Use of a polymer as an intraocular lens material and an intraocular lens

Abstract

The 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. The polymer is prepared from hydrophobic monomers, hydrophilic monomers, a crosslinking agent and an initiator as raw materials, and is used as the intraocular lens. The obtained intraocular lens can be water-triggered hardened, and has the advantages of being foldable, implanted through a small incision, hardened after implantation, high support, etc.

Description

Technical Field

[0001] This invention belongs to the field of polymer materials, specifically relating to the use of a polymer as a material for intraocular lenses and the intraocular lens itself. Background Technology

[0002] An intraocular lens (IOL) is a miniature lens made of biocompatible polymer materials used to replace or supplement the refractive function of the human eye's lens, restoring the ability of light to focus on the retina. It is surgically implanted into the eye to correct refractive errors caused by cataracts, high myopia, and other conditions. Depending on whether the patient's own lens is preserved during implantation, IOLs are divided into two categories: those that preserve the patient's own lens (such as ICL implantation) are phakic IOLs; those that require removal of the patient's own lens (such as phacoemulsification combined with IOL implantation) are aphakic IOLs.

[0003] The earliest intraocular lenses were rigid, such as those made of PMMA, which have excellent structural and optical stability and biocompatibility. However, they are not foldable and require an incision at least the size of the optical zone in the cornea to implant the intraocular lens. This large incision can cause a variety of complications, such as significant surgical astigmatism, incision healing disorders, corneal endothelial damage, and secondary damage to intraocular structures.

[0004] To address this issue, later intraocular lenses (IOLs) used soft materials such as silicone and acrylic, which can be folded and implanted through a small incision of ≤3mm, avoiding or reducing the complications caused by the large incisions of rigid IOLs. However, soft IOLs have poor support, insufficient structural and optical stability, and are prone to deformation, rotation, displacement, abnormal arching, and affecting optical quality. Summary of the Invention

[0005] The technical problem to be solved by this invention is that the polymer prepared by using hydrophobic monomers, hydrophilic monomers, crosslinking agents and initiators as raw materials can be used as an intraocular lens, thereby solving the disadvantages of rigid intraocular lenses such as non-foldability, large implantation incision and related complications, as well as the disadvantages of soft intraocular lenses such as insufficient support, poor dimensional and optical stability and related complications.

[0006] This invention first provides a use of a polymer as a material for intraocular lenses (IOLs). The polymer is soft and foldable when dry or partially hydrated, allowing the IOL prepared from it to be foldable in both dry and partially hydrated states, enabling implantation into the eye through small incisions less than 3.5 mm in length. Furthermore, after the polymer absorbs water and fully hydrates, its elastic modulus increases and it becomes harder, causing the IOL prepared from it to harden after implantation, thereby improving the structural and optical stability of the IOL. The polymer is made from hydrophobic and hydrophilic monomers. The intraocular lens is obtained by polymerization after mixing a crosslinking agent and an initiator. The hydrophilic monomer contains polyethylene glycol segments. Specifically, the hydrophobic monomer comprises 50-88 wt%, the hydrophilic monomer 12-50 wt%, the crosslinking agent comprises 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers, and the initiator comprises 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers. 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. Complete hydration refers to the state where the intraocular lens absorbs water until it is completely saturated. Partial hydration refers to the state where the intraocular lens absorbs water but does not reach complete saturation.

[0007] Furthermore, in the above-mentioned applications, small incisions refer to incisions with a length of less than 3.5mm, specifically such as 3.2mm, 3mm, 2.0mm, or 1.8mm.

[0008] Furthermore, in the above-mentioned applications, the polymer raw material also includes a UV absorber. The polymer is obtained by polymerizing a mixture of 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 and hydrophilic monomers is 94-99.5 wt%, and the UV absorber is 0.5-6 wt%; and in the total mass of the hydrophobic and hydrophilic monomers, the hydrophobic monomers account for 50-88 wt%, and the hydrophilic monomers account for 12-50 wt%; the crosslinking agent is 0.01-5 wt% of the total mass of the hydrophobic, hydrophilic, and UV absorbers, and the initiator is 0.01-5 wt% of the total mass of the hydrophobic, hydrophilic, and UV absorbers; 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.

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

[0010] Preferably, in the above-mentioned applications, the hydrophobic monomer accounts for 60-80 wt% and the hydrophilic monomer accounts for 20-40 wt%.

