WO2021185271A1

WO2021185271A1 - Phakic intraocular lens

Info

Publication number: WO2021185271A1
Application number: PCT/CN2021/081265
Authority: WO
Inventors: 解江冰; 王曌; 隋信策
Original assignee: 爱博诺德(北京)医疗科技股份有限公司
Priority date: 2020-03-17
Filing date: 2021-03-17
Publication date: 2021-09-23
Also published as: CN111358594A

Abstract

Disclosed is a phakic intraocular lens capable of maintaining a stable arch height in an eye. The phakic intraocular lens has the following structure: the central thickness (d4) of an 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 (d5) of a support part is 0.05-0.25 mm, preferably 0.05-0.20 mm, and more preferably 0.08-0.18 mm; and the thickness (d6) of the thickest part is 0.1-0.8 mm, preferably 0.15-0.75 mm, and more preferably 0.15-0.70 mm. By means of such a special size design, the phakic intraocular lens can maintain a stable arch height without collapse and deformation, and without damage to intraocular tissue caused by over-hardness.

Description

Phakic intraocular lens

Technical field

The invention relates to a phakic intraocular lens.

Background technique

Phakic intraocular lenses (PIOL) are classified according to the placement and fixation methods, including anterior chamber angle support type phakic intraocular lenses, iris fixed type phakic intraocular lenses and posterior chamber type phakic intraocular lenses.

As a posterior chamber type phakic intraocular lens, as shown in Figures 1 and 2, it is composed of an optical part and a supporting part. It is implanted between the natural lens 23 and the iris 22, and its supporting part (support loop) is supported on the ciliary In the ditch 24. By implanting the posterior chamber type phakic intraocular lens 10, the refractive state of the human eye can be changed.

After the posterior chamber type phakic intraocular lens 10 is implanted, a sufficient distance is maintained between the corneal endothelium 21a of the cornea 21 and the natural lens 23 to prevent the posterior chamber type phakic intraocular lens 10 from the corneal endothelium 21a and/or the natural lens 23 The contact causes damage to the corneal endothelium 21a and/or opacity of the natural lens 23. Since the space between the iris 22 and the natural lens 23 is very limited, there are strict requirements on the size of the posterior chamber type phakic intraocular lens 10 and the stability after implantation, as follows:

1) The distance between the posterior chamber phakic intraocular lens 10 and the natural lens 23 should be sufficient to prevent the two lenses from contacting each other and cause contact cataracts. This requires the posterior chamber phakic intraocular lens 10 to have sufficient dome height A (figure 2);

2) The distance between the posterior chamber phakic intraocular lens 10 and the corneal endothelium 21a must be sufficient to prevent contact and cause damage to the corneal endothelium 21a. This requires that the dome height A of the posterior chamber phakic intraocular lens 10 should not 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 stuck 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 be arched. Although it is far away from the natural lens 23, it is close to the corneal endothelium 21a, which is easy to cause the corneal endothelium 21a. Injury, and the angle B (Figure 2) is compressed, it is easy to cause the angle B to close, causing complications such as glaucoma; and if the posterior chamber type phakic intraocular lens 10 is too short compared with the ciliary sulcus 24, it is easy to cause posterior The supporting force of the phakic intraocular lens 10 is insufficient, and it comes into contact with the natural lens 23 under the pressure of the iris 22, causing cataracts.

4) Angle B: Referring to Fig. 2, as the posterior chamber type phakic intraocular lens 10 is implanted, the human iris 22 is affected by the shape of the posterior chamber type phakic intraocular lens 10 and is slightly arched, which will make the human eye chamber Angle B becomes smaller. If the angle B is closed, it will cause complications such as closed angle high intraocular pressure and glaucoma. Therefore, the posterior chamber type phakic intraocular lens 10 should be designed to minimize the impact on the angle B, so as to set aside more for the human eye. Big corner B.

To sum up, in order to ensure the safety and effectiveness of the posterior chamber phakic intraocular lens implantation, it is necessary to ensure that as many posterior chamber phakic intraocular lenses as possible are separated from the natural lens and the corneal endothelium as much as possible. Corner. In order to achieve the above goals, the design of posterior chamber intraocular lenses must be comprehensively measured in terms of optical zone diameter, shape, lens riding height, and dome height. The existing posterior chamber phakic intraocular lenses generally have a riding distance of 1.1 to 2.0 mm. Straddle height to avoid excessively high arching after implantation, resulting in too small angles, or contact with natural lens due to low arch heights. At the same time, various methods are used to obtain a larger posterior chamber with lens when the arch height is determined. The gap between the intraocular lens and the natural lens, such as CN108078652A, uses a high-refractive-index material and double-concave shape to obtain a more stable arch height and a larger lens gap.

