CN108078654B

CN108078654B - Method for manufacturing intraocular lens and intraocular lens manufactured by the method

Info

Publication number: CN108078654B
Application number: CN201710635558.0A
Authority: CN
Inventors: 王曌; 解江冰
Original assignee: Abbott (beijing) Medical Technology Co Ltd
Current assignee: Abbott (beijing) Medical Technology Co Ltd
Priority date: 2017-07-28
Filing date: 2017-07-28
Publication date: 2020-02-07
Anticipated expiration: 2037-07-28
Also published as: CN108078654A

Abstract

The present invention relates to a method for manufacturing an intraocular lens and an intraocular lens manufactured by the method. The intraocular lens is implanted in the anterior or posterior chamber of a human eye having a natural crystalline lens for changing the refractive condition of the human eye. The intraocular lens includes an optic portion, a support portion, and a connecting portion at a periphery of the optic portion connected to the support portion. The optical portion includes an anterior surface and a posterior surface, at least one of which includes an aspheric surface. The intraocular lens is made of a material that swells upon hydration by absorbing water. The intraocular lenses of the invention are processed in the dry state or by injection molding and are used after hydration. The manufacturing method of the invention considers the expansion characteristic of the material in the manufacturing process, and ensures that the artificial lens obtains the expected optical performance after absorbing water and expanding through the trial manufacturing process of successive approximation.

Description

Method for manufacturing intraocular lens and intraocular lens manufactured by the method

Technical Field

The present invention relates to a method for manufacturing an intraocular lens and an intraocular lens manufactured by the method.

Background

Phakic intraocular lenses are intraocular lenses that are implanted in the anterior or posterior chamber (between the cornea and the natural lens) of a human eye to change the refractive state of the eye, typically with negative refractive power, for correcting myopia, particularly high myopia. There are also a few with positive diopters to correct hyperopia.

Intraocular lenses for phakic eyes can be classified into anterior chamber type and posterior chamber type according to the implantation position and fixation mode. The posterior chamber type artificial lens has few postoperative complications and definite curative effect, and is the most mainstream at present. Such intraocular lenses are implanted between the natural lens and the iris and have plate-type haptics or similar flat haptics supported in the ciliary sulcus. Because the position relation between the artificial lens and the human eye tissue structure is very close and is easy to contact with the human eye tissue structure, such as ciliary sulcus tissue, the requirements on the softness of the material, namely the softness degree and the lubrication degree of the material are high, so that the material is prevented from rubbing the surface of the human eye tissue to cause inflammation and complications. Therefore, the intraocular lens with the lens is preferably made of acrylic ester materials with certain water content and higher softness. For example, ICL manufactured by STAAR corporation is made of hydrophilic material with a water content of 34%. The artificial lens made of the acrylate material with the water content is processed in a dry state or is molded by injection, and expands after the artificial lens absorbs enough water and is fully hydrated, so that the artificial lens is in a final use state in the aspects of size, optical performance and the like.

The prior art has the following defects:

(1) the existing intraocular lenses of the phakic eyes are all designed in a spherical surface

The implantation environment of the intraocular lens with the lens is a human eye with a complete structure, and the ideal intraocular lens with the lens should not introduce additional aberration, especially spherical aberration, to the human eye, otherwise problems in the aspects of optical quality reduction, contrast difference, night glare and the like will be caused. The existing intraocular lenses of the crystalline eyes are designed in a spherical surface, and various aberrations, especially spherical aberration, can be introduced into the eyes of people after the intraocular lenses are implanted. It is well known to those skilled in the art that an intraocular lens with a positive diopter will introduce positive spherical aberration to the eye and an intraocular lens with a negative diopter will introduce negative spherical aberration to the eye, the stronger the diopter of the intraocular lens, the greater the amount of spherical aberration introduced, the more severe the interference with visual quality.

For example, the ICL manufactured by STAAR company in the prior art is declared to have an aspheric effect by a "progressive refractive index change" so as to reduce the spherical aberration effect caused by the spherical design by the material characteristics and improve the visual quality. However, the preparation process of the material is very complicated, and the precise control on the aspects of the change amplitude, the change uniformity and the like is difficult to achieve. And thus the spherical aberration control of the actual product is not ideal. ICL is clinically seen with glaring phenomena, which may be indistinguishable from the large amount of spherical aberration it introduces into the human eye.

(2) The existing aspheric surface design method is not suitable for the intraocular lens with the lens made of hydrophilic material

The characteristic of water swelling of the hydrophilic material brings new difficulties to the aspheric surface design of the intraocular lens with the lens, because the surface shape of the intraocular lens made of the hydrophilic material after water swelling can be changed significantly, so that the size and the optical performance of the intraocular lens are changed significantly and deviate from the expected design values.

In summary, the existing intraocular lenses with lens are all designed to be spherical, which can introduce a large amount of spherical aberration to the human eye, while the existing aspheric design technology is not suitable for the intraocular lens design with a certain water content, and even brings negative aberration interference.

The intraocular lens implanted with the lens for correcting the refractive state of the eye is generally a middle-aged and young-aged population, the requirement on the visual quality is high, the diopter of the generally implanted intraocular lens is high, and the spherical intraocular lens made of the hydrophilic material can bring very serious visual disturbance to patients.

Disclosure of Invention

An aspect of the present invention provides a method of manufacturing an intraocular lens to be implanted in an anterior chamber or a posterior chamber of a human eye having a natural crystalline lens for changing a refractive state of the human eye, the intraocular lens including an optical portion, a supporting portion, and a connecting portion connected to the supporting portion at a periphery of the optical portion, the optical portion including an anterior surface and a posterior surface, at least one of the anterior surface and the posterior surface including an aspherical surface, the intraocular lens being made of a material capable of water-swelling upon hydration, the method comprising the steps of:

(a) determining target parameters expected to be realized after the artificial lens is fully water-absorbed and expanded;

(b) determining an intermediate parameter of the intraocular lens before water absorption and expansion according to the target parameter, and determining a structural parameter of the intraocular lens according to the intermediate parameter;

(c) manufacturing an intraocular lens from the material before water swelling according to the structural parameters;

(d) the artificial lens is fully inflated by water;

(e) detecting the artificial lens after the artificial lens is fully swelled by water absorption to obtain actual parameters of the artificial lens;

(f) comparing the actual parameter with the target parameter;

(g) if the difference between the actual parameter and the target parameter exceeds a predetermined threshold range, adjusting the intermediate parameter to obtain an adjusted intermediate parameter and determining the structural parameter of the intraocular lens according to the adjusted intermediate parameter, and if the difference between the actual parameter and the target parameter does not exceed the predetermined threshold range, taking the manufactured intraocular lens as a final intraocular lens; and

(h) if the difference between the actual parameter and the target parameter is outside a predetermined threshold range, repeating steps (c) - (g).

In one embodiment, the expression of the curve of the aspheric surface on the two-dimensional coordinate system plane rZ is:

wherein R is the curvature radius of the base spherical surface of the aspheric surface, R is the vertical distance from any point on the curve to the abscissa axis Z, A_2iM and n are integers not less than 1 and n is aspheric high-order coefficient>m and Q are aspheric coefficients,

wherein each point on the surface shape of the aspherical surface is obtained from the curve by a rotationally symmetrical change about the abscissa axis Z, and

wherein the configuration parameters include a radius of curvature of the anterior surface, a radius of curvature of the posterior surface, the aspheric coefficients, and the aspheric high-order term coefficients.

