and its derivatives, dihydrochlorin e4 and its derivatives, dihydrochlorin f and its derivatives, protoporphyrin and its derivatives, benzochloroporphyrin, metalloporphyrin, hematoporphyrin derivatives (HpD), porphyrin sodium, cancer photophyll (PSD-007), nano-gold, nano-tungsten oxide, nano-copper sulfide, nano-iron oxide, nano-nickel carbide, nano-molybdenum oxide, and other water-soluble or fat-soluble derivatives modified or modified based on the above photosensitizers.

[0184] In another embodiment of the present invention, the photosensitizer can be a photosensitizer whose activated laser light source has a wavelength range of 400 to 600 nm, such as fluorescein; the photosensitizer can be a photosensitizer whose activated laser light source has a wavelength range of 600 to 750 nm, such as rhodocyanine 18; the photosensitizer can be a photosensitizer whose activated laser light source has a wavelength range of 700 to 900 nm, such as indocyanine green ICG; the photosensitizer can be a photosensitizer whose activated laser light source has a wavelength range of 800 to 1100 nm, such as nanogold.

[0185] In another embodiment of the present invention, the light absorber for reducing adverse optical phenomena suitable for the present invention can be selected from any light absorber that can be used in ophthalmic lenses, especially intraocular lenses, which can reduce adverse optical phenomena, for example: organic dyes, such as azo series, anthraquinone series, aromatic methane series, indigo series, porphyrin series, phthalocyanine series, nitro and nitroso series, methine and polymethine series, heterocyclic compounds and their derivatives; various organic or inorganic pigments, such as carbon black, graphite, graphene, metal particles, metal oxides, metal salt compounds, metal alkali compounds, metal sulfides, etc. Preferred light absorbers include various dyes or pigments used for colored contact lenses, such as compounds disclosed in U.S. Pat. Nos. 4,668,240, 4,857,072, 5,272,010, and 8,915,590, and Chinese Patent No. CN200580017745.8, and any colorant licensed and approved by the FDA for use in medical devices, such as chlorophyll derivatives (e.g., rhodamine 18), D&C Blue 6, D&C Green 6, D&C Violet 2, carbazole violet, certain copper complexes, certain chromium complexes, various iron oxides, phthalocyanine green, phthalocyanine blue, etc.; preferred pigments include blue phthalocyanine blue (Pigment Blue 15, CI 74160), cobalt blue (Pigment Blue 15, CI 77343), green phthalocyanine green (Pigment Green 7, CI 74260) and chromium trioxide, various iron oxides in yellow, red, brown and black, purple carbazole violet, and black Monolith black CK (Ciba).

[0186] In another embodiment of the present invention, the molecular structure of the drug, light absorber, fluorescent agent and / or photosensitizer contains active groups, such as hydroxyl, thiol, amino, imino, carboxyl, anhydride, aldehyde, isocyanate, siloxane, epoxy, cyclic nitrogen, etc., which can undergo grafting reaction with the groups on the side chains of the copolymer material molecules. The photosensitizer molecules are combined with the copolymer material molecular chains in the form of covalent bonds. The photosensitizer is fixed inside the copolymer material or on its surface and cannot freely enter the blood or other body fluids.

[0187] In one embodiment of the present invention, when the molecular structure of the drug, light absorber, fluorescent agent and / or photosensitizer contains a polymerizable group, such as: vinyl, allyl, butylene, acryloyloxy, methacryloyloxy, acrylamide, methacrylamide, vinyl ether, alkynyl, hydroxyl, thiol, amino, imino, carboxyl, anhydride, aldehyde, isocyanate, siloxane, epoxy, cyclic nitrogen, etc., it can undergo copolymerization reaction with the polymerizable monomer of the copolymer material, and the drug, light absorber, fluorescent agent and / or photosensitizer molecules exist in the molecular chain of the copolymer material in the form of covalent bonds, and the drug, light absorber, fluorescent agent and / or photosensitizer are fixed in the copolymer material, so the toxicity of the drug, light absorber, fluorescent agent and / or photosensitizer itself can be completely ignored.

[0188] In another embodiment of the present invention, when the drug, light absorber, fluorescent agent and / or photosensitizer are dispersed in the copolymer material by blending or doping, the drug, light absorber, fluorescent agent and / or photosensitizer molecules are combined with the molecular chains of the copolymer material by hydrogen bonds or van der Waals forces, and the drug, light absorber, fluorescent agent and / or photosensitizer molecules are bound in the copolymer material and cannot freely enter the blood or other body fluids.

[0189] In another embodiment of the present invention, when drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the copolymer material by surface grafting or surface modification, the copolymer material is selected from a polymerizable copolymer material, preferably containing polymerizable groups with good biocompatibility on the surface, such as vinyl, allyl, butylene, acryloyloxy, methacryloyloxy, acrylamide, methacrylamide, vinyl ether, alkynyl, hydroxyl, thiol, amino, imino, carboxyl, anhydride, aldehyde, isocyanate, siloxane, epoxy, cyclic nitrogen, etc., wherein the drugs, light absorbers, fluorescent agents and / or photosensitizers can undergo a grafting reaction with the copolymer material, and the copolymer material and the drug, light absorber, fluorescent agent and / or photosensitizer molecules are combined together in the form of covalent bonds, and the drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed inside or on the surface of the copolymer material and cannot freely enter the blood or other body fluids.

[0190] In another preferred embodiment, the drug, light absorber, fluorescent agent and / or photosensitizer are dispersed in other auxiliary agents (for example, cosolvents, emulsifiers, lubricants, hydrophilic coatings, drug carriers, masterbatches, ultraviolet absorbers, crosslinking agents, coupling agents, pH regulators, antistatic agents, release agents, etc.) by dissolving, suspending, emulsifying, etc., and coated on the surface of the copolymer material. The drug, light absorber, fluorescent agent and / or photosensitizer molecules are combined with the molecular chains of the copolymer material by hydrogen bonds or van der Waals forces. The light absorber, fluorescent agent and / or photosensitizer are bound to the surface of the copolymer material and cannot freely enter the blood or other body fluids.

[0191] In another preferred embodiment, in order to enhance the affinity between the drug, light absorber, fluorescent agent and / or photosensitizer molecules and the copolymer material molecules, the drug, light absorber, fluorescent agent and / or photosensitizer molecules can be chemically modified without changing the photosensitivity; the copolymer material can also be activated by treatments including but not limited to plasma treatment, corona treatment, flame treatment, strong acid treatment, strong alkali treatment, etc.

[0192] Other polymerizable monomers that can be used in the present invention include butadiene, styrene, α-methylstyrene, sodium styrene sulfonate, vinyl toluene, acrylonitrile, methacrylonitrile, α-chloroacrylonitrile, ethylacrylonitrile, methyl vinyl ether, isopropyl vinyl ether, n-butyl vinyl ether, isobutyl vinyl ether, tert-butyl vinyl ether, 2-ethylhexyl vinyl ether, 4-hydroxybutyl vinyl ether, 1,4-butanediol divinyl ether, diethylene glycol divinyl ether, vinyl esters such as vinyl acetate, vinyl esters of alkanehydroxycarboxylic acids, vinyl propionate, vinyl butyrate, vinyl isobutyrate, vinyl hexanoate, vinyl 2-ethylhexanoate and vinyl decanoate; allyl chloride, methylallyl chloride, vinyl dichloride, vinyl chloride, vinyl fluoride, vinyl difluoride, sodium vinyl sulfonate, butyl vinyl sulfonate, phenyl vinyl sulfone, methyl ethyl Alkenyl sulfone, N-vinyl pyrrolidinedione, N-vinyl oxazolidinedione, acrolein, acrylamide, methacrylamide, N,N-dimethyl (meth) acrylamide, hydroxymethyl acrylamide, N-butoxy (meth) acrylamide, isobutoxy (meth) acrylamide, etc., etc.; other ethylenically unsaturated carboxylic acids and esters thereof such as dialkyl and trialkyl esters of dibasic and tribasic carboxylic acids (such as itaconic acid, etc.), including di(2-ethylhexyl) maleate, dibutyl maleate, dimethyl fumarate, dimethyl itaconate, diethyl citrate, trimethyl aconitate, diethyl mesaconic acid, di(2-ethylhexyl) itaconate, di(2-chloroethyl) itaconate, maleic acid, maleic anhydride, fumaric acid, itaconic acid; and olefins such as diisobutylene, 1-octene, 1-decene, 1-hexadecene, etc., or mixtures thereof.

[0193] In one embodiment of the present invention, when the drug, light absorber, fluorescent agent and / or photosensitizer are polymerized with a copolymer material to obtain the material of the present invention, or when the drug, light absorber, fluorescent agent and / or photosensitizer are dispersed in a copolymer material to obtain the material of the present invention, the material of the present invention can be prepared by a method comprising the following steps:

[0194] 1) mixing a polymerizable monomer with optional additives such as a thermal crosslinking agent, an initiator, an ultraviolet absorber, etc.;

[0195] 2) Add drugs, light absorbers, fluorescent agents and / or photosensitizers, dissolve them, and then polymerize them.

