Application of polymer as intraocular lens material and intraocular lens

Abstract

The invention belongs to the field of high polymer materials, and particularly relates to application of a polymer as an intraocular lens material and an intraocular lens. The polymer prepared by using the hydrophobic monomer, the hydrophilic monomer, the cross-linking agent and the initiator as raw materials is used as the artificial lens, and the obtained artificial lens can be water-triggered to harden, and has the advantages of foldability, small incision implantation, water absorption hardening after implantation, strong supporting property and the like.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of high polymer materials, and particularly relates to a use of a polymer as an intraocular lens material and an intraocular lens. BACKGROUND

[0002] An intraocular lens (IOL) is a micro-lens made of a biocompatible high polymer material, which is used to replace or supplement the refractive function of the human lens to restore the ability of light focusing on the retina. It can be implanted into the eye through surgery to correct refractive errors caused by cataracts, high myopia, etc. According to whether the patient's own lens is retained during implantation, the intraocular lens is divided into two types: if the patient's own lens is retained (such as ICL implantation), it is a phakic intraocular lens; if the patient's own lens needs to be removed (such as cataract phacoemulsification combined with IOL implantation), it is an aphakic intraocular lens.

[0003] The earliest intraocular lens is hard, such as PMMA material, which has excellent structural and optical stability and biocompatibility, but it cannot be folded and needs to be implanted into the eye through a cut at least the size of the optical zone on the cornea. This large incision can cause a variety of complications, such as significant surgical-induced astigmatism, wound healing disorders, corneal endothelial damage, and secondary damage to intraocular structures.

[0004] In order to solve this problem, the later intraocular lens uses soft materials such as silicone and acrylate, which can be folded and then implanted through a small incision of ≤3mm, avoiding or reducing the complications caused by the large incision of hard intraocular lenses. However, soft intraocular lenses have poor support, insufficient structural and optical stability, and are prone to deformation, rotation, displacement, abnormal arch height, and affect optical quality. SUMMARY

[0005] The technical problem to be solved by the present application is to use a polymer prepared from hydrophobic monomers, hydrophilic monomers, cross-linking agents and initiators as an intraocular lens, thereby simultaneously solving the shortcomings of hard intraocular lenses such as non-foldable, large implantation incision and related complications, and the shortcomings of soft intraocular lenses such as insufficient support, poor size and optical stability, and related complications.

[0006] The present application provides a use of a polymer as an intraocular lens material, the polymer is soft and foldable in dry state or partially hydrated state, so that the intraocular lens made of the polymer is foldable in dry state or partially hydrated state, and can be implanted into the eye through a small incision with a length of less than 3.5 mm; and the modulus of elasticity of the polymer increases and becomes hard after fully hydrated by absorbing water, so that the intraocular lens made of the polymer becomes hard after being implanted into the eye, thereby improving the structural and optical stability of the intraocular lens; wherein the polymer is obtained by polymerization of a mixture of a hydrophobic monomer, a hydrophilic monomer, a crosslinking agent and an initiator; the hydrophilic monomer contains a polyethylene glycol segment; wherein the hydrophobic monomer accounts for 50-88 wt%, the hydrophilic monomer accounts for 12-50 wt%, the crosslinking agent accounts for 0.01-5 wt% of the total mass of the hydrophobic monomer and the hydrophilic monomer, and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic monomer and the hydrophilic monomer; the hydrophilic monomer is selected from at least one of polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate and polyethylene glycol aralkyl ether (meth) acrylate; the fully hydrated state refers to a state that the intraocular lens absorbs water until fully saturated; and the partially hydrated state refers to a state that the intraocular lens absorbs water but does not reach the fully saturated state.

[0007] Further, in the above use, the small incision refers to an incision with a length of less than 3.5 mm, specifically 3.2 mm, 3 mm, 2.0 mm or 1.8 mm.

[0008] Further, in the above use, the polymer raw material further comprises a UV absorber; the polymer is obtained by polymerization of a mixture of a hydrophobic monomer, a hydrophilic monomer, a UV absorber, a crosslinking agent and an initiator; the hydrophilic monomer contains a polyethylene glycol segment; wherein the total mass of the hydrophobic monomer and the hydrophilic monomer accounts for 94-99.5 wt%, and the UV absorber accounts for 0.5-6 wt%; and the total mass of the hydrophobic monomer and the hydrophilic monomer, the hydrophobic monomer accounts for 50-88 wt%, and the hydrophilic monomer accounts for 12-50 wt%; the crosslinking agent accounts for 0.01-5 wt% of the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber, and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber; the hydrophilic monomer is selected from at least one of polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate and polyethylene glycol aralkyl ether (meth) acrylate.

