CN111358594A

CN111358594A - Intraocular lens with lens

Info

Publication number: CN111358594A
Application number: CN202010188048.5A
Authority: CN
Inventors: 解江冰; 王曌; 隋信策
Original assignee: Abbott Beijing Medical Technology Co ltd
Current assignee: Abbott Beijing Medical Technology Co ltd; Eyebright Medical Technology Beijing Co Ltd
Priority date: 2020-03-17
Filing date: 2020-03-17
Publication date: 2020-07-03
Also published as: WO2021185271A1

Abstract

The present invention provides a phakic intraocular lens capable of maintaining a stable vault height in the eye. The intraocular lens with the lens has the structure that the central thickness of the optical part of the intraocular lens with the lens is 0.05-0.25 mm, preferably 0.05-0.20 mm, 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. With the above configuration, as described in the embodiments and the like to be described later, the intraocular lens with lens according to the present invention can maintain a stable vault height by the above-described special dimensional design. Can keep the artificial lens arched without collapsing and deforming and causing damage to intraocular tissues due to over-hardness.

Description

Intraocular lens with lens

Technical Field

The invention relates to an intraocular lens with a lens.

Background

Phakic intraocular lenses (PIOL) are classified according to implantation location and fixation, and include anterior chamber angle supporting type phakic intraocular lenses, iris fixation type phakic intraocular lenses, and posterior chamber type phakic intraocular lenses.

As shown in fig. 1 and 2, a posterior chamber type intraocular lens for phakic eyes is composed of an optical portion and a haptic portion, which is implanted between a natural crystalline lens 23 and an iris 22 and whose haptic portion (haptic) is supported in a ciliary sulcus 24. By implanting the posterior chamber phakic intraocular lens 10, the refractive condition of the human eye can be altered.

After the posterior chamber type phakic intraocular lens 10 is implanted, a sufficient distance is kept between the corneal endothelium 21a and the natural crystalline lens 23 of the cornea 21, so as to prevent injury of the corneal endothelium 21a and/or clouding of the natural crystalline lens 23 caused by contact between the posterior chamber type phakic intraocular lens 10 and the corneal endothelium 21a and/or the natural crystalline lens 23. Because of the very limited space between the iris 22 and the natural lens 23, there are strict requirements on the size and post-implantation stability of the posterior chamber phakic intraocular lens 10, as follows:

1) the spacing between the posterior chamber phakic intraocular lens 10 and the natural crystalline lens 23 needs to be sufficient to prevent contact between the two lenses, which can cause contact cataract, requiring that the posterior chamber phakic intraocular lens 10 have a sufficient dome height a (fig. 2);

2) the space between the posterior chamber type phakic intraocular lens 10 and the corneal endothelium 21a needs to be sufficient to prevent contact and damage to the corneal endothelium 21a, which requires that the dome height a of the posterior chamber type phakic intraocular lens 10 cannot be too high;

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 caught in the ciliary sulcus 24. If the posterior chamber type phakic intraocular lens 10 is too long compared to the ciliary sulcus 24, the posterior chamber type phakic intraocular lens 10 will vault, apart from the natural crystalline lens 23, but close to the corneal endothelium 21a, easily causing damage to the corneal endothelium 21a, and the chamber angle B (fig. 2) is compressed, easily causing the closing of the chamber angle B, and causing complications such as glaucoma; on the other hand, if the posterior chamber type phakic intraocular lens 10 is too short compared to the ciliary sulcus 24, insufficient supporting force of the posterior chamber type phakic intraocular lens 10 is likely to be caused, and the lens contacts the natural crystalline lens 23 under the pressure of the iris 22, which may cause cataract.

4) Corner B: referring to fig. 2, as the posterior chamber phakic intraocular lens 10 is implanted, the human iris 22 is slightly arched by the shape of the posterior chamber phakic intraocular lens 10, which reduces the human chamber angle B. Since closed angle B causes complications such as closed angle ocular hypertension and glaucoma, posterior chamber type phakic intraocular lens 10 should be designed to minimize the influence on angle B and to leave a larger angle B for the human eye.

In summary, in order to ensure the safety and effectiveness of the implanted posterior chamber type phakic intraocular lens, the gaps between the posterior chamber type phakic intraocular lens and the natural crystalline lens and between the posterior chamber type phakic intraocular lens and the corneal endothelium and the residual chamber angle as large as possible should be ensured. In order to achieve the above object, the posterior chamber intraocular lens design needs to be comprehensively measured in the aspects of optical zone diameter, shape, lens riding height, vault height and the like, the existing posterior chamber intraocular lens with lens generally has the riding height within 1.1-2.0 mm so as to avoid too high arch after implantation to cause too small chamber angle or contact with natural lens due to too low arch height, and meanwhile, various methods are adopted to obtain larger gap between the posterior chamber intraocular lens with lens and the natural lens when arch height is determined, for example, CN108078652A adopts a high-refractive-index material and a biconcave shape to obtain more stable arch height and larger lens gap.

The supporting part (supporting loop) of the posterior chamber type artificial lens is supported in the ciliary sulcus of the human eye, under the theoretical condition, a doctor can select the total diameter of the artificial lens according to the length of the ciliary sulcus of the human eye, so that the total length (diameter) of the artificial lens is just matched with the diameter of the ciliary sulcus, and the artificial lens cannot deform while being fixed.