[0196] More specifically, the material for preparing an ophthalmic lens of the present invention can be prepared by a method comprising the following steps:

[0197] 1) mixing a polymerizable monomer with a thermal initiator, a crosslinking agent and / or an ultraviolet absorber;

[0198] 2) adding drugs, light absorbers, fluorescent agents and / or photosensitizers to dissolve them;

[0199] 3) placing the reaction system obtained in 2) in a mold;

[0200] 4) performing polymerization, such as water bath polymerization;

[0201] 5) Repolymerization in the dryer.

[0202] In another embodiment of the present invention, when the drug, light absorber, fluorescent agent and / or photosensitizer is fixed on the surface of the copolymer material by surface grafting or surface modification, the material of the present invention can be prepared by a method comprising the following steps:

[0203] 1) mixing a polymerizable monomer with optional additives such as a crosslinking agent, a thermal initiator, an ultraviolet absorber, etc., and then polymerizing to obtain a copolymer material;

[0204] 2) Add drugs, light absorbers, fluorescent agents and / or photosensitizers and dissolve them, for example, dissolving the drugs, light absorbers, fluorescent agents and / or photosensitizers with suitable auxiliary agents (such as polymerizable monomers), and then performing polymerization such as graft polymerization or surface modification or transfer printing.

[0205] More specifically, the material of the present invention can be prepared by a method comprising the following steps:

[0206] 1) mixing a polymerizable monomer with a thermal initiator, a crosslinking agent and / or an ultraviolet absorber;

[0207] 2) transferring the reaction system obtained in 1) into a mold;

[0208] 4) performing polymerization, such as water bath polymerization;

[0209] 5) Repolymerization in the dryer;

[0210] 6) dissolving the drug, light absorber, fluorescent agent and / or photosensitizer, for example, dissolving the drug, light absorber, fluorescent agent and / or photosensitizer with a suitable polymerizable monomer;

[0211] 7) The system obtained above is polymerized again, such as graft polymerization, surface modification or transfer printing.

[0212] In another embodiment of the present invention, when the drug, light absorber, fluorescent agent and / or photosensitizer is fixed on the surface of the copolymer material by surface coating, the material of the present invention can be prepared by a method comprising the following steps:

[0213] 1) Obtaining suitable copolymer materials;

[0214] 2) Dissolving the drug, light absorber, fluorescent agent and / or photosensitizer in a suitable solvent and coating the drug, light absorber, fluorescent agent and / or photosensitizer on the surface of the copolymer material.

[0215] The material for preparing ophthalmic lenses of the present invention can also be used to manufacture medical treatment devices and medical detection devices, for example, to manufacture corneal contact lenses, orthokeratology lenses, scleral contact lenses, iris retractors, intraocular lenses, artificial corneas, intracorneal rings, capsular bag tension rings, intracorneal lenses, glaucoma drainage valves, drug sustained-release carriers, intraocular fillers, fundus fillers, glasses, goggles, medical device lenses, or when it contains a therapeutic agent and / or a photosensitizer, it can be used to manufacture a medical treatment device (such as a device for treating ophthalmic diseases), such as a device for treating post-haemorrhage (such as a device for treating post-haemorrhage). ophthalmic lenses), or when it contains a fluorescent agent, it can be used to manufacture medical detection devices (so that the resulting product can be detected using fluorescent properties, especially ophthalmic equipment, such as lenses with fluorescent properties, especially ophthalmic lenses, ophthalmic lenses with fluorescent properties, corneal contact lenses, orthokeratology lenses, iris retractors, intraocular lenses, artificial corneas, intracorneal rings, capsular bag tension rings, intracorneal lenses, glaucoma drainage valves, drug sustained-release carriers, intraocular fillers, fundus fillers, glasses, goggles, medical device lenses, telescopes, observation mirrors, etc.) and other ophthalmic equipment or consumables.

[0216] The present invention also relates to the use of the material of the present invention for preparing medical devices (such as ophthalmic lenses, especially intraocular lenses) in the preparation of the above-mentioned devices or equipment (such as medical treatment devices, medical detection devices), for example: ophthalmic lenses, especially intraocular lenses, corneal contact lenses, orthokeratology lenses, scleral contact lenses, iris retractors, intraocular lenses, artificial corneas, intracorneal rings, capsular bag tension rings, intracorneal lenses, glaucoma drainage valves, drug sustained-release carriers, intraocular fillers, fundus fillers, glasses, goggles, medical device lenses or when they contain therapeutic agents and / or photosensitizers, they can be used to manufacture medical treatment devices (such as devices for treating ophthalmic diseases), such as devices for treating post-ophthalmic diseases, or when they contain light absorbers When it contains a fluorescent agent, it can be used to manufacture therapeutic devices that prevent optical interference (such as devices for treating ophthalmic diseases, such as ophthalmic lenses, especially artificial lenses), or when it contains a fluorescent agent, it can be used to manufacture medical detection devices (so that the resulting product can be detected using fluorescent properties, especially ophthalmic equipment, such as lenses with fluorescent properties, especially ophthalmic lenses, ophthalmic lenses with fluorescent properties, corneal contact lenses, orthokeratology lenses, scleral contact lenses, iris retractors, intraocular lenses, artificial corneas, intracorneal rings, capsular bag tension rings, intracorneal lenses, glaucoma drainage valves, drug sustained-release carriers, intraocular fillers, fundus fillers, glasses, goggles, medical device lenses, telescopes, observation mirrors, etc.) and other ophthalmic equipment or consumables.

[0217] The term "alkyl" as used herein refers to a straight or branched hydrocarbon containing 1 to 500 carbon atoms, or 1 to 100 carbon atoms, or 1 to 50 carbon atoms, or 1 to 20 carbon atoms, or 1 to 10 carbon atoms, or 1 to 8 carbon atoms, 1 to 6 carbon atoms, 1 to 4 carbon atoms, or 1 to 3 carbon atoms (unless otherwise specified). Representative examples of alkyl include, but are not limited to, methyl, ethyl, n-propyl, isopropyl, n-butyl, sec-butyl, isobutyl, tert-butyl, n-pentyl, isopentyl, neopentyl, n-hexyl, 3-methylhexyl, 2,2-dimethylpentyl, 2,3-dimethylpentyl, n-heptyl, n-octyl, n-nonyl and n-decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, hexadecyl, heptadecyl, octadecyl, nonadecyl, eicosyl. When an "alkyl" group is a linking group between two other moieties, it may also be straight or branched; examples include, but are not limited to, -CH2-, -CH2CH2-, -CH2CH2CH(CH3)-, -CH2CH(CH2CH3)CH2-.

[0218] The term "aryl" as used herein refers to phenyl (i.e., monocyclic aryl) or a bicyclic system containing at least one phenyl ring or an aromatic bicyclic ring containing only carbon atoms in the aromatic bicyclic system. The bicyclic aryl can be azulenyl, naphthyl, or a phenyl fused to a monocyclic cycloalkyl, a monocyclic cycloalkenyl, or a monocyclic heterocyclic group. The bicyclic aryl is connected to the parent molecular moiety by any carbon atom contained in the phenyl portion of the bicyclic system or any carbon atom of the naphthyl or azulenyl ring. The fused monocyclic cycloalkyl or monocyclic heterocyclic moiety of the bicyclic aryl is optionally substituted by one or two oxo and / or thia groups.Representative examples of bicyclic aryl groups include, but are not limited to, azulenyl, naphthyl, indan-1-yl, indan-2-yl, indan-3-yl, indan-4-yl, 2,3-indan-4-yl, 2,3-indan-5-yl, 2,3-indan-6-yl, 2,3-indan-7-yl, indan-1-yl, indan-2-yl, indan-3-yl, indan-4-yl, dihydronaphthalen-2-yl, dihydronaphthalen-3-yl, dihydronaphthalen-4-yl, dihydronaphthalen-1-yl, 5,6,7,8-tetrahydronaphthalen-1-yl, 5,6,7,8-tetrahydronaphthalen-2-yl, 2,3-dihydrobenzofuran-4-yl, 2,3-dihydrobenzofuran-7-yl, furan-5-yl, 2,3-dihydrobenzofuran-6-yl, 2,3-dihydrobenzofuran-7-yl, benzo[d][1,3]dioxol-4-yl, benzo[d][1,3]dioxol-5-yl, 2H-chromen-2-one-5-yl, 2H-chromen-2-one-6-yl, 2H-chromen-2-one-7-yl, 2H-chromen-2-one-8-yl, isoindoline-1,3-dione-4-yl, isoindoline-1,3-dione-5-yl, inden-1-one-4-yl, inden-1-one-5-yl, inden-1-one-6-yl, inden-1-one-7-yl, 2,3-dihydrobenzo[ b][1,4]dioxan-5-yl, 2,3-dihydrobenzo[b][1,4]dioxan-6-yl, 2H-benzo[b][1,4]oxazin-3(4H)-on-5-yl, 2H-benzo[b][1,4]oxazin-3(4H)-on-6-yl, 2H-benzo[b][1,4]oxazin-3(4H)-on-7-yl, 2H-benzo[b][1,4]oxazin-3(4H)-on-8-yl, benzo[d]oxazin-2(3H)-on-5-yl, benzo[d]oxazin-2(3H)-on-6-yl, benzo[d]oxazin-2(3H)-on-7-yl, benzo[d]oxazin-2( d]thiazol-2(3H)-one-4-yl, benzo[d]thiazol-2(3H)-one-5-yl, benzo[d]thiazol-2(3H)-one-6-yl, benzo[d]thiazol-2(3H)-one-7-yl, benzo[d]thiazol-2(3H)-one-8-yl, benzo[d]thiazol-2(3H)-one-4-yl, benzo[d]thiazol-2(3H)-one-5-yl, benzo[d]thiazol-2(3H)-one-6-yl, benzo[d]thiazol-2(3H)-one-7-yl, benzo[d]thiazol-2(3H)-one-8-yl, benzo[d]thiazol-2(3H)-one-4-yl, benzo[d]thiazol-2(3H)-one-5-yl, benzo[d]thiazol-2(3H)-one-6-yl, and benzo[d]thiazol-2(3H)-one-7-yl. In certain embodiments, the bicyclic aryl is a (i) naphthyl or (ii) phenyl ring fused to a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, or a 5 or 6 membered monocyclic heterocyclyl, wherein the fused cycloalkyl, cycloalkenyl, and heterocyclyl groups are optionally substituted with one or two groups that are independently oxo or thia.