In one embodiment, said determining structural parameters of said intraocular lens based on said intermediate parameters in step (b) comprises determining a radius of curvature of said anterior surface, a radius of curvature of said posterior surface, said aspheric coefficients, and said aspheric high order term coefficients based on said intermediate parameters; and wherein step (c) further comprises, prior to fabricating an intraocular lens from the material prior to imbibition according to the structural parameters:

dividing the determined radius of curvature of the anterior surface by k,

dividing the determined radius of curvature of the posterior surface by k, an

Determining the coefficient A of the aspheric surface high-order term_2iAre respectively multiplied by

，

Wherein k is the coefficient of expansion of the material.

In one embodiment, the target parameter comprises a target diopter and/or a target spherical aberration, and the intermediate parameter comprises an intermediate diopter and/or an intermediate spherical aberration, wherein the target diopter is a diopter expected to be achieved after the intraocular lens is fully water-swelled, the target spherical aberration is a spherical aberration expected to be achieved after the intraocular lens is fully water-swelled, the intermediate diopter is a diopter of the intraocular lens before water-swelling, and the intermediate spherical aberration is a spherical aberration of the intraocular lens before water-swelling.

In one embodiment, the target spherical aberration is zero.

In one embodiment, the target diopter is from 0 to-30.0 diopter, preferably from-3.0 diopter to-25.0 diopter.

In one embodiment, the determining the intermediate parameter of the intraocular lens before water-swelling according to the target parameter in step (b) comprises: determining the intermediate diopter to be equal to a target diopter and/or determining the intermediate spherical aberration to be equal to a target spherical aberration.

In one embodiment, the determining the intermediate parameter of the intraocular lens before water-swelling according to the target parameter in step (b) comprises: determining the intermediate diopter as a more negative value than the target diopter and/or determining the intermediate spherical aberration as a more positive value than the target spherical aberration.

In one embodiment, the adjusting of the intermediate parameters in step (g) comprises: adjusting the intermediate diopter to a more negative value than the target diopter and/or adjusting the intermediate spherical aberration to a more positive value than the target spherical aberration.

In one embodiment, the material is an acrylate based material having a coefficient of expansion between 1.01 and 1.615, preferably between 1.01 and 1.29, more preferably between 1.04 and 1.20.

In one embodiment, the material is an acrylate based material having a refractive index between 1.38 and 1.55, preferably between 1.44 and 1.53, more preferably between 1.48 and 1.51.

In one embodiment, the material is an acrylate based material having a water content of between 3.5% and 74.5%, preferably between 6% and 38%, more preferably between 8% and 20%.

In one embodiment, the total diameter of the intraocular lens is between 11.0mm and 14.5mm, preferably between 11.5mm and 14.2mm, more preferably between 11.8mm and 13.9 mm.

In one embodiment, the diameter of the optical portion is equal to or greater than 4.2mm, preferably between 4.5mm and 6.5mm, more preferably between 5.0mm and 6.0 mm.

In one embodiment, the optic portion and the connecting portion together comprise a body of an intraocular lens, the body having a diameter of between 5.5mm and 8.0mm, preferably between 6.0mm and 7.5mm, more preferably between 6.2mm and 7.0 mm.

In one embodiment, the central thickness of the intraocular lens is between 0.05mm and 0.50mm, preferably between 0.08mm and 0.20mm, more preferably between 0.10mm and 0.15 mm.

In one embodiment, the intraocular lens has an vault height of between 1.00mm and 1.80mm, preferably between 1.10mm and 1.60mm, more preferably between 1.20mm and 1.50 mm.

In another aspect of the present invention, an intraocular lens manufactured by the above manufacturing method is also provided.

Drawings

Figure 1a shows a schematic plan view of an intraocular lens of the invention.

Figure 1b shows a schematic cross-sectional view of an intraocular lens of the invention.

Figure 2 shows a schematic representation of the change in surface shape of an intraocular lens made of a material capable of water swelling after hydration before and after water swelling.

Fig. 3 shows a flow chart of an embodiment of a manufacturing method according to the invention.

Fig. 4 shows a flow chart of another embodiment of a manufacturing method according to the invention.

Figure 5 is a graph of MTF after implantation of a phakic intraocular lens using the present invention manufacturing method and using a conventional manufacturing method into the same standard human eye model.

Figure 6 is a graph of Seidel aberration distribution after implantation of a phakic intraocular lens using the present invention manufacturing method and using a conventional manufacturing method into the same standard human eye model.

Detailed Description

The following specific examples are merely illustrative of the present invention, but the present invention is not limited to the following specific embodiments. Any variations on these embodiments, which fall within the spirit and scope of the principles of the invention, are intended to be within the scope of the invention.

The present invention relates to a method of manufacturing an intraocular lens to be implanted in the anterior or posterior chamber of a human eye having a natural crystalline lens for changing the refractive state of the human eye. As shown in fig. 1a, the intraocular lens of the present invention comprises an optical portion 1, a supporting portion 2, and a connecting portion 3 connected to the supporting portion at the periphery of the optical portion. The optical portion 1 includes a front surface and a rear surface. At least one of the anterior and posterior surfaces includes an aspheric surface. The intraocular lenses of the invention are made of materials that are capable of water-swelling upon hydration.

Figure 2 shows a schematic representation of the change in surface shape of an intraocular lens made of a material capable of water swelling after hydration before and after water swelling. Although fig. 2 exemplifies an intraocular lens in which the optical portion has a plano-concave structure, the principle shown in fig. 2 is applicable to an intraocular lens in which the optical portion has other structures, such as a biconcave structure, a convex-concave structure, and the like. In fig. 2, the solid line is a cross-sectional view of the optic portion of the intraocular lens prior to imbibition. Since the intraocular lens is made of hydrophilic material, the intraocular lens will expand in volume after absorbing water, and the degree of expansion can be described by an "expansion coefficient" k, which refers to the change in dimension before and after expansion, including the change in length and thickness. Assuming that the coordinates of a point on the surface of the intraocular lens are (h, d) with O as the origin, and the intraocular lens is fully swollen by absorbing water, the coordinates of a ' are (h ', d '), and h ' = k × h, d ' = k × d.

If the intraocular lens is designed to be spherical, the optical surface shape of the sphere satisfies the formula:

（1）

wherein Z (R) is a curve expression of the spherical surface on a two-dimensional coordinate system plane rZ, R is a curvature radius of the spherical surface, R is a vertical distance from any point on the curve to an abscissa axis Z, and each point on the spherical surface shape is obtained by rotationally symmetrically changing the curve around the abscissa axis Z.

The coordinates of the point A satisfy the formula:

（2）

expressing the coordinates of A as the coordinates of A' after expansion, obtaining:

（3）

the above formula is simplified and can be obtained:

（4）

it can be seen that the coordinates (h ', d') of a 'also satisfy the optical surface shape expression of a spherical surface, except that the radius of curvature is changed from the original R to R' = Rk. It can be seen that, after the spherical intraocular lens is fully swelled by water absorption, the surface remains spherical, but the radius of curvature changes, and when the swelling coefficient k > 1, the radius of curvature becomes larger after swelling by water absorption. If it is desired to achieve a lens that achieves the desired diopter after sufficient hydroscopic expansion, an adjustment of the radius of curvature is required.

However, for the purpose of correcting aberrations, the situation becomes complicated if the anterior and/or posterior surfaces of the intraocular lens are designed to be aspherical. In optical design, the even-order aspheric surface for correcting aberrations is generally expressed as:

（5）

wherein Z (R) is a curve expression of the aspheric surface on a two-dimensional coordinate system plane rZ, R is a curvature radius of a basic spherical surface of the aspheric surface, R is a vertical distance from any point on the curve to an abscissa axis Z, A_2iM and n are integers not less than 1 and n is aspheric high-order coefficient>m and Q are aspheric coefficients; each point on the aspherical surface shape is obtained by rotationally symmetrically changing the curve around the abscissa axis Z.