[0011] Furthermore, in the above-mentioned uses, the hydrophilic monomer is selected from polyethylene glycol methyl ether methacrylate.

[0012] Specifically, in the above-mentioned uses, the hydrophobic monomer is selected from at least one of benzyl methacrylate, 2-phenylethyl methacrylate, 2-phenoxyethyl methacrylate, and 4-phenylbutyl methacrylate.

[0013] Specifically, in the above-mentioned applications, 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-mentioned applications, the initiator is a thermal initiator or a photoinitiator.

[0015] Furthermore, in the above-mentioned uses, the thermal initiator is selected from at least one of 2,2'-azobisisobutyronitrile, 2,2'-azobisisopentanitrile, 2,2'-azobisisoheptanenitrile, benzoyl peroxide, and bis-(4-tert-butylcyclohexyl) peroxide dicarbonate.

[0016] Furthermore, in the above-mentioned uses, the photoinitiator is selected from at least one of phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide, 2-hydroxy-4′-(2-hydroxyethoxy)2-methylacetone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, and phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide.

[0017] Specifically, in the above applications, the polymerization is either thermal polymerization or photopolymerization. Furthermore, the thermal polymerization temperature is 40-125°C. The thermal polymerization time is 0.5 hours to 7 days. A thermal initiator is used in the thermal polymerization. The photopolymerization time is more than 10 minutes. A photoinitiator is used in the photopolymerization.

[0018] The present invention also provides an artificial lens, which is obtained by mixing, casting, and polymerizing a hydrophobic monomer, a hydrophilic monomer, a crosslinking agent, and an initiator; wherein the hydrophilic monomer contains polyethylene glycol segments; wherein the hydrophobic monomer is 50-88 wt%, the hydrophilic monomer is 12-50 wt%, the crosslinking agent is 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers, and the initiator is 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers; 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.

[0019] Furthermore, in the aforementioned intraocular lens, the raw material of the intraocular lens also includes an ultraviolet absorber. The intraocular lens is obtained by mixing, casting, and polymerizing a hydrophobic monomer, a hydrophilic monomer, an ultraviolet absorber, a crosslinking agent, and an initiator; the hydrophilic monomer contains polyethylene glycol segments; wherein the total mass of the hydrophobic and hydrophilic monomers is 94-99.5 wt%, and the ultraviolet absorber is 0.5-6 wt%; and in the total mass of the hydrophobic and hydrophilic monomers, the hydrophobic monomer accounts for 50-88 wt%, and the hydrophilic monomer accounts for 12-50 wt%; the crosslinking agent is 0.01-5 wt% of the total mass of the hydrophobic, hydrophilic, and ultraviolet absorber, and the initiator is 0.01-5 wt% of the total mass of the hydrophobic, hydrophilic, and ultraviolet 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.

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

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

[0022] Furthermore, in the aforementioned intraocular lens, the hydrophilic monomer is selected from polyethylene glycol methyl ether methacrylate.

[0023] Specifically, in the aforementioned intraocular lens, the hydrophobic monomer is selected from at least one of benzyl methacrylate, 2-phenylethyl methacrylate, 2-phenoxyethyl methacrylate, and 4-phenylbutyl methacrylate.

[0024] Specifically, in the aforementioned intraocular lens, 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).

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

[0026] Furthermore, in the aforementioned intraocular lens, the thermal initiator is selected from at least one of 2,2'-azobisisobutyronitrile, 2,2'-azobisisovalerate, 2,2'-azobisisoheptanenitrile, benzoyl peroxide, and bis-(4-tert-butylcyclohexyl) peroxide dicarbonate.

[0027] Furthermore, in the aforementioned intraocular lens, the photoinitiator is selected from at least one of phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide, 2-hydroxy-4′-(2-hydroxyethoxy)2-methylacetone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, and phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide.

[0028] Specifically, in the aforementioned intraocular lens, the polymerization is either thermal polymerization or photopolymerization. Furthermore, the thermal polymerization temperature is 40-125°C, and the polymerization time is 0.5 hours to 7 days. A thermal initiator is used for thermal polymerization. The photopolymerization time is more than 10 minutes, and a photoinitiator is used for photopolymerization.

