CN113040976B - Ultrathin zero-spherical-aberration implantable myopia lens - Google Patents
Ultrathin zero-spherical-aberration implantable myopia lens Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
Abstract
The invention discloses an ultrathin zero-spherical-aberration implantable myopia lens, which is made of transparent hydrophilic polymethacrylate materials, comprises an optical area of the lens and a plate-shaped supporting loop along the edge of the optical area of the lens, is used for correcting the eyesight of myopia by surgical implantation, and is positioned behind the iris and in front of a natural crystalline lens (ciliary sulcus); the optical area of the lens has zero spherical aberration distribution, does not cause the change of the total spherical aberration of human eyes after being implanted, corrects the vision and simultaneously increases the natural comfort of the eyes of a patient after operation.
Description
Technical Field
The invention relates to the technical field of production and manufacture of intraocular lenses for crystalline eyes, in particular to a design