[0219] The term "arylalkyl" or "alkylaryl" as used herein refers to an aryl group as defined herein attached to the parent molecular moiety through an alkyl group as defined herein. Representative examples of arylalkyl include, but are not limited to, benzyl, 2-phenylethyl, 3-phenylpropyl and 2-naphth-2-ylethyl.

[0220] The term "cycloalkyl" as used herein refers to a monocyclic or bicyclic cycloalkyl ring system. A monocyclic ring system is a cyclic hydrocarbon group containing 3 to 8 carbon atoms, wherein such a group may be saturated or unsaturated, but not aromatic. In certain embodiments, the cycloalkyl group is fully saturated. Examples of monocyclic cycloalkyls include cyclopropyl, cyclobutyl, cyclopentyl, cyclopentenyl, cyclohexyl, cyclohexenyl, cycloheptyl, and cyclooctyl. A bicyclic cycloalkyl ring system is a bridged monocyclic or fused bicyclic ring. A bridged monocyclic ring contains a monocyclic cycloalkyl ring in which two non-adjacent carbon atoms of the monocyclic ring are connected by an alkylene bridge of one to three additional carbon atoms (i.e., -(CH2) w -type bridging groups, wherein w is 1, 2 or 3). Representative examples of bicyclic ring systems include, but are not limited to, bicyclo[3.1.1]heptane, bicyclo[2.2.1]heptane, bicyclo[2.2.2]octane, bicyclo[3.2.2]nonane, bicyclo[3.3.1]nonane and bicyclo[4.2.1]nonane. Fused bicyclic cycloalkyl ring systems contain a monocyclic cycloalkyl ring fused to a phenyl, monocyclic cycloalkyl, monocyclic cycloalkenyl, monocyclic heterocyclyl or monocyclic heteroaryl. The bridged or fused bicyclic cycloalkyl is attached to the parent molecular moiety via any carbon atom contained within the monocyclic cycloalkyl ring. The cycloalkyl group is optionally substituted with one or two groups that are independently oxo or thia. In certain embodiments, the fused bicyclic cycloalkyl is a 5 or 6 membered monocyclic cycloalkyl ring fused to a phenyl ring, a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, a 5 or 6 membered monocyclic heterocyclyl, or a 5 or 6 membered monocyclic heteroaryl, wherein the fused bicyclic cycloalkyl is optionally substituted with one or two groups which are independently oxo or thia.

[0221] The term "heteroaryl" as used herein refers to a monocyclic heteroaryl or bicyclic system containing at least one heteroaromatic ring. The monocyclic heteroaryl can be a 5- or 6-membered ring. The 5-membered ring consists of two double bonds and one, two, three or four nitrogen atoms and optionally one oxygen or sulfur atom. The 6-membered ring consists of three double bonds and one, two, three or four nitrogen atoms. The 5- or 6-membered heteroaryl is connected to the parent molecular moiety through any carbon atom or any nitrogen atom contained in the heteroaryl. Representative examples of monocyclic heteroaryls include, but are not limited to, furanyl, imidazolyl, isoxazolyl, isothiazolyl, oxadiazolyl, oxazolyl, pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, pyrazolyl, pyrrolyl, tetrazolyl, thiadiazolyl, thiazolyl, thienyl, triazolyl and triazinyl. The bicyclic heteroaryl consists of a monocyclic heteroaryl fused to a phenyl, a monocyclic cycloalkyl, a monocyclic cycloalkenyl, a monocyclic heterocyclyl or a monocyclic heteroaryl. The fused cycloalkyl or heterocyclyl portion of the bicyclic heteroaryl group is optionally substituted with one or two groups that are independently oxo or thia. When the bicyclic heteroaryl contains a fused cycloalkyl, cycloalkenyl or heterocyclyl ring, the bicyclic heteroaryl group is connected to the parent molecular moiety through any carbon or nitrogen atom contained in the monocyclic heteroaryl portion of the bicyclic system. When the bicyclic heteroaryl is a monocyclic heteroaryl fused to a phenyl ring, the bicyclic heteroaryl group is connected to the parent molecular moiety through any carbon atom or nitrogen atom in the bicyclic system. Representative examples of bicyclic heteroaryl include, but are not limited to, benzimidazolyl, benzofuranyl, benzothiophenyl, benzoxadiazolyl, benzoxathiadiazolyl, benzothiazolyl, cinnolinyl, 5,6-dihydroquinolin-2-yl, 5,6-dihydroisoquinolin-1-yl, furopyridinyl, indazolyl, indolyl, isoquinolinyl, naphthyridinyl, quinolinyl, purinyl, 5,6,7,8-tetrahydroquinolin-2-yl, 5,6,7,8-tetrahydroquinolin-3-yl, 5,6,7,8-tetrahydroquinolin-4-yl, 5,6,7,8-tetrahydroisoquinolin-1-yl, thienopyridinyl, 4,5,6,7-tetrahydrobenzo[c][1,2,5]oxadiazolyl, and 6,7-dihydrobenzo[c][1,2,5]oxadiazol-4(5H)-onyl. In certain embodiments, the fused bicyclic heteroaryl is a 5 or 6 membered monocyclic heteroaryl ring fused to a phenyl ring, a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, a 5 or 6 membered monocyclic heterocyclyl, or a 5 or 6 membered monocyclic heteroaryl, wherein the fused cycloalkyl, cycloalkenyl, and heterocyclyl groups are optionally substituted with one or two groups that are independently oxo or thia.

[0222] The terms "heteroarylalkyl" and "-alkylheteroaryl" as used herein refer to a heteroaryl group, as defined herein, attached to the parent molecular moiety through an alkyl group, as defined herein. Representative examples of heteroarylalkyl include, but are not limited to, furan-3-ylmethyl, 1H-imidazol-2-ylmethyl, 1H-imidazol-4-ylmethyl, 1-(pyridin-4-yl)ethyl, pyridin-3-ylmethyl, pyridin-4-ylmethyl, pyrimidin-5-ylmethyl, 2-(pyrimidin-2-yl)propyl, thien-2-ylmethyl, and thien-3-ylmethyl.

[0223] The term "heterocyclyl" as used herein refers to a monocyclic heterocycle or a bicyclic heterocycle. The monocyclic heterocycle is a 3, 4, 5, 6 or 7-membered ring containing at least one heteroatom independently selected from O, N and S, wherein the ring is saturated or unsaturated, but not aromatic. The 3 or 4-membered ring contains 1 heteroatom selected from O, N and S. The 5-membered ring may contain zero or one double bond and one, two or three heteroatoms selected from O, N and S. The 6 or 7-membered ring contains zero, one or two double bonds and one, two or three heteroatoms selected from O, N and S. The monocyclic heterocycle is connected to the parent molecular moiety through any carbon atom or any nitrogen atom contained within the monocyclic heterocycle. Representative examples of monocyclic heterocycles include, but are not limited to, azetidinyl, azepanyl, aziridinyl, diazepanyl, 1,3-dioxanyl, 1,3-dioxolanyl, 1,3-dithiolanyl, 1,3-dithianyl, imidazolinyl, imidazolidinyl, isothiazolinyl, isothiazolidinyl, isoxazolinyl, isoxazolidinyl, morpholinyl, oxadiazolinyl, oxadiazolidinyl, oxazolinyl, oxazolidinyl, piperazinyl, piperidinyl, pyranyl, pyrazolinyl, pyrazolidinyl, pyrrolinyl, pyrrolidinyl, tetrahydrofuranyl, tetrahydrothiophenyl, thiadiazolinyl, thiadiazolidinyl, thiazolinyl, thiazolidinyl, thiamorpholinyl, 1,1-dioxidothiomorpholinyl (thiomorpholine sulfone), thiopyranyl, and trithianyl. Bicyclic heterocycle is a monocyclic heterocycle fused to phenyl, monocyclic cycloalkyl, monocyclic cycloalkenyl, monocyclic heterocycle or monocyclic heteroaryl. Bicyclic heterocycle is connected to the parent molecular part by any carbon atom or any nitrogen atom contained in the monocyclic heterocyclic ring part of the bicyclic system. Representative examples of bicyclic heterocyclic radicals include but are not limited to 2,3-dihydrobenzofuran-2-yl, 2,3-dihydrobenzofuran-3-yl, indole-1-yl, indole-2-yl, indole 3-yl, 2,3-dihydrobenzothiophene-2-yl, decahydroquinolyl, decahydroisoquinolyl, octahydro-1H-indolyl and octahydrobenzofuranyl. Heterocyclic radical groups are optionally substituted by one or two independently oxo or thia radicals. In certain embodiments, the bicyclic heterocyclyl is a 5 or 6 membered monocyclic heterocyclyl ring fused to a phenyl ring, a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, a 5 or 6 membered monocyclic heterocyclyl, or a 5 or 6 membered monocyclic heteroaryl, wherein the bicyclic heterocyclyl is optionally substituted with one or two groups which are independently oxo or thia.