[0009] Specifically, in the above use, the UV absorber is selected from at least one of 2-hydroxy-4-(methacryloyloxy)benzophenone, 2-acrylic acid-2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester and 2-[3(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl-2-methyl acrylate.

[0010] Preferably, in the above use, the hydrophobic monomer is 60-80wt%, and the hydrophilic monomer is 20-40wt%.

[0011] Further, in the above use, the hydrophilic monomer is selected from polyethylene glycol methyl ether methacrylate.

[0012] Specifically, in the above use, the hydrophobic monomer is selected from at least one of benzyl (meth)acrylate, 2-phenylethyl (meth)acrylate, 2-phenoxyethyl (meth)acrylate, and 4-phenylbutyl (meth)acrylate.

[0013] Specifically, in the above use, the crosslinking agent is selected from at least one of polyethylene glycol dimethacrylate (average molecular weight 300-20000), ethylene glycol di(meth)acrylate, diethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, 1,6-hexanediol di(meth)acrylate, 1,4-butanediol di(meth)acrylate, N,N'-methylenebisacrylamide, and N,N'-hexamethylenebis(methacrylamide).

[0014] Specifically, in the above use, the initiator is a thermal initiator or a photoinitiator.

[0015] Further, in the above use, the thermal initiator is selected from at least one of 2,2'-azobisisobutyronitrile, 2,2'-azobisisopentyl nitrile, 2,2'-azobisisoheptyl nitrile, dibenzoyl peroxide, and bis-(4-tert-butylcyclohexyl) peroxydicarbonate.

[0016] Further, in the above use, the photoinitiator is selected from at least one of phenyl bis(2,4,6-trimethylbenzoyl) phosphine oxide, 2-hydroxy-4'-(2-hydroxyethoxy) 2-methylpropiophenone, diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide, and phenyl bis(2,4,6-trimethylbenzoyl) phosphine oxide.

[0017] Specifically, in the above use, the polymerization is thermal polymerization or photopolymerization. Further, the thermal polymerization temperature is 40-125°C. The thermal polymerization time is 0.5 hours-7 days. The thermal polymerization uses a thermal initiator. The photopolymerization time is more than 10 minutes. The photopolymerization uses a photoinitiator.

[0018] The application further provides an intraocular lens, which is obtained by mixing, pouring, and polymerizing hydrophobic monomers, hydrophilic monomers, a crosslinking agent, and an initiator; the hydrophilic monomers contain polyethylene glycol segments; wherein the hydrophobic monomers account for 50-88 wt%, the hydrophilic monomers account for 12-50 wt%, the crosslinking agent accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers and the hydrophilic monomers, and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers and the hydrophilic monomers; and the hydrophilic monomers are at least one selected from polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate, and polyethylene glycol aralkyl ether (meth) acrylate.

[0019] Further, in the above-mentioned intraocular lens, the raw material of the intraocular lens further comprises an ultraviolet absorber. The intraocular lens is obtained by mixing, pouring, and polymerizing hydrophobic monomers, hydrophilic monomers, an ultraviolet absorber, a crosslinking agent, and an initiator; the hydrophilic monomers contain polyethylene glycol segments; wherein the total mass of the hydrophobic monomers and the hydrophilic monomers accounts for 94-99.5 wt%, and the ultraviolet absorber accounts for 0.5-6 wt%; and the total mass of the hydrophobic monomers and the hydrophilic monomers, the hydrophobic monomers account for 50-88 wt%, and the hydrophilic monomers account for 12-50 wt%; the crosslinking agent accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers, and the ultraviolet absorber, and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers, and the ultraviolet absorber; and the hydrophilic monomers are at least one selected from polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate, and polyethylene glycol aralkyl ether (meth) acrylate.

[0020] Specifically, in the above-mentioned intraocular lens, the ultraviolet absorber is at least one selected from 2-hydroxy-4-(methacryloyloxy)benzophenone, 2-acrylic acid-2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester, and 2-[3(2H-benzotriazole-2-yl)-4-hydroxyphenyl]ethyl-2-methacrylate.

[0021] Preferably, in the above-mentioned intraocular lens, the hydrophobic monomers account for 60-80 wt%, and the hydrophilic monomers account for 20-40 wt%.