However, after actual surgical implantation of an intraocular lens, it is not always in an ideal state. Firstly, the ciliary sulcus of the human eyes is different from person to person, the ciliary sulcus length of each person is different, the total diameter specification of the existing posterior chamber type intraocular lens product with the lens is limited, and the product is difficult to customize according to the ciliary sulcus length of each person.

Secondly, the current technical means can not accurately measure the actual length of the ciliary sulcus, and the ciliary sulcus length is usually estimated by the length of white to white or measured by UBM. Clinical results show that the results of these two detection methods are not accurate, and thus affect the accuracy of selecting intraocular lens dimensions.

Thirdly, after the artificial lens of the posterior chamber type phakic eye is implanted into the human eye, the iris is lightly lapped on the front surface of the artificial lens to generate certain axial pressure on the artificial lens; on the other hand, the ciliary sulcus tissue has certain horizontal direction compression force on the artificial crystalline lens supporting part, the two forces are continuously changed under the human eye adjusting mechanism, including that ciliary muscles can be correspondingly tightened and loosened along with the expansion or contraction of pupils under the photopic vision or scotopic vision of human eyes, and the changes can continuously change the diameter matching condition of the artificial crystalline lens in eyes.

Therefore, under the real implantation condition of the artificial lens, the total length of the lens can not be matched with the ciliary sulcus in many times and is in continuous dynamic change, so that the angle of the human eye after the artificial lens is implanted and the front and back gaps of the artificial lens are influenced, and the safety of the artificial lens after the artificial lens is implanted is influenced.

In addition, existing phakic intraocular lenses (PIOLs), whether of the anterior chamber angle supporting type, iris fixated type or posterior chamber type, typically employ materials conventionally used for aphakic intraocular lenses (IOLs), including PMMA, silicone, hydrophilic acrylates (typically > 20% water content), hydrophobic acrylates (typically < 2% water content). One of the materials occupying the market absolute position has high water content, low elastic modulus and low refractive index. At present, no suitable material designed and developed aiming at the use characteristics and structural parameters of the intraocular lens with the lens is available.

If the posterior chamber type intraocular lens with the lens is made of soft materials, the intraocular lens can be always pressed by the iris after being implanted; if the lengths are not perfectly matched or the ciliary muscle is moving, it is compressed by the ciliary sulcus. Long-term clinical result statistics show that the intraocular lens with the lens can deform under the long-term intraocular stress condition, and the distance (arch height) between the intraocular lens and the natural crystalline lens can be gradually reduced.

Data show that the difference between the arch height of the prior intraocular lens with the lens during initial implantation and the arch height after a plurality of months of implantation is dozens of micrometers, and the difference is more than 200 micrometers, the ideal arch height of the intraocular lens after implantation is preferably about 500 micrometers, and the front and back variation amplitude of the arch height can bring potential safety hazards, so the phenomenon also brings great trouble to the prejudgment of the arch height by doctors and the postoperative safety of patients.

Disclosure of Invention

In view of the above, it is an object of the present invention to provide a phakic intraocular lens capable of maintaining a stable vault height in the eye.

In order to achieve the above object, the intraocular lens with lens of the present invention has a structure in which the center thickness of the optical portion of the intraocular lens with lens is 0.05 to 0.25mm, preferably 0.05 to 0.20mm, and more preferably 0.08 to 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.

With the above configuration, as described in the embodiments and the like to be described later, the intraocular lens with lens according to the present invention can maintain a stable vault height by the above-described special dimensional design. Can keep the artificial lens arched without collapsing and deforming and causing damage to intraocular tissues due to over-hardness.

Preferably, the intraocular lens with lens of the invention is made of soft and foldable material, and the elastic modulus of the material is more than 10.0kPa, preferably, 0.1-2.0 MPa, more preferably, 0.3-1.8 MPa, more preferably, 0.5-1.5 MPa.

With the above configuration, the setting of the elastic modulus more reliably ensures the stability of the vault height of the intraocular lens.

Preferably, when the pressure in the horizontal direction is not more than 0.3g, the axial displacement is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm.

Preferably, when the pressure in the horizontal direction is not more than 0.2g, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm.

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

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

The material may have a water content of 5-20 wt%, preferably 6-15 wt%, more preferably 7-12 wt% at 35 ℃.

The material can have a refractive index of 1.46-1.55; preferably, the refractive index is 1.48 to 1.52.

The total height of the intraocular lens with the lens can be between 1.0 and 2.0mm, preferably between 1.2 and 1.9mm, and more preferably between 1.3 and 1.6mm in a natural non-compressed state.

In the invention, the diameter of the optical part is preferably not less than 4.2mm, preferably not less than 4.5mm, and more preferably not less than 5.5 mm.

The diameter of the intraocular lens with lens of the invention is preferably between 11.0 mm and 15.0mm, preferably between 11.2 mm and 14.5mm, and more preferably between 11.5 mm and 14.2 mm.