These coefficients may or may not be 0, depending on design requirements.

The relationship between the points on the aspheric surface before and after the expansion is also estimated by the coordinates of a (h, d), a ' (h ', d '):

（6）

it can be seen that after the artificial lens with an aspheric design is fully expanded by water, the aspheric surface of the artificial lens is not only a simple change of the curvature radius, but also related to the aspheric surface high order coefficient, and the proportion of the change of each aspheric surface high order coefficient is different.

The correction of the aspheric artificial lens on the aberration is mainly achieved through even term coefficients in an equation (6), the even term coefficients have positive and negative values, and the purpose of correcting various aberrations is achieved through mutual matching. The interference of different expansion coefficients of different orders of the artificial lens made of hydrophilic materials brings two negative effects to the aspheric surface design:

(1) the aspheric spherical aberration correction capability is reduced;

(2) additional higher order aberrations are introduced, causing aberration aberrations.

Taking the aspheric surface design with the Q value of 0 as an example, the aspheric surface expression still refers to the formula (5), the Q value is 0, the expression before the even term represents a spherical surface, and the subsequent even term is used for enabling the aspheric surface to generate the surface shape difference different from the spherical surface and correcting the aberration. When the lens has negative power, if correction of the aberrations is desired to achieve 0 spherical aberration, the even term characterizes a negative offset in height, making the lens thinner in the peripheral region than in the spherical region. After the material of the artificial lens has water absorption characteristics and expansion coefficients, as can be seen from formula (6), when k is larger than 1, the negative offset in height is reduced, so that the degree that the peripheral area is thinner than the spherical surface is reduced, and the spherical aberration correction capability of the aspheric surface is reduced. Meanwhile, matching between even-order terms causes matching imbalance due to orders of different k, and additional high-order aberration is brought.

In the invention, the actual parameters of the artificial lens after the artificial lens is fully water-swollen are compared with the target parameters, and trial production is repeatedly carried out for one time or a plurality of times, so that the actual parameters of the artificial lens gradually approach the target parameters, and the structural parameters of the aspheric artificial lens are finally determined, so that the artificial lens manufactured according to the structural parameters provides expected optical performance after the artificial lens is fully water-swollen.

In one embodiment, as shown in fig. 3, the manufacturing method of the present invention includes the following steps (a) - (h).

In step (a), the target parameters desired to be achieved after sufficient imbibition of the intraocular lens are determined. Here, the target parameter may include any parameter that the intraocular lens is expected to achieve after sufficient water swelling. For example, the target parameters may include a target diopter and/or a target spherical aberration, wherein the target diopter is a diopter desired to be achieved after sufficient water-swelling of the intraocular lens, and the target spherical aberration is a spherical aberration desired to be achieved after sufficient water-swelling of the intraocular lens.

In some embodiments, the target spherical aberration is zero.

In some embodiments, the target diopter is from 0 to-30.0 diopter, preferably-3.0 diopter to-25.0 diopter.

In step (b), an intermediate parameter of the intraocular lens before imbibition is determined based on the target parameter, and a structural parameter of the intraocular lens is determined based on the intermediate parameter. Here, the intermediate parameter may include an intermediate diopter and/or an intermediate spherical aberration, wherein the intermediate diopter is a diopter of the intraocular lens before water swelling, and the intermediate spherical aberration is a spherical aberration of the intraocular lens before water swelling. Here, the structural parameters may include, but are not limited to, a radius of curvature of an anterior surface of the intraocular lens, a radius of curvature of a posterior surface of the intraocular lens, an aspheric coefficient of an aspheric surface of the intraocular lens, and an aspheric higher-order term coefficient of the aspheric surface of the intraocular lens. Optical design software such as Zemax, CODE V, etc. may be used to determine the structural parameters of the intraocular lens.

In step (c), the intraocular lens is manufactured from the material before imbibition according to the structural parameters.

In step (d), the intraocular lens is caused to fully imbibe water to swell. In some embodiments, the intraocular lens is hydrated by a balanced salt solution so that it is sufficiently water swellable. In other embodiments, the intraocular lens is hydrated by BSS solution so that it swells sufficiently to absorb water. In other embodiments, the intraocular lens is hydrated by a solution that is close to the aqueous humor component, allowing it to swell with sufficient water.

The hydration time may be determined by the material moisture content of the intraocular lens, the thickness of the intraocular lens, and other factors. During the hydration of an intraocular lens, it is believed that sufficient hydration or sufficient water swelling is achieved when the intraocular lens has no change in size, weight, or shape. In some embodiments, the hydration time is 2 days. In other embodiments, the hydration time may be 2 hours, 4 hours, 8 hours, and the like.

In step (e), the intraocular lens after being fully swelled by water absorption is detected to obtain the actual parameters of the intraocular lens. The actual parameter here refers to a parameter actually measured after the intraocular lens has been sufficiently swollen by water, which corresponds to a target parameter, such as the diopter actually measured after the intraocular lens has been sufficiently swollen by water and/or the spherical aberration actually measured after the intraocular lens has been sufficiently swollen by water. The fully imbibed, fully swollen iol may be examined, for example, for spherical aberration and/or diopter, using an optical examination device and the numerical values recorded.

In step (f), the actual parameter is compared to the target parameter.

In step (g), if the difference between the actual parameter and the target parameter exceeds the predetermined threshold range, the intraocular lens manufactured at this time is considered not to achieve the desired target parameter, adjusting the intermediate parameter to obtain an adjusted intermediate parameter and determining the structural parameter of the intraocular lens according to the adjusted intermediate parameter; and if the difference between the actual parameter and the target parameter does not exceed the preset threshold range, the manufactured artificial lens is regarded as the artificial lens which has achieved the expected target parameter, and the manufactured artificial lens is taken as the final artificial lens.

In step (h), if the difference between the actual parameter and the target parameter is outside a predetermined threshold range, repeating steps (c) - (g) above.

In some embodiments, the determining the intermediate parameter of the intraocular lens before imbibition from the target parameter in step (b) comprises: the intermediate diopter is determined to be equal to the target diopter and/or the intermediate spherical aberration is determined to be equal to the target spherical aberration.

The aspheric expression of the intraocular lens is shown in formula (5), and the coefficient of expansion of the intraocular lens material is k. As can be seen from the derivation of equations (5) to (6), the structural parameters of the intraocular lens (e.g., the base spherical radius of curvature of the aspherical surface, the aspherical surface coefficients, and the aspherical surface high-order term coefficients) have a proportional relationship before and after the intraocular lens is fully swelled with water, as shown in table 1.

TABLE 1

Before expansion

R

Q

A₂

A₄

A₆

…

A_2i

After expansion

Rk

Q

A₂/k

A₄/k³

A₆/k⁵

…

A_2i/k^2i-1

As can be seen from Table 1, the aspherical base spherical radius of curvature R of the intraocular lens after the water-swelling is k times as large as that before the water-swelling, the aspherical coefficient Q of the intraocular lens remains unchanged before and after the water-swelling, and the aspherical high-order term coefficient A of the intraocular lens_2iSwelling on water absorptionFollowed by 1/k before water swelling^2i-1And (4) doubling.

