Phakic intraocular lens

Abstract

The present invention provides an intraocular lens with a crystalline lens that can maintain a stable vault height in the eye. The intraocular lens with a crystalline lens of the present invention has the following structure. The central thickness of the optical part of the intraocular lens with a crystalline lens is 0.05 to 0.25 mm, preferably 0.05 to 0.20 mm, and more preferably 0.08 to 0.18 mm; the edge thickness of the support part is 0.05 to 0.25 mm, preferably 0.05 to 0.20 mm, and more preferably 0.08 to 0.18 mm; the thickness of the thickest part is 0.1 to 0.8 mm, preferably 0.15 to 0.75 mm, and more preferably 0.15 to 0.70 mm. With the above structure, as described in the following embodiments and the like, through such a special size design, the intraocular lens with a crystalline lens of the present invention can maintain a stable vault height. It can enable the intraocular lens to maintain the vault height, prevent it from collapsing and deforming, and also prevent it from being too hard to cause damage to the intraocular tissues.

Description

Technical Field

[0001] The present invention relates to a phakic intraocular lens. Background Art

[0002] Phakic intraocular lenses (PIOLs) are classified according to the implantation position and fixation method, including anterior chamber angle-supported phakic intraocular lenses, iris-fixed phakic intraocular lenses, and posterior chamber phakic intraocular lenses.

[0003] As a posterior chamber phakic intraocular lens, as shown in Figure 1 、 2 , it consists of an optical part and a supporting part, and is implanted between the natural lens 23 and the iris 22, and its supporting part (supporting loop) is supported in the ciliary sulcus 24. By implanting the posterior chamber phakic intraocular lens 10, the refractive state of the human eye can be changed.

[0004] After the posterior chamber phakic intraocular lens 10 is implanted, sufficient spacing must be maintained between the corneal endothelium 21a of the cornea 21 and the natural lens 23 to prevent damage to the corneal endothelium 21a and / or clouding of the natural lens 23 caused by contact between the posterior chamber phakic intraocular lens 10 and the corneal endothelium 21a and / or the natural lens 23. Since the space between the iris 22 and the natural lens 23 is very limited, strict requirements are imposed on the size and stability of the posterior chamber phakic intraocular lens 10 after implantation, as follows:

[0005] 1) The spacing between the posterior chamber phakic intraocular lens 10 and the natural lens 23 needs to be sufficient to prevent contact between the two lenses and cause contact cataract, which requires the posterior chamber phakic intraocular lens 10 to have a sufficient vault height A( Figure 2 );

[0006] 2) The spacing between the posterior chamber phakic intraocular lens 10 and the corneal endothelium 21a needs to be sufficient to prevent contact and cause damage to the corneal endothelium 21a, which requires that the vault height A of the posterior chamber phakic intraocular lens 10 cannot be too high;

[0007] 3) The total length of the posterior chamber phakic intraocular lens 10 must match the size of the ciliary sulcus 24, so that the posterior chamber phakic intraocular lens 10 can just be stuck in the ciliary sulcus 24. If the posterior chamber phakic intraocular lens 10 is too long compared with the ciliary sulcus 24, the posterior chamber phakic intraocular lens 10 will arch up. Although it is far from the natural lens 23, it is close to the corneal endothelium 21a, which is likely to cause damage to the corneal endothelium 21a, and the anterior chamber angle B( Figure 2)When compressed, it is likely to cause the closure of the angle B of the chamber, leading to complications such as glaucoma. If the posterior chamber phakic intraocular lens 10 is too short compared to the ciliary sulcus 24, it is likely to cause insufficient support for the posterior chamber phakic intraocular lens 10, resulting in contact with the natural lens 23 under the pressure of the iris 22 and causing cataracts.

[0008] 4) Angle B of the chamber: Refer to Figure 2 , as the posterior chamber phakic intraocular lens 10 is implanted, the iris 22 of the human eye is slightly arched under the influence of the shape of the posterior chamber phakic intraocular lens 10, which will make the angle B of the human eye chamber smaller. If the angle B of the chamber closes, it will cause complications such as angle-closure glaucoma and glaucoma. Therefore, when designing the posterior chamber phakic intraocular lens 10, the impact on the angle B of the chamber should be minimized as much as possible to leave a larger angle B for the human eye.

[0009] In summary, to ensure the safety and effectiveness after the implantation of the posterior chamber phakic intraocular lens, there should be as much space as possible between the posterior chamber phakic intraocular lens and the natural lens and the corneal endothelium, and as large a remaining chamber angle as possible. To achieve the above goals, the design of the posterior chamber intraocular lens must be comprehensively considered in terms of the diameter of the optical zone, shape, lens straddling height, vault height, etc. The existing posterior chamber phakic intraocular lenses generally have a straddling height within 1.1 - 2.0 mm to avoid excessive arching after implantation, which may cause too small a chamber angle, or contact with the natural lens due to too low a vault height. At the same time, various methods are used to obtain a larger space between the posterior chamber phakic intraocular lens and the natural lens when the vault height is determined. For example, in CN108078652A, a high refractive index material and a biconcave shape are used to obtain a more stable vault height and a larger lens space.

[0010] The support part (support loop) of the posterior chamber intraocular lens supports in the ciliary sulcus of the human eye. In theory, doctors will select the total diameter of the intraocular lens according to the length of the ciliary sulcus of the human eye, so that the total length (diameter) of the intraocular lens exactly matches the diameter of the ciliary sulcus. Thus, while the intraocular lens can be fixed, it will not deform.

[0011] However, after the actual surgical implantation of the intraocular lens, it is not always in an ideal state. First, the ciliary sulcus of the human eye is a quantity that varies from person to person, and the ciliary sulcus lengths of each person are different. The total diameter specifications of the existing posterior chamber phakic intraocular lens products are limited, and it is difficult to customize according to the ciliary sulcus length of each person.