The phakic intraocular lens of the present invention suitably has a width of greater than 6.0mm, preferably 6.5 to 8.0mm, more preferably 6.5 to 7.5mm, more preferably 6.8 to 7.2 mm.

The invention is particularly applicable to posterior chamber phakic intraocular lenses having a haptic supported in the ciliary sulcus of the human eye.

With the phakic intraocular lens of the present application, which has a specially designed size and is made of a soft material of moderate rigidity, more excellent deformation stability under compressive force can be maintained. Compared with the existing products, the artificial lens material has higher elastic modulus, and when the artificial lens is pressed by the downward front iris pressure, especially when the length of the artificial lens is less than the diameter of the ciliary sulcus, the artificial lens is not easy to collapse and deform; when the length of the artificial lens is longer than that of the ciliary sulcus, the artificial lens is not easy to deform and arch under the condition of being properly extruded by the ciliary sulcus so as to avoid influencing the angle of the room; meanwhile, the elastic modulus of the material is not too high, so that the problem that when the diameter of the artificial lens exceeds the ciliary sulcus too much, the rigidity of the lens is too high, the lens is not deformed completely, and human eye tissues are damaged is avoided.

Through the size design of the intraocular lens with the lens, the selection of key parameters including thickness, diameter, arch height and the like and the combination of materials with proper elastic modulus, the intraocular lens has the advantages that when the lens is subjected to pressure not greater than 0.3g in the horizontal direction in a use state, the axial displacement is not greater than 0.2 mm; when the crystal is subjected to a pressure of not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm.

Thus, the intraocular lens is moderately rigid, maintains better vault stability when exposed to ciliary sulcus squeezing forces and iris pressure after implantation, and is not so rigid as to cause damage to intraocular tissues. And the selected material has higher refractive index than the prior art, and the manufactured intraocular lens with the lens can be thinner, which is beneficial to keeping the distance between the intraocular lens and other tissues in the eye.

Drawings

FIG. 1 is a schematic view for explaining an implantation position of a posterior chamber type phakic intraocular lens;

FIG. 2 is an illustration of the gap and angle change after implantation of a posterior chamber phakic intraocular lens;

figure 3 is a diagram illustrating the structure of a posterior chamber phakic intraocular lens.

Description of the reference numerals

10 posterior chamber type phakic intraocular lens; 11 an optical portion; 12 a support part; 13, positioning holes; 14 a central aperture; 21 the cornea; 21a corneal endothelium; 22 iris; 23 a natural crystalline lens; the ciliary sulcus 24; a dome height (vault height) of the intraocular lens; a corner of the room B; d1 diameter of optic; d2 intraocular lens diameter (maximum diameter); d3 width of intraocular lens; d4 center thickness of optic of intraocular lens; d5 support part edge thickness; d6 thickness of the thickest part of the intraocular lens; h total height of the intraocular lens.

Detailed Description

Hereinafter, specific embodiments of the present invention will be described in detail with reference to the accompanying drawings.

The structure of a posterior chamber type phakic intraocular lens will be briefly described.

Fig. 3 shows the structure of a posterior chamber type phakic intraocular lens (hereinafter, sometimes simply referred to as an intraocular lens). As shown in fig. 3, the intraocular lens 10 includes a circular optical portion 11 and haptic portions 12 located on the outer periphery of the optical portion.

Wherein the optical portion 11 has a lens function and can provide diopters of +30D to-30D, preferably, 0 to-30D, and more preferably, 0 to-25D. In addition to diopter, the optical portion 11 may be attached with an astigmatism design, an aspherical design, an aberration design, a large depth of field design, a multifocal design, or the like. The center of the optical portion 11 may be perforated with a center hole 14 for promoting the flow of aqueous humor. The diameter d1 of the optical portion 11 is not less than 4.2mm, preferably not less than 4.5mm, and more preferably not less than 5.5 mm.

The support portion 12 is located at the periphery of the optical portion 11, and may be designed in a plate shape such as a square shape or a rectangular shape, or have hollow designs with various sizes and shapes, or other shapes such as a butterfly shape, and is used for fixing the intraocular lens 10 in the ciliary sulcus of the human eye. In this embodiment, it is of rectangular plate-shaped design, with positioning holes 13, or it may also be provided with holes that promote the flow of aqueous humor. The longest point of the intraocular lens 10 where the haptic 12 joins the optic 11 is referred to as the diameter d2 of the intraocular lens 10. The haptic portions 12 form an arch structure with the optical portion 11 when viewed from the side, and the total height of the intraocular lens 10 is h. The diameter d2 of the artificial lens 10 is between 11.0 mm and 15.0mm, preferably 11.2 mm to 14.5mm, and more preferably 11.5 mm to 14.2 mm. The total height h is between 1.0 and 2.0mm, preferably between 1.2 and 1.9mm, and more preferably between 1.3 and 1.6 mm.

Given the above structure, when the intraocular lens 10 is implanted, in a theoretical fit with the ciliary sulcus, it will provide the eye with a suitable atrial angle (> 10 °) and vault height (≈ 500 μm).