[0022] Further, in the above-mentioned intraocular lens, the hydrophilic monomers are selected from polyethylene glycol methyl ether methacrylate.

[0023] Specifically, in the above-mentioned intraocular lens, the hydrophobic monomers are at least one selected from benzyl (meth) acrylate, 2-phenylethyl (meth) acrylate, 2-phenoxyethyl (meth) acrylate, and 4-phenylbutyl (meth) acrylate.

[0024] Specifically, in the artificial lens, the cross-linking agent is selected from at least one of polyethylene glycol dimethacrylate (average molecular weight 300-20000), ethylene glycol di(meth)acrylate, diethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, 1,6-hexanediol di(meth)acrylate, 1,4-butanediol di(meth)acrylate, N,N'-methylenebisacrylamide, and N,N'-hexamethylenebis(methacrylamide).

[0025] Specifically, in the artificial lens, the initiator is a thermal initiator or a photoinitiator.

[0026] Further, in the artificial lens, the thermal initiator is selected from at least one of 2,2'-azobisisobutyronitrile, 2,2'-azobisisopentyl nitrile, 2,2'-azobisisoheptyl nitrile, dibenzoyl peroxide, and bis-(4-tert-butylcyclohexyl) peroxydicarbonate.

[0027] Further, in the artificial lens, the photoinitiator is selected from at least one of phenyl bis(2,4,6-trimethylbenzoyl) phosphine oxide, 2-hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone, diphenyl(2,4,6-trimethylbenzoyl) phosphine oxide, and phenyl bis(2,4,6-trimethylbenzoyl) phosphine oxide.

[0028] Specifically, in the artificial lens, the polymerization is thermal polymerization or photopolymerization. Further, the thermal polymerization temperature is 40-125°C. The thermal polymerization time is 0.5 hours-7 days. The thermal polymerization uses a thermal initiator. The photopolymerization time is more than 10 minutes. The photopolymerization uses a photoinitiator.

[0029] Advantages of the present application:

[0030] The artificial lens of the present application is soft and foldable in dry state or partially hydrated state, and can be implanted through a small incision; the elastic modulus increases after water absorption, and the artificial lens becomes hard. Compared with the conventional hard artificial lens, the artificial lens material of the present application is soft and foldable before water absorption or partial water absorption, and can be implanted through a small incision, thereby preventing or reducing the complications caused by hard lens implantation. Compared with the existing foldable artificial lens, the artificial lens material of the present application is also foldable and can be implanted through a small incision, and the elastic modulus of the artificial lens can be increased by more than 100 times after water absorption, thereby having higher structural and optical stability. At the same time, the artificial lens material of the present application is free of flash, and is resistant to protein, cell, and bacterial adhesion, and has ultraviolet resistance.

[0031] The artificial lens material of the present application is soft before or during partial hydration, and can be implanted through a small incision; after implantation, it gradually hydrates and hardens, and the elastic modulus significantly increases, providing enhanced structural and optical stability. The artificial lens material of the present application comprises hydrophilic segments and hydrophobic segments; upon hydration, the hydrophilic segments absorb water, forming a water phase and microphase separation with the hydrophobic segments, resulting in physical crosslinking and thus enhanced mechanical properties. The artificial lens material of the present application can be a pseudophakic intraocular lens or a phakic intraocular lens. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 Infrared spectra (a), water content (b), water contact angle (c), and differential scanning calorimetry thermal analysis curves (d) of the comparative example and example materials.

[0033] Figure 2 Transmittance curves (a), pictures on a resolution chart (b), refractive index (c), and Abbe number (d) of the comparative example and example materials. The transmittance curves and pictures on a resolution chart indicate that the materials are transparent, and are tested using a UV-Vis spectrophotometer; the refractive index is a core parameter for determining the dioptric power of an intraocular lens, and a high refractive index allows the intraocular lens to have a higher dioptric power or a thinner thickness; the Abbe number and the refractive index of the intraocular lens together affect its dispersion characteristics, and a high Abbe number can reduce chromatic aberration and improve imaging clarity. The refractive index and Abbe number are tested using an Abbe refractometer.

[0034] Figure 3 Tensile curves (a) and elastic modulus, tensile rate (b) of the comparative example and example materials before and after hydration, which are tested using a universal testing machine.

[0035] Figure 4 Cell survival rate (a) of the comparative example and example materials in MTT cytotoxicity test, and pictures taken by fluorescence microscope after staining the cells cultured for 24 hours with Hoechst 33342 reagent (b). a is tested according to GB / T 16886.5 Appendix C using human lens epithelial cells. It is shown that the cytotoxicity of the example is comparable to that of the control, and the control is non-cytotoxic, so the example is also non-cytotoxic.