[0224] The additional part of the present invention can be a degradable material, such as polycaprolactone, polybutylene succinate, polylactic acid, polyhydroxyalkanoate, aliphatic aromatic copolyester, polyvinyl alcohol, carbon dioxide copolymer, poly-β-hydroxybutyrate, or a mixture thereof, or a copolymer thereof. The degradable material is an ideal carrier of the drug, with uniform sustained release position, uniform amount, and long sustained release time. When the degradable material is completely degraded, the drug is completely released, and can last for 1 week to 1 year depending on the different degradable materials, and the residual epithelial cells are more thoroughly removed. After complete release, the groove in the optical zone of the lens forms a structure similar to a sharp right-angled square edge, and has a preventive effect at the same time. When the additional part does not use a degradable material, the therapeutic active agent can be fixed to the surface of the additional part using any surface coating and modification technology disclosed in the prior art. Unlike other coatings, there is no therapeutic agent in the center of the optical zone, and the removal of upper cells is more targeted, the required dose is also reduced accordingly, and the damage to other normal tissue cells is small.

[0225] In another embodiment of the present invention, the additional part and the main body material are selected from hydrophobic acrylate, acrylate hydrogel, silicone, silicone hydrogel, fluorosilicone acrylate, polystyrene and polymethyl methacrylate, polycarbonate, polysiloxane, or a mixture thereof.

[0226] In another embodiment of the present invention, the additional part material is selected from biodegradable plastics, such as polycaprolactone, polybutylene succinate, polylactic acid, polyhydroxyalkanoate, aliphatic aromatic copolyesters, polyvinyl alcohol, carbon dioxide copolymers, poly-β-hydroxybutyrate, or mixtures thereof, or copolymers thereof.

[0227] In another embodiment of the present invention, the additional part can carry drugs, such as various antibiotics, steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs, to prevent postoperative inflammation and microbial infection. It can also carry anti-metabolism drugs and mitosis inhibitors, immunotoxins and cytotoxins that inhibit inflammatory responses, drugs that inhibit cell adhesion to the extracellular matrix, and drugs that induce cell apoptosis to eliminate LEC or inhibit epithelial cell mitosis, prevent and treat posterior capsule opacification, and the drugs are slowly released during the degradation of the degradable material.

[0228] In another embodiment of the present invention, the additional part can be connected to the main body by an adhesive, and the adhesive is selected from but not limited to α-cyanoacrylate medical adhesives, such as α-cyanoacrylate n-butyl ester, α-cyanoacrylate n-octyl ester, α-cyanoacrylate isobutyl ester and a mixture of two or three components thereof.

[0229] In another embodiment of the present invention, the adhesive of the additional part and the main body is selected from medical silicone adhesives, such as MED-1131, MED-1137, MED-1511, MED-1540, MED-1555, MED-2000, MED1-4213 of Nusil Company and medical silicone adhesives with the same function.

[0230] In another embodiment of the present invention, the material for preparing the additional part of the present invention can be the same as or different from the material for preparing the main body, and can be selected from a main body material containing a polymerizable monomer or any suitable main body material preferably having good biocompatibility. The polymerizable monomer is selected from a hydrophilic polymerizable monomer or a hydrophobic polymerizable monomer, and can be a homopolymer of the monomer or a copolymer of multiple monomers. It can also be selected from a polymer biodegradable material.

[0231] In another embodiment of the present invention, the material for preparing the main body part can be, but is not limited to: the above-mentioned ophthalmic medical materials with suitable water content and suitable refractive index suitable for manufacturing micro-incision medical devices (such as ophthalmic lenses), collagen, hydrogel, silicone hydrogel, fluorosilicone acrylate, silicone, polystyrene, methyl methacrylate, siloxane, methylsiloxane, phenylsiloxane, vinyl silicone, acrylate silicone, methacrylate silicone, or a mixture of the above.

[0232] In another embodiment of the present invention, the hydrogel is selected from, including but not limited to: collagen, gelatin, keratin, elastin, vegetable protein, reticulin and quaternized protein, or polysaccharide, heparin, chondroitin sulfate, hyaluronic acid, gum arabic, agar, carrageenan, pectin, guar gum and alginate, or modified starch, modified cellulose, carboxymethyl starch, acetate starch, methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, or polyvinyl acetate, polymethyl vinyl ether, polyvinyl alcohol, polyethylene glycol, polyoxyethylene, polyacrylamide (PAM), hydrolyzed polyacrylamide (HPAM)), polyvinyl pyrrolidone (PVP), polyethyleneimine (PEI), or a blend of the above.

[0233] In another embodiment of the present invention, the material used to prepare the additional part can also be selected from biodegradable materials, including but not limited to polycaprolactone, polybutylene succinate, polylactic acid, polyhydroxyalkanoate, aliphatic aromatic copolyesters, polyvinyl alcohol, carbon dioxide copolymer, poly-β-hydroxybutyrate, or a mixture thereof, or a copolymer thereof.

[0234] In another embodiment of the present invention, the additional part comprises therapeutic drugs, including hormonal and non-hormonal anti-inflammatory drugs and broad-spectrum antibacterial drugs and any drugs that eliminate lens epithelial cells or inhibit the mitosis of epithelial cells, such as ofloxacin, ascorbic acid, aspirin, colchicine, lidocaine, nepafenac, ketorolac, bromfenac, recombinant hirudin, methotrexate, 5-fluorouracil, paclitaxel, doxorubicin, daunorubicin, saponin, and other known or unknown drugs or compositions with similar functions.

[0235] In another embodiment of the invention, the additional moiety is cyclic and comprises a light absorber and / or a photosensitizer.

[0236] In another embodiment of the present invention, the body portion of the ophthalmic lens of the present invention has at least two sharp edges.

[0237] In another embodiment of the present invention, in the main body, the support loop forms a certain angle with the optical plane; the proximal end of the rear surface of the support loop has a right-angle edge step structure; the distal end of the rear surface of the support loop has a right-angle edge step structure, wherein the thickness of the proximal end of the step structure of the rear surface of the support loop is greater than the thickness at the distal end.

[0238] In another embodiment of the present invention, the step height of the right-angle edge stepped structure at the distal end of the rear surface of the support loop is 0.1-5 mm, preferably 0.1-1 mm, more preferably 0.2-0.5 mm, wherein the thickness of the stepped structure at the proximal end of the rear surface of the support loop is greater than the thickness at the distal end.

[0239] In another embodiment of the present invention, the step height of the right-angle edge stepped structure at the proximal end of the rear surface of the support loop is 0.1-5 mm, preferably 0.3-3 mm, and more preferably 0.5-2 mm, wherein the thickness of the stepped structure at the proximal end of the rear surface of the support loop is greater than the thickness at the distal end.

[0240] According to another preferred embodiment of the present invention, the optical component and the support haptic in the main body of the ophthalmic lens are made of the same material as a whole.

[0241] According to another preferred embodiment of the present invention, the front surface and / or the rear surface of the optical component in the main part of the medical device (such as ophthalmic lenses such as artificial lenses, etc.; and non-ophthalmic lenses such as frame glasses, corneal contact lenses (invisible lenses), corneal intraocular lenses, etc.) comprises an optical device, for example, selected from aspheric devices, multifocal devices, complex curved devices, non-dispersive devices, variable focus devices, light filtering devices or various conventional and suitable devices in the art.

[0242] According to another preferred embodiment of the present invention, the proximal end of the support loop has an open groove.

[0243] The present invention also relates to a method for preparing a medical device, such as an ophthalmic lens, comprising the steps of:

[0244] (A) Preparation of the main body of medical devices (such as ophthalmic lenses):

[0245] 1) preparing a main body from the above-mentioned materials for preparing the main body;

[0246] 2) preparing a light absorption region portion from the above-mentioned material for preparing the light absorption region portion;

[0247] 3) obtaining a main body of a medical device (such as an ophthalmic lens) optionally containing a groove;

[0248] (B) Preparation of additional moieties containing drugs, light absorbers, photosensitizers and / or fluorescent agents:

[0249] 1) preparing the above-mentioned material for preparing the additional part to obtain the additional part, which contains a drug, a light absorber, a photosensitizer and / or a fluorescent agent,

[0250] (C) Optionally, add a binder.