Based on the above analysis, the present invention innovatively proposes to take into account the influence of the expansion coefficient during design and manufacturing and to pre-adjust the structural parameters of the intraocular lens (e.g., the base spherical radius of curvature, the aspherical coefficients, and the aspherical high-order term coefficients) according to table 2 so that the intraocular lens after imbibition has the desired structural parameters. Specifically, after the optical design software is used to determine the structural parameters of the intraocular lens based on the target parameters, the structural parameters of the intraocular lens are pre-adjusted according to table 2, so that the intraocular lens "changes" to the desired structural parameters after imbibition.

TABLE 2

Before adjustment

R

Q

A₂

A₄

A₆

…

A_2i

After adjustment

R/k

Q

A₂k

A₄k³

A₆k⁵

…

A_2ik^2i-1

It can be seen that when the structural parameters of the intraocular lens are pre-adjusted, the multiple factor of the base spherical radius of curvature R of the aspherical surface is 1/k, and the coefficient a of the aspherical surface higher order term₂、A₄、A₆、……A_2iThe multiple factors of are respectively k,

、

、……

. No adjustment is required since the aspheric coefficient Q of the intraocular lens remains constant before and after the water-swelling.

The aspherical expression of the intraocular lens after the above adjustment is made:

（7）

accordingly, in some embodiments, as shown in fig. 4, the determining structural parameters of the intraocular lens according to the intermediate parameters in step (b) comprises determining a radius of curvature of the anterior surface, a radius of curvature of the posterior surface, aspheric coefficients, and aspheric high-order term coefficients according to the intermediate parameters, and the step (c) further comprises adjusting the structural parameters according to the expansion coefficients of the materials before the intraocular lens is manufactured using the materials before water-imbibition expansion according to the structural parameters, wherein adjusting the structural parameters according to the expansion coefficients of the materials comprises: will be determined to be beforeDividing the radius of curvature of the surface by k, dividing the determined radius of curvature of the back surface by k, and determining the aspheric higher-order term coefficient A_2iAre respectively multiplied by

Wherein k is the coefficient of expansion of the material.

According to the invention, by matching the expansion coefficient-related multiple factors with different proportions in the structural parameters of the intraocular lens (such as the curvature radius of the front surface, the curvature radius of the rear surface, the aspheric surface coefficients and the aspheric surface high-order term coefficients), the method adopts a successive approximation manufacturing method to make the aberration and diopter of the intraocular lens accord with the target and eliminate the influence caused by the expansion coefficient.

It can be known from the foregoing derivation that the water swelling reduces the spherical aberration modification effect of the aspheric surface of the intraocular lens, i.e., the surface shape change caused by the aspheric surface is not large enough, and the correction amount for the negative spherical aberration is not sufficient, so that the spherical aberration provided by the intraocular lens tends to be more positive during the design, thereby increasing the surface shape change amount caused by the aspheric surface, and further compensating for the reduction of the spherical aberration modification amount after the water swelling.

It is noted that, as mentioned above, in order to obtain the correct diopter, the processing procedure needs to be adjusted to decrease the curvature radius to a certain degree (i.e. the intraocular lens is designed to have more negative diopter before water swelling) in order to obtain the desired diopter after sufficient water swelling. The degree of the adjustment is determined by the expansion coefficient of the material of the artificial lens and the size of the theoretical curvature radius, and the larger the expansion coefficient is, the larger the adjustment amount is; the larger the radius of curvature itself, the larger the adjustment amount. In order to eliminate the influence of machining errors, a plurality of pieces are tried to be averaged to be used as a final spherical aberration measurement result. Finally, the obtained artificial lens meets the expected design requirements in the aspects of diopter and aberration.

Accordingly, in some embodiments, the determining the intermediate parameter of the intraocular lens before imbibition from the target parameter in step (b) comprises: the intermediate diopter is determined to be more negative than the target diopter and/or the intermediate spherical aberration is determined to be more positive than the target spherical aberration.

Accordingly, in some embodiments, adjusting the intermediate parameter in step (g) comprises: the intermediate diopter is adjusted to a more negative value than the target diopter and/or the intermediate spherical aberration is adjusted to a more positive value than the target spherical aberration.

Examples 1 to 8 show some specific examples of the present invention schematically. The invention adds the expansion characteristic of the material into the design of the aspheric surface and the manufacturing process of the artificial lens, and utilizes the trial manufacturing process of successive approximation to ensure that the artificial lens can obtain the expected spherical aberration and/or diopter after full water absorption and expansion. In one scheme, the method comprises the steps of comparing actual parameters detected after the intraocular lens fully absorbs water and expands with target parameters, determining aspheric surface design, and eliminating the influence of expansion coefficients; in another further preferred embodiment, the structural parameters of the intraocular lens are matched with different proportional multiple factors related to the expansion coefficient, so as to eliminate the influence of the expansion coefficient.

Example 1

The refractive index of the material is 1.502, the expansion coefficient is 1.04, and the target parameters are-15.0D and zero spherical aberration. That is, the target diopter is-15.0D and the target spherical aberration is 0.

An optical design software Zemax is adopted to design an aspheric surface of an optical part of the intraocular lens, the front surface and the rear surface of the intraocular lens are designed to be spherical surfaces, when the clear aperture of the intraocular lens is 5.0mm, the spherical aberration in water is 0, and diopter is-15.0D and is used as an intermediate parameter (namely, the intermediate spherical aberration is 0, and the intermediate diopter is-15.0D), so that the structural parameters of the intraocular lens are obtained, and the structural parameters are shown in Table 3.

TABLE 3

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

0.00λ

-48.70

14.22

1.122

-1.1186e-04

-5.015e-07

-1.345e-09

Where Ra and Rp are the radii of curvature of the anterior and posterior surfaces, respectively, in mm. Q is an aspherical coefficient, A₄、A₆、A₈Are aspheric high-order term coefficients.

Manufacturing a processing drawing according to the structural parameters, and trial-manufacturing the aspheric intraocular lens by using a numerical control lathe and adopting an acrylate material with the refractive index of 1.502 and the expansion coefficient of 1.04.

And (3) putting the artificial lens obtained by trial production into a balanced salt solution, soaking for two days to hydrate the artificial lens, fully absorbing water and expanding, and then taking out.

And detecting the actual parameters of the hydrated artificial lens by using an optical detector, observing the spherical aberration or diopter distribution curve, and recording the numerical value. Through detection, the average actual spherical aberration of a plurality of artificial lenses obtained by the primary trial production is found to be-0.12 lambda, and the difference with the expected 0 spherical aberration is larger. Diopter detection results show that the actual diopter of the obtained intraocular lens is-13.8D, and the diopter difference is larger than the target diopter expected to be realized at-15.0D.

For negative power intraocular lenses, the spherical aberration of the intraocular lens is negative, so the nature of the '0 spherical aberration' design given for the first time is to provide additional positive spherical aberration for the intraocular lens through an aspheric surface, and to reconcile with the negative spherical aberration of the lens itself. The trial results show that the intraocular lens still shows negative spherical aberration, which means that the blending force of the positive spherical aberration provided by the aspheric surface is insufficient, so the force of the interference of the aspheric surface shape should be increased in the design, and the middle spherical aberration should be adjusted to a positive value, that is, the intraocular lens is designed to have larger spherical aberration before water swelling.

Meanwhile, the diopter does not meet the expected requirement, and the detected value shows that the diopter is not enough, so that the intermediate diopter needs to be adjusted to a more negative value than the target diopter, that is, the intraocular lens is designed to have a more negative diopter before the water-swelling, that is, the curvature radius is adjusted to be small.

The intermediate spherical aberration was adjusted to +0.1 λ, when the clear aperture was 5.0mm, and the design parameters were obtained after optimization, as shown in table 4.