[0036] Figure 5 Flowchart of subcutaneous implantation experiment (a), pictures of wounds after implantation for 0 days and 7 days (b), pictures of material sampling (c), scanning electron microscope pictures of the removed material (d), and HE staining pictures of the tissue near the material (e) of the comparative example and example materials. b and c show that there is no hyperemia, exudation, or abscess formation at the implantation site of the material. d shows that increasing the hydrophilic component helps to reduce tissue adhesion on the surface of the material. e shows that there is no obvious inflammatory reaction at the implantation site of the material. The above in vivo animal experiments show that these materials have good biological safety.

[0037] Figure 6 Transmittance curve (a) and picture on the resolution plate (b) of the phakic intraocular lens prepared in Example 2.

[0038] Figure 7 Picture of the injection process of the phakic intraocular lens prepared in Example 2.

[0039] Figure 8 Compressive force (a) and axial displacement under the compressive force (b) of the phakic intraocular lens prepared in Example 2 before hydration (dry state) and after hydration (fully hydrated). DETAILED DESCRIPTION

[0040] The present application provides a kind of intraocular lens, which is obtained by mixing hydrophobic monomer, hydrophilic monomer, and crosslinking agent and initiator, pouring, polymerization;The hydrophilic monomer contains polyethylene glycol segment;The hydrophilic monomer is selected from at least one of polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate, polyethylene glycol aralkyl ether (meth) acrylate.

[0041] Further, ultraviolet absorber can also be added, so as to have anti-ultraviolet function.

[0042] The present application uses hydrophobic monomer, hydrophilic monomer, crosslinking agent and initiator, or further adds ultraviolet absorber, mixes raw materials, pours, and polymerizes the polymer, which has different shapes according to different molds used during pouring, and can be sheet or intraocular lens shape. When the mold is in the shape of an intraocular lens, the polymer obtained by polymerization is an intraocular lens. When the mold is in other shapes, the polymer can also be machined into an intraocular lens by secondary processing.

[0043] Comparative Example 1

[0044] 99wt% hydrophobic monomer benzyl methacrylate (BzMA), 1wt% ultraviolet absorber 2-hydroxy-4-(methacryloyloxy) benzophenone (HMBP) monomer, and 1wt% crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) of the total mass of hydrophobic monomer and ultraviolet absorber, and 1wt% initiator azobisisobutyronitrile (AIBN) of the total mass of hydrophobic monomer and ultraviolet absorber are stirred and mixed to form a transparent precursor solution. After degassing treatment, the precursor solution is injected into a clean mold. Then, the precursor solution is heated at 80℃ for 3 hours to prepare material S0.

[0045] Figure 1 The infrared spectrum test results show that the polymer is successfully polymerized; the water content of the prepared material is 0.58±0.32% (as shown in Table 1). Figure 1b) the water contact angle is 85.34±0.05° (as shown in Figure 1 c) the glass transition temperature is 45.39℃ (as shown in Figure 1 d).

[0046] transmittance (400-800nm) >90% (as shown in Figure 2 a); the material placed on the resolution plate can be visually observed to exhibit excellent light transmittance (as shown in Figure 2 b); the dry refractive index is 1.564, and the wet refractive index is 1.563 (as shown in Figure 2 c); the dry Abbe number is 35.16, and the wet Abbe number is 35.10 (as shown in Figure 2 d).

[0047] Figure 3 a is the tensile curve before and after hydration, Figure 3 b is the elastic modulus and elongation before and after hydration, and it can be seen that the elastic modulus of the material before hydration is 509.96±38.87MPa, and the breaking elongation is 6.82±1.11%, which exhibits a hard characteristic and is not suitable for use as a foldable intraocular lens; the elastic modulus after complete hydration is 508.00±24.52MPa, and the breaking elongation is 8.08±2.00%, which does not exhibit a hardening effect compared to before hydration, indicating that the material is not suitable for use as a hydration-hardening intraocular lens.

[0048] as shown in Figure 4 is a cytotoxicity experiment, Figure 5 is a subcutaneous injection experiment, from Figure 4 a, 4b, 5a, 5b, 5c, 5d, 5e can be seen that the material exhibits excellent in vitro and in vivo safety.