[0029] The beneficial effects of this invention are:

[0030] The intraocular lens of this invention is soft and foldable when dry or partially hydrated, allowing for implantation through a small incision. After absorbing water and hydrating, its elastic modulus increases, and it hardens. Compared to traditional rigid intraocular lenses, the intraocular lens material of this invention is soft and foldable before or partially before water absorption, allowing for implantation through a small incision and preventing or reducing complications associated with rigid lens implantation. Compared to existing foldable intraocular lenses, the intraocular lens material of this invention is also foldable and implantable through a small incision, but after implantation, it hardens upon water absorption, increasing its elastic modulus by more than 100 times, resulting in higher structural and optical stability. Furthermore, the intraocular lens material of this invention is scintillation-free, prevents protein, cell, and bacterial adhesion, and is UV resistant.

[0031] The intraocular lens material of this invention is soft before or during partial hydration, allowing for implantation through a small incision. After implantation, it gradually hydrates and hardens, significantly increasing its elastic modulus and providing enhanced structural and optical stability. The intraocular lens material of this invention comprises hydrophilic and hydrophobic segments. During hydration, the hydrophilic segments absorb water, forming an aqueous phase, which separates from the hydrophobic segments into microphases, resulting in physical cross-linking and thus enhancing mechanical properties. The intraocular lens material of this invention can be used as aphakic or phakic intraocular lens. Attached Figure Description

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

[0033] Figure 2 The transmittance curves (a), magnification plate images (b), refractive index (c), and Abbe value (d) of the materials in the comparative examples and embodiments are shown. The transmittance curves and magnification plate images demonstrate the transparency of the materials, measured using a UV-Vis spectrophotometer. The refractive index is a core parameter determining the refractive power of an intraocular lens (IOL); a high refractive index allows for a higher refractive power or a thinner IOL. The Abbe value, along with the refractive index, affects the dispersive properties of the IOL; a high Abbe value reduces chromatic aberration and improves image clarity. The refractive index and Abbe value were measured using an Abbe refractometer.

[0034] Figure 3 The tensile curves (a) and elastic modulus and elongation (b) of the materials before and after hydration in the comparative examples and embodiments were tested using a universal testing machine.

[0035] Figure 4 Comparative and Example Materials: MTT cytotoxicity assay cell viability (a), cells cultured for 24 hours stained with Hoechst 33342 reagent and then photographed under a fluorescence microscope (b). a is the test using human lens epithelial cells according to Appendix C of GB / T 16886.5. This indicates that the cytotoxicity of the examples is comparable to that of the control; if the control is non-cytotoxic, then the examples are also non-cytotoxic.

[0036] Figure 5 The flowchart of the subcutaneous implantation experiment of the comparative and example materials is shown in (a). Images of the wound 0 and 7 days after implantation are shown in (b). Materials were photographed (c). Scanning electron micrographs of the removed materials are shown in (d). HE-stained images of the tissue near the materials are shown in (e). b and c show that no hyperemia, exudation, or abscess formation was observed at the implantation site. d shows that the increased hydrophilic components help reduce tissue adhesion to the material surface. e shows that there was no obvious inflammatory response at the implantation site. These in vivo animal experiments demonstrate that these materials have good biocompatibility.

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

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

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

[0040] This invention provides an artificial lens, which is obtained by mixing, casting, and polymerizing a hydrophobic monomer, a hydrophilic monomer, a crosslinking agent, and an initiator; the hydrophilic monomer contains polyethylene glycol segments; 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.

[0041] Furthermore, ultraviolet absorbers can be added to give it UV protection.

[0042] This invention uses hydrophobic monomers, hydrophilic monomers, crosslinking agents, and initiators, or further adds ultraviolet absorbers, to mix, cast, and polymerize the raw materials. The resulting polymer can be a sheet or an artificial lens shape, depending on the mold used during casting. When the mold is shaped like an artificial lens, the polymer is an artificial lens; when the mold is of other shapes, the polymer can be further processed into an artificial lens using a turning process.

[0043] Comparative Example 1

[0044] A transparent precursor solution was prepared by mixing 99 wt% of the hydrophobic monomer benzyl methacrylate (BzMA), 1 wt% of the UV absorber 2-hydroxy-4-(methacryloyloxy)benzophenone (HMBP), 1 wt% of the crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) (total mass of hydrophobic monomer and UV absorber), and 1 wt% of the initiator azobisisobutyronitrile (AIBN) (total mass of hydrophobic monomer and UV absorber). After degassing, the precursor solution was injected into a clean mold. Subsequently, the precursor solution was heated at 80°C for 3 hours to prepare material S0.