TABLE 4

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

+0.1λ

-45.0

14.01

-1.588

-7.317e-05

-1.285e-06

-2.932e-08

Wherein λ represents a wavelength, for example, 550nm is adopted in design, and then the spherical aberration +0.1 λ represents the spherical aberration with a size of +0.055 μm.

Repeating the processing, hydrating and detecting processes, finally detecting to find that the spherical aberration of the obtained artificial lens is-0.01 lambda = -0.0055 mu m and is approximately equal to 0 mu m, and the diopter is-14.90D, and judging that the artificial lens meets the target parameters.

In the manufacturing process of the invention, if the difference between the measured diopter and the target diopter of the manufactured intraocular lens after sufficient water absorption and expansion does not exceed the preset threshold range and/or the difference between the measured spherical aberration and the target spherical aberration of the manufactured intraocular lens after sufficient water absorption and expansion does not exceed the preset threshold range, the manufactured intraocular lens is judged to be in accordance with the target parameter.

The predetermined threshold range of diopters for intraocular lenses can be determined according to the requirements of industry standards, such as the diopter pass standard specified in YY0290, ISO 11979. The control is typically designed such that the actual measured power does not differ from the target power beyond industry standard tolerances. Additionally, in some embodiments, the predetermined threshold range of diopters may also be set as a percentage of the target diopter, such as set to 10%, ± 8%, ± 6%, ± 4%, ± 2%, ± 1%, ± 0.5% of the target diopter, and so forth. The predetermined threshold range of spherical aberration of the intraocular lens may be determined by the designer's requirements. For example, it is considered that the difference between the actually measured spherical aberration and the target spherical aberration is controlled to be within ± 0.05 λ. In addition, in some embodiments, the predetermined threshold range of spherical aberration may be set in units of μm, for example, may be set to ± 0.05 μm, ± 0.1 μm, or the like. Additionally, in some embodiments, the predetermined threshold range of spherical aberration may also be set as a percentage of the target spherical aberration, such as set as 10%, ± 8%, ± 6%, ± 4%, ± 2%, ± 1%, ± 0.5% of the target spherical aberration, and so forth.

In this example, a satisfactory intraocular lens was obtained by two trial runs to achieve approximately the target parameters of 0 spherical aberration and-15.0D diopters. If the second trial fails to obtain an intraocular lens that meets the requirements, the above steps need to be repeated repeatedly until an intraocular lens that can achieve 0 spherical aberration and-15.0D diopters is obtained.

In another approach, the structural parameters are adjusted during the manufacturing process using coefficients of expansion.

An optical design software Zemax is adopted to design an aspheric surface of an optical part of the intraocular lens, the front surface and the rear surface of the intraocular lens are designed to be aspheric surfaces, when the clear aperture of the intraocular lens is 5.0mm, the spherical aberration in water is 0, and diopter is-15.0D and is taken as an intermediate parameter (namely, the intermediate spherical aberration is 0, and the intermediate diopter is-15.0D), so that structural parameters are obtained, and the structural parameters are shown in Table 5.

TABLE 5

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

0.00λ

-48.049

14.22

-0.6398

6.224e-05

-2.933e-07

3.140e-08

The structural parameters of the intraocular lens shown in table 5 were adjusted according to the processing method of table 2 based on the material expansion coefficient of 1.04 to obtain adjusted structural parameters, as shown in table 6.

TABLE 6

Ra	Rp	Q	A₄	A₆	A₈
						-46.20	13.67	-0.6398	7.001E-05	-3.568E-07	4.132E-08

Machining drawings are prepared according to the structural parameters shown in table 6, and an aspherical intraocular lens is manufactured in a trial manner by using an acrylate material with a refractive index of 1.502 and an expansion coefficient of 1.04 by using a numerically controlled lathe.

And (3) putting the artificial lens into a balanced salt solution, soaking for two days to hydrate the artificial lens, fully absorbing water and expanding, and then taking out.

And detecting the actual parameters of the hydrated artificial lens by using an optical detector, observing the spherical aberration or diopter distribution curve, and recording the numerical value. The average diopter value of a plurality of artificial lenses is-15.12D after detection. For a target diopter of-15.0D, the diopter tolerance (i.e., the predetermined threshold range) specified in the industry standard is 0.3D, which diopter can be considered satisfactory. It was detected that the spherical aberration was-0.06. lambda. and close to-0.1. lambda. it was considered that a part of negative spherical aberration remained.

As mentioned above, for negative power IOLs, the spherical aberration of the IOL itself is negative, and thus the nature of the first given "0 spherical aberration" design is to provide additional positive spherical aberration to the IOL through the aspheric surface, blending with the negative spherical aberration of the lens itself. The trial results show that the intraocular lens still has negative spherical aberration characteristics, which means that the aspheric surface provides insufficient harmonic force of positive spherical aberration, so the force of surface shape interference of the aspheric surface should be increased in the design, and the intermediate spherical aberration should be adjusted to a positive value, that is, the intraocular lens is designed to have larger spherical aberration before water swelling.

The intermediate spherical aberration was adjusted to +0.1 λ in water at a clear aperture of 5.0mm, resulting in the structural parameters shown in table 7.

TABLE 7

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

+0.1λ

-48.049

14.22

-418.516

-2.72E-04

2.92E-05

-8.74E-07

The structural parameters of the intraocular lens were adjusted according to the processing method of table 2 based on the material expansion coefficient of 1.04, resulting in adjusted structural parameters, as shown in table 8.

TABLE 8

Ra	Rp	Q	A₄	A₆	A₈
						-46.20	13.67	-418.516	-3.060E-04	3.549E-05	-1.150E-06

And repeating the steps, carrying out mechanical processing, hydration and detection, and finally obtaining the average value of diopters of the plurality of artificial lenses, wherein the diopter average value is-15.04D, the spherical aberration average value is 0.03 lambda and is approximately equal to 0 mu m, and the target parameter is judged to be reached.

Examples 2-8 differ in the target parameters, materials used, but the procedure is similar to example 1, with only the key steps and implementation information listed below.

Example 2

The material had a refractive index of 1.458, a coefficient of expansion of 1.13, and target parameters of-25.0D and zero spherical aberration. That is, the target diopter is-25.0D and the target spherical aberration is 0.

The structural parameters are adjusted during the manufacturing process using the coefficient of expansion.

The structural parameters of the intraocular lens were obtained by setting the intermediate refractive power to-25.0D and the intermediate spherical aberration to 0, +0.1 λ, +0.2 λ, +0.25 λ, respectively, as shown in table 9, in which the anterior surface of the intraocular lens was spherical and the posterior surface was aspherical.

TABLE 9

Intraocular lens serial number	Mean spherical aberration	Ra	Rp	Q	A₄	A₆	A₈
								1	0	-15.00	7.02	1.943	-1.267e-03	-1.242e-05	-3.825e-06
2	+0.1λ	-15.00	7.00	1.479	-1.209e-03	-1.660e-05	-1.886e-06
								3	+0.2λ	-15.00	7.00	1.448	-1.212e-03	-1.908e-05	-1.965e-06
4	+0.25λ	-15.00	7.00	1.418	-1.348e-03	-2.009e-05	-2.006e-06

The structural parameters of the intraocular lens shown in table 9 were adjusted according to the processing method of table 2 based on the material expansion coefficient of 1.13 to obtain adjusted structural parameters, as shown in table 10.