[0012] Secondly, the current existing technical means are still unable to accurately measure the actual length of the ciliary sulcus. Generally, the white-to-white length is used to estimate the ciliary sulcus length, or the UBM is used to measure the ciliary sulcus length. Clinical results show that the results of these two detection methods are not accurate, thus affecting the accuracy of selecting the intraocular lens size.

[0013] Again, after the posterior chamber phakic intraocular lens is implanted into the human eye, the iris gently rests on the front surface of the intraocular lens, exerting a certain axial pressure on the intraocular lens; on the other hand, the ciliary sulcus tissue has a certain horizontal compression force on the supporting part of the intraocular lens. These two forces continuously change under the human eye accommodation mechanism, including the ciliary muscle relaxing or tightening as the human eye looks at distant or near objects, and the iris tightening or relaxing correspondingly as the pupil dilates or constricts under bright or dark vision conditions of the human eye. These changes will continuously alter the diameter matching situation of the intraocular lens in the eye.

[0014] Therefore, under real implantation conditions, in many cases, the total length of the lens cannot exactly match the ciliary sulcus and is in a continuous dynamic change, thereby affecting the anterior chamber angle of the human eye and the anterior and posterior spaces of the intraocular lens after the intraocular lens is implanted, and affecting the safety after the intraocular lens implantation.

[0015] In addition, existing phakic intraocular lenses (PIOLs), whether they are anterior chamber angle-supported, iris-fixed or posterior chamber types, generally use the materials commonly used for aphakic intraocular lenses (IOLs), including PMMA, silicone, hydrophilic acrylate (water content generally > 20%), and hydrophobic acrylate (water content generally < 2%). One of the materials that occupies an absolute position in the market has a very high water content, a low elastic modulus, and a low refractive index. Currently, there is no suitable material designed and developed specifically for the usage characteristics and structural parameters of phakic intraocular lenses.

[0016] If the posterior chamber phakic intraocular lens is made of a soft material, it will be continuously pressured by the iris after implantation; if the length is not completely matched or when the ciliary muscle moves, it will be squeezed by the ciliary sulcus. Long-term clinical result statistics show that phakic intraocular lenses will deform under long-term intraocular force conditions, and the distance (vault height) between the intraocular lens and the natural lens will gradually decrease.

[0017] Data shows that for existing phakic intraocular lenses, the difference in vault height between the initial implantation and several months after implantation is at least dozens of micrometers, and in some cases, it is more than 200 micrometers or even higher. The ideal vault height after intraocular lens implantation should be about 500 micrometers. Such a large change in vault height before and after is sufficient to pose a safety hazard, and thus this phenomenon also brings great troubles to doctors' prediction of vault height and the postoperative safety of patients. Summary of the Invention

[0018] In view of this, the purpose of the present invention is to provide a phakic intraocular lens that can maintain a stable vault height in the eye.

[0019] To achieve the above object, the phakic intraocular lens of the present invention has the following structure. The central thickness of the optical part of the phakic intraocular lens is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm; the edge thickness of the support part is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm; the thickness of the thickest part is 0.1 - 0.8 mm, preferably 0.15 - 0.75 mm, and more preferably 0.15 - 0.70 mm.

[0020] Adopting the above structure, as described in the following embodiments and the like, through such a special size design, the phakic intraocular lens of the present invention can maintain a stable vault height. It can keep the intraocular lens in a vault height state, not collapsing or deforming, nor being too hard to cause damage to intraocular tissues.

[0021] Preferably, the phakic intraocular lens of the present invention is made of a soft and foldable material, and the elastic modulus of the material is greater than 10.0 kPa, preferably 0.1 - 2.0 MPa, more preferably 0.3 - 1.8 MPa, and even more preferably 0.5 - 1.5 MPa.

[0022] Adopting the above structure, through such a setting of the elastic modulus, the stability of the vault height of the intraocular lens is more reliably ensured.

[0023] Preferably, in the present invention, when a pressure not greater than 0.3 g is applied in the horizontal direction, the axial displacement does not exceed 0.2 mm; when a pressure not greater than 0.3 g is applied axially, the axial deformation does not exceed 0.2 mm.

[0024] Preferably, in the present invention, when a pressure not greater than 0.2 g is applied in the horizontal direction, the axial displacement does not exceed 0.1 mm; when a pressure not greater than 0.2 g is applied axially, the axial deformation does not exceed 0.1 mm.

[0025] The material may be such that the elongation at break in the wet state > 80%.

[0026] The material may be such that the breaking strength in the wet state > 1 MPa.

[0027] The material may be such that the moisture content at 35°C is 5 - 20 wt%, preferably 6 - 15 wt%, and more preferably 7 - 12 wt%.

[0028] The material may be such that the refractive index is 1.46 - 1.55; preferably, the refractive index is 1.48 - 1.52.

[0029] In the natural non-compressed state, the total height of the phakic intraocular lens of the present invention can be between 1.0 and 2.0 mm, preferably between 1.2 and 1.9 mm, and more preferably between 1.3 and 1.6 mm.

[0030] Preferably, the diameter of the optical portion of the present invention is not less than 4.2 mm, preferably not less than 4.5 mm, and more preferably not less than 5.5 mm.

[0031] The diameter of the phakic intraocular lens of the present invention is preferably between 11.0 and 15.0 mm, preferably between 11.2 and 14.5 mm, and more preferably between 11.5 and 14.2 mm.

[0032] The phakic intraocular lens of the present invention suitably has a width greater than 6.0 mm, preferably between 6.5 and 8.0 mm, more preferably between 6.5 and 7.5 mm, and even more preferably between 6.8 and 7.2 mm.

[0033] The present invention is particularly applicable to a posterior chamber phakic intraocular lens whose supporting portion is supported in the ciliary sulcus of the human eye.