The support part (support loop) of the posterior chamber intraocular lens is supported in the ciliary sulcus of the human eye. In theory, the doctor will choose 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 is the same as the ciliary sulcus. The groove diameter is exactly matched, so that the intraocular lens can be fixed without deformation.

However, after the actual surgical implantation of the intraocular lens, it is not always in an ideal state. First of all, the human ciliary sulcus is a quantity that varies from person to person. The length of the ciliary sulcus is different for each person. The total diameter of the existing posterior chamber type phakic intraocular lens products is limited. The groove length can be customized.

Secondly, the current existing technical methods cannot accurately measure the actual length of the ciliary sulcus. Generally, the length of the ciliary sulcus is estimated by the length of white-to-white, or the length of the ciliary sulcus is measured by UBM. Clinical results show that the results of these two detection methods are not accurate, which affects the accuracy of selecting the size of the intraocular lens.

Third, after the posterior chamber phakic intraocular lens is implanted in the human eye, the iris is lightly placed on the front surface of the intraocular lens, which produces a certain axial pressure on the intraocular lens; on the other hand, the ciliary sulcus tissue has a certain level of support for the intraocular lens Directional compression force, these two forces are constantly changing under the human eye adjustment mechanism, including the ciliary muscle will relax or tighten as the human eye sees far, near, and the iris will follow the human eye under the condition of photopic or dark vision. Zoom in or zoom out and tighten and relax accordingly. These changes will constantly change the diameter matching of the intraocular lens in the eye.

Therefore, under the actual implantation conditions of the intraocular lens, in many cases, the total length of the lens cannot exactly match the ciliary sulcus, and it is in constant dynamic changes. The gap affects the safety of intraocular lens implantation.

In addition, the existing phakic intraocular lens (PIOL), whether it is an anterior chamber angle support type, an iris fixation type or a posterior chamber type, generally uses the materials conventionally used in aphakic intraocular lens (IOL), including PMMA and silica gel. , Hydrophilic acrylate (generally moisture content> 20%), hydrophobic acrylate (generally moisture content <2%). Among them, a material that occupies an absolute position in the market has a high moisture content, a low elastic modulus, and a low refractive index. Currently, there is no suitable material designed and developed for the characteristics and structural parameters of phakic intraocular lenses.

If the posterior chamber phakic intraocular lens is made of a soft material, it will always be under pressure from 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. Statistics of long-term clinical results show that the phakic intraocular lens deforms under long-term intraocular stress, and the distance between the intraocular lens and the natural lens (the dome height) will gradually decrease.

Data shows that the arch height of the existing phakic intraocular lens at the initial implantation and the arch height after implantation is as small as tens of microns, and the arch height is higher than 200 microns and above, while the ideal after implantation of the intraocular lens The arch height should be around 500 microns. The range of changes in the arch height before and after is sufficient to bring potential safety hazards. Therefore, this phenomenon also brings great troubles to doctors' prediction of the arch height and postoperative safety of patients.

Summary of the invention

In view of this, the object of the present invention is to provide a phakic intraocular lens that can maintain a stable arch height in the eye.

In order 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 to 0.25 mm, preferably, 0.05 to 0.20 mm, more preferably, 0.08 to 0.18 mm; the edge thickness of the support portion is 0.05-0.25mm, preferably, 0.05-0.20mm, more preferably, 0.08-0.18mm; the thickness of the thickest part is 0.1-0.8mm, preferably, 0.15-0.75mm, more preferably , 0.15～0.70mm.

With the above structure, as explained in the embodiments described later, through the above-mentioned special size design, the crystalline intraocular lens of the present invention can maintain a stable arch height. It can keep the intraocular lens arched high, will not collapse and deform, and will not be too hard to cause intraocular tissue damage.

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

With the above structure, through such setting of elastic modulus, the stability of the arch height of the intraocular lens is more reliably ensured.

Preferably, the axial displacement does not exceed 0.2mm when the pressure is not more than 0.3g in the horizontal direction; the axial deformation does not exceed 0.2mm when the pressure is not more than 0.3g in the axial direction.

Preferably, in the present invention, when the pressure is not more than 0.2g in the horizontal direction, the axial displacement is not more than 0.1mm; when the pressure in the axial direction is not more than 0.2g, the axial deformation is not more than 0.1mm.

The material may have an elongation at break in a wet state> 80%.

The material may have a breaking strength in a wet state> 1 MPa.

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

The material may have a refractive index of 1.46 to 1.55; preferably, a refractive index of 1.48 to 1.52.

In the natural uncompressed state of the phakic intraocular lens of the present invention, the total height can be between 1.0 and 2.0 mm, preferably between 1.2 and 1.9 mm, more preferably between 1.3 and 1.6 mm.

In the present invention, preferably, 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.