[0045] Figure 1 Infrared spectroscopy results indicate that the polymer was successfully polymerized; the prepared material has a water content of 0.58 ± 0.32% (e.g., ...). Figure 1b) The water contact angle is 85.34 ± 0.05° (e.g. Figure 1 c), the glass transition temperature is 45.39℃ (e.g. Figure 1 d).

[0046] Transmittance (400-800nm) > 90% (e.g.) Figure 2 a) Placing the material on a resolution plate allows for a direct visual observation of its excellent light transmittance (e.g., ...). Figure 2 b) The dry refractive index is 1.564, and the wet refractive index is 1.563 (e.g., ...). Figure 2 c) The dry Abbe value is 35.16, and the wet Abbe value is 35.10 (e.g., ...). Figure 2 d).

[0047] Figure 3 a represents the stretching curves before and after hydration. Figure 3 b represents the elastic modulus and elongation before and after hydration. It can be seen that the elastic modulus of the unhydrated material is 509.96±38.87MPa, and the elongation at break is 6.82±1.11%, exhibiting rigid characteristics and unsuitable for use as a foldable intraocular lens. After full hydration, the elastic modulus is 508.00±24.52MPa, and the elongation at break is 8.08±2.00%. Compared with the unhydrated material, it does not show a hardening effect, indicating that the material is not suitable for use as a hydration-hardening intraocular lens.

[0048] like Figure 4 For cytotoxicity experiments, Figure 5 For subcutaneous injection experiments, from Figure 4 As can be seen from a, 4b, 5a, 5b, 5c, 5d, and 5e, the material exhibits excellent in vitro and in vivo safety.

[0049] Comparative Example 2

[0050] A transparent precursor solution was prepared by mixing 89 wt% of the hydrophobic monomer benzyl methacrylate (BzMA), 10 wt% of the hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1 wt% of the UV absorber 2-hydroxy-4-(methacryloyloxy)benzophenone (HMBP), 1 wt% of the crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) (total mass of hydrophobic monomers, hydrophilic monomers, and UV absorbers), and 1 wt% of the initiator azobisisobutyronitrile (AIBN) (total mass of hydrophobic monomers, hydrophilic monomers, and UV absorbers). After degassing, the precursor solution was injected into a clean mold. Subsequently, the precursor solution was heated at 80°C for 3 hours to prepare material S1.

[0051] Figure 1 Infrared spectroscopy results indicate that the polymer was successfully polymerized; the prepared material has a water content of 2.28 ± 0.22% (e.g., ...). Figure 1 b) The water contact angle is 74.39 ± 0.07° (e.g. Figure 1 c), the glass transition temperature is 35.39℃ (e.g. Figure 1 d). The water content and water contact angle indicate that the material's hydrophilicity is increased, meaning that the surface is less likely to adhere to proteins, cells, etc.

[0052] Transmittance (400-800nm) > 90% (e.g.) Figure 2 a) Placing the material on a resolution plate allows for a direct visual observation of its excellent light transmittance (e.g., ...). Figure 2 b) The dry refractive index is 1.558, and the wet refractive index is 1.555 (e.g., Figure 2 c) The dry Abbe value is 36.53, and the wet Abbe value is 37.91 (e.g. Figure 2 d).

[0053] Figure 3 a represents the stretching curves before and after hydration. Figure 3 b represents the elastic modulus and elongation before and after hydration. The material has an elastic modulus of 436.39±17.00MPa and an elongation at break of 16.07±4.30% when unhydrated, exhibiting rigid characteristics and unsuitable for use as a foldable intraocular lens. After full hydration, the elastic modulus is 419.66.00±22.91MPa and the elongation at break is 11.55±1.56%. Compared to the unhydrated material, it does not exhibit a hardening effect, indicating that the material is unsuitable for use as a hydration-hardening intraocular lens.

[0054] like Figure 4 For cytotoxicity experiments, Figure 5 For subcutaneous injection experiments, from Figure 4 As can be seen from a, 4b, 5a, 5b, 5c, 5d, and 5e, the material exhibits excellent in vitro and in vivo safety.