[0034] By using the phakic intraocular lens of the present application, which has a specially designed size and is made of a moderately rigid soft material, it can maintain better deformation stability under compressive force. Compared with existing products, the intraocular lens material has a relatively high elastic modulus. When the intraocular lens is subjected to the downward compressive force from the front of the iris, especially when the length of the intraocular lens is less than the diameter of the ciliary sulcus, the intraocular lens is not easily collapsed and deformed; when the length of the intraocular lens is longer than the ciliary sulcus, it is not easily deformed and arched under the moderate extrusion of the ciliary sulcus to avoid affecting the anterior chamber angle; at the same time, the elastic modulus of the material is not too high to avoid that when the diameter of the intraocular lens exceeds the ciliary sulcus too much, the rigidity of the lens is too large and it does not deform at all, thus damaging the human eye tissue.

[0035] Through the above-mentioned size design of the phakic intraocular lens, including the selection of key parameters such as thickness, diameter, and vault height, combined with a material with an appropriate elastic modulus, when the lens is under a pressure not greater than 0.3 g in the horizontal direction during use, the axial displacement does not exceed 0.2 mm; when the lens is under a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when the lens is under a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when the lens is under a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm.

[0036] Thus, the intraocular lens has a moderate rigidity. After the intraocular lens is implanted, when facing the ciliary sulcus extrusion pressure and iris pressure, it can maintain better vault stability and will not be too hard to cause damage to intraocular tissues. Moreover, the selected material has a higher refractive index than the prior art, and the manufactured phakic intraocular lens can be thinner, which is beneficial for the intraocular lens to maintain a distance from other tissues in the eye. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 is a schematic diagram for explaining the implantation position of the posterior chamber phakic intraocular lens;

[0038] Figure 2 is an explanatory diagram of the gap and the change of the anterior chamber angle after the implantation of the posterior chamber phakic intraocular lens;

[0039] Figure 3 is a structural explanatory diagram of the posterior chamber phakic intraocular lens.

[0040] DESCRIPTION OF THE REFERENCE NUMERALS

[0041] 10 Posterior chamber phakic intraocular lens; 11 Optical part; 12 Support part; 13 Positioning hole; 14 Central hole; 21 Cornea; 21a Corneal endothelium; 22 Iris; 23 Natural lens; 24 Ciliary sulcus; A Vault height (vault) of the intraocular lens; B Anterior chamber angle; d1 Diameter of the optical part; d2 Diameter (maximum diameter) of the intraocular lens; d3 Width of the intraocular lens; d4 Central thickness of the optical part of the intraocular lens; d5 Edge thickness of the support part; d6 Thickness of the thickest part of the intraocular lens; h Total height of the intraocular lens. DETAILED DESCRIPTION OF THE INVENTION

[0042] Hereinafter, the detailed description of the specific embodiments of the present invention will be given with reference to the drawings.

[0043] First, a brief description of the structure of the posterior chamber phakic intraocular lens will be given.

[0044] Figure 3 shows the structure of the posterior chamber phakic intraocular lens (hereinafter, sometimes simply referred to as the intraocular lens). As shown in this Figure 3 figure, the intraocular lens 10 has a circular optical part 11 and a support part 12 located on the outer periphery of the optical part.

[0045] Among them, the optical part 11 has a lens function and can provide a diopter of +30D to -30D. Preferably, it is 0 to -30D, and more preferably, it is 0 to -25D. In addition to the diopter, the optical part 11 can be additionally provided with an astigmatism design, an aspherical design, an aberration design, a large depth of field design, a multifocal design, etc. A central hole 14 can be provided through the center of the optical part 11 to promote the circulation of aqueous humor. The diameter d1 of the optical part 11 is not less than 4.2 mm, preferably not less than 4.5 mm, and more preferably not less than 5.5 mm.

[0046] The supporting part 12 is located on the outer periphery of the optical part 11 and can be designed in a plate shape such as square or rectangular, or with various hollow designs of different sizes and shapes, or other shapes such as butterfly shape, etc., for fixing the intraocular lens 10 in the ciliary sulcus of the human eye. In this embodiment, it is a rectangular plate shape design with positioning holes 13, or it can also be provided with holes for promoting the circulation of aqueous humor. The longest part of the intraocular lens 10 where the supporting part 12 is combined with the optical part 11 is called the diameter d2 of the intraocular lens 10. Viewed from the side, the supporting part 12 and the optical part 11 form an arched structure, and the total height of the intraocular lens 10 is h. The diameter d2 of the intraocular lens 10 is between 11.0 and 15.0 mm, preferably 11.2 to 14.5 mm, and more preferably 11.5 to 14.2 mm. The total height h is between 1.0 and 2.0 mm, preferably between 1.2 and 1.9 mm, and more preferably between 1.3 and 1.6 mm.

[0047] On the premise of the above structure, when the intraocular lens 10 is implanted and remains in a theoretically matching state with the ciliary sulcus, it will make the human eye have a suitable anterior chamber angle (>10°) and vault height (≈500 microns).

[0048] The intraocular lens 10 is made of a soft foldable material, such as silicone, acrylate materials. The material can be hydrophilic or hydrophobic. Preferably, it has a certain water content, and the water content of the material at 35°C is 5 - 20 wt%, preferably 6 - 15 wt%, and more preferably 7 - 12 wt%. The material must have sufficient strength to meet the folding, unfolding, and pulling of the intraocular lens during use. Its elongation at break (wet state) > 80%, and its breaking strength (wet state) > 1.0 MPa. The material must have suitable refractive power, with a refractive index of 1.46 to 1.55; preferably, the refractive index is 1.48 to 1.52.