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

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

The present invention is particularly suitable for the posterior chamber type phakic intraocular lens in which the support part is supported in the ciliary sulcus of the human eye.

The phakic intraocular lens of the present application has a specially designed size and is made of a moderately rigid soft material, which can maintain better deformation stability under compression. Compared with the existing products, the intraocular lens material has a higher elastic modulus. When the intraocular lens is compressed by the front side 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 easy to collapse Deformation; when the length of the intraocular lens is longer than the ciliary sulcus, it is not easy to deform and arch under the condition of moderate compression of the ciliary sulcus to avoid affecting the angle of the chamber; at the same time, the elastic modulus of the material is not too high to avoid being artificial When the lens diameter exceeds the ciliary sulcus too much, the lens is too rigid and does not deform at all, which will damage the human eye tissue.

Through the above phakic intraocular lens size design, including the selection of key parameters such as thickness, diameter, arch height, etc., combined with suitable elastic modulus materials, when the intraocular lens is in use, when the horizontal direction of the lens is not more than When the pressure is 0.3g, the axial displacement does not exceed 0.2mm; when the horizontal direction of the crystal is not more than 0.2g pressure, the axial displacement does not exceed 0.1mm; when the axial pressure is not more than 0.3g, the axial deformation does not exceed 0.2 mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm.

Therefore, the intraocular lens has moderate rigidity. After the intraocular lens is implanted, it maintains better arch height stability when facing the ciliary sulcus compression force and iris pressure, and it is not too hard to cause intraocular tissue damage. In addition, 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 keeping the distance between the intraocular lens and other tissues in the eye.

Description of the drawings

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

Figure 2 is an explanatory diagram of the changes in the gap and the angle of the chamber after the posterior chamber type phakic intraocular lens is implanted;

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

Description of Reference Signs

10 Posterior chamber type 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 dome of intraocular lens Height (arch height); B chamber angle; d1 diameter of the optical part; d2 diameter of the intraocular lens (maximum diameter); d3 width of the intraocular lens; d4 central thickness of the optical part of the intraocular lens; d5 support edge thickness; d6 artificial lens The thickness of the thickest part of the lens; h the total height of the intraocular lens.

Detailed ways

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

First, the structure of the posterior chamber type phakic intraocular lens is briefly explained.

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

The optical part 11 has a lens function and can provide a refractive power of +30D to -30D, preferably 0 to -30D, and more preferably 0 to -25D. In addition to the diopter, the optical section 11 may be added with an astigmatism design, an aspheric design, aberration design, a large depth of field design, a multi-focus design, and the like. A central hole 14 can be formed through the center of the optical part 11 to promote the circulation of aqueous humor. The diameter d1 of the optical portion 11 is not less than 4.2 mm, preferably, not less than 4.5 mm, and more preferably, not less than 5.5 mm.

The supporting part 12 is located on the outer periphery of the optical part 11, and can be a square, rectangular, or other plate-shaped design, or a hollow design with various sizes and shapes, or a butterfly-shaped or other shape, and is used to fix the intraocular lens 10 to the human eye In the ciliary sulcus. In this embodiment, it is a rectangular plate-shaped design with positioning holes 13, or may also have holes for promoting the circulation of aqueous humor. The longest part of the intraocular lens 10 where the supporting part 12 and the optical part 11 are combined 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.

Under the premise of the above structure, when the intraocular lens 10 is implanted and maintains a theoretical matching state with the ciliary sulcus, the human eye will have a suitable chamber angle (>10°) and dome height (≈500 microns).

The intraocular lens 10 is made of a soft foldable material, such as silica gel or acrylic material. The material can be hydrophilic or hydrophobic. Preferably, it has a certain water content. The water content of the material at 35°C is 5-20wt%, preferably 6-15wt%, more preferably 7- 12wt%. The material must have sufficient strength to meet the folding, unfolding and pulling of the intraocular lens during use, its breaking elongation (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, a refractive index of 1.48 to 1.52.

The material should have moderate rigidity and can maintain better deformation stability under compressive force. The elastic modulus of the intraocular lens material is higher than that of the human iris. When the intraocular lens is compressed by the front side 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 easy to collapse and deform; The elastic modulus of the material should be close to that of the human ciliary muscle. When the length of the intraocular lens is longer than the ciliary sulcus, it is not easy to deform and arch under the condition of moderate compression by the ciliary sulcus to avoid affecting the angle of the chamber; At the same time, the elastic modulus of the material is not too high, so that when the diameter of the intraocular lens exceeds the ciliary sulcus too much, the rigidity of the lens is too large and does not deform at all, thereby damaging the human eye tissue. In addition, a too high elastic modulus is not conducive to the implantation of the folded intraocular lens into the eye through a micro incision.