[0055] Example 1

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

[0057] Figure 1Infrared spectroscopy results indicate that the polymer was successfully polymerized; the prepared material has a water content of 7.17 ± 0.28% (e.g., ...). Figure 1 b), the water contact angle is 71.86 ± 0.13° (e.g. Figure 1 c), the glass transition temperature is 19.63℃ (e.g. Figure 1 d). The water content and water contact angle indicate that the material's hydrophilicity is increased, meaning that the surface is less likely to adhere to proteins, cells, etc.

[0058] Transmittance (400-800nm) > 90% (e.g.) Figure 2 a) Placing the material on a resolution plate allows for a direct visual observation of its excellent light transmittance (e.g., ...). Figure 2 b) The dry refractive index is 1.550, and the wet refractive index is 1.536 (e.g., ...). Figure 2 c); The dry Abbe value is 38.41, and the wet Abbe value is 40.36 (e.g., ...). Figure 2 d).

[0059] Figure 3 a represents the stretching curves before and after hydration. Figure 3 b represents the elastic modulus and elongation before and after hydration. The material has an elastic modulus of 71.22±17.78 MPa and an elongation at break of 316.33±48.10% when unhydrated, exhibiting soft and foldable characteristics. After full hydration, the elastic modulus is 340.74±6.47 MPa and the elongation at break is 14.58±1.69%, showing a significant hardening effect compared to the unhydrated state, indicating that the material is suitable for use as a hydration-hardening intraocular lens.

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

[0061] Example 2

[0062] A transparent precursor solution was prepared by mixing 68 wt% of the hydrophobic monomer benzyl methacrylate (BzMA), 31 wt% of the hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1 wt% of the UV absorber 2-hydroxy-4-(methacryloyloxy)benzophenone (HMBP), 1 wt% of the crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) (total mass of hydrophobic, hydrophilic, and UV absorbers), and 1 wt% of the initiator azobisisobutyronitrile (AIBN) (total mass of hydrophobic, hydrophilic, and UV absorbers). After degassing, the precursor solution was injected into a clean mold or a mold for phakic intraocular lenses. Subsequently, the precursor solution was heated at 80°C for 3 hours to prepare copolymer sheets or phakic intraocular lens samples S3.

[0063] Figure 1 Infrared spectroscopy results indicate that the polymer was successfully polymerized; the prepared material has a water content of 25.66 ± 1.92% (e.g., ...). Figure 1 b), the water contact angle is 66.99±0.20° (e.g. Figure 1 c), the glass transition temperature is 15.16℃ (e.g. Figure 1 d). The water content and water contact angle indicate that the material's hydrophilicity is increased, meaning that the surface is less likely to adhere to proteins, cells, etc.

[0064] Transmittance (400-800nm) > 90% (e.g.) Figure 2 a) Placing the material on a resolution plate allows for a direct visual observation of its excellent light transmittance (e.g., ...). Figure 2 b) The dry refractive index is 1.539, and the wet refractive index is 1.492 (e.g., ...). Figure 2 c); The dry Abbe value is 40.13, and the wet Abbe value is 45.08 (e.g., ...). Figure 2 d). The above properties indicate that this material is suitable for use as an artificial lens.

[0065] Figure 3 a represents the stretching curves before and after hydration. Figure 3 b represents the elastic modulus and elongation before and after hydration. The material, when unhydrated, has an elastic modulus of 1.33 ± 0.26 MPa and an elongation at break of 509.58 ± 43.47%, exhibiting soft and foldable properties. After full hydration, the elastic modulus is 191.96 ± 16.37 MPa, and the elongation at break is 37.31 ± 6.02%, showing a significant hardening effect compared to the unhydrated state. These properties indicate that this material is suitable for use as a hydration-hardening intraocular lens.

[0066] like Figure 4 For cytotoxicity experiments, Figure 5 For subcutaneous injection experiments, from Figure 4As can be seen from a, 4b, 5a, 5b, 5c, 5d, and 5e, the material exhibits excellent in vitro and in vivo safety.

[0067] The artificial lens prepared in Example 2 has a transmittance (400-800nm) >90%, exhibiting excellent light transmittance, such as... Figure 6 a, Figure 6 b. This indicates that the intraocular lens sample is transparent.