[0049] Comparative Example 2

[0050] 89wt% of the hydrophobic monomer benzyl methacrylate (BzMA), 10wt% of the hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1wt% of the UV absorber 2-hydroxy-4-(methacryloyloxy) benzophenone (HMBP) monomer, 1wt% of the crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber, and 1wt% of the initiator azobisisobutyronitrile (AIBN) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber were mixed under stirring to form a transparent precursor solution. After degassing treatment, the precursor solution was injected into a clean mold. Subsequently, the precursor solution was heated at 80℃ for 3 hours to prepare the material S1.

[0051] Figure 1 The infrared spectrum test results show that the polymer is successfully polymerized; the water content of the prepared material is 2.28±0.22% (as shown inFigure 1 b) the water contact angle is 74.39±0.07° (as shown in Figure 1 c) the glass transition temperature is 35.39℃ (as shown in Figure 1 d) the water content and the water contact angle indicate that the hydrophilicity of the material is improved, and the surface is less likely to adhere to proteins, cells, etc.

[0052] transmittance (400-800nm) > 90% (as shown in Figure 2 a); the material is placed on a resolution plate, and it can be visually observed that the material exhibits excellent light transmittance (as shown in Figure 2 b); the dry refractive index is 1.558, and the wet refractive index is 1.555 (as shown in Figure 2 c); the dry Abbe number is 36.53, and the wet Abbe number is 37.91 (as shown in Figure 2 d).

[0053] Figure 3 a is the tensile curve before and after hydration, Figure 3 b is the elastic modulus and elongation before and after hydration, the elastic modulus of the material before hydration is 436.39±17.00MPa, and the breaking elongation is 16.07±4.30%, which exhibits a hard characteristic and is not suitable for a foldable intraocular lens; the elastic modulus after complete hydration is 419.66.00±22.91MPa, and the breaking elongation is 11.55±1.56%, which does not exhibit a hardening effect compared to before hydration, indicating that the material is not suitable for use as a hydration-hardening intraocular lens.

[0054] as shown in Figure 4 for a cytotoxicity experiment, Figure 5 for a subcutaneous injection experiment, from Figure 4 a, 4b, 5a, 5b, 5c, 5d, 5e can be seen that the material exhibits excellent in vitro and in vivo safety.

[0055] Example 1

[0056] A transparent precursor solution was prepared by stirring and mixing 79wt% of the hydrophobic monomer benzyl methacrylate (BzMA), 20wt% of the hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1wt% of the UV absorber 2-hydroxy-4-(methacryloyloxy) benzophenone (HMBP) monomer, 1wt% of the crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber, and 1wt% of the initiator azobisisobutyronitrile (AIBN) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber. After degassing treatment, the precursor solution was injected into a clean mold. Subsequently, the precursor solution was heated at 80℃ for 3 hours to prepare the material S2.

[0057] Figure 1a Infrared spectrum test results show that the polymer is successfully polymerized; the water content of the prepared material is 7.17±0.28% (as shown in Figure 1 b), the water contact angle is 71.86±0.13° (as shown in Figure 1 c), and the glass transition temperature is 19.63°C (as shown in Figure 1 d). The water content and water contact angle indicate that the hydrophilicity of the material is improved, and the surface is less likely to adhere to proteins, cells, etc.

[0058] The transmittance (400-800nm) is >90% (as shown in Figure 2 a); the material placed on the resolution plate can intuitively show that the material exhibits excellent light transmittance (as shown in Figure 2 b); the dry-state refractive index is 1.550, and the wet-state refractive index is 1.536 (as shown in Figure 2 c); the dry-state Abbe number is 38.41, and the wet-state Abbe number is 40.36 (as shown in Figure 2 d).

[0059] Figure 3 a is the tensile curve before and after hydration, Figure 3 b is the elastic modulus and elongation before and after hydration, the elastic modulus of the material when unhydrated is 71.22±17.78MPa, and the elongation at break is 316.33±48.10%, showing soft foldable characteristics; after complete hydration, the elastic modulus is 340.74±6.47MPa, and the elongation at break is 14.58±1.69%, which shows a significant hardening effect compared to unhydrated, indicating that the material is suitable for use as a hydrated hardening intraocular lens.

[0060] As Figure 4 is a cytotoxicity experiment, Figure 5 is a subcutaneous injection experiment, from Figure 4 a, 4b, 5a, 5b, 5c, 5d, 5e, it can be seen that the material exhibits excellent in vitro and in vivo safety.