The intraocular lens 10 is made of a soft foldable material, such as silicone or an acrylic material. The material may be hydrophilic or hydrophobic, preferably with a water content of 5-20 wt%, preferably 6-15 wt%, more preferably 7-12 wt% at 35 ℃. The material has enough strength, can meet the folding, unfolding and pulling of the artificial lens in the using process, and has elongation at break (wet state) of more than 80 percent and breaking strength (wet state) of more than 1.0 MPa. The material has proper refractive power, and the refractive index is 1.46-1.55; preferably, the refractive index is 1.48 to 1.52.

The material should have a moderate stiffness to maintain more excellent deformation stability under compressive forces. The elastic modulus of the artificial lens material is higher than that of the iris of a human eye, and when the artificial lens is pressed downwards by the front face of the iris, particularly 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 is close to that of ciliary muscle of human eyes, and when the length of the artificial lens is longer than that of ciliary sulcus, the artificial lens is not easy to deform and arch under the condition of being moderately pressed by the ciliary sulcus so as to avoid influencing the angle of the room; meanwhile, the elastic modulus of the material is not too high, so that the problem that when the diameter of the artificial lens exceeds the ciliary sulcus too much, the rigidity of the lens is too high, the lens is not deformed completely, and human eye tissues are damaged is avoided. In addition, too high a modulus of elasticity is not conducive to implantation of a folded intraocular lens through a micro-incision into an eye.

The Young's modulus measurement method is characterized in that the elastic modulus of the iris of a human eye is about 3.0 to 10.0kPa, the tissues near the ciliary sulcus belong to human soft tissues, and the elastic modulus of the human soft tissues in the body is about 1.0MPa, so that the Young's modulus of the material is more than 10.0kPa, preferably 0.1 to 2.0MPa, more preferably 0.3 to 1.8MPa, and more preferably 0.5 to 1.5MPa. The material is beneficial to keeping the artificial lens 10 arched without collapsing and deforming and causing damage to intraocular tissues due to over hardness.

In addition to selecting a material with an appropriate modulus of elasticity, the shape and size design of intraocular lens 10 is also an important indicator of ensuring its stability in the eye after surgical implantation. Firstly, the thickness of the artificial lens 10 is an important index influencing the rigidity of the artificial lens, and under the condition of determining the elastic modulus, the larger the overall thickness is, the harder the artificial lens 10 is, and the less easily the artificial lens is deformed under pressure; conversely, the smaller the overall thickness, the thinner the intraocular lens 10, and the more susceptible it is to compressive deformation. Therefore, in designing the intraocular lens 10, on one hand, the entire lens is thin enough to leave enough room in the eye to prevent damage to the tissues in the eye, and on the other hand, the intraocular lens 10 is not too thin, and the overall consideration of the elastic modulus is combined to provide the intraocular lens 10 with a suitable stiffness.

In this embodiment, the overall thickness of intraocular lens 10 is measured by three key metrics: center thickness d4, haptic edge thickness d5, and thickness d6 at the thickest portion of intraocular lens 10 (typically at the edge of the optic of intraocular lens 10). The material selected for this embodiment, in addition to having a suitable modulus of elasticity and other mechanical properties, also has a higher refractive index than the prior art, and the resulting intraocular lens 10 can be made thinner.

Therefore, the center thickness d4 of the optical part 11 of the intraocular lens 10 is 0.05 to 0.25mm, preferably 0.05 to 0.20mm, and more preferably 0.08 to 0.18mm with the aid of the above materials. The thickness d5 of the edge of the support portion 12 is 0.05 to 0.25mm, preferably 0.05 to 0.20mm, and more preferably 0.08 to 0.18 mm. The thickness d6 of the thickest part of the intraocular lens 10 is 0.1 to 0.8mm, preferably 0.15 to 0.75mm, and more preferably 0.15 to 0.70 mm.

In addition, the long axis direction (length direction, up and down in fig. 3) dimension of the intraocular lens 10 matches the ciliary sulcus dimension, and when the lens is compressed, force tends to be transmitted from the long axis direction to the intraocular lens 10. While the major effect on the rigidity of the intraocular lens 10 is the length in the short axis direction, i.e., the width d3 of the crystal. The wider the width d3 of intraocular lens 10, the less likely it will deform under force. The intraocular lens 10 of the present embodiment has a width d3 of > 6.0mm, preferably 6.5 to 8.0mm, more preferably 6.5 to 7.5mm, and still more preferably 6.8 to 7.2 mm.

Through the structural design, when the artificial lens 10 is subjected to pressure not greater than 0.3g in the horizontal direction in a use state, the axial displacement does not exceed 0.2 mm; when the horizontal direction is subjected to pressure of not more than 0.2g, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm.

Wherein, the measurement of the use state refers to the measurement of the intraocular lens under the self-form during the actual use, and if the material of the intraocular lens is hydrophilic, the intraocular lens needs to be in a wet state after hydration. Axial refers to the direction perpendicular to the anterior surface of the optic of the intraocular lens (the surface that faces the cornea when implanted). The horizontal direction refers to the direction parallel to the anterior surface of the optic of the intraocular lens and in the measurement, to the horizontal direction through the edge of the supporting part of the intraocular lens.

[ examples ] A method for producing a compound

The present inventors have conducted experiments in accordance with the present invention to obtain examples 1 to 5 described below.