[0251] In another embodiment of the present invention, in order to improve the affinity between the main body of the medical device (ophthalmic lens) and the additional part, the main body of the medical device (e.g. ophthalmic lens) can be subjected to activation treatment, including but not limited to plasma treatment, corona treatment, flame treatment, strong acid treatment, strong alkali treatment, etc. Alternatively, a primer is applied in the groove of the main body of the medical device (e.g. ophthalmic lens) to increase the adhesion between the additional part and the main body of the medical device (e.g. ophthalmic lens).

[0252] In the method of the present invention, the amount of the crosslinking agent is 0.1-20% by weight of the polymerizable monomer, preferably 0.5-15%, especially 1-5%. The amount of the ultraviolet absorber is 0-10% by weight of the polymerizable monomer, preferably 0-5%, especially 0-1%. The amount of the initiator is 0.01-10% by weight of the polymerizable monomer, preferably 0.01-5%, especially 0.05%-1%.

[0253] Other optional components that can be used in the present invention include cosolvents, emulsifiers, hydrophilic coatings, drug carriers, masterbatches, crosslinking agents, coupling agents, pH adjusters, antistatic agents, release agents, pigments, fillers, dispersants, curing agents, wetting agents, defoaming agents, ultraviolet absorbers, antioxidants, sterilizers and stabilizers, etc.

[0254] The present invention also relates to a method for treating ophthalmic diseases by laser-driven phototherapy, wherein the method can be performed using only the medical device (such as an ophthalmic lens) prepared by the present invention. Specifically, for example, only the medical device (such as an ophthalmic lens) with a photosensitizer according to the present invention (without the need to add additional photosensitizer) is used to irradiate the desired treatment site under a laser device. Since the medical device prepared by the present invention has a photosensitizer, the photosensitizer is activated, and the lens epithelial cells in the lens capsule can be killed by generating cytotoxic active oxygen or high temperature heat, thereby achieving the effect of preventing or treating secondary cataracts.

[0255] It can be seen that the material of the present invention and the medical device prepared by the present invention completely get rid of exogenous photosensitizers (no need to take photosensitizers in advance, etc.), the method of the present invention does not require the addition of any additional reagents (including photosensitizers), and has the advantages of non-invasiveness, non-toxicity, high efficiency, repeatability, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0256] Figure 1 The plan views of an intraocular lens with a ring-shaped additional part are exemplified, wherein (a) is the main body; and (b) is the ring-shaped additional part.

[0257] Figure 2 A cross-sectional view of an intraocular lens having a ring-shaped additional portion is illustrated.

[0258] FIG3 illustrates an additional part combined with the rear surface of the intraocular lens body and its cross-sectional view, wherein FIG3(a) illustrates a circular ring located on the rear surface of the lens; FIG3(b) illustrates a cross-sectional view of the circular ring located on the rear surface of the lens.

[0259] FIG4 illustrates an additional part combined with the front surface of the intraocular lens and its cross-sectional view, wherein FIG4(a) illustrates a circular ring located on the front surface of the lens; FIG4(b) illustrates a cross-sectional view of the circular ring located on the front surface of the lens.

[0260] FIG5 illustrates an additional part embedded in the rear surface of the intraocular lens body and its cross-sectional view, wherein FIG5(a) illustrates an annular ring embedded in the rear surface; FIG5(b) illustrates an annular ring embedded in the rear surface cross-sectional view.

[0261] Figure 6 The example shows that the shape of the additional portion is a discontinuous circle.

[0262] Figure 7 The example shows that the shape of the additional portion is a discontinuous sector.

[0263] Figure 8 A specific example is illustrated in which the shape of the additional portion is a polygon, forming a light absorption closed loop around the optical zone.

[0264] Fig. 9 A specific example of an intraocular lens in which the edge of the optical zone is coated with a light absorber is illustrated, wherein the shaded portion is the portion coated with the light absorber.

[0265] Fig.10 The schematic diagram of the mold cross section is illustrated, where cavity A is the optical area and cavity B is the edge and support part.

[0266] Fig.11 An example of a combination of an additional circular ring and an artificial lens is provided, wherein the optical zone of the artificial lens is concave in front and convex in the back; the intersection of the circular ring and the front and back surfaces of the lens matches the main surface shape without edge steps.

[0267] Fig.12 An example of combining an additional circular ring with an intraocular lens is provided, wherein the optical zone of the intraocular lens is concave in front and convex in the back; the circular ring forms a step structure on the rear surface of the lens, and the step height is 0.05 mm.

[0268] Fig.13 An example of combining an additional circular ring with an intraocular lens is provided, wherein the optical zone of the intraocular lens is equal and biconcave; the circular ring forms a step structure on both the front and rear surfaces of the lens, and the step height is 0.005 mm.

[0269] Fig.14 An example of combining an additional circular ring with an intraocular lens is provided, wherein the optical zone of the intraocular lens is equal and biconvex; the circular ring forms a step structure on the rear surface of the lens, and the step height is 0.15 mm.

[0270] Fig.15 An example of a combination of an additional circular ring and an intraocular lens is shown, wherein the optical zone of the intraocular lens is approximately convex in front and flat in the back; the circular ring forms a step structure on the front surface of the lens, and the step height is 0.3 mm.

[0271] Fig.16 An example of combining an additional circular ring with an intraocular lens is provided, wherein the optical zone of the intraocular lens is approximately flat in front and concave in the back; the circular ring forms a step structure on the back surface of the lens, and the step height is 0.4 mm.

[0272] Fig.17 An example of combining an additional circular ring with an intraocular lens is provided, wherein the optical zone of the intraocular lens is convex in front and concave in the back; the circular ring forms a step structure on the back surface of the lens, and the step height is 0.001 mm.

[0273] Fig.18 An example of combining an additional circular ring with an intraocular lens is provided, wherein the optical zone of the intraocular lens is convex in front and concave in the back; the circular ring forms a step structure on the rear surface of the lens, and the step height is 0.005 mm.

[0274] Fig.19 An example of a combination of an additional circular ring and an intraocular lens is provided, wherein the optical zone of the intraocular lens is unequally biconvex; the circular ring forms a step structure on the rear surface of the lens, and the step height is 0.01 mm.

[0275] Fig. 20 An example of a combination of an additional circular ring and an intraocular lens is provided, wherein the optical zone of the intraocular lens is unequally biconvex; the circular ring forms a step structure on the rear surface of the lens, and the step height is 1.0 mm.

[0276] Fig.21 The example shows that the refractive index of the material in the light absorption zone of the artificial lens is ≥ the refractive index of the material in the optical zone. When light is incident on the boundary between the optical zone and the absorption zone of the artificial lens, total reflection will not occur, and the incident angle of light from the absorption zone to the aqueous humor is reduced to avoid secondary total reflection. DETAILED DESCRIPTION

[0277] Example 1-6 Synthesis of main material

[0278] Examples 1-6 illustrate the monomer composition of the main material synthesis, in terms of molar percentage. All examples in Table 1 are prepared in the following manner, and all monomers are purified by vacuum distillation. In a beaker, the monomers are mixed in corresponding proportions, and additives such as initiators and light absorbers are optionally added, stirred thoroughly and filtered, and transferred to a special mold. The various utensils and molds used in the above implementation process must be cleaned, dried and sterilized before use.

[0279] Nitrogen is introduced into the monomer solution in the mold, and the mold is sealed under nitrogen protection, and then the mold is placed in a water bath at a set temperature for polymerization reaction for at least 24 hours, and then the mold is transferred to an oven at a set temperature and kept warm for 24 hours (Note: the set temperature of the oven should be higher than the set temperature of the water bath). The polymer formed in the mold is taken out and naturally cooled to room temperature, or cut into blanks of desired size and shape while hot, extracted with an alcohol solvent at a certain temperature for at least 24 hours to remove residual small molecules, and finally the blank is placed in a vacuum drying oven at a set temperature and dried overnight to obtain the material of the main part of the present invention.

[0280] Example 1 2 3 4 5 6 EA 70 60.5 26 46 EMA 27.5 MMA 17.5 97.5 HEMA 80 40 40 POEA 30 ST 36 KH570 10 AIBN 0.2 0.15 0.2 0.15 0.12 0.12 EGDMA 2 2 2 3 3.5 3.5

[0281] EA: Ethyl acrylate

[0282] EMA: Ethyl Methacrylate

[0283] MMA:Methyl Methacrylate

[0284] HEMA: Hydroxyethyl Methacrylate

[0285] POEA: 2-phenoxyethyl acrylate

[0286] ST:Styrene

[0287] KH570: 3-(Methacryloyloxy)propyltrimethoxysilane

[0288] AIBN: Azobisisobutyronitrile

[0289] EGDMA: Ethylene glycol dimethacrylate.

[0290] Examples Additional Parts Synthesis Method Monomer Formula

[0291] Examples 7-13 illustrate the synthetic formula of the ring-shaped treatment part material, in terms of molar percentage. The treatment part is formed by cutting, casting, spraying, and molding.