Under the Young’s modulus measurement method, the elastic modulus of the human iris is about 3.0～10.0kPa, the tissue near the ciliary sulcus belongs to the soft tissue of the human body, and the elastic modulus of the human soft tissue is about 1.0MPa. The modulus of elasticity should be greater than 10.0 kPa, preferably 0.1 to 2.0 MPa, more preferably 0.3 to 1.8 MPa, more preferably 0.5 to 1.5 MPa. The above-mentioned materials can help keep the intraocular lens 10 arched high, and will not collapse and deform, and will not be too hard to cause damage to the intraocular tissue.

In addition to selecting materials with a suitable elastic modulus, the shape and size design of the intraocular lens 10 is also an important index to ensure its intraocular stability after surgical implantation. First, the thickness of the intraocular lens 10 is an important indicator that affects its rigidity. When the elastic modulus is determined, the larger the overall thickness, the harder the intraocular lens 10 will be The thinner the lens 10 is, the easier it is to deform under pressure. Therefore, in the design of the intraocular lens 10, on the one hand, the lens should be sufficiently thin as a whole, leaving enough space in the eye to prevent damage to the intraocular tissues. On the other hand, the intraocular lens 10 should not be too thin, and the elastic modulus Based on comprehensive considerations, the intraocular lens 10 has an appropriate rigidity.

In this embodiment, the overall thickness of the intraocular lens 10 is measured by three key indicators: the central thickness d4, the edge thickness of the support portion d5, and the thickest part thickness d6 of the intraocular lens 10 (generally located at the edge of the optical portion of the intraocular lens 10). The material selected in this embodiment not only has a suitable elastic modulus and other mechanical performance indicators, but also has a higher refractive index than the prior art, and the manufactured intraocular lens 10 can be thinner.

Therefore, with the support of the aforementioned materials, the central thickness d4 of the optical portion 11 of the intraocular lens 10 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 d5 of the edge of the support portion 12 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 d6 of the thickest part of the intraocular lens 10 is 0.1 to 0.8 mm, preferably 0.15 to 0.75 mm, more preferably 0.15 to 0.70 mm.

In addition, the size of the long axis direction of the intraocular lens 10 (longitudinal direction, the up-down direction in FIG. 3) matches the size of the ciliary sulcus. When the lens is compressed, force is often transmitted to the intraocular lens 10 from the long axis direction. The length in the minor axis direction, that is, the width d3 of the lens, has a greater effect on the rigidity of the intraocular lens 10. 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> 6.0 mm, preferably, 6.5-8.0 mm, more preferably 6.5-7.5 mm, more preferably 6.8-7.2 mm.

Through the above-mentioned structural design, when the intraocular lens 10 is in use, when the horizontal direction is not more than 0.3g pressure, the axial displacement does not exceed 0.2mm; when the horizontal direction is not more than 0.2g pressure, the axial displacement is not More than 0.1mm; when the axial pressure is not more than 0.3g, the axial deformation does not exceed 0.2mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm.

Among them, the use state measurement refers to the measurement of the intraocular lens in its own shape during actual use. If the intraocular lens material is a hydrophilic material, the intraocular lens must be in a 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 when implanted). The horizontal direction refers to the direction parallel to the front surface of the optical portion of the intraocular lens, and in the measurement, refers to the horizontal direction passing through the edge of the intraocular lens support portion.

[Examples]

The inventors of the present invention have implemented the scheme of the present invention and obtained the following Examples 1-5.

In these examples, several materials used in intraocular lenses were fabricated, and intraocular lenses of various specifications were fabricated using these materials.

First, the method of preparing the materials involved in these examples and the method of measuring experimental results will be briefly described below.

1) Preparation method of materials

The preparation method of the material is a relatively conventional method, which is briefly explained here. All the materials of the examples were prepared in the following manner, and all the monomers were purified by distillation under reduced pressure. In a 250ml beaker, mix the acrylate monomers in the corresponding proportions, including but not limited to hydroxyethyl methacrylate (HEMA), ethyl acrylate (EA), ethyl methacrylate (EMA), acrylic acid- 2-phenoxyethyl (POEA), butyl acrylate (BA), hydroxyethyl acrylate (HEA), phenylethyl acrylate (PEA), phenylethyl methacrylate (PEMA), benzyl methacrylate Ethyl ethyl (BMA), ethoxy ethyl methacrylate (EOEMA), ethoxy ethoxy ethyl acrylate (EOEOEA) and ethylene glycol dimethacrylate (EGDMA), butanediol diacrylate (BDDA), etc., and add initiator and light absorber, stir well, filter, and transfer to a special mold.