[0049] The material should have moderate rigidity to maintain better deformation stability under compression. The elastic modulus of the artificial lens material is higher than that of the human iris. When the artificial lens is subjected to downward pressure from the front of the iris, especially when the length of the artificial lens is smaller than the diameter of the ciliary sulcus, the artificial lens is not easy to collapse and deform. The elastic modulus of the material should be close to the elastic modulus of the ciliary muscle of the human eye. When the length of the artificial lens is longer than the ciliary sulcus, it is not easy to deform and arch under moderate compression of the ciliary sulcus to avoid affecting the chamber angle. At the same time, the elastic modulus of the material should not be too high to avoid the situation where the diameter of the artificial lens exceeds the ciliary sulcus too much, the lens is too rigid, does not deform at all, and damages the human eye tissue. In addition, an elastic modulus that is too high is not conducive to the folding of the artificial lens and implantation into the eye through a micro-incision.

[0050] According to the Young's modulus measurement method, the elastic modulus of the human iris is about 3.0-10.0 kPa, and the tissue near the ciliary sulcus belongs to the human soft tissue, and the elastic modulus of the human soft tissue in vivo is about 1.0 MPa, so the Young's modulus of the material should be greater than 10.0 kPa, preferably 0.1-2.0 MPa, more preferably 0.3-1.8 MPa, and more preferably 0.5-1.5 MPa. The above material can help keep the artificial lens 10 arched, so that it will not collapse and deform, and it will not be too hard to cause damage to the intraocular tissue.

[0051] In addition to selecting materials with suitable elastic modulus, the shape and size design of the artificial lens 10 is also an important indicator to ensure its stability in the eye after surgical implantation. First of all, the thickness of the artificial lens 10 is an important indicator that affects its rigidity. When the elastic modulus is determined, the greater the overall thickness, the harder the artificial lens 10 is, and the less likely it is to deform when subjected to pressure; conversely, the smaller the overall thickness, the thinner the artificial lens 10 is, and the easier it is to deform under pressure. Therefore, in the design of the artificial lens 10, on the one hand, the lens as a whole should be sufficiently thin to leave enough space in the eye to prevent damage to the intraocular tissue. On the other hand, the artificial lens 10 should not be too thin, and the comprehensive consideration of the elastic modulus should be combined to make the artificial lens 10 have appropriate rigidity.

[0052] In this embodiment, the overall thickness of the intraocular lens 10 is measured by three key indicators: the center thickness d4, the edge thickness d5 of the support portion, and the thickness d6 of the thickest part of the intraocular lens 10 (generally located at the edge of the optical portion of the intraocular lens 10). In addition to having a suitable elastic modulus and other mechanical performance indicators, the material selected in this embodiment also has a higher refractive index than the prior art, so the manufactured intraocular lens 10 can be thinner.

[0053] Therefore, supported by the above materials, the central thickness d4 of the optical part 11 of the intraocular lens 10 is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm. The thickness d5 at the edge of the supporting part 12 is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm. The thickness d6 of the thickest part of the intraocular lens 10 is 0.1 - 0.8 mm, preferably 0.15 - 0.75 mm, and more preferably 0.15 - 0.70 mm.

[0054] In addition, the size of the long axis direction (length direction, Figure 3 the up and down direction in the middle) of the intraocular lens 10 matches the size of the ciliary sulcus. When the lens is pressed, the force often conducts from the long axis direction to the intraocular lens 10. And what has a greater impact on the rigidity of the intraocular lens 10 is the length in the short axis direction, that is, the width d3 of the lens. The wider the width d3 of the intraocular lens 10, the less likely it is to deform under force. The intraocular lens 10 of this embodiment has a width d3 greater than 6.0 mm, preferably 6.5 - 8.0 mm, more preferably 6.5 - 7.5 mm, and more preferably 6.8 - 7.2 mm.

[0055] Through the above structural design, when the intraocular lens 10 is in the use state, when it is subjected to a pressure not greater than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when it is subjected to a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when it is subjected to a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when it is subjected to a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm.

[0056] Among them, the measurement in the use state refers to the measurement in the self - form of the intraocular lens during actual use. If the material of the intraocular lens is a hydrophilic material, the intraocular lens must be in the wet state after hydration. The axial direction refers to the direction perpendicular to the front surface of the optical part of the intraocular lens (the surface facing the cornea during implantation). The horizontal direction refers to the direction parallel to the front surface of the optical part of the intraocular lens. In the said measurement, it refers to the horizontal direction passing through the edge of the supporting part of the intraocular lens.

[0057]

Embodiment

[0058] The inventors of the present invention implemented according to the scheme of the present invention and obtained the following Embodiments 1 - 5.

[0059] In these embodiments, several materials used for making the intraocular lens were made, and intraocular lenses of various specifications were made with these materials.

[0060] First, the manufacturing methods of the materials involved in these embodiments and the measurement methods of the experimental results will be briefly described below.

[0061] 1) Preparation method of materials

[0062] The preparation method of the materials is a relatively conventional method, which will be briefly described here. All the materials in the embodiments are prepared in the following manner. All monomers are purified by vacuum distillation. In a 250 ml beaker, acrylate monomers are mixed in corresponding proportions, including but not limited to 2-hydroxyethyl methacrylate (HEMA), ethyl acrylate (EA), ethyl methacrylate (EMA), 2-phenoxyethyl acrylate (POEA), butyl acrylate (BA), 2-hydroxyethyl acrylate (HEA), phenethyl acrylate (PEA), phenethyl methacrylate (PEMA), benzyl ethyl methacrylate (BMA), ethoxyethyl methacrylate (EOEMA), ethoxyethoxyethyl acrylate (EOEOEA), ethylene glycol dimethacrylate (EGDMA), butanediol diacrylate (BDDA), etc., and initiators and light absorbers are added. After stirring well and filtering, it is transferred to a special mold.