Watch 10

Intraocular lens serial number	Ra	Rp	Q	A₄	A₆	A₈
							1	-13.27	6.21	1.943	-1.828E-03	-2.288E-05	-8.999E-06
2	-13.27	6.19	1.479	-1.744E-03	-3.058E-05	-4.437E-06
							3	-13.27	6.19	1.448	-1.749E-03	-3.515E-05	-4.623E-06
4	-13.27	6.19	1.418	-1.945E-03	-3.701E-05	-4.719E-06

After trial processing, hydration was carried out, spherical aberration and diopter measurement were carried out with an aperture of 5.0mm, and the results are shown in Table 11, confirming that intraocular lens No. 1 was the final result.

TABLE 11

Intraocular lens serial number	1	2	3	4
					Actual spherical aberration	+0.04λ	+0.17λ	+0.23λ	+0.39λ
Actual diopter	-25.11D	-24.93D	-24.85D	-25.07D

As can be seen from the implementation of the embodiment, in the case of adjusting the structural parameters by using the expansion coefficient, the actual parameters of the actually processed intraocular lens deviate less from the target parameters because the expansion coefficient is already involved in the design stage. In most cases, the desired results are obtained by trial production 1-2 times. Under individual conditions, such as large expansion coefficient of materials, large deformation, poor calibration of a machine tool, unstable trial-manufacturing environment and the like, more trial-manufacturing is needed, various system and design errors are eliminated, and the final design is obtained.

Examples 3-8 also use the coefficient of expansion to adjust structural parameters during the manufacturing process.

Example 3

The refractive index of the material is 1.453, the expansion coefficient is 1.17, and the target parameters are-5.0D and zero spherical aberration. That is, the target diopter is-5.0D and the target spherical aberration is 0.

The intermediate diopter was set to-5.0D and the intermediate spherical aberration was set to 0, resulting in the structural parameters of the intraocular lens, as shown in Table 12, in which the aspherical surface was located on the posterior surface of the optical portion of the intraocular lens.

TABLE 12

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

0.00

-100.00

30.55

-0.723

-2.592e-06

1.075e-06

-8.536e-08

The structural parameters of the intraocular lens shown in table 12 were adjusted according to the processing method of table 2 based on the material expansion coefficient of 1.17 to obtain adjusted structural parameters, as shown in table 13.

Watch 13

Ra	Rp	Q	A₄	A₆	A₈
						-85.47	26.11	-0.723	-4.151E-06	2.357E-06	-2.562E-07

After the trial processing hydration, the spherical aberration and diopter measurements were made at 5.0mm aperture with the average spherical aberration of-0.01 λ and the average diopter of-5.22D for a number of lenses, confirming that the lenses were the final results.

Example 4

The refractive index of the material is 1.453, the coefficient of expansion is 1.17, and the target parameters are-5.0D and-0.2 lambda spherical aberration. That is, the target diopter is-5.0D and the target spherical aberration is-0.2 λ.

The intermediate diopter was set to-5.0D and the intermediate spherical aberration was set to-0.2 λ, resulting in the structural parameters of the intraocular lens in which the posterior surface of the optical portion of the intraocular lens was aspherical, as shown in Table 14.

TABLE 14

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

-0.2λ

-100.00

30.55

46.009

1.095e-04

-5.011e-06

-3.673e-07

The structural parameters of the intraocular lens shown in table 14 were adjusted according to the processing method of table 2 based on the material expansion coefficient of 1.17 to obtain adjusted structural parameters, as shown in table 15.

Watch 15

Ra	Rp	Q	A₄	A₆	A₈
						-85.47	26.11	46.009	1.754E-04	-1.099E-05	-1.102E-06

After the trial hydration, the intraocular lens was confirmed to be the final result by performing spherical aberration and diopter measurements at a 5.0mm aperture with a measured spherical aberration of-0.22 λ and a diopter mean of-5.13D.

Example 5

The refractive index of the material is 1.502, the expansion coefficient is 1.04, and the target parameters are-5.0D and +0.2 lambda spherical aberration. That is, the target diopter is-5.0D and the target spherical aberration is +0.2 λ.

The structural parameters of the intraocular lens were obtained with the intermediate refractive power set to-5.0D and the intermediate spherical aberration set to +0.2 λ, as shown in table 16, in which the posterior surface of the optical portion of the intraocular lens was aspherical.

TABLE 16

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

+0.2λ

-100.00

30.55

18.267

-3.500e-04

-5.670e-06

-3.016e-07

The structural parameters of the intraocular lens shown in table 16 were adjusted according to the processing method of table 2 based on the material expansion coefficient of 1.04 to obtain adjusted structural parameters, as shown in table 17.

TABLE 17

Ra	Rp	Q	A₄	A₆	A₈
						-96.15	29.38	18.267	-3.937E-04	-6.898E-06	-3.969E-07

After the trial hydration, the intraocular lens was confirmed to be the final result by performing spherical aberration and diopter measurements at a 5.0mm aperture with a measured spherical aberration of +0.19 λ and a diopter mean of-5.15D.

Example 6

The material had a refractive index of 1.375, a coefficient of expansion of 1.615, and target parameters of-3.0D and zero spherical aberration. That is, the target diopter is-3.0D and the target spherical aberration is 0.

The structural parameters of the intraocular lens were obtained with the intermediate diopter set to-3.0D and the intermediate spherical aberration set to 0, wherein the posterior surface of the optical portion of the intraocular lens was aspherical. The initial structural parameters and the structural parameters adjusted by the expansion coefficient are shown in Table 18.

Watch 18

Type (B)

Ra

Rp

Q

A₄

A₆

A₈

Initial

-100

14.94

-0.186

-6.873e-06

-3.339e-06

1.370e-07

After adjustment

-61.92

9.25

-0.186

-2.895E-05

-3.668E-05

3.926E-06

After trial production and hydration, an optical detector is used for detecting diopter and spherical aberration of the sample, and the diopter average value of a plurality of artificial lenses is found to be-3.72D, the spherical aberration average value is-0.12 lambda, and the difference between the diopter average value and the spherical aberration average value and the target parameter is larger. This is because the expansion coefficient reaches 1.615, and an excessively large expansion coefficient causes the influence of the expansion coefficient intervening in the design stage on the aspheric coefficient to be multiplied, which affects the accuracy of the final result.

In this case, adjustment is required. From the above results, it can be seen that the adjustment means should include a reduction in diopter and an increase in spherical aberration interference. From the results, the intermediate diopter was set to-2.5D, and the intermediate spherical aberration was set to +0.1 λ, +0.15 λ, +0.2 λ, respectively, to obtain the structural parameters of the intraocular lens, as shown in Table 19.

Watch 19

Serial number

Spherical aberration

Ra

Rp

Q

A₄

A₆

A₈

1

+0.1λ

-61.92

9.50

-26.681

3.069e-03

-2.570e-04

7.036e-06

2

+0.15λ

-61.92

9.50

-19.773

1.882e-03

-1.680e-04

4.175e-06

3

+0.2λ

-61.92

9.50

-16.357

1.302e-03

-1.270e-04

2.880e-06

The intraocular lens design of table 19 was mechanically mapped, processed, hydrated, and examined using an optical detector, with the results shown in table 20.

Watch 20

Intraocular lens serial number	1	2	3
				Spherical aberration detectionValue of	-0.07λ	-0.01λ	0.06λ

The sphere difference of the No. 2 intraocular lens is considered to be closest to the target parameter of 0 sphere difference, and the diopter mean value of the No. 2 intraocular lens is-2.98D, which is determined to be the final design.

Example 7

The refractive index of the material was 1.438, the coefficient of expansion was 1.20, the target parameters were-10.0D and zero spherical aberration. That is, the target diopter is-10.0D and the target spherical aberration is 0.