[0292] Example 7 8 9 10 11 12 13 EA 70 70 60.5 26 46 EMA 27.5 27.5 MMA 17.5 97.5 HEMA 80 40 40 POEA 30 ST 36 KH570 10 AIBN 0.2 0.2 0.15 0.2 0.15 0.12 0.12 EGDMA 2 2 2 2 3 3.5 3.5 Purpurin-18 0.01 0.01 0.01 Indole monocyanine 0.01 IR780 0.02 0.02 IR783 0.01

[0293] Example 14: Preparation of peripheral therapeutic intraocular lens by adhesion

[0294] A) The peripheral treatment part of the intraocular lens body is processed by the material prepared in Example 1, and the prepared polymer material is divided into a crystal blank with a thickness of about 3 mm and a diameter of about 16 mm by a turning process. The intraocular lens is processed on a single-point diamond lathe (OPTOFORM), and the molded intraocular lens has a body diameter of 6 mm, and the body has a therapeutic groove, the inner edge of which is 2.2 mm from the center of the intraocular lens, the width is 0.2 mm, and the depth is 0.1 mm. The molded intraocular lens is polished with a polishing medium.

[0295] B) According to the formulation of Example 8, the treatment part material was prepared by molding the main material in a glass plate, and then the treatment part material was mechanically processed into a treatment part with a width of 0.2 mm and a thickness of 0.1 mm by cutting.

[0296] C) The main body with the groove prepared in step A) is treated in an oxygen atmosphere with a vacuum plasma machine at a power of 100 W for 1 minute, and then the organic silicone adhesive MED-2000 is coated in the groove. The treatment part prepared in step B) is embedded in the groove of the main body, and placed in an oven at 60° C. for 3 hours to fully dry the adhesive, thereby obtaining an artificial lens with a treatment part on the periphery.

[0297] Example 15: Preparation of peripheral therapeutic intraocular lens by spraying

[0298] A) The peripheral additional part of the artificial lens body is processed by the material prepared in Example 1, and the prepared polymer material is divided into a crystal blank with a thickness of about 3 mm and a diameter of about 16 mm by a turning process. The artificial lens is processed on a single-point diamond lathe (OPTOFORM), and the molded artificial lens has a main body diameter of 6.5 mm, and the main body has a treatment part groove, the inner edge of which is 2.1 mm from the center of the artificial lens, the width is 0.8 mm, and the depth is 0.1 mm. The artificial lens after molding is polished with a polishing medium.

[0299] B) The main body with grooves prepared in step A) is treated in an oxygen atmosphere with a vacuum plasma machine at a power of 100W for 1 minute to improve the surface adhesion performance

[0300] C) Prepolymerize the formula in Example 10 of the additional part formula, and load the prepolymer into the spray gun. Cover the main part of the artificial lens except the groove part. Control the spray amount, spray the prepolymer, and cure it in a 90°C oven overnight to obtain the peripheral additional part of the artificial lens.

[0301] Example 16: Preparation of peripheral additional part intraocular lens by casting

[0302] A) The peripheral additional part of the intraocular lens body is processed by the material prepared in Example 1, and the prepared polymer material is divided into a crystal blank with a thickness of about 3 mm and a diameter of about 16 mm by a turning process. The intraocular lens is processed on a single-point diamond lathe (OPTOFORM), and the molded intraocular lens has a main body diameter of 6 mm, and the main body has an additional part-shaped groove, the inner edge of which is 2.1 mm from the center of the intraocular lens, the width is 0.2 mm, and the depth is 1 mm. The molded intraocular lens is polished with a polishing medium.

[0303] B) The materials in Example 10 were prepolymerized in the presence of azobisisobutyronitrile in a three-necked flask at 88°C for 1 hour. Stirring was stopped when the system became viscous.

[0304] C) The prepolymer obtained in step B) is injected into the groove of the main part of the intraocular lens in step A) through a syringe to fill the groove, and then placed horizontally in a vacuum oven at 90° C. to cure overnight to obtain an intraocular lens with a peripheral attachment part.

[0305] Example 17: Preparation of additional partially drug-loaded intraocular lens

[0306] A) The peripheral additional part of the intraocular lens body is processed by the material prepared in Example 1, and the prepared polymer material is divided into a crystal blank with a thickness of about 3 mm and a diameter of about 16 mm by a turning process. The intraocular lens is processed on a single-point diamond lathe (OPTOFORM), and the molded intraocular lens has a main body diameter of 6.5 mm, and the main body has an additional part-shaped groove, the inner edge of which is 2.5 mm from the center of the intraocular lens, the width is 0.2 mm, and the depth is 0.02 mm. The molded intraocular lens is polished with a polishing medium.

[0307] B) Ofloxacin is dissolved in chloroform, added to the chloroform solution of polylactic acid, and the mixed solution is concentrated.

[0308] C) After concentration, the solution is injected into the groove of the main part of the intraocular lens prepared in step A) through a micro syringe, and placed in a vacuum oven at 45° C. to dry the organic solvent, thereby obtaining an intraocular lens with a peripheral additional part loaded with drugs.

[0309] Embodiment 18

[0310] In a 250ml beaker, add a light absorber carbon black at a ratio of 2% to a commercially available one-component or two-component silicone rubber system (Nusil's MED-6820 brand), stir well and remove bubbles to obtain a silicone coating containing a light absorber, which has a certain fluidity before further curing and is combined with the existing artificial lens by surface coating to form a light absorption area. The silicone coating containing the light absorber is further cured, and after the coating is cured and formed, the light absorber is firmly locked in the silicone material to ensure long-term stability after implantation.

[0311] Embodiment 19

[0312] The edge of a commercially available intraocular lens is uniformly coated with the silicone coating containing a light absorber obtained in Example 18, wherein the intraocular lens is a silicone-type intraocular lens, AMO's Tecnis Z9001 intraocular lens. The edge is then coated with the silicone coating containing a light absorber for further curing, and the NusilMED-6820 containing 2% carbon black component is transferred to an oven above 100°C for curing for 30 minutes or more. After curing, not only can the light absorber be firmly locked in the silicone material, but it can also be tightly combined with the intraocular lens matrix material to form a light absorption zone at the edge of the intraocular lens. In this way, an intraocular lens coated with a silicone coating containing a light absorber is obtained, eliminating adverse optical phenomena such as glare and ghosting.

[0313] Embodiment 20

[0314] The silicone coating containing light absorber obtained in Example 18 is used to uniformly coat the edge or equatorial region of the optical part of a commercially available intraocular lens, wherein the intraocular lens is a silicone type intraocular lens, SI60NB or KS-3 intraocular lens of CanonStaar. Then the edge is coated with the silicone coating containing light absorber for further curing, and Nusil MED-6820 containing 2% carbon black component is transferred to an oven above 100°C for curing for 30 minutes or more. After curing, not only can the light absorber be firmly locked in the silicone material, but it can also be tightly combined with the intraocular lens matrix material to form a light absorption zone at the edge of the intraocular lens. The intraocular lens coated with the silicone coating containing light absorber thus obtained eliminates adverse optical phenomena such as glare and ghosting.

[0315] Embodiment 21

[0316] These monomers were mixed to prepare 100g of intraocular lens monomer solution: 70 mole% of phenylethyl acrylate (PEA), 30 mole% of phenylethyl methacrylate (PEMA), and 3 mole% of butanediol acrylate (BDDA); then, 0.06% of Purpurin 18 was added. The light absorber Purpurin 18 was mixed evenly with the monomer solution, and then directly molded into a ring of light absorption area. The intraocular lens coated with the light absorber thus obtained eliminated adverse optical phenomena such as glare and ghosting.

[0317] Embodiment 22

[0318] As in Example 21, 100 g of a monomer solution containing a light absorber was obtained, and then 0.1% of AIBN as an initiator and 0.5% of 2-acryloyloxy-5-methyl-phenylbenzotriazole as an ultraviolet absorber were added to the monomer solution containing the light absorber, and injected into the Fig. 9 The A cavity in the mold shown in the figure is heated and copolymerized to obtain the optical zone of the artificial lens. The monomer solution containing the light absorber is added with 0.1% AIBN as an initiator and 0.5% 2-acryloxy-5-methyl-phenylbenzotriazole as an ultraviolet absorber and injected into the B cavity in the mold for copolymerization to form the light absorption zone and the support haptic component of the artificial lens. After the heating copolymerization begins, the barrier device between the two cavities AB is removed in time, so that the components in the B cavity can be bonded with the optical components in the A cavity during the copolymerization process to form a combined structure. After the polymerization molding is completed, the mold is fully opened to obtain an artificial lens with light absorption function at the edge, wherein the edge area can absorb harmful scattered light to eliminate glare, ghosting and other undesirable optical phenomena.

[0319] Embodiment 23

[0320] An intraocular lens with a groove structure around the optical body was prepared by turning the commercially available intraocular lens Definitive contact lens material from Contamac. Then, the light absorber monomer solution obtained in Example 22 was added with 0.1% AIBN as an initiator and poured into the groove to form a light absorption area after polymerization.

[0321] Embodiment 24

[0322] A hydrophobic acrylic light-absorbing coating containing a light-absorbing component is prepared from ethyl methacrylate (EMA, 33g), styrene acrylate (PEA, 23g), phenoxyethyl acrylate (POEA, 39g), ethyl acrylate (EA, 5g), and 0.05% of Purpurin 18. Then, 0.5% of 2-acryloyloxy-5-methyl-phenylbenzotriazole containing a light-absorbing agent with a polymerizable unsaturated carbon-carbon double bond is added, and then the system is irradiated to start a polymerization reaction, thereby obtaining a light-absorbing material containing a light-absorbing group in the molecular chain structure, i.e., a viscous liquid containing 0.05% of Purpurin 18, 100g. This system is in a non-completely cured state and has a certain fluidity, and then solidifies again. Through various surface coating and curing methods, it is combined with existing artificial lenses or other ophthalmic lens products to form a light-absorbing area to achieve the absorption of harmful scattered light.