[0063] All kinds of utensils and molds used in the above implementation process should be cleaned, dried, and disinfected before use. Nitrogen is introduced into the monomer solution in the mold, and the mold is sealed under nitrogen protection. Then the mold is placed in a water bath at a set temperature for at least 24 hours for polymerization reaction, 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 it is cut into blanks of the required size and shape while it is hot, extracted with an alcohol solvent at a certain temperature for at least 24 hours to remove residual small molecules, and finally the blanks are placed in a vacuum drying oven and dried overnight at a set temperature to obtain the materials for manufacturing intraocular lenses.

[0064] 2) Measurement of refractive index

[0065] For the measurement method of the refractive index of the material, a test method well-known to those skilled in the art is adopted. The material sheet is hydrated with physiological saline, placed in a constant temperature incubator at 35 °C for 7 days to balance, taken out and quickly dried the surface moisture, and the refractive index of the hydrated state of the material is measured using an Abbe refractometer. The Abbe refractometer is connected to a constant temperature water bath. When testing, the temperature of the constant temperature water bath is set to 35 °C, and the refractive index of the material is obtained after the temperature of the material sheet is balanced in the Abbe refractometer.

[0066] 3) Measurement of the mechanical properties of the material (tensile fracture strength and Young's elastic modulus of the fully hydrated material)

[0067] The obtained material was hydrated in physiological saline at 35°C for 7 days. After complete hydration, the material was punched into a standard shape using a punch conforming to Type IV in ASTM D638. The material was placed in a constant temperature water bath at 35°C and the mechanical properties of the material were tested using an electronic universal tensile testing machine according to the standard requirements of ASTM. The tensile speed was selected as 50 mm / min, and the tensile stress and strain data of the material were recorded, and the fracture strength and Young's modulus of elasticity of the material were calculated.

[0068]

Example 1

[0069] A hydrophilic acrylate material was used. The material had a refractive index of 1.502 and a water content of 8%. The material had a Young's modulus of elasticity of 1.25 MPa. An intraocular lens was made using this material, and the specific design parameters are shown in Table 1.

[0070] Table 1 Design parameters of the intraocular lens

[0071]

[0072] Where Ra is the curvature radius of the front surface of the lens, and Rp is the curvature radius of the rear surface of the lens.

[0073] For the above-specified phakic intraocular lenses, 5 lenses were made for each diopter. After sufficient hydration, different magnitudes of pressure were applied to the phakic intraocular lenses in the horizontal and axial directions respectively. The magnitude of the pressure was read using an electronic balance, with the unit being grams (g). Table 2 shows the measured results, that is, the axial displacement of the intraocular lens under different pressure applications in the horizontal and axial directions. It can be seen from Table 2 that when the Young's modulus of elasticity of the lens material is 1.25 MPa, the diameter is 11.5 - 14.2 mm, the width is 7.0 mm, the total height of the lens is 1.46 - 1.56 mm, the central thickness is 0.15 mm, the edge thickness is 0.12 mm, and the thickness at the thickest part of the lens is 0.29 - 0.73 mm, when the lens is subjected to a pressure not greater than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when the lens is subjected to a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm. It can be seen that the material has a moderate stiffness.

[0074] Table 2 Axial displacement of the intraocular lens after applying pressure

[0075] Pressure magnitude / g Pressure direction Axial displacement / mm [0.20, 0.28], average value 0.24 Horizontal ≈0.2，≤0.2 [0.10, 0.17], average value 0.15 Horizontal ≈0.1，≤0.1 [0.16, 0.29], average value 0.24 Axial ≈0.2，≤0.2 [0.09, 0.16], average value 0.13 Axial ≈0.1，≤0.1

[0076]

Example 2

[0077] A hydrophobic acrylate material is adopted, and the material has a refractive index of 1.55. The material has a Young's modulus of elasticity of 2.0 MPa. Different specifications of intraocular lenses are made using this material, and the specific design parameters are shown in Table 3.

[0078] Table 3 Design parameters of intraocular lenses

[0079]

[0080] Among them, Ra is the curvature radius of the front surface of the lens, and Rp is the curvature radius of the rear surface of the lens.

[0081] For the above - specified phakic intraocular lenses, 5 of each are made. After sufficient hydration, different magnitudes of pressure are applied to the phakic intraocular lenses in the horizontal and axial directions respectively. The magnitude of the pressure is read using an electronic balance, and the unit is grams (g). Table 4 shows the axial displacements of the intraocular lenses under different pressures applied in the horizontal and axial directions. It can be seen from Table 4 that at this time, the elastic modulus of the lens is relatively high. Although thinning treatments have been carried out at the center and edge of the lens, and the lens width has been made 6.5 mm, when the pressure in the horizontal and axial directions is greater than 0.30 g, the deformation of the lens is still small. Therefore, compared with the iris and ciliary sulcus tissues, it may be too hard and there is a risk of damaging intraocular tissues. When the thickness at the center and edge of the lens reaches the mechanical processing limit of 0.05 mm, the appropriate mechanical properties can just be achieved. This situation can be regarded as the limit situation of the elastic modulus.

[0082] Table 4 Axial displacements of intraocular lenses after applying pressure

[0083]

[0084]

[0085]

Example 3

[0086] A hydrophilic acrylate material is adopted, and the material has a refractive index of 1.52 and a water content of 5%. The material has a Young's modulus of elasticity of 1.8 Mpa. Different specifications of intraocular lenses are made using this material, and the specific design parameters are shown in Table 5.

[0087] Table 5 Design parameters of intraocular lenses

[0088]

[0089] Among them, Ra is the curvature radius of the front surface of the lens, and Rp is the curvature radius of the rear surface of the lens.

[0090] For the above - mentioned phakic intraocular lenses of various specifications, 5 pieces were made for each. After sufficient hydration, different magnitudes of pressure were applied to the phakic intraocular lenses in the horizontal direction and the axial direction respectively. The magnitude of the pressure was read using an electronic balance, with the unit being grams (g). Table 6 shows the axial displacement of the intraocular lens under different pressure conditions applied in the horizontal direction and the axial direction. As can be seen from Table 6, when the Young's modulus of elasticity of the lens material is 1.8 MPa, when the lens is subjected to a pressure not greater than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when the lens is subjected to a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm. It can be seen that the material has a moderate stiffness.