[0068] The compressive force in the unhydrated state is 0.0034±0.0004N (tested according to Appendix A of YY 0290.3-2018 Ophthalmic Optical Intraocular Lens Part 3: Mechanical Properties and Test Methods), and it can be injected using a 3mm syringe. After injection, it can quickly regain its shape, allowing for small incision implantation. Figure 7 This indicates that the intraocular lens is foldable and can be injected through small incisions.

[0069] After hydration, the intraocular lens prepared in Example 2 gradually hardened, with a compressive force of 1.9797±0.2041N (tested according to Appendix A of YY 0290.3-2018 Ophthalmic Optical Intraocular Lens Part 3: Mechanical Properties and Test Methods), significantly higher than the unhydrated soft state, providing better stability. Under the same compressive force (0.0034N), the axial displacement of the unhydrated intraocular lens was 2.89±0.08mm (tested according to Appendix B of YY 0290.3-2018 Ophthalmic Optical Intraocular Lens Part 3: Mechanical Properties and Test Methods), while the axial displacement of the fully hydrated intraocular lens was only 0.10±0.10mm (tested according to Appendix B of YY 0290.3-2018 Ophthalmic Optical Intraocular Lens Part 3: Mechanical Properties and Test Methods). Figure 8 a, Figure 8 b indicates its excellent stability. This means that after hydration, the artificial lens hardens, its support is enhanced, and its stability is increased.

[0070] Example 3

[0071] A transparent precursor solution was prepared by mixing 58 wt% of the hydrophobic monomer benzyl methacrylate (BzMA), 41 wt% of the hydrophilic monomer polyethylene glycol methyl ether methacrylate (PEGMMA), 1 wt% of the UV absorber 2-hydroxy-4-(methacryloyloxy)benzophenone (HMBP), 1 wt% of the crosslinking agent polyethylene glycol dimethacrylate (PEGDMA) (total mass of hydrophobic monomers, hydrophilic monomers, and UV absorber), and 1 wt% of the initiator azobisisobutyronitrile (AIBN) (total mass of hydrophobic monomers, hydrophilic monomers, and UV absorber). After degassing, the precursor solution was injected into a clean mold. Subsequently, the precursor solution was heated at 80°C for 3 hours to prepare material S4.

[0072] Figure 1 Infrared spectroscopy results indicate that the polymer was successfully polymerized; the prepared material has a water content of 58.29 ± 1.93% (e.g., ...). Figure 1 b), the water contact angle is 61.66 ± 0.10° (e.g. Figure 1 c), the glass transition temperature is -28.71℃ (e.g. Figure 1 d). The water content and water contact angle indicate that the material's hydrophilicity is increased, meaning that the surface is less likely to adhere to proteins, cells, etc.

[0073] Transmittance (400-800nm) > 90% (e.g.) Figure 2 a) Placing the material on a resolution plate allows for a direct visual observation of its excellent light transmittance (e.g., ...). Figure 2 b) The dry refractive index is 1.530, and the wet refractive index is 1.448 (e.g., Figure 2 c) The dry Abbe value is 41.34, and the wet Abbe value is 49.54 (e.g., ...). Figure 2 d). The above properties indicate that this material is suitable for use as an artificial lens.

[0074] Figure 3 a represents the stretching curves before and after hydration. Figure 3 b represents the elastic modulus and elongation before and after hydration. The material, when unhydrated, has an elastic modulus of 0.37 ± 0.07 MPa and an elongation at break of 570.25 ± 3.67%, exhibiting soft and foldable properties. After full hydration, the elastic modulus is 60.64 ± 4.94 MPa and the elongation at break is 123.67 ± 27.29%, showing a significant hardening effect compared to the unhydrated state. These properties indicate that this material is suitable for use as a hydration-hardening intraocular lens.

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

Claims

1. The use of a polymer in the preparation of materials for artificial lenses, characterized in that: The polymer is soft and foldable when dry or partially hydrated, allowing the artificial lens made from it to be foldable when dry or partially hydrated, enabling implantation into the eye through a small incision of less than 3.5 mm in length. When the polymer is fully hydrated after absorbing water, its elastic modulus increases and it becomes harder, thus making the artificial lens made from it harder after implantation into the eye, thereby improving the structural and optical stability of the artificial lens. The polymer is obtained by polymerizing a mixture of hydrophobic monomers, hydrophilic monomers, a crosslinking agent, and an initiator; the hydrophilic monomers contain polyethylene glycol segments; wherein the hydrophobic monomers comprise 50-88 wt%, the hydrophilic monomers comprise 12-50 wt%, the crosslinking agent comprises 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers, and the initiator comprises 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers. 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.