[0061] Example 2

[0062] A precursor solution was prepared by mixing 68 wt% of hydrophobic monomer benzyl methacrylate (BzMA), 31 wt% of hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1 wt% of UV absorber 2-hydroxy-4-(methacryloyloxy) benzophenone (HMBP) monomer, 1 wt% of crosslinker polyethylene glycol dimethacrylate (PEGDMA) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber, and 1 wt% of initiator azobisisobutyronitrile (AIBN) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber. The precursor solution was degassed and then injected into a clean mold or a mold with a phakic intraocular lens. Subsequently, the precursor solution was heated at 80°C for 3 hours to prepare a copolymer sheet or a phakic intraocular lens sample S3.

[0063] Figure 1 The infrared spectrum test results showed that the polymer was successfully polymerized; the prepared material had a water content of 25.66±1.92% (as shown in Figure 1 b), a water contact angle of 66.99±0.20° (as shown in Figure 1 c), and a glass transition temperature of 15.16°C (as shown in Figure 1 d). The water content and the water contact angle indicated that the hydrophilicity of the material was improved, and the surface was less likely to adhere to proteins, cells, etc.

[0064] The transmittance (400-800 nm) was >90% (as shown in Figure 2 a); the material was placed on a resolution plate, and it could be visually observed that the material exhibited excellent light transmittance (as shown in Figure 2 b); the dry-state refractive index was 1.539, and the wet-state refractive index was 1.492 (as shown in Figure 2 c); the dry-state Abbe number was 40.13, and the wet-state Abbe number was 45.08 (as shown in Figure 2 d). The above properties indicated that the material was suitable for use as an intraocular lens.

[0065] Figure 3 a are tensile curves before and after hydration, Figure 3 b are the elastic modulus and the elongation before and after hydration; the elastic modulus of the material before hydration was 1.33±0.26 MPa, and the elongation at break was 509.58±43.47%, which exhibited soft foldable properties; the elastic modulus after complete hydration was 191.96±16.37 MPa, and the elongation at break was 37.31±6.02%, which exhibited a significant hardening effect compared to before hydration. The above properties indicated that the material was suitable for use as a hydration-hardening intraocular lens.

[0066] as Figure 4 is a cytotoxicity experiment, Figure 5 is a subcutaneous injection experiment, from Figure 4a, 4b, 5a, 5b, 5c, 5d, 5eIt can be seen that the material exhibits excellent in vitro and in vivo safety.

[0067] The artificial lens prepared in this embodiment 2 has a transmittance (400-800 nm) > 90%, and the light transmittance is excellent, as shown in Figure 6 a, Figure 6 b. It is indicated that the artificial lens sample is transparent.

[0068] The compression force of the artificial lens prepared in this embodiment 2 in the unhydrated state is 0.0034±0.0004N (tested according to YY 0290.3-2018 Ophthalmic optics - Intraocular lenses - Part 3: Mechanical properties and test methods - Appendix A test), and it can be injected through a 3mm injector, and it can quickly recover its shape after being injected out, realizing small incision implantation, as shown in Figure 7 . It is indicated that the artificial lens can be folded and can be injected through a small incision.

[0069] The artificial lens prepared in this embodiment 2 gradually becomes hard after hydration, and its compression force is 1.9797±0.2041N (tested according to YY 0290.3-2018 Ophthalmic optics - Intraocular lenses - Part 3: Mechanical properties and test methods - Appendix A test), which is significantly higher than that in the unhydrated soft state, and can provide better stability. Under the same compression force (0.0034N), the axial displacement of the unhydrated artificial lens is 2.89±0.08mm (tested according to YY 0290.3-2018 Ophthalmic optics - Intraocular lenses - Part 3: Mechanical properties and test methods - Appendix B test), and the axial displacement of the completely hydrated artificial lens is only 0.10±0.10mm (tested according to YY 0290.3-2018 Ophthalmic optics - Intraocular lenses - Part 3: Mechanical properties and test methods - Appendix B test), as shown in Figure 8 a, Figure 8 b, indicating its excellent stability. It is indicated that after hydration, the artificial lens becomes hard, the supporting force is enhanced, and the stability is enhanced.

[0070] Embodiment 3

[0071] 58wt% of hydrophobic monomer benzyl methacrylate (BzMA), 41wt% of hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1wt% of UV absorber 2-hydroxy-4-(methacryloyloxy) benzophenone (HMBP) monomer, 1wt% of crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber, and 1wt% of initiator azobisisobutyronitrile (AIBN) based on the total mass of the hydrophobic monomer, the hydrophilic monomer and the UV absorber are stirred and mixed to form a transparent precursor solution. After degassing treatment, the precursor solution is injected into a clean mold. Subsequently, the precursor solution is heated at 80℃ for 3 hours to prepare the material S4.