In these examples, several materials for intraocular lenses were made and various specifications of intraocular lenses were made from these materials.

First, the method for producing the material and the method for measuring the experimental results and the like in the examples will be briefly described.

1) Method for producing a material

The method of preparation of the material is relatively conventional and will be briefly described herein. All example materials were prepared in the following manner and all monomers were purified by distillation under reduced pressure. Acrylate monomers including, but not limited to, hydroxyethyl methacrylate (HEMA), Ethyl Acrylate (EA), Ethyl Methacrylate (EMA), 2-phenoxyethyl acrylate (POEA), Butyl Acrylate (BA), hydroxyethyl acrylate (HEA), phenylethyl acrylate (PEA), phenylethyl methacrylate (PEMA), Benzylethyl Methacrylate (BMA), ethoxyethyl methacrylate (EOEMA), ethoxyethoxyethyl acrylate (EOEA), and Ethylene Glycol Dimethacrylate (EGDMA), butylene glycol diacrylate (BDDA), etc., which are mixed in corresponding proportions, respectively, in a 250ml beaker, are added with an initiator and a light absorber, stirred well and filtered, and transferred to a custom made mold.

The various utensils and molds used in the above-described implementation process are cleaned, dried and sterilized before use. Introducing nitrogen into the monomer solution in the mold, sealing the mold under the protection of the nitrogen, putting the mold into a water bath with a set temperature for polymerization reaction for at least 24 hours, and transferring the mold into an oven with the set temperature for continuously keeping the temperature for 24 hours (note: the set temperature of the oven is higher than the set temperature of the water bath). And taking out the polymer formed in the mold, naturally cooling to room temperature, or cutting the polymer into blanks with required size and shape while the polymer is hot, extracting for at least 24 hours at a certain temperature by using an alcohol solvent to remove residual micromolecules, and finally drying the blanks at a set temperature in a vacuum drying oven overnight to obtain the material for manufacturing the artificial lens.

2) Measurement of refractive index

The method for measuring the refractive index of the material adopts a testing method well known by the technicians in the field, the material sheet is hydrated by normal saline, the material sheet is put into a constant temperature incubator with the temperature of 35 ℃ for balancing for 7 days, the material sheet is taken out and is quickly wiped to dry the surface moisture, and the Abbe refractometer is utilized to test the refractive index of the material in the hydration state. The Abbe refractometer is connected with a constant-temperature water bath, the temperature of the constant-temperature water bath is set to be 35 ℃ during testing, and the refractive index of the material is obtained by testing the material sheet after the temperature of the Abbe refractometer is balanced.

3) Measurement of mechanical Properties of materials (tensile breaking Strength and Young's modulus of elasticity of the materials after complete hydration)

The resulting material was hydrated in physiological saline at 35 ℃ for 7 days and, after complete hydration, the material was punched into a standard shape using a punch conforming to Type IV in the ATSMD638 table. The material is placed in a constant temperature water tank at 35 ℃, an electronic universal tensile testing machine is utilized to test the mechanical property of the material according to the standard requirement of ATSM, the tensile speed is selected to be 50mm/min, the tensile stress and strain data of the material are recorded, and the breaking strength and Young modulus of the material are calculated.

[ example 1 ]

A hydrophilic acrylate material is used, which has a refractive index of 1.502 and a water content of 8%. The material has a Young's modulus of elasticity of 1.25 MPa. The material is used for manufacturing the artificial lens, and specific design parameters are shown in table 1.

TABLE 1 intraocular lens design parameters

Wherein Ra is the curvature radius of the front surface of the crystal, and Rp is the curvature radius of the rear surface of the crystal.

The intraocular lenses with the specifications are prepared with 5 diopters, after full hydration, pressure with different magnitudes is applied to the intraocular lenses with the lenses in the horizontal direction and the axial direction respectively, the magnitude of the pressure is read by an electronic balance, the unit is gram (g), and table 2 shows the measured results, namely the axial displacement of the intraocular lenses under the condition of applying different pressures in the horizontal direction and the axial direction. As can be seen from Table 2, when the Young's modulus of the crystal material is 1.25MPa, the diameter is 11.5-14.2 mm, the width is 7.0mm, the total height of the crystal is 1.46-1.56 mm, the center thickness is 0.15mm, the edge thickness is 0.12mm, and the thickness of the thickest part of the crystal is 0.29-0.73 mm, the axial displacement is not more than 0.2mm when the crystal is stressed by not more than 0.3g in the horizontal direction; when the crystal is subjected to a pressure of not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm. It can be seen that the material stiffness is moderate.

TABLE 2 axial Displacement after pressure application to the intraocular lens

Magnitude of pressure/g	Direction of pressure	Axial displacement/mm
			[0.20,0.28]Average value of 0.24	Level of	≈0.2，≤0.2
[0.10,0.17]Average value of 0.15	Level of	≈0.1，≤0.1
			[0.16,0.29]Average value of 0.24	Axial direction	≈0.2，≤0.2
[0.09,0.16]Average value of 0.13	Axial direction	≈0.1，≤0.1

[ example 2 ]

A hydrophobic acrylate material is used, said material having a refractive index of 1.55. The material has a Young's modulus of elasticity of 2.0 MPa. The material is used for manufacturing artificial lenses with different specifications, and specific design parameters are shown in table 3.