[0323] Embodiment 25

[0324] A hydrophobic acrylic light-absorbing coating containing the same light-absorbing agent component as in Example 24 was obtained, and the edge of the commercially available intraocular lens MZ60BD (PMMA) produced by Alcon was uniformly coated. The coating coated on the edge was then heated to form a mutually penetrating combination of the coating and the intraocular lens matrix material, forming a light-absorbing area at the edge of the intraocular lens to absorb harmful scattered light, thereby achieving the absorption effect of harmful scattered light.

[0325] Embodiment 26

[0326] A hydrophobic acrylic light-absorbing coating containing a light-absorbing component identical to that of Example 24 was obtained, and the coating was injected into a mold, and the system was subjected to a polymerization reaction by means of ultraviolet irradiation, so that the rhodopsin 18 molecules having a light-absorbing function could participate in the polymerization process of the monomer and be anchored in the polymer molecular chain structure, and finally a plate-type intraocular lens material having a light-absorbing property was obtained, which was then first processed into a blank, and further processed into a ring having the following dimensions by means of turning:

[0327] Ring inner diameter: 5mm

[0328] Ring width: 0.6mm

[0329] Ring thickness: 0.3mm.

[0330] Embodiment 27

[0331] A hydrophobic acrylic light-absorbing coating containing a light-absorbing agent component is prepared from a monomer solution of 70 mole% of phenylethyl acrylate (PEA), 30 mole% of phenylethyl methacrylate (PEMA), and 3 mole% of butanediol acrylate (BDDA) in total of 100 g; the mixture is mixed to prepare an artificial lens monomer solution, and then 0.05% of purpurin 18 as a light-absorbing agent is added. The light-absorbing agent, the monomer solution, and 0.1% of AIBN as an initiator are mixed evenly, injected into a mold of a ring-shaped structural component, and the system is subjected to ultraviolet irradiation to undergo a polymerization reaction, so that the purpurin 18 molecules with a light-absorbing function participate in the polymerization process of the monomer and are anchored in the polymer molecular chain structure, and finally a ring with light-absorbing properties and a size as in Example 26 is obtained.

[0332] Embodiment 28

[0333] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.11 shown.

[0334] Step 2: Combine the light absorption zone ring with the optical zone.

[0335] The intraocular lens is made of a material with a refractive index of 1.43, a diopter of -10D, an optical zone center thickness of 0.1mm, an anterior surface curvature radius of -3.66mm, a posterior surface curvature radius of -6mm, an optical zone diameter of 3.0mm, an optical zone edge thickness of 0.23mm, and a main body edge thickness of 0.30mm. The inner edge of the lens peripheral groove is 1.50mm away from the center of the lens, the groove width is 3.5mm, the groove penetrates the front and back surfaces of the lens, and the groove depth is 0.30mm. The inner edge diameter of the ring is 3.0mm, the ring width is 3.5mm, and the ring thickness is 0.3mm. In this example, the optical zone of the lens is concave in front and convex in the back; the intersection of the ring and the front and back surfaces of the lens matches the main body surface shape, and the step drop is 0mm.

[0336] Embodiment 29

[0337] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.12 shown.

[0338] Step 2: Combine the light absorption zone ring with the optical zone.

[0339] The intraocular lens is made of a material with a refractive index of 1.47, a refractive power of +6D, an optical zone center thickness of 0.1mm, an anterior surface curvature radius of -8.19mm, a posterior surface curvature radius of -6.0mm, an optical zone diameter of 2.0mm, and an optical zone edge thickness (main body edge thickness) of 0.08mm. The inner edge of the lens peripheral groove is 1.0 mm away from the center of the lens, the groove width is 0.80mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 0.01mm. The inner edge diameter of the ring is 2.0mm, the ring width is 0.80mm, and the ring thickness is 0.06mm. In this example, the optical zone of the lens is concave in front and convex in the back; the ring forms a step structure on the posterior surface of the lens, and the step height is 0.05mm.

[0340] Embodiment 30

[0341] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.13 shown.

[0342] Step 2: Combine the light absorption zone ring with the optical zone.

[0343] The intraocular lens is made of a material with a refractive index of 1.50, a refractive power of -25D, an optical zone center thickness of 0.2mm, an anterior surface curvature radius of -13.13, a posterior surface curvature radius of 13.13mm, an optical zone diameter of 4.5mm, and an optical zone edge thickness (main body edge thickness) of 0.59mm. The inner edge of the lens peripheral groove is 2.25mm away from the center of the lens, the groove width is 1.5mm, the groove penetrates the anterior and posterior surfaces of the lens, and the groove depth is 0.59mm. The inner edge diameter of the ring is 4.5mm, the ring width is 1.5mm, and the ring thickness is 0.0.60mm. In this example, the optical zone of the lens is equal and biconcave; the ring forms a step structure on the anterior and posterior surfaces of the lens, and the step height is 0.005mm.

[0344] Embodiment 31

[0345] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.14 shown.

[0346] Step 2: Combine the light absorption zone ring with the optical zone.

[0347] The intraocular lens is made of a material with a refractive index of 1.52, a refractive power of +36D, an optical zone center thickness of 1.0mm, an anterior surface curvature radius of 10.16, a posterior surface curvature radius of -10.16mm, an optical zone diameter of 4.2mm, an optical zone edge thickness of 0.56mm, and a main body edge thickness of 0.50mm. The inner edge of the peripheral groove of the lens is 2.1mm away from the center of the lens, the groove width is 0.05mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 0.2mm. The inner edge diameter of the ring is 4.2mm, the ring width is 0.05mm, and the ring thickness is 0.35mm. In this example, the optical zone of the lens is equal and biconvex; the ring forms a step structure on the posterior surface of the lens, and the step height is 0.15mm.

[0348] Embodiment 32

[0349] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.15 shown.

[0350] Step 2: Combine the light absorption zone ring with the optical zone.

[0351] The intraocular lens is made of a material with a refractive index of 1.51, a refractive power of +10D, an optical zone center thickness of 0.5mm, an anterior surface curvature radius of 17.92, a posterior surface curvature radius of -600mm, an optical zone diameter of 6.5mm, an optical zone edge thickness of 0.19mm, and a main body edge thickness of 0.15mm. The inner edge of the peripheral groove of the lens is 3.25mm away from the center of the lens, the groove width is 0.1mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 0.1mm. The inner edge diameter of the ring is 6.5mm, the ring width is 0.1mm, and the ring thickness is 0.4mm. In this example, the optical zone of the lens is close to being convex in front and flat in the back; the ring forms a step structure on the anterior surface of the lens with a step height of 0.3mm.

[0352] Embodiment 33

[0353] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.16 shown.

[0354] Step 2: Combine the light absorption zone ring with the optical zone.

[0355] The intraocular lens is made of a material with a refractive index of 1.53, a diopter of -18D, an optical zone center thickness of 0.1mm, an anterior surface curvature radius of -5244.15mm, a posterior surface curvature radius of 10.8mm, an optical zone diameter of 6.0mm, an optical zone edge thickness of 0.53mm, and a main body edge thickness of 0.10mm. The inner edge of the peripheral groove of the lens is 3.0mm away from the center of the lens, the groove width is 0.5mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 0.05mm. The inner edge diameter of the ring is 6.0mm, the ring width is 0.5mm, and the ring thickness is 0.45mm. In this example, the optical zone of the lens is close to being flat in front and concave in the back; the ring forms a step structure on the posterior surface of the lens, and the step height is 0.4mm.

[0356] Embodiment 34

[0357] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.17 shown.

[0358] Step 2: Combine the light absorption zone ring with the optical zone.

[0359] The intraocular lens is made of a material with a refractive index of 1.56, a refractive power of +30D, an optical zone center thickness of 1.5mm, an anterior surface curvature radius of 4.82mm, a posterior surface curvature radius of 13mm, an optical zone diameter of 6.0mm, an optical zone edge thickness of 0.80mm, and a main body edge thickness of 0.6mm. The inner edge of the lens peripheral groove is 3.0mm away from the center of the lens, the groove width is 1.2mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 0.7mm. The inner edge diameter of the ring is 6mm, the ring width is 1.2mm, and the ring thickness is 0.701mm. In this example, the optical zone of the lens is convex in front and concave in the back; the ring forms a step structure on the posterior surface of the lens, and the step height is 0.001mm.

[0360] Embodiment 35

[0361] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.18 shown.

[0362] Step 2: Combine the light absorption zone ring with the optical zone.

[0363] The intraocular lens is made of a material with a refractive index of 1.50, a diopter of -25D, an optical zone center thickness of 0.9mm, an anterior surface curvature radius of 6.84, a posterior surface curvature radius of 3.3mm, an optical zone diameter of 6.5mm, an optical zone edge thickness of 2.81mm, and a main body edge thickness of 0.55mm. The inner edge of the peripheral groove of the lens is 3.25mm away from the center of the lens, the groove width is 0.2mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 2mm. The inner edge diameter of the ring is 6.5mm, the width of the ring is 0.2mm, and the thickness of the ring is 2.005mm. In this example, the optical zone of the lens is convex in front and concave in the back; the ring forms a step structure on the posterior surface of the lens, and the step height is 0.005mm.