[0072] Figure 1 The infrared spectrum test results show that the polymer is successfully polymerized; the prepared material has a water content of 58.29±1.93% (as shown in Figure 1 b), a water contact angle of 61.66±0.10° (as shown in Figure 1 c), and a glass transition temperature of -28.71℃ (as shown in Figure 1 d). The water content and water contact angle indicate that the hydrophilicity of the material is improved, and the surface is less likely to adhere to proteins, cells, etc.

[0073] The transmittance (400-800nm) is >90% (as shown in Figure 2 a); the material placed on the resolution plate can intuitively show that the material exhibits excellent light transmittance (as shown in Figure 2 b); the dry refractive index is 1.530, and the wet refractive index is 1.448 (as shown in Figure 2 c); the dry Abbe number is 41.34, and the wet Abbe number is 49.54 (as shown in Figure 2 d). The above performances show that the material is suitable for use as an intraocular lens.

[0074] Figure 3 a is the tensile curve before and after hydration, Figure 3 b is the elastic modulus and elongation before and after hydration, the elastic modulus of the material when unhydrated is 0.37±0.07MPa, and the elongation at break is 570.25±3.67%, showing soft foldable performance; after complete hydration, the elastic modulus is 60.64±4.94MPa, and the elongation at break is 123.67±27.29%, showing a significant hardening effect compared to unhydrated. The above performances show that the material is suitable for use as a hydration-hardening intraocular lens.

[0075] As Figure 4 is a cytotoxicity experiment, Figure 5 is a subcutaneous injection experiment, from Figure 4 a, 4b, 5a, 5b, 5c, 5d, 5e, it can be seen that the material exhibits excellent in vitro and in vivo safety.

Claims

1. Use of a polymer as an intraocular lens material, characterized in that: The polymer is soft and foldable in dry state or partially hydrated state, so that the intraocular lens made of the polymer is foldable in dry state or partially hydrated state, and can be implanted into the eye through a small incision with a length of less than 3.5 mm; and the modulus of elasticity of the polymer increases and becomes hard after being fully hydrated, so that the intraocular lens made of the polymer becomes hard after being implanted into the eye, thereby improving the structural and optical stability of the intraocular lens; The polymer is obtained by mixing and polymerizing hydrophobic monomers, hydrophilic monomers, a crosslinking agent and an initiator; the hydrophilic monomers contain polyethylene glycol segments; the total mass of the hydrophobic monomers and the hydrophilic monomers is 94-99.5 wt%, the total mass of the hydrophobic monomers and the hydrophilic monomers accounts for 50-88 wt%, and the total mass of the hydrophilic monomers accounts for 12-50 wt%; the crosslinking agent accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers and the ultraviolet absorber; and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers and the ultraviolet absorber. The hydrophilic monomers are at least one of polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate and polyethylene glycol aralkyl ether (meth) acrylate.

2. Use of a polymer according to claim 1 as an intraocular lens material, characterized in that: The polymer raw material further comprises an ultraviolet absorber, and the polymer is obtained by mixing and polymerizing hydrophobic monomers, hydrophilic monomers, an ultraviolet absorber, a crosslinking agent and an initiator; the hydrophilic monomers contain polyethylene glycol segments; the total mass of the hydrophobic monomers and the hydrophilic monomers is 94-99.5 wt%, the total mass of the hydrophobic monomers and the hydrophilic monomers accounts for 50-88 wt%, and the total mass of the hydrophilic monomers accounts for 12-50 wt%; the crosslinking agent accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers and the ultraviolet absorber; and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers and the ultraviolet absorber; and the hydrophilic monomers are at least one of polyethylene glycol alkyl ether (meth) acrylate, polyethylene glycol phenyl ether (meth) acrylate and polyethylene glycol aralkyl ether (meth) acrylate.

3. Use of a polymer according to claim 2 as an intraocular lens material, characterized in that: The ultraviolet absorber is at least one of 2-hydroxy-4-(methacryloyloxy) benzophenone, 2-acrylic acid-2-(4-benzoyl-3-hydroxyphenoxy) ethyl ester and 2-[3(2H-benzotriazole-2-yl)-4-hydroxyphenyl] ethyl-2-methacrylate.