[0091] Table 6 Axial displacement of the intraocular lens after applying pressure

[0092] Pressure magnitude / g Pressure direction Axial displacement / mm [0.19, 0.29], average value 0.26 Horizontal ≈0.2，≤0.2 [0.10, 0.15], average value 0.13 Horizontal ≈0.1，≤0.1 [0.16, 0.29], average value 0.28 Axial ≈0.2，≤0.2 [0.09, 0.18], average value 0.18 Axial ≈0.1，≤0.1

[0093]

Example 4

[0094] A hydrophilic acrylate material is used. The material has a refractive index of 1.48 and a water content of 15%. The material has a Young's modulus of elasticity of 0.3 MPa. Different - specification phakic intraocular lenses are made using this material, and the specific design parameters are shown in Table 7.

[0095] Table 7 Design parameters of the intraocular lens

[0096]

[0097] Where Ra is the radius of curvature of the front surface of the lens and Rp is the radius of curvature of the rear surface of the lens.

[0098] For the above - mentioned phakic intraocular lenses of various specifications, 5 pieces were made for each. After sufficient hydration, different magnitudes of pressure were applied to the phakic intraocular lenses in the horizontal direction and the axial direction respectively. The magnitude of the pressure was read using an electronic balance, with the unit being grams (g). Table 8 shows the axial displacement of the intraocular lens under different pressure conditions applied in the horizontal direction and the axial direction. As can be seen from Table 8, when the Young's modulus of elasticity of the lens material is 0.3 MPa, when the lens is subjected to a pressure not greater than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when the lens is subjected to a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm. It can be seen that the material has a moderate stiffness.

[0099] Table 8 Axial displacement of the intraocular lens after applying pressure

[0100] Pressure magnitude / g Pressure direction Axial displacement / mm [0.15, 0.22], average value 0.20 Horizontal ≈0.2，≤0.2 [0.07, 0.15], average value 0.10 Horizontal ≈0.1，≤0.1 [0.16, 0.23], average value 0.21 Axial ≈0.2，≤0.2 [0.05, 0.13], average value 0.10 Axial ≈0.1，≤0.1

[0101]

Example 5

[0102] A hydrophilic acrylate material is adopted. The material has a refractive index of 1.45 and a water content of 20%. The material has a Young's elastic modulus of 0.1 Mpa. Different specifications of intraocular lenses are made using this material, and the specific design parameters are shown in Table 9.

[0103] Table 9 Intraocular lens design parameters

[0104]

[0105] Among them, Ra is the curvature radius of the front surface of the lens, and Rp is the curvature radius of the rear surface of the lens.

[0106] For the above-mentioned specifications of phakic intraocular lenses, 5 of each are made. After sufficient hydration, different magnitudes of pressure are applied to the phakic intraocular lenses in the horizontal and axial directions respectively. The magnitude of the pressure is read using an electronic balance, and the unit is grams (g). Table 10 shows the axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen from Table 10 that when the Young's elastic modulus of the lens material is 0.1 MPa, although the overall thickness of the lens is increased, when the lens thickness is 0.18 mm, when the lens is subjected to a pressure greater than 0.2 g in the horizontal direction, the axial displacement will exceed 0.2 mm; when the lens is subjected to a pressure greater than 0.2 g in the axial direction, the axial deformation will exceed 0.2 mm. When the center of the lens is thickened to 0.25 mm, the purpose of the present invention can be barely achieved. It can be seen that at this time, the elastic modulus of the intraocular lens material is too low, and it is prone to deformation when stressed and difficult to maintain the stability of the shape.

[0107] Table 10 Axial displacement of the intraocular lens after applying pressure

[0108]

[0109]

Example 6

[0110] A hydrophilic acrylate material is adopted. The material has a refractive index of 1.50 and a water content of 10%. The material has a Young's elastic modulus of 0.5 Mpa. Different specifications of intraocular lenses are made using this material, and the specific design parameters are shown in Table 11.

[0111] Table 11 Intraocular lens design parameters

[0112]

[0113] Among them, Ra is the curvature radius of the front surface of the lens, and Rp is the curvature radius of the rear surface of the lens.

[0114] For the above - mentioned phakic intraocular lenses of each specification, 5 pieces were made. After sufficient hydration, different magnitudes of pressure were applied to the phakic intraocular lenses in the horizontal direction and the axial direction respectively. The magnitude of the pressure was read by an electronic balance, with the unit of gram (g). Table 8 shows the axial displacement of the intraocular lens under different pressure conditions in the horizontal direction and the axial direction. It can be seen that when the Young's elastic modulus of the lens material is 0.5 MPa, when the lens is subjected to a pressure not greater than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when the lens is subjected to a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm. It can be seen that the material stiffness is appropriate.

[0115] Table 12 Axial displacement of the intraocular lens after applying pressure

[0116] Pressure magnitude / g Pressure direction Axial displacement / mm [0.15, 0.22], average value 0.21 Horizontal ≈0.2，≤0.2 [0.07, 0.14], average value 0.10 Horizontal ≈0.1，≤0.1 [0.16, 0.25], average value 0.23 Axial ≈0.2，≤0.2 [0.05, 0.13], average value 0.12 Axial ≈0.1，≤0.1

[0117]

Example 7

[0118] A hydrophilic acrylate material is used. The material has a refractive index of 1.53 and a water content of 12%. The material has a Young's elastic modulus of 1.50 MPa. Different - specification phakic intraocular lenses are made with this material, and the specific design parameters are shown in Table 13.

[0119] Table 13 Design parameters of the intraocular lens

[0120]

[0121] Where Ra is the curvature radius of the front surface of the lens and Rp is the curvature radius of the rear surface of the lens.