[0364] Embodiment 36

[0365] Step 1: Process an intraocular lens with a peripheral groove, such as Fig.19 shown.

[0366] Step 2: Combine the light absorption zone ring with the optical zone.

[0367] The intraocular lens is made of a material with a refractive index of 1.53, a refractive power of +20D, an optical zone center thickness of 1.5mm, an anterior surface curvature radius of 15.73, a posterior surface curvature radius of -25mm, an optical zone diameter of 3.0mm, an optical zone edge thickness of 1.38mm, and a main body edge thickness of 0.5mm. The inner edge of the peripheral groove of the lens is 1.5mm away from the center of the lens, the groove width is 0.15mm, the groove is opened on the posterior surface of the lens and does not penetrate the anterior surface, and the groove depth is 1.0mm. The inner edge diameter of the ring is 3.0mm, the width of the ring is 0.15mm, and the thickness of the ring is 1.01mm. In this example, the optical zone of the lens is unequally biconvex; the ring forms a step structure on the posterior surface of the lens, and the step height is 0.01mm.

[0368] Embodiment 37

[0369] Step 1: Process an intraocular lens with a peripheral groove, such as Fig. 20 shown.

[0370] Step 2: Combine the light absorption zone ring with the optical zone.

[0371] The intraocular lens is made of a material with a refractive index of 1.56, a refractive power of +20D, an optical zone center thickness of 1.5mm, an anterior surface curvature radius of 25.18mm, a posterior surface curvature radius of -20mm, an optical zone diameter of 2.0mm, an optical zone edge thickness of 1.46mm, and a main body edge thickness of 0.4mm. The inner edge of the lens peripheral groove is 1.0mm away from the center of the lens, the groove width is 1.0mm, the groove penetrates the posterior surface of the lens, and the groove depth is 1.0mm. The inner edge diameter of the ring is 2.0mm, the ring width is 1.0mm, and the ring thickness is 2.0mm. In this example, the optical zone of the lens is unequal biconvex; the ring forms a step structure on the posterior surface of the lens, and the step height is 1.0mm.

[0372] Example 38: Intraocular lens having a light absorber at the edge of the optic

[0373] The intraocular lens is made of hydrophobic acrylic with a refractive index of 1.48, has a modified L-loop, a total diameter of 13.0 mm, an optical diameter of 6.0 mm, and an optical zone edge thickness of 0.25 mm. The intraocular lens is measured in a standard saline solution, and the transmittance of the optical zone in the spectral range of 300 nm to 1100 nm is ≥90% as measured by a UV-visible spectrophotometer. A silicone material with 2% carbon black added is evenly coated on the edge of the optical zone of the intraocular lens. Carbon black has the ability to absorb visible light spectrum radiation. After adding 2% carbon black to the material, the spectral transmittance in the 300 nm-1100 nm band is ≤0.6% as measured by a UV-visible spectrophotometer. It can be seen that most of the spectral energy is absorbed by the light absorber. After the obtained artificial lens (having a therapeutic component containing a light absorber at the edge of the optical part) is implanted in the human eye, if the pupil is large, part of the light is obliquely incident on the edge of the artificial lens at a large angle, and the edge of the optical zone coated with a carbon black light absorber fully absorbs the scattered light incident on the edge, and almost no light is incident on the human eye in the form of reflection from the edge of the artificial lens, thereby achieving the effect of eliminating glare, ghosting and other adverse optical phenomena.

[0374] Example 39: Intraocular lens having a light absorbing region and an additional portion containing a photosensitizer

[0375] The intraocular lens is made of hydrophobic acrylic ester with a refractive index of 1.50, has a modified L-loop, a total diameter of 13.0 mm, an optical diameter of 6.0 mm, and an optical zone edge thickness of 0.30 mm. At the edge of the optical zone of the intraocular lens, 2 g of carbon black is added to 100 g of Nusil MED-6820 silicone material, mixed evenly and evenly coated at 2.75 mm from the center of the intraocular lens, and an additional part ring with a width of 0.1 mm and a thickness of 0.20 mm is embedded from the rear surface of the intraocular lens by inlaying. The additional part is added with 0.06 g of indocyanine green in 100 g of monomer solution as in Example 21. At the initial stage of implantation of the intraocular lens into the human eye, an 808 nm laser is used to irradiate the additional part for 5 seconds, so that the additional part is heated by 9° C. due to the photothermal effect of indocyanine green, resulting in denaturation of cell proteins, directly causing cell death, and killing the lens epithelial cells in contact with it, thereby preventing the occurrence of secondary cataracts. After the artificial lens is implanted, the light absorption zone coated on the edge of the lens can absorb edge light incident at large angles, preventing night glare.

Claims

1. An artificial lens comprising: a) an intraocular lens main body, wherein the main body comprises an optical zone and one or more light absorbing zones, wherein the light absorbing zones comprise light absorbers, the light absorbing zones comprising light absorbers are located at the edge of the optical zone, wherein the edge of the optical zone has one or more grooves, the light absorbing zones are embedded in the grooves as additional parts, the additional parts are higher than the intraocular lens main body at the far end of the optical zone, forming an edge step structure; the additional parts comprise light absorbers; b) one or more additional parts containing active agents, which are located on the main part of the intraocular lens and connected to the main part of the intraocular lens, the width of the additional part is 0.05 to 3.5 mm; the thickness of the additional part is 0.01 to 2 mm, wherein the inner edge of the additional part is greater than 2 mm from the center of the intraocular lens, The light absorber is selected from organic dyes, and the organic dyes are selected from chlorophyll derivatives, azo series, anthraquinone series, aromatic methane series, indigo series, porphyrin series, phthalocyanine series, nitro and nitroso series, methine and polymethine series and / or heterocyclic compounds.

2. An intraocular lens according to the preceding claim 1, wherein the light absorbing region and / or the additional portion comprises a drug, a light absorber, a fluorescent agent and / or a photosensitizer.

3. An intraocular lens according to claim 1 or 2, wherein the additional portion has a width of 0.1 to 1.5 m.

4. The intraocular lens according to claim 1 or 2, wherein the distance between the inner edge of the light absorption zone and the center of the optical zone is greater than or equal to 1.0 mm.

5. The intraocular lens according to claim 1 or 2, wherein the light absorber contained in the light absorption region absorbs light within a wavelength range of 300 to 1100 nm.

6. The intraocular lens according to claim 1 or 2, wherein the main part of the intraocular lens has one or more grooves, and the additional part and / or the light absorbing area is embedded in the grooves of the main part of the intraocular lens.

7. An intraocular lens according to claim 1 or 2, wherein: In the main part thereof, the proximal end of the rear surface of the support loop has a right-angle edge step structure; and / or the distal end of the rear surface of the support loop has a right-angle edge step structure, wherein the thickness of the proximal end of the step structure of the rear surface of the support loop is greater than the thickness at the distal end, the shape of the junction between the light absorption zone and the optical zone matches the surface of the ophthalmic lens, and the additional part is higher than the main part of the ophthalmic lens at the distal end of the optical zone, forming an edge step structure, and the step height is 0.001 to 1.0 mm.

8. The intraocular lens according to claim 1 or 2, wherein the combination of the drug, light absorber, fluorescent agent and / or photosensitizer contained in the light absorbing region and / or the additional part and the material of the light absorbing region and / or the additional part is selected from: - Drugs, light absorbers, fluorescent agents and / or photosensitizers participate in polymerization during the molding process of the light absorbing region and / or the additional part of the material; - drugs, light absorbers, fluorescent agents and / or photosensitizers are added to the copolymer material by physical dispersion during the molding process of the light absorbing region and / or the additional part material; - drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the light absorption area and / or the additional material by surface grafting or surface modification; and / or - Drugs, light absorbers, fluorescent agents and / or photosensitizers are fixed on the surface of the light absorbing area and / or the additional part material by surface coating.

9. The intraocular lens according to claim 1, wherein the step height is 0.005 to 0.4 mm.

10. The intraocular lens of claim 1, wherein the additional portion has a width of 0.2 to 0.8 mm.

11. The intraocular lens according to claim 1, wherein the additional portion has a thickness of 0.01 to 1 mm.

12. The intraocular lens of claim 1, wherein the additional portion has a thickness of 0.01 to 0.7 mm.

13. The intraocular lens according to claim 4, wherein the distance between the inner edge of the light absorption zone and the center of the optical zone is greater than or equal to 2.1 mm.

14. The intraocular lens according to claim 4, wherein the distance between the inner edge of the light absorption zone and the center of the optical zone is greater than or equal to 2.25 mm.

15. The intraocular lens according to claim 5, wherein the light absorber contained in the light absorbing region absorbs visible light of 400 to 700 nm.

16. The intraocular lens according to claim 7, wherein the step height is 0.005 to 0.3 mm.

17. The intraocular lens according to claim 7, wherein the step height is 0.01 to 0.3 mm.

18. Medical device comprising an intraocular lens according to any of the preceding claims.

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