4. Use of a polymer according to claim 1 or 2 as an intraocular lens material, characterized in that: The hydrophobic monomers are at least one of benzyl (meth) acrylate, 2-phenylethyl (meth) acrylate, 2-phenoxyethyl (meth) acrylate and 4-phenylbutyl (meth) acrylate.

5. Use of a polymer according to claim 1 or 2 as an intraocular lens material, characterized in that: The crosslinking agent is selected from at least one of polyethylene glycol di(meth)acrylate, ethylene glycol di(meth)acrylate, diethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, 1,6-hexanediol di(meth)acrylate, 1,4-butanediol di(meth)acrylate, N,N'-methylenebisacrylamide, N,N'-hexamethylenebis(methacrylamide); the initiator is a thermal initiator or a photoinitiator; the thermal initiator is selected from at least one of 2,2'-azobisisobutyronitrile, 2,2'-azobisisovaleronitrile, 2,2'-azobisisoheptane nitrile, dibenzoyl peroxide, bis-(4-tert-butylcyclohexyl)peroxydicarbonate; the photoinitiator is selected from at least one of phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide, 2-hydroxy-4'-(2-hydroxyethoxy)2-methylpropiophenone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide.

6. An intraocular lens, characterized in that: It is obtained by mixing, pouring, and polymerizing hydrophobic monomers, hydrophilic monomers, a crosslinking agent, and an initiator; the hydrophilic monomers contain polyethylene glycol segments; wherein the hydrophobic monomers are 50-88wt%, the hydrophilic monomers are 12-50wt%, the crosslinking agent is 0.01-5wt% of the total mass of the hydrophobic monomers and the hydrophilic monomers, and the initiator is 0.01-5wt% of the total mass of the hydrophobic monomers and the hydrophilic monomers; the hydrophilic monomers are selected from at least one of polyethylene glycol alkyl ether (meth)acrylate, polyethylene glycol phenyl ether (meth)acrylate, and polyethylene glycol aralkyl ether (meth)acrylate.

7. The artificial lens of claim 6, wherein: The artificial lens material further comprises a UV absorber, and the artificial lens is obtained by mixing, pouring, and polymerizing hydrophobic monomers, hydrophilic monomers, a UV absorber, a crosslinking agent, and an initiator; the hydrophilic monomers contain polyethylene glycol segments; wherein the total mass of the hydrophobic monomers and the hydrophilic monomers is 94-99.5wt%, and the mass of the UV absorber is 0.5-6wt%; and in the total mass of the hydrophobic monomers and the hydrophilic monomers, the mass of the hydrophobic monomers is 50-88wt%, and the mass of the hydrophilic monomers is 12-50wt%; the crosslinking agent is 0.01-5wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers, and the UV absorber, and the initiator is 0.01-5wt% of the total mass of the hydrophobic monomers, the hydrophilic monomers, and the UV absorber; the hydrophilic monomers are selected from at least one of polyethylene glycol alkyl ether (meth)acrylate, polyethylene glycol phenyl ether (meth)acrylate, and polyethylene glycol aralkyl ether (meth)acrylate.

8. The artificial lens of claim 7, wherein: The UV absorber is selected from at least one of 2-hydroxy-4-(methacryloyloxy)benzophenone, 2-acrylic acid-2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester, and 2-[3(2H-benzotriazole-2-yl)-4-hydroxyphenyl]ethyl-2-methacrylate.

9. The artificial lens according to claim 6 or 7, characterized in that: The hydrophobic monomer is selected from at least one of benzyl (meth)acrylate, 2-phenylethyl (meth)acrylate, 2-phenoxyethyl (meth)acrylate, and 4-phenylbutyl (meth)acrylate.

10. The artificial lens according to claim 6 or 7, characterized in that: The crosslinking agent is selected from at least one of polyethylene glycol di(meth)acrylate, ethylene glycol di(meth)acrylate, diethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, 1,6-hexanediol di(meth)acrylate, 1,4-butanediol di(meth)acrylate, N,N'-methylenebisacrylamide, N,N'-hexamethylenebis(methacrylamide); the initiator is a thermal initiator or a photo initiator; the thermal initiator is selected from at least one of 2,2'-azobisisobutyronitrile, 2,2'-azobisisovaleronitrile, 2,2'-azobisisoheptanenitrile, dibenzoyl peroxide, bis-(4-tert-butylcyclohexyl)peroxydicarbonate; the photo initiator is selected from at least one of phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide, 2-hydroxy-4'- (2-hydroxyethoxy)2-methylpropiophenone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide.

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