2. The use of the polymer according to claim 1 as a material for preparing artificial lenses, characterized in that: The polymer raw material also includes a UV absorber. The polymer is obtained by polymerizing a mixture of hydrophobic monomers, hydrophilic monomers, a UV absorber, a crosslinking agent, and an initiator. The hydrophilic monomers contain polyethylene glycol segments. The total mass of the hydrophobic and hydrophilic monomers is 94-99.5 wt%, and the UV absorber is 0.5-6 wt%. Furthermore, of the total mass of the hydrophobic and 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, hydrophilic, and UV absorbers, and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic, hydrophilic, and UV absorbers.

3. The use of the polymer according to claim 2 as a material for preparing artificial lenses, characterized in that: The ultraviolet absorber is selected from at least one of 2-hydroxy-4-(methacryloyloxy)benzophenone, 2-acrylate-2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester, and 2-[3(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl-2-methacrylate.

4. The use of the polymer according to claim 1 or 2 as a material for preparing artificial lenses, characterized in that: The hydrophobic monomer is selected from at least one of benzyl methacrylate, 2-phenylethyl methacrylate, 2-phenoxyethyl methacrylate, and 4-phenylbutyl methacrylate.

5. The use of the polymer according to claim 1 or 2 as a material for preparing artificial lenses, 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, and N,N′-hexamethylenebis(methacrylamide); the initiator is a thermal initiator or a photoinitiator; the thermal initiator is selected from 2,2'-azobisisobutyronitrile, 2,2'-azobisisovalerate, and 2,2'-azobisisovalerate. The photoinitiator is selected from at least one of '-azobisisoheptanenitrile, benzoyl peroxide, and bis-(4-tert-butylcyclohexyl) peroxide dicarbonate; the photoinitiator is selected from at least one of phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide, 2-hydroxy-4′-(2-hydroxyethoxy)2-methylphenylacetone, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, and phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide.

6. An intraocular lens, characterized in that: It is obtained by mixing, casting, and polymerizing hydrophobic monomers, hydrophilic monomers, crosslinking agents, and initiators; the hydrophilic monomers contain polyethylene glycol segments; wherein, the hydrophobic monomers are 50-88 wt%, the hydrophilic monomers are 12-50 wt%, the crosslinking agent is 0.01-5 wt% of the total mass of the hydrophobic and hydrophilic monomers, and the initiator is 0.01-5 wt% of the total mass of the hydrophobic and 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. An intraocular lens according to claim 6, characterized in that: The artificial lens material also includes an ultraviolet absorber. The artificial lens is obtained by mixing, casting, and polymerizing hydrophobic monomers, hydrophilic monomers, ultraviolet absorbers, crosslinking agents, and initiators. The hydrophilic monomers contain polyethylene glycol segments. The total mass of the hydrophobic and hydrophilic monomers is 94-99.5 wt%, and the ultraviolet absorber is 0.5-6 wt%. Furthermore, of the total mass of the hydrophobic and 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, hydrophilic, and ultraviolet absorbers, and the initiator accounts for 0.01-5 wt% of the total mass of the hydrophobic, hydrophilic, and ultraviolet absorbers.

8. An intraocular lens according to claim 7, characterized in that: The ultraviolet absorber is selected from at least one of 2-hydroxy-4-(methacryloyloxy)benzophenone, 2-acrylate-2-(4-benzoyl-3-hydroxyphenoxy)ethyl ester, and 2-[3(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl-2-methacrylate.

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

10. An intraocular 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, and 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'-azobisisopentanolitrile, 2,2'-azobisisoheptanenitrile, benzoyl peroxide, and bis-(4-tert-butylcyclohexyl) peroxide dicarbonate; the photoinitiator is selected from at least one of phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide, 2-hydroxy-4′-(2-hydroxyethoxy)2-methylphenylacetone, and diphenyl(2,4-trimethylbenzoyl)phosphine oxide. At least one of (2,4,6-trimethylbenzoyl)phosphine oxide and phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide.

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