The various utensils and molds used in the above implementation process must be cleaned, dried and disinfected before use. Blow nitrogen into the monomer solution in the mold, and seal the mold under the protection of nitrogen, then put the mold in a water bath at a set temperature for polymerization for at least 24 hours, and then transfer the mold to the oven at the set temperature Continue to keep warm for 24 hours (Note: the set temperature of the oven should be higher than the set temperature of the water bath). Take out the polymer molded in the mold and cool it to room temperature naturally, or cut it into blanks of the desired size and shape while it is hot, and extract them with alcohol solvents at a certain temperature for at least 24 hours to remove residual small molecules, and finally The blank is placed in a vacuum drying oven at a set temperature and dried overnight to obtain the material for manufacturing the intraocular lens.

2) Measurement of refractive index

The measurement method of the refractive index of the material adopts a test method well known to those skilled in the art. The material piece is hydrated with physiological saline, put in a constant temperature incubator at 35°C for 7 days, taken out and quickly wiped off the surface moisture, using an Abbe refractometer Test the refractive index of the hydrated state of the material. The Abbe refractometer is connected to a constant temperature water bath, the temperature of the constant temperature water bath is set to 35°C during the test, and the material sheet is tested to obtain the refractive index of the material after the temperature of the Abbe refractometer is balanced.

3) Measurement of material mechanical properties (tensile fracture strength and Young's modulus of elasticity of the material after fully hydrated)

The obtained material was hydrated in physiological saline at 35°C for 7 days. After being completely hydrated, the material was punched into a standard shape with a punch that complies with Type IV in the ATSM D638 table. Put the material in a constant temperature water tank at 35℃ and use the electronic universal tensile testing machine to test the mechanical properties of the material in accordance with ATSM standard requirements. The tensile speed is 50mm/min, the tensile stress and strain data of the material are recorded, and the material breaking strength and strength are calculated. Young's modulus of elasticity.

[Example 1]

A hydrophilic acrylate material is used, which has a refractive index of 1.502 and a moisture content of 8%. The material has a Young's modulus of 1.25 MPa. Using this material to make intraocular lenses, the specific design parameters are shown in Table 1.

Table 1 Design parameters of intraocular lens

Among them, Ra is the radius of curvature of the front surface of the crystal, and Rp is the radius of curvature of the back surface of the crystal.

The above specifications have phakic intraocular lenses, each of which has 5 diopters. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance. The unit is Gram (g), Table 2 shows the measured results, that is, the axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen from Table 2 that when the Young’s modulus of the crystal material is 1.25MPa, the diameter is 11.5~14.2mm, the width is 7.0mm, the total height of the crystal is 1.46~1.56mm, the center thickness is 0.15mm, the edge thickness is 0.12mm, and the thickest part of the crystal When the thickness is 0.29～0.73mm, when the horizontal direction of the crystal is not more than 0.3g pressure, the axial displacement does not exceed 0.2mm; when the horizontal direction of the crystal is not more than 0.2g pressure, the axial displacement does not exceed 0.1mm; When the pressure is not more than 0.3g, the axial deformation does not exceed 0.2mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm. It can be seen that the stiffness of the material is moderate.

Table 2 Axial displacement after applying pressure to the intraocular lens

压力大小/gPressure/g	压力方向Direction of pressure	轴向位移/mmAxial displacement/mm
[0.20,0.28]，平均值0.24[0.20,0.28], average 0.24	水平level	≈0.2，≤0.2≈0.2, ≤0.2
[0.10,0.17]，平均值0.15[0.10,0.17], average 0.15	水平level	≈0.1，≤0.1≈0.1, ≤0.1
[0.16,0.29]，平均值0.24[0.16,0.29], average 0.24	轴向Axial	≈0.2，≤0.2≈0.2, ≤0.2
[0.09,0.16]，平均值0.13[0.09,0.16], average 0.13	轴向Axial	≈0.1，≤0.1≈0.1, ≤0.1

[Example 2]

A hydrophobic acrylate material is used, which has a refractive index of 1.55. The material has a Young's modulus of 2.0 MPa. The material is used to make intraocular lenses of different specifications, and the specific design parameters are shown in Table 3.

Table 3 Design parameters of intraocular lens

There are 5 phakic intraocular lenses of the above specifications. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance, and the unit is grams (g ), Table 4 shows the measured axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen from Table 4 that the elastic modulus of the crystal is relatively high at this time. Although the center and edge of the crystal have been thinned, the width of the crystal has also been 6.5mm, but when the horizontal and axial pressure is greater than 0.30g , The amount of lens deformation is still small, so compared to the iris and ciliary sulcus tissue, it may be too hard and there is a risk of damaging the intraocular tissue. When the center and edge of the crystal reach the machining limit of 0.05mm thickness, the proper mechanical performance can just be achieved. This situation can be regarded as the limit of the elastic modulus.

Table 4 Axial displacement after applying pressure to the intraocular lens

[Example 3]

A hydrophilic acrylate material is used, which has a refractive index of 1.52 and a moisture content of 5%. The material has a Young's modulus of 1.8Mpa. Use this material to make intraocular lenses of different specifications, and the specific design parameters are shown in Table 5.

Table 5 Design parameters of intraocular lens

There are 5 phakic intraocular lenses of the above specifications. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance, and the unit is grams (g ), Table 6 shows the measured axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen from Table 6 that when the Young's elastic modulus of the crystal material is 1.8MPa, when the horizontal direction of the crystal is not more than 0.3g pressure, the axial displacement does not exceed 0.2mm; when the horizontal direction of the crystal is not more than 0.2g pressure , The axial displacement does not exceed 0.1mm; when the axial pressure is not more than 0.3g, the axial deformation does not exceed 0.2mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm. It can be seen that the rigidity of the material is moderate.

Table 6 Axial displacement after applying pressure to the intraocular lens

压力大小/gPressure/g	压力方向Direction of pressure	轴向位移/mmAxial displacement/mm
[0.19,0.29]，平均值0.26[0.19,0.29], average 0.26	水平level	≈0.2，≤0.2≈0.2, ≤0.2

[0.10,0.15]，平均值0.13[0.10,0.15], average value 0.13	水平level	≈0.1，≤0.1≈0.1, ≤0.1
[0.16,0.29]，平均值0.28[0.16,0.29], average 0.28	轴向Axial	≈0.2，≤0.2≈0.2, ≤0.2
[0.09,0.18]，平均值0.18[0.09,0.18], average 0.18	轴向Axial	≈0.1，≤0.1≈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 0.3 MPa. Use this material to make intraocular lenses of different specifications. The specific design parameters are shown in Table 7.

Table 7 Design parameters of intraocular lens

There are 5 phakic intraocular lenses of the above specifications. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance, and the unit is grams (g ), Table 8 shows the axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen from Table 8 that when the Young's elastic modulus of the crystal material is 0.3MPa, when the horizontal direction of the crystal is not more than 0.3g pressure, the axial displacement does not exceed 0.2mm; when the horizontal direction of the crystal is not more than 0.2g pressure , The axial displacement does not exceed 0.1mm; when the axial pressure is not more than 0.3g, the axial deformation does not exceed 0.2mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm. It can be seen that the rigidity of the material is moderate.

Table 8 Axial displacement after applying pressure to the intraocular lens

压力大小/gPressure/g	压力方向Direction of pressure	轴向位移/mmAxial displacement/mm
[0.15,0.22]，平均值0.20[0.15, 0.22], average 0.20	水平level	≈0.2，≤0.2≈0.2, ≤0.2
[0.07,0.15]，平均值0.10[0.07,0.15], average value 0.10	水平level	≈0.1，≤0.1≈0.1, ≤0.1
[0.16,0.23]，平均值0.21[0.16,0.23], average 0.21	轴向Axial	≈0.2，≤0.2≈0.2, ≤0.2
[0.05,0.13]，平均值0.10[0.05,0.13], average value 0.10	轴向Axial	≈0.1，≤0.1≈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 0.1Mpa. Use this material to make intraocular lenses of different specifications, and the specific design parameters are shown in Table 9.

Table 9 Design parameters of intraocular lens

Crystallinity

Ra/mm

Rp/mm

Optical zone straight

Center thickness

Crystal straight

Crystal width

Total crystal height

Crystal edge

The thickest part of the crystal

数/DNumber/D	To	To	径/mmDiameter/mm	度/mmDegree/mm	径/mmDiameter/mm	度/mmDegree/mm	度/mmDegree/mm	厚度/mmThickness/mm	厚度/mmThickness/mm
-10.0D-10.0D	平flat	11.411.4	5.05.0	0.180.18	12.712.7	7.57.5	1.901.90	0.180.18	0.460.46
-10.0D-10.0D	平flat	11.411.4	5.05.0	0.250.25	12.712.7	7.57.5	1.901.90	0.250.25	0.530.53

The above specifications of phakic intraocular lenses are made of 5 each. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance, and the unit is gram (g ), Table 10 shows the measured 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 crystal material is 0.1MPa, although the crystal as a whole is thickened, when the crystal thickness is 0.18mm, when the crystal is subjected to a pressure greater than 0.2g in the horizontal direction, the axial direction The displacement will exceed 0.2mm; when the axial pressure is greater than 0.2g, the axial deformation will exceed 0.2mm. When the crystal center is thickened to 0.25 mm, the objective of the present invention can barely be achieved. It can be seen that at this time, the elastic modulus of the intraocular lens material is too low, and it is easy to deform when subjected to force, and it is difficult to maintain the stability of the shape.

Table 10 Axial displacement after applying pressure 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 0.5 MPa. Use this material to make intraocular lenses of different specifications, and the specific design parameters are shown in Table 11.

Table 11 Design parameters of intraocular lens

The above specifications of phakic intraocular lenses are made of 5 each. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance, and the unit is gram (g ), Table 8 shows the measured axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen that when the Young's elastic modulus of the crystal material is 0.5MPa, when the horizontal direction of the crystal is not more than 0.3g pressure, the axial displacement does not exceed 0.2mm; when the horizontal direction of the crystal is not more than 0.2g pressure, the axial displacement The displacement does not exceed 0.1mm; when the axial pressure is not more than 0.3g, the axial deformation does not exceed 0.2mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm. It can be seen that the stiffness of the material is moderate.

Table 12 Axial displacement after applying pressure to the intraocular lens

压力大小/gPressure/g	压力方向Direction of pressure	轴向位移/mmAxial displacement/mm
[0.15,0.22]，平均值0.21[0.15, 0.22], average 0.21	水平level	≈0.2，≤0.2≈0.2, ≤0.2
[0.07,0.14]，平均值0.10[0.07,0.14], average value 0.10	水平level	≈0.1，≤0.1≈0.1, ≤0.1
[0.16,0.25]，平均值0.23[0.16,0.25], average 0.23	轴向Axial	≈0.2，≤0.2≈0.2, ≤0.2
[0.05,0.13]，平均值0.12[0.05,0.13], average value 0.12	轴向Axial	≈0.1，≤0.1≈0.1, ≤0.1

[Example 7]

A hydrophilic acrylate material is used, which has a refractive index of 1.53 and a water content of 12%. The material has a Young's modulus of 1.50 MPa. Use this material to make intraocular lenses of different specifications, and the specific design parameters are shown in Table 13.

Table 13 Design parameters of intraocular lens

There are 5 phakic intraocular lenses of the above specifications. After being fully hydrated, different pressures are applied to the phakic intraocular lenses in the horizontal and axial directions. The pressure is read by an electronic balance, and the unit is grams (g ), Table 8 shows the axial displacement of the intraocular lens under different pressures applied in the horizontal and axial directions. It can be seen that when the Young’s elastic modulus of the crystal material is 1.50MPa, when the horizontal direction of the crystal is not more than 0.3g pressure, the axial displacement does not exceed 0.2mm; when the horizontal direction of the crystal is not more than 0.2g pressure, the axial displacement The displacement does not exceed 0.1mm; when the axial pressure is not more than 0.3g, the axial deformation does not exceed 0.2mm; when the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm. It can be seen that the stiffness of the material is moderate.

Table 14 Axial displacement after applying pressure to the intraocular lens

压力大小/gPressure/g	压力方向Direction of pressure	轴向位移/mmAxial displacement/mm
[0.15,0.20]，平均值0.18[0.15, 0.20], average 0.18	水平level	≈0.2，≤0.2≈0.2, ≤0.2
[0.07,0.15]，平均值0.13[0.07,0.15], average 0.13	水平level	≈0.1，≤0.1≈0.1, ≤0.1
[0.15,0.22]，平均值0.20[0.15, 0.22], average 0.20	轴向Axial	≈0.2，≤0.2≈0.2, ≤0.2
[0.05,0.13]，平均值0.12[0.05,0.13], average value 0.12	轴向Axial	≈0.1，≤0.1≈0.1, ≤0.1

It can be seen from the above examples that the appropriate central thickness of the optical part of the phakic intraocular lens is 0.05 to 0.25 mm, preferably 0.05 to 0.20 mm, 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, 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, more preferably, 0.15 to 0.70 mm.

The suitable elastic modulus of the material of phakic intraocular lens should be 0.1～2.0MPa, more preferably, 0.3～1.8MPa, more preferably, 0.5～1.5MPa.

Correspondingly, the central thickness of the optical part of the phakic intraocular 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 portion 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 of the phakic intraocular lens is 0.1 to 0.8 mm, preferably 0.15 to 0.75 mm, more preferably 0.15 to 0.70 mm. The phakic intraocular lens has a lens width> 6.0 mm, preferably, 6.5-8.0 mm, more preferably 6.5-7.5 mm, more preferably 6.8-7.2 mm.

In this embodiment, when the crystal is subjected to a pressure of no more than 0.3g in the horizontal direction, the axial displacement is no more than 0.2mm; when the crystal is subjected to a pressure of no more than 0.2g in the horizontal direction, the axial displacement is no more than 0.1mm; when the crystal is subjected to no more than 0.3 in the axial direction. g pressure, the axial deformation does not exceed 0.2mm; the axial pressure is not more than 0.2g, the axial deformation does not exceed 0.1mm, the material stiffness is moderate, after the intraocular lens is implanted, it faces the ciliary sulcus compression force and iris pressure At the same time, it maintains better arch height stability, and it will not be too hard to cause damage to the intraocular tissue.