[0122] For the above - mentioned phakic intraocular lenses of each specification, 5 pieces were made. After sufficient hydration, different magnitudes of pressure were applied to the phakic intraocular lenses in the horizontal direction and the axial direction respectively. The magnitude of the pressure was read by an electronic balance, with the unit of gram (g). Table 8 shows the axial displacement of the intraocular lens under different pressure conditions in the horizontal direction and the axial direction. It can be seen that when the Young's elastic modulus of the lens material is 1.50 MPa, when the lens is subjected to a pressure not greater than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when the lens is subjected to a pressure not greater than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when the lens is subjected to a pressure not greater than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm. It can be seen that the material stiffness is appropriate.

[0123] Table 14 Axial displacement of the intraocular lens after applying pressure

[0124] Pressure magnitude / g Pressure direction Axial displacement / mm [0.15, 0.20], average value 0.18 Horizontal ≈0.2，≤0.2 [0.07, 0.15], average value 0.13 Horizontal ≈0.1，≤0.1 [0.15, 0.22], average value 0.20 Axial ≈0.2，≤0.2 [0.05, 0.13], average value 0.12 Axial ≈0.1，≤0.1

[0125] As can be seen from the above embodiments, the suitable central thickness of the optical part of the phakic intraocular lens is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm; the edge thickness of the supporting part is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm; the thickness of the thickest part is 0.1 - 0.8 mm, preferably 0.15 - 0.75 mm, and more preferably 0.15 - 0.70 mm.

[0126] The suitable elastic modulus of the material of the phakic intraocular lens should be 0.1 - 2.0 MPa, more preferably 0.3 - 1.8 MPa, and more preferably 0.5 - 1.5 MPa.

[0127] Correspondingly, the central thickness of the optical part of the phakic intraocular lens is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm. The edge thickness of the supporting part is 0.05 - 0.25 mm, preferably 0.05 - 0.20 mm, and more preferably 0.08 - 0.18 mm. The thickness of the thickest part of the phakic intraocular lens is 0.1 - 0.8 mm, preferably 0.15 - 0.75 mm, and more preferably 0.15 - 0.70 mm. The phakic intraocular lens has a lens width of > 6.0 mm, preferably 6.5 - 8.0 mm, more preferably 6.5 - 7.5 mm, and more preferably 6.8 - 7.2 mm.

[0128] In this embodiment, when the lens is subjected to a pressure of no more than 0.3 g in the horizontal direction, the axial displacement does not exceed 0.2 mm; when the lens is subjected to a pressure of no more than 0.2 g in the horizontal direction, the axial displacement does not exceed 0.1 mm; when subjected to a pressure of no more than 0.3 g in the axial direction, the axial deformation does not exceed 0.2 mm; when subjected to a pressure of no more than 0.2 g in the axial direction, the axial deformation does not exceed 0.1 mm. The material stiffness is moderate. After the intraocular lens is implanted, when facing the ciliary sulcus extrusion pressure and iris pressure, it maintains better vault stability and is not too hard to cause damage to intraocular tissues.

[0129] The materials and design parameters of the above embodiments are only several typical embodiments. More generally, the intraocular lens is made of a soft and foldable material, such as silicone or acrylate materials. The material can be hydrophilic or hydrophobic. Preferably, it has a certain water content, and the water content of the material at 35 °C is 5-15 wt%, preferably 6-13 wt%, and more preferably 7-12 wt%. The material must have sufficient strength to meet the folding, unfolding, and pulling of the intraocular lens during use. Its elongation at break (wet state) > 80%, and its tensile strength (wet state) > 1 MPa. The material must have suitable refractive power, with a refractive index of 1.46-1.55; preferably, the refractive index is 1.48-1.52. Through the above materials, it is beneficial to keep the intraocular lens in a vault height, not to collapse and deform, nor to be too hard to cause damage to intraocular tissues. For example, in the prior art, there is a material with an elastic modulus of about 0.2 MPa, a water content of about 40%, and a refractive index of about 1.44. Compared with this material, the material of the present embodiment can obtain the above technical effects and has excellent performance.

[0130] The diopter of the intraocular lens is +30D to -30D, preferably 0 to -30D, and more preferably 0 to -25D. In addition to the diopter, the optical part can be additionally designed with astigmatism, asphericity, aberration, large depth of field, multifocal, etc. A central hole can be opened in the center of the optical part to promote the circulation of aqueous humor. The diameter of the optical part is not less than 4.2 mm, preferably not less than 4.5 mm, and more preferably not less than 5.5 mm.

[0131] The support part of the intraocular lens has a plate-shaped design such as square or rectangular, or has various hollow designs of different sizes and shapes, or other shapes such as butterfly-shaped. If it is a plate-shaped design, it can have positioning holes or holes to promote the circulation of aqueous humor. The diameter of the intraocular lens is between 11.0 and 15.0 mm, preferably 11.2 to 14.5 mm, and more preferably 11.5 to 14.2 mm. The total height is between 1.0 and 2.0 mm, preferably between 1.2 and 1.9 mm, and more preferably between 1.3 and 1.6 mm.

[0132] The phakic intraocular lens of the present embodiment has characteristic dimensions and is made of a moderately rigid soft material. Under real implantation conditions, it can resist the pressure from the ciliary sulcus and iris to a certain extent. In the use state, the change in vault height can be kept within 0.2 mm, and it has better deformation stability under compressive force, improving the vault height stability of the intraocular lens when the diameter of the ciliary sulcus does not match or when the eye is under stress. The change in vault height in the early and late postoperative periods is small, improving the doctor's prediction of the vault height, and it is not too hard to cause damage to intraocular tissues, improving the safety after intraocular lens implantation.

[0133] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

[0134] In the above embodiment, an intraocular lens of the posterior chamber type is taken as an example for illustration. However, the setting of the size parameters and material parameters of the present invention can be applied not only to the intraocular lens of the posterior chamber type, but also to other phakic intraocular lenses.