The structural parameters of the intraocular lens were obtained with the intermediate diopter set to-10.0D and the intermediate spherical aberration set to 0, wherein the posterior surface of the optical portion of the intraocular lens was aspherical. The initial structural parameters and the structural parameters adjusted by the expansion coefficient are shown in table 21.

TABLE 21

Type (B)

Ra

Rp

Q

A₄

A₆

A₈

Initial

-100

11.30

-0.233

-8.329e-05

4.691e-06

-3.814e-07

After adjustment

-83.33

9.42

-0.233

-1.439E-04

1.167E-05

-1.367E-06

After drawing, processing and hydration of a mechanical diagram, detecting by an optical instrument, and determining the final result that the mean value of spherical aberration of a plurality of artificial lenses is-0.03 lambda and the mean value of diopter is-9.84D.

Example 8

The refractive index of the material is 1.530, the expansion coefficient is 1.01, and the target parameters are-30.0D and zero spherical aberration. That is, the target diopter is-30.0D and the target spherical aberration is 0.

The structural parameters of the intraocular lens were obtained with the intermediate refractive power set to-30.0D and the intermediate spherical aberration set to 0, wherein the posterior surface of the optical portion of the intraocular lens was aspherical. The initial structural parameters and the structural parameters adjusted by the expansion coefficient are shown in table 22.

TABLE 22

Type (B)

Ra

Rp

Q

A₄

A₆

A₈

Initial

-30.00

8.15

3.059

-9.973e-04

-1.191e-05

-3.471e-06

After adjustment

-29.70

8.07

3.059

-1.028E-03

-1.252E-05

-3.721E-06

After drawing, processing and hydration of a mechanical diagram, detecting by an optical instrument, and determining the final result that the mean value of spherical aberration of a plurality of artificial lenses is-0.01 lambda and the mean value of diopter is-30.16D.

In the above embodiments, some embodiments have aspheric surfaces on the anterior surface of the intraocular lens and other embodiments have aspheric surfaces on the posterior surface of the intraocular lens, and the aspheric higher order coefficients are commonly referred to as A₄、A₆、A₈Combinations of (a) and (b). It is contemplated that in some embodiments, the anterior and posterior surfaces of the intraocular lens may both be aspheric. It is contemplated that in some embodiments, A may be employed simultaneously₂、A₁₀、A₁₂、A₁₄The coefficients of aspheric high-order terms are equalized and combined with the Q value.

In the above embodiments, the target parameters of the intraocular lens are selected to be both diopter and spherical. In other embodiments, the target parameter of the intraocular lens may be selected as diopters or as spherical aberration.

The predetermined spherical aberration of the intraocular lens is determined by the purpose of use. In some embodiments, the intraocular lens has a target spherical aberration that is positive, and in other embodiments, the intraocular lens has a target spherical aberration that is negative. For the application of a phakic intraocular lens, preferably the intraocular lens has a target spherical aberration of 0. It is known to those skilled in the art that the detection aperture, the solution environment, the front or rear optical element, etc. all affect the expression of the spherical aberration, and the design value of the spherical aberration and the detection value may have different expressions under different conditions without departing from the concept of the present invention.

Table 23 is some examples of materials that can be used that are acrylates, are suitable for ophthalmic implants, have good spectral transmittance properties, and are soft and foldable after hydration.

TABLE 22 refractive index, moisture content and coefficient of expansion examples of materials

Serial number	Refractive index (wet 20 ℃ C.)	Water content (20 ℃ C.)	Coefficient of expansion k (20 ℃ C.)
				1	1.406	50%	1.29
2	1.385	65%	1.45
				3	1.375	74%	1.615
4	1.417	50%	1.28
				5	1.400	60%	1.36
6	1.402	59%	1.38
				7	1.405	58%	1.37
8	1.390	67%	1.49
				9	1.375	74.5%	1.61
10	1.438	38%	1.20
				11	1.407	55%	1.35
12	1.458	26%	1.13
				13	1.502	8%	1.04
14	1.453	34%	1.17
				15	1.530	4%	1.01

As shown in figure 1a, the intraocular lens according to the invention comprises an optic portion 1 and a support portion 2. The intraocular lens is sized to fit the anatomy of the human eye with an overall diameter 4 of between 11.0mm and 14.5mm, preferably between 11.5mm and 14.2mm, and more preferably between 11.8mm and 13.9 mm. The optical part of the artificial lens is positioned in the center of the artificial lens and is the core part of the artificial lens for realizing the dioptric function, and the periphery of the optical part 1 of some artificial lenses is provided with a connecting part 3 connected with the supporting part 2. The diameter of the optic portion 1 of the intraocular lens is equal to or greater than 4.2mm, preferably the diameter of the optic portion 1 of the intraocular lens is between 4.5mm and 6.5mm, more preferably the diameter of the optic portion 1 of the intraocular lens is between 5.0mm and 6.0 mm. The optical part 1 of the artificial lens, the connecting part 3 of the periphery of the optical part 1 and the supporting part 2 jointly form the main body of the artificial lens, and the diameter 5 of the main body of the artificial lens is between 5.5mm and 8.0mm, preferably between 6.0mm and 7.5mm, and more preferably between 6.2mm and 7.0 mm. The support part 2, for example a haptic, is used for position fixation after implantation of the intraocular lens. Preferably, the present invention employs plate haptics or flat haptics. In some embodiments, the support portion 2 of the intraocular lens has a positioning hole or hole 6 to facilitate the flow of aqueous humor.

In some embodiments, the central thickness of the intraocular lens is between 0.05mm and 0.50mm, preferably between 0.08mm and 0.20mm, more preferably between 0.10mm and 0.15 mm. As shown in fig. 1b, the lens vault height 7 refers to the distance between the lens apex plane, which is perpendicular to the optical axis, proximal to the natural lens, and the lens plane, which is perpendicular to the optical axis, closest to the cornea when unstressed. In some embodiments, the intraocular lens vault height 7 is between 1.00mm and 1.80mm, preferably between 1.10mm and 1.60mm, more preferably between 1.20mm and 1.50 mm.

The intraocular lens of the present invention has a negative diopter, preferably the intraocular lens has a diopter of 0 to-30.0D in aqueous humor, more preferably the intraocular lens has a diopter of 0 to-25.0D in aqueous humor, more preferably the intraocular lens has a diopter of-3.0D to-25.0D in aqueous humor. The anterior and posterior surfaces of the optic portion of the intraocular lens are plano-concave, biconcave, or convex-concave structures, preferably the optic portion of the intraocular lens is biconcave. At least one surface of the optical part of the artificial lens is an aspheric surface, the front surface of the optical part can be an aspheric surface, the back surface of the optical part can be an aspheric surface, and the front surface and the back surface of the optical part can be both aspheric surfaces.

The intraocular lenses of the invention are capable of providing a desired spherical aberration and/or diopter upon sufficient imbibition of water. Preferably, the lenses of the invention provide, after sufficient imbibition, a spherical aberration of zero and/or a diopter of 0 to-30.0D, preferably-3.0D to-25.0D.

The artificial lens is made of acrylate materials with certain water content, and the materials are soft and foldable after absorbing water and expanding. In some embodiments, the soft foldable acrylate material has a coefficient of expansion between 1.01 and 1.615; preferably, the soft foldable acrylate material has a coefficient of expansion between 1.01 and 1.29; more preferably, the soft foldable acrylate material has a coefficient of expansion between 1.04 and 1.20. The refractive index of the soft foldable acrylate material is between 1.375 and 1.530; preferably, the refractive index of the soft foldable acrylate material is between 1.406 and 1.530; more preferably, the refractive index of the soft foldable acrylate material is between 1.438 and 1.502.