TABLE 3 intraocular lens design parameters

The intraocular lenses with the specifications are respectively prepared into 5 intraocular lenses, after full hydration, the intraocular lenses with the specifications are respectively applied with different pressures in the horizontal direction and the axial direction, the pressures are read by an electronic balance and have the unit of gram (g), and the measured axial displacements of the intraocular lenses under the conditions of applying different pressures in the horizontal direction and the axial direction are shown in table 4. As can be seen from table 4, the elastic modulus of the crystal is relatively high, and although the center and the edge of the crystal are thinned and the width of the crystal is 6.5mm, the amount of deformation of the crystal is still small when the horizontal and axial direction is pressed by more than 0.30g, so that the crystal may be too hard compared with the iris and ciliary sulcus tissues, thereby damaging the intraocular tissues. When the thickness of the center and the edge of the crystal is 0.05mm, the proper mechanical property can be just achieved. This case can be regarded as the limit case of the elastic modulus.

TABLE 4 axial Displacement after pressure application to the intraocular lens

[ example 3 ]

A hydrophilic acrylate material is used, which 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. The material is used for manufacturing artificial lenses with different specifications, and specific design parameters are shown in table 5.

TABLE 5 intraocular lens design parameters

The intraocular lenses with the specifications are prepared into 5 intraocular lenses, after full hydration, the intraocular lenses with the specifications are respectively applied with different pressures in the horizontal direction and the axial direction, the pressures are read by an electronic balance and have the unit of gram (g), and the measured axial displacements of the intraocular lenses under the conditions of applying different pressures in the horizontal direction and the axial direction are shown in table 6. As can be seen from Table 6, when the Young's modulus of elasticity of the material of the crystal is 1.8MPa, the axial displacement does not exceed 0.2mm when the crystal is subjected to a pressure of not more than 0.3g in the horizontal direction; when the crystal is subjected to a pressure of not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm. It can be seen that the material stiffness is moderate.

TABLE 6 axial Displacement after pressure application to the intraocular lens

Magnitude of pressure/g	Direction of pressure	Axial displacement/mm
			[0.19,0.29]Average value of 0.26	Level of	≈0.2，≤0.2
[0.10,0.15]Average value of 0.13	Level of	≈0.1，≤0.1
			[0.16,0.29]Average value of 0.28	Axial direction	≈0.2，≤0.2
[0.09,0.18]Average value of 0.18	Axial direction	≈0.1，≤0.1

[ example 4 ]

A hydrophilic acrylate material is used, which 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. The material is used for manufacturing artificial lenses with different specifications, and specific design parameters are shown in a table 7.

TABLE 7 intraocular lens design parameters

The intraocular lenses with the same specification are respectively prepared into 5 intraocular lenses, after the intraocular lenses are fully hydrated, the intraocular lenses with the same specification are respectively applied with different pressures in the horizontal direction and the axial direction, the pressures are read by an electronic balance and have the unit of gram (g), and the axial displacement of the intraocular lenses under the condition of applying different pressures in the horizontal direction and the axial direction is shown in table 8. As can be seen from Table 8, when the Young's modulus of elasticity of the material of the crystal is 0.3MPa, the axial displacement does not exceed 0.2mm when the crystal is subjected to a pressure of not more than 0.3g in the horizontal direction; when the crystal is subjected to a pressure of not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm. It can be seen that the material stiffness is moderate.

TABLE 8 axial Displacement after pressure application to the intraocular lens

Magnitude of pressure/g	Direction of pressure	Axial displacement/mm
			[0.15,0.22]Average value of 0.20	Level of	≈0.2，≤0.2
[0.07,0.15]Average value of 0.10	Level of	≈0.1，≤0.1
			[0.16,0.23]Average value of 0.21	Axial direction	≈0.2，≤0.2
[0.05,0.13]Average value of 0.10	Axial direction	≈0.1，≤0.1

[ example 5 ]

A hydrophilic acrylate material is used, which has a refractive index of 1.45 and a water content of 20%. The material has a Young's modulus of elasticity of 0.1 MPa. The material is used for manufacturing artificial lenses with different specifications, and specific design parameters are shown in a table 9.

TABLE 9 intraocular lens design parameters

The intraocular lenses with the specifications are respectively prepared into 5 intraocular lenses, after full hydration, the intraocular lenses with the specifications are applied with pressures with different magnitudes in the horizontal direction and the axial direction respectively, the pressures are read by an electronic balance and have the unit of gram (g), and the axial displacement of the intraocular lenses under the condition of applying different pressures in the horizontal direction and the axial direction is measured in a table 10. As can be seen from Table 10, when the Young's modulus of the material of the crystal is 0.1MPa, although the whole crystal is thickened, when the thickness of the crystal is 0.18mm, the axial displacement exceeds 0.2mm when the crystal is subjected to a pressure of more than 0.2g in the horizontal direction; when subjected to a pressure greater than 0.2g in the axial direction, the axial deformation will exceed 0.2 mm. When the center of the crystal is thickened to 0.25mm, the object of the present invention can be barely achieved. Therefore, the elastic modulus of the intraocular lens material is too low, deformation is easy to occur when stress is applied, and the shape stability is not easy to maintain.

TABLE 10 axial Displacement after pressure application to the intraocular lens

[ example 6 ]

A hydrophilic acrylate material is used, which has a refractive index of 1.50 and a water content of 10%. The material has a Young's modulus of elasticity of 0.5 MPa. The material is used for manufacturing artificial lenses with different specifications, and specific design parameters are shown in a table 11.

TABLE 11 intraocular lens design parameters

The intraocular lenses with the specifications are respectively prepared into 5 intraocular lenses, after full hydration, the intraocular lenses with the specifications are applied with pressures with different magnitudes in the horizontal direction and the axial direction respectively, the pressures are read by an electronic balance and have the unit of gram (g), and the measured axial displacements of the intraocular lenses under the conditions of applying different pressures in the horizontal direction and the axial direction are shown in table 8. It can be seen that when the material Young's modulus of elasticity of the crystal is 0.5MPa, the axial displacement does not exceed 0.2mm when the crystal is subjected to a pressure of not more than 0.3g in the horizontal direction; when the crystal is subjected to a pressure of not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm. It can be seen that the material stiffness is moderate.

TABLE 12 axial Displacement after pressure application to the intraocular lens

Magnitude of pressure/g	Direction of pressure	Axial displacement/mm
			[0.15,0.22]Average value of 0.21	Level of	≈0.2，≤0.2
[0.07,0.14]Average value of 0.10	Level of	≈0.1，≤0.1
			[0.16,0.25]Average value of 0.23	Axial direction	≈0.2，≤0.2
[0.05,0.13]Average value of 0.12	Axial direction	≈0.1，≤0.1

[ example 7 ]

A hydrophilic acrylate material was used, which had a refractive index of 1.53 and a water content of 12%. The material has a Young's modulus of elasticity of 1.50 MPa. The material is used for manufacturing artificial lenses with different specifications, and specific design parameters are shown in a table 13.

TABLE 13 intraocular lens design parameters

The intraocular lenses with the same specification are respectively prepared into 5 intraocular lenses, after the intraocular lenses are fully hydrated, the intraocular lenses with the same specification are respectively applied with different pressures in the horizontal direction and the axial direction, the pressures are read by an electronic balance and have the unit of gram (g), and the axial displacement of the intraocular lenses under the condition of applying different pressures in the horizontal direction and the axial direction is shown in table 8. It can be seen that when the material Young's modulus of elasticity of the crystal is 1.50MPa, the axial displacement does not exceed 0.2mm when the crystal is subjected to a pressure of not more than 0.3g in the horizontal direction; when the crystal is subjected to a pressure of not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1 mm; when the axial direction is subjected to pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm. It can be seen that the material stiffness is moderate.

TABLE 14 axial Displacement after pressure application to the intraocular lens

Magnitude of pressure/g	Direction of pressure	Axial displacement/mm
			[0.15,0.20]Average value of 0.18	Level of	≈0.2，≤0.2
[0.07,0.15]Average value of 0.13	Level of	≈0.1，≤0.1
			[0.15,0.22]Average value of 0.20	Axial direction	≈0.2，≤0.2
[0.05,0.13]Average value of 0.12	Axial direction	≈0.1，≤0.1

As can be seen from the above examples, the center thickness of the optical portion of the intraocular lens for phakic eyes is preferably 0.05 to 0.25mm, more preferably 0.05 to 0.20mm, still more preferably 0.08 to 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.

The material of the intraocular lens with the lens is preferably 0.1 to 2.0MPa, more preferably 0.3 to 1.8MPa, and still more preferably 0.5 to 1.5MPa in elastic modulus.

Correspondingly, the central thickness of the optical part of the intraocular lens with the lens is 0.05-0.25 mm, preferably 0.05-0.20 mm, and more preferably 0.08-0.18 mm. The thickness of the edge 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 of the intraocular lens with the 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 > 6.0mm, preferably 6.5 to 8.0mm, more preferably 6.5 to 7.5mm, more preferably 6.8 to 7.2 mm.

In the embodiment, when the crystal is subjected to pressure not greater than 0.3g in the horizontal direction, the axial displacement is not greater than 0.2 mm; when the crystal is subjected to pressure not greater than 0.2g in the horizontal direction, the axial displacement is not greater than 0.1 mm; the axial deformation does not exceed 0.2mm under the axial pressure of not more than 0.3 g; the artificial lens is stressed by no more than 0.2g in the axial direction, the axial deformation is no more than 0.1mm, the rigidity of the material is moderate, and the artificial lens keeps better arch height stability when being subjected to ciliary sulcus extrusion force and iris pressure after being implanted and is not too hard to cause damage to intraocular tissues.

The materials and design parameters of the above-described embodiments are only exemplary, and more generally, the intraocular lens is made of a soft foldable material, such as silicone or an acrylic material. The material may be hydrophilic or hydrophobic, preferably with a water content of 5-15 wt%, preferably 6-13 wt%, more preferably 7-12 wt% at 35 ℃. The material has enough strength, can meet the folding, unfolding and pulling of the artificial lens in the using process, and has elongation at break (wet state) of more than 80 percent and breaking strength (wet state) of more than 1 MPa. The material has proper refractive power, and the refractive index is 1.46-1.55; preferably, the refractive index is 1.48 to 1.52. The material is beneficial to keeping the artificial lens arched, so that the artificial lens does not collapse or deform and is not too hard to cause damage to intraocular tissues. For example, there is a conventional material having an elastic modulus of about 0.2MPa, a water content of about 40% and a refractive index of about 1.44, and the material of the present embodiment can achieve the above-described technical effects and is superior in performance to the material.

The intraocular lens has a diopter ranging from +30D to-30D, preferably, from 0 to-30D, and more preferably, from 0 to-25D. In addition to diopters, the optical portion may be added with an astigmatic design, an aspherical design, an aberration design, a large depth of field design, a multifocal design, and the like. The center of the optical part can be provided with a central hole for promoting the circulation of aqueous humor. The diameter of the optical part is not less than 4.2mm, preferably not less than 4.5mm, and more preferably not less than 5.5 mm.

The artificial lens supporting part has a plate shape design such as a square shape, a rectangular shape and the like, or a hollow design with various sizes and shapes, or other shapes such as a butterfly shape and the like. If the design is plate-shaped, it can be provided with positioning holes or holes for promoting the circulation of aqueous humor. The diameter of the artificial lens is 11.0-15.0 mm, preferably 11.2-14.5 mm, and more preferably 11.5-14.2 mm. The total height is 1.0-2.0 mm, preferably 1.2-1.9 mm, and more preferably 1.3-1.6 mm.

The intraocular lens with lens of the present embodiment has a characteristic size and is made of a soft material with moderate rigidity, and under actual implantation conditions, the intraocular lens can resist pressure from the ciliary sulcus and iris to a certain extent, and in a use state, the change in vault height can be kept to be not more than 0.2mm, and more excellent deformation stability under compressive force can be kept, and the vault height stability of the intraocular lens under the condition of being not matched with the diameter of the ciliary sulcus or under intraocular stress can be improved, and the vault height change at early and late post-operation stages is small, so that the anticipation of vault height by a doctor can be improved, and the intraocular tissue damage can not be caused by being too hard, and the safety of the intraocular lens after implantation can be improved.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

In the above-described embodiment, the posterior chamber intraocular lens is described as an example, but the setting of the dimensional parameters and material parameters according to the present invention can be applied not only to the posterior chamber intraocular lens but also to other intraocular lenses with crystalline lenses.

Claims

1. A phakic intraocular lens, wherein the central optic thickness of the phakic intraocular lens is 0.05 to 0.25mm, preferably 0.05 to 0.20mm, more preferably 0.08 to 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.

2. A phakic intraocular lens according to claim 1, wherein the lens is made of a soft foldable material having an elastic modulus of greater than 10.0kPa, preferably 0.1 to 2.0MPa, more preferably 0.3 to 1.8MPa, more preferably 0.5 to 1.5MPa.

3. A phakic intraocular lens according to claim 1 wherein when subjected to a pressure of no more than 0.3g in the horizontal direction, the axial displacement is no more than 0.2 mm; when the axial direction is subjected to a pressure of not more than 0.3g, the axial deformation is not more than 0.2 mm.

4. A phakic intraocular lens according to claim 1 wherein when subjected to a pressure of no more than 0.2g in the horizontal direction, the axial displacement is no more than 0.1 mm; when the axial direction is subjected to a pressure of not more than 0.2g, the axial deformation is not more than 0.1 mm.

5. A phakic intraocular lens according to claim 2 wherein the material has an elongation at break in the wet state of > 80%.

6. A phakic intraocular lens according to claim 2 wherein the material has a break strength in the wet state >1 MPa.

7. A phakic intraocular lens according to claim 2, wherein the material has a water content of 5-20 wt%, preferably 6-15 wt%, more preferably 7-12 wt% at 35 ℃.

8. A phakic intraocular lens according to claim 2 wherein the material has a refractive index of 1.46 to 1.55; preferably, the refractive index is 1.48 to 1.52.

9. A phakic intraocular lens according to any one of claims 1 to 8, wherein the total height in a natural non-compressed state is between 1.0 and 2.0mm, preferably between 1.2 and 1.9mm, more preferably between 1.3 and 1.6 mm.

10. A phakic intraocular lens according to any one of claims 1 to 8, wherein the optic diameter is not less than 4.2mm, preferably not less than 4.5mm, more preferably not less than 5.5 mm.

11. A phakic intraocular lens according to any one of claims 1 to 8, wherein the diameter is between 11.0 and 15.0mm, preferably 11.2 and 14.5mm, more preferably 11.5 and 14.2 mm.

12. A crystalline ocular intraocular lens according to any one of claims 1 to 8, characterized in that it has a width of more than 6.0mm, preferably 6.5 to 8.0mm, more preferably 6.5 to 7.5mm, more preferably 6.8 to 7.2 mm.

13. A phakic intraocular lens according to any one of claims 1 to 8, wherein the phakic intraocular lens is of the posterior chamber type with the support portion supported in the ciliary sulcus of the human eye.