Claims

1. A phakic intraocular lens, comprising an optical part and a support part, the optical part and the support part forming an arch structure, characterized in that, It is made of a soft and foldable material, and the elastic modulus of the material is greater than 0.1 MPa; the central thickness of the optical part of the phakic intraocular lens is 0.05 - 0.25 mm; the edge thickness of the supporting part is 0.05 - 0.25 mm; the thickness of the thickest part of the phakic intraocular lens is 0.1 - 0.8 mm; so that when a pressure not greater than 0.3 g is applied in the horizontal direction, the axial displacement does not exceed 0.2 mm; when a pressure not greater than 0.3 g is applied axially, the axial deformation does not exceed 0.2 mm.

2. The phakic intraocular lens according to claim 1, characterized in that, The central thickness of the optical part is 0.05 - 0.20 mm.

3. The phakic intraocular lens according to claim 1, characterized in that, The central thickness of the optical part is 0.08 - 0.18 mm.

4. The phakic intraocular lens according to claim 1, characterized in that, The edge thickness of the supporting part is 0.05 - 0.20 mm.

5. The phakic intraocular lens according to claim 1, wherein, The edge thickness of the supporting part is 0.08 - 0.18 mm.

6. The phakic intraocular lens according to claim 1, wherein, The thickness of the thickest part is 0.15 - 0.75 mm.

7. The phakic intraocular lens according to claim 1, wherein, The thickness of the thickest part is 0.15 - 0.70 mm.

8. The phakic intraocular lens according to claim 1, characterized in that, The elastic modulus of the material is 0.1 - 2.0 MPa.

9. The phakic intraocular lens according to claim 1, wherein The elastic modulus of the material is 0.3 - 1.8 MPa.

10. The phakic intraocular lens according to claim 1, characterized in that, The elastic modulus of the material is 0.5 - 1.5 MPa.

11. The phakic intraocular lens according to claim 1, characterized in that, When a pressure not greater than 0.2 g is applied in the horizontal direction, the axial displacement does not exceed 0.1 mm; when a pressure not greater than 0.2 g is applied axially, the axial deformation does not exceed 0.1 mm.

12. The phakic intraocular lens according to claim 1, wherein, The elongation at break of the material in the wet state > 80%.

13. The phakic intraocular lens according to claim 1, characterized in that, The breaking strength of the material in the wet state > 1 MPa.

14. The phakic intraocular lens according to claim 1, characterized in that, The moisture content of the material at 35°C is 5 - 20 wt%.

15. The phakic intraocular lens according to claim 14, wherein, The moisture content of the material at 35°C is 6 - 15 wt%.

16. The phakic intraocular lens according to claim 14, wherein, The moisture content of the material at 35°C is 7 - 12 wt%.

17. The phakic intraocular lens according to claim 1, wherein, The refractive index of the material is 1.46 - 1.

55.

18. The intraocular lens with a crystalline lens according to claim 17, characterized in that, The refractive index of the material is 1.48 - 1.

52.

19. The phakic intraocular lens according to any one of claims 1-17, characterized in that, In the natural non-compressed state, the total height is between 1.0 - 2.0 mm.

20. The phakic intraocular lens according to claim 19, wherein The total height is between 1.2 - 1.9 mm.

21. The phakic intraocular lens according to claim 19, wherein, The total height is between 1.3 - 1.6 mm.

22. The phakic intraocular lens according to any one of claims 1-17, characterized in that, The diameter of its optical part is not less than 4.2 mm.

23. The phakic intraocular lens according to claim 22, wherein The diameter of the optical part is not less than 4.5 mm.

24. The phakic intraocular lens according to claim 22, characterized in that, The diameter of the optical part is not less than 5.5 mm.

25. The phakic intraocular lens according to any one of claims 1-17, characterized in that, Its diameter is between 11.0 - 15.0 mm.

26. The phakic intraocular lens according to claim 25, wherein, Its diameter is 11.2 - 14.5 mm.

27. The phakic intraocular lens according to claim 25, wherein, Its diameter is 11.5 - 14.2 mm.

28. The phakic intraocular lens according to any one of claims 1-17, characterized in that, Its width is greater than 6.0 mm.

29. The phakic intraocular lens according to claim 28, wherein, Its width is 6.5 - 8.0 mm.

30. The phakic intraocular lens according to claim 28, wherein Its width is 6.5 - 7.5 mm.

31. The phakic intraocular lens according to claim 28, characterized in that, Its width is 6.8 - 7.2 mm.

32. The phakic intraocular lens according to any one of claims 1-17, characterized in that, It is a posterior chamber phakic intraocular lens with the supporting part supported in the ciliary sulcus of the human eye.

33. The phakic intraocular lens according to any one of claims 1-17, characterized in that, The supporting part is in the shape of a rectangular plate or a butterfly.

34. The phakic intraocular lens according to any one of claims 1-17, characterized in that, The thickest part is located at the edge of the optical part.

35. A manufacturing method of a phakic intraocular lens, the phakic intraocular lens comprising an optical part and a supporting part, the optical part and the supporting part forming an arch structure, characterized in that, A soft and foldable material is used as the manufacturing material of the phakic intraocular lens, and the elastic modulus of the material is designed to be greater than 0.1 MPa; the central thickness of the optical part of the phakic intraocular lens is designed to be 0.05 - 0.25 mm; the edge thickness of the support part is designed to be 0.05 - 0.25 mm; the thickness of the thickest part of the phakic intraocular lens is designed to be 0.1 - 0.8 mm; so that when a pressure not greater than 0.3 g is applied in the horizontal direction, the axial displacement does not exceed 0.2 mm; when a pressure not greater than 0.3 g is applied axially, the axial deformation does not exceed 0.2 mm.

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