The materials and design parameters of the foregoing embodiments are only a few typical embodiments. More generally, the intraocular lens is made of a soft foldable material, such as silica gel or acrylic material. The material can be hydrophilic or hydrophobic. Preferably, it has a certain water content. The water content of the material at 35°C is 5-15 wt%, preferably 6-13 wt%, more preferably 7- 12wt%. The material must have sufficient strength to meet the folding, unfolding and pulling of the intraocular lens during use, its breaking elongation (wet state)>80%, and its breaking strength (wet state)>1MPa. The material must have suitable refractive power, with a refractive index of 1.46 to 1.55; preferably, a refractive index of 1.48 to 1.52. The above materials can help keep the intraocular lens arched high, and will not collapse and deform, and will not be too hard to cause damage to the intraocular tissue. 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 this embodiment can achieve the above technical effects. Excellent performance.

The refractive power 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 added with astigmatism design, aspheric design, aberration design, large depth of field design, multi-focus design, 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.

The intraocular lens supporting part has a plate-shaped design such as a square, a rectangle, etc., or a hollow design of various sizes and shapes, or other shapes such as a butterfly. If it is a plate-shaped design, it can be provided with positioning holes or holes to promote the flow 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.

The phakic intraocular lens of this embodiment has a characteristic size and is made of a moderately rigid soft material. Under actual implantation conditions, it can resist pressure from the ciliary sulcus and iris to a certain extent. It can keep the arch height change no more than 0.2mm, maintain better deformation stability under compressive force, and improve the arch height stability of the intraocular lens when the diameter of the intraocular lens does not match the ciliary sulcus or under the condition of intraocular force. The arch height changes in the early and later stages are small, which can improve the doctor's prediction of the arch height, and it will not be too hard to cause damage to the intraocular tissue, and improve the safety of the intraocular lens implantation.

The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the present invention. Within the scope of protection.

In the above-mentioned embodiments, the posterior chamber intraocular lens is taken as an example. However, the setting of the size parameters and material parameters of the present invention can be applied not only to posterior chamber intraocular lenses, but also to other phakic intraocular lenses. .

Claims

A phakic intraocular lens, characterized in that the central thickness of the optical part of the phakic intraocular lens is 0.05 to 0.25 mm, preferably, 0.05 to 0.20 mm, more preferably, 0.08 to 0.18 mm; the edge of the support portion The thickness is 0.05 to 0.25 mm, preferably, 0.05 to 0.20 mm, 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, more preferably, 0.15 to 0.70 mm .
The phakic intraocular lens according to claim 1, characterized in that it is made of a soft foldable material, the elastic modulus of the material is greater than 10.0 kPa, preferably 0.1 to 2.0 MPa, more preferably 0.3 to 1.8 MPa, more preferably, 0.5 to 1.5 MPa.
The phakic intraocular lens according to claim 1, wherein the axial displacement does not exceed 0.2mm when the horizontal pressure is not more than 0.3g; when the axial pressure is not more than 0.3g, the axial deformation No more than 0.2mm.
The phakic intraocular lens according to claim 1, wherein the axial displacement does not exceed 0.1mm when the pressure is not more than 0.2g in the horizontal direction; the axial deformation is not more than 0.2g when the pressure is not more than 0.2g in the axial direction. No more than 0.1mm.
The phakic intraocular lens according to claim 2, wherein the elongation at break of the material in a wet state is >80%.
The phakic intraocular lens according to claim 2, wherein the breaking strength of the material in a wet state is> 1 MPa.
The phakic intraocular lens according to claim 2, wherein the material has a water content of 5-20 wt% at 35°C, preferably 6-15 wt%, more preferably 7-12 wt%.
The phakic intraocular lens according to claim 2, wherein the refractive index of the material is 1.46 to 1.55; preferably, the refractive index is 1.48 to 1.52.
The phakic intraocular lens according to any one of claims 1-8, characterized in that, in a natural uncompressed state, the total height is between 1.0 and 2.0 mm, preferably between 1.2 and 1.9 mm, More preferably, it is between 1.3 mm and 1.6 mm.
The phakic intraocular lens according to any one of claims 1-8, wherein 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.
The phakic intraocular lens according to any one of claims 1-8, characterized in that its diameter 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 phakic intraocular lens according to any one of claims 1-8, characterized in that it has a width greater than 6.0 mm, preferably, 6.5 to 8.0 mm, more preferably, 6.5 to 7.5 mm, more preferably , 6.8～7.2mm.
The phakic intraocular lens according to any one of claims 1-8, characterized in that it is a posterior chamber type phakic intraocular lens supported by a support part in the ciliary sulcus of the human eye.