The manufacturing method provided by the invention eliminates the weakening influence of material hydration expansion on the aspheric surface design, eliminates aberration disorder, enables the artificial lens to obtain the expected aberration modification effect, and improves the optical quality of the artificial lens eye.

Figure 5 is a graph of MTF of a phakic intraocular lens manufactured using the present invention and using a conventional manufacturing method (without regard to expansion coefficient) implanted in the same standard human eye model. Therefore, the method adopted by the invention can ensure that the artificial lens eye obtains better optical quality.

Figure 6 is a graph of Seidel aberration distribution after implantation of a phakic intraocular lens using the method of manufacture of the present invention and using a conventional method of manufacture (without consideration of expansion coefficients) in the same standard model human eye. Therefore, the method of the invention can reduce various aberrations of human eyes, eliminate the weakening influence of material hydration expansion on the aspheric surface design and eliminate aberration disorder.

The embodiments described in the foregoing are illustrative only and not limiting, and the embodiments described above may be modified, combined, or substituted without departing from the inventive concepts disclosed herein.

Claims

1. A method of manufacturing an intraocular lens to be implanted in an anterior chamber or a posterior chamber of a human eye having a natural crystalline lens for changing a refractive state of the human eye, the intraocular lens comprising an optical portion, a supporting portion, and a connecting portion at a periphery of the optical portion and connected to the supporting portion, the optical portion including an anterior surface and a posterior surface, at least one of the anterior surface and the posterior surface including an aspherical surface, the intraocular lens being made of a material capable of water-swelling upon hydration, the manufacturing method comprising the steps of:

(d) the artificial lens is fully inflated by water;

(f) comparing the actual parameter with the target parameter;

(h) if the difference between the actual parameter and the target parameter is outside a predetermined threshold range, repeating steps (c) - (g),

wherein, the expression of the curve of the aspheric surface on the two-dimensional coordinate system plane rZ is:

wherein each point on the surface shape of the aspheric surface is obtained by the curve through rotationally symmetrical change around an abscissa axis Z,

wherein the structural parameters include a radius of curvature of the anterior surface, a radius of curvature of the posterior surface, the aspheric coefficients, and the aspheric high-order term coefficients, and

wherein determining structural parameters of the intraocular lens based on the intermediate parameters in step (b) comprises determining radii of curvature of the anterior surface, radii of curvature of the posterior surface, the aspheric coefficients, and the aspheric high order term coefficients based on the intermediate parameters; and wherein step (c) further comprises adjusting the structural parameter according to the coefficient of expansion of the material prior to fabricating the intraocular lens from the material prior to imbibition of water according to the structural parameter, wherein adjusting the structural parameter according to the coefficient of expansion of the material comprises:

dividing the determined radius of curvature of the anterior surface by k,

dividing the determined radius of curvature of the posterior surface by k, an

，

Wherein k is the coefficient of expansion of the material.

2. The manufacturing method according to claim 1, wherein the target parameter comprises a target diopter and/or a target spherical aberration, and the intermediate parameter comprises an intermediate diopter and/or an intermediate spherical aberration, wherein the target diopter is a diopter expected to be achieved after the intraocular lens is fully water-swelled, the target spherical aberration is a spherical aberration expected to be achieved after the intraocular lens is fully water-swelled, the intermediate diopter is a diopter before the intraocular lens is water-swelled, and the intermediate spherical aberration is a spherical aberration before the intraocular lens is water-swelled.

3. The manufacturing method according to claim 2, wherein the target spherical aberration is zero.

4. The manufacturing method according to claim 2, wherein the target diopter is 0 to-30.0D.

5. The manufacturing method according to claim 2, wherein the target diopter is from-3.0D to-25.0D.

6. The manufacturing method according to claim 2, wherein the determining the intermediate parameter of the intraocular lens before water swelling according to the target parameter in step (b) comprises: determining the intermediate diopter to be equal to a target diopter and/or determining the intermediate spherical aberration to be equal to a target spherical aberration.

7. The manufacturing method according to claim 2, wherein the determining the intermediate parameter of the intraocular lens before water swelling according to the target parameter in step (b) comprises: determining the intermediate diopter as a more negative value than the target diopter and/or determining the intermediate spherical aberration as a more positive value than the target spherical aberration.

8. The method of manufacturing of claim 2, wherein adjusting the intermediate parameter in step (g) comprises: adjusting the intermediate diopter to a more negative value than the target diopter and/or adjusting the intermediate spherical aberration to a more positive value than the target spherical aberration.

9. The method of claim 1, wherein the material is an acrylate based material having a coefficient of expansion of between 1.01 and 1.615.

10. The method of claim 1, wherein the material is an acrylate material having a coefficient of expansion of between 1.01 and 1.29.

11. The method of claim 1, wherein the material is an acrylate material having a coefficient of expansion of between 1.04 and 1.20.

12. The method of claim 1, wherein the material is an acrylate material having a refractive index between 1.38 and 1.55.

13. The method of claim 1, wherein the material is an acrylate material having a refractive index between 1.44 and 1.53.

14. The method of claim 1, wherein the material is an acrylate material having a refractive index between 1.48 and 1.51.

15. The method of claim 1, wherein the material is an acrylate material having a moisture content of between 3.5% and 74.5%.

16. The method of claim 1, wherein the material is an acrylate material having a moisture content of between 6% and 38%.

17. The method of claim 1, wherein the material is an acrylate material having a moisture content of between 8% and 20%.

18. The method of manufacturing of claim 1, wherein the intraocular lens has an overall diameter of between 11.0mm and 14.5 mm.

19. The method of manufacturing of claim 1, wherein the intraocular lens has an overall diameter of between 11.5mm and 14.2 mm.

20. The method of manufacturing of claim 1, wherein the intraocular lens has an overall diameter of between 11.8mm and 13.9 mm.

21. The manufacturing method according to claim 1, wherein a diameter of the optical portion is 4.2mm or more.

22. The method of manufacturing of claim 1, wherein the optical portion has a diameter between 4.5mm and 6.5 mm.

23. The method of manufacturing of claim 1, wherein the optical portion has a diameter between 5.0mm and 6.0 mm.

24. The method of manufacturing of claim 1, wherein the optic portion and the connecting portion together comprise a body of an intraocular lens, the body having a diameter between 5.5mm and 8.0 mm.

25. The method of manufacturing of claim 1, wherein the optic portion and the connecting portion together comprise a body of an intraocular lens, the body having a diameter of between 6.0mm and 7.5 mm.

26. The method of manufacturing of claim 1, wherein the optic portion and the connecting portion together comprise a body of an intraocular lens, the body having a diameter of between 6.2mm and 7.0 mm.

27. The method of manufacturing of claim 1, wherein the intraocular lens has a center thickness of between 0.05mm and 0.50 mm.

28. The method of manufacturing of claim 1, wherein the intraocular lens has a center thickness of between 0.08mm and 0.20 mm.

29. The method of manufacturing of claim 1, wherein the intraocular lens has a center thickness of between 0.10mm and 0.15 mm.

30. The method of manufacturing of claim 1, wherein the intraocular lens has an arch height of between 1.00mm and 1.80 mm.

31. The method of manufacturing of claim 1, wherein the intraocular lens has an arch height of between 1.10mm and 1.60 mm.

32. The method of manufacturing of claim 1, wherein the intraocular lens has an arch height of between 1.20mm and 1.50 mm.

33. An intraocular lens manufactured using the manufacturing method of any one of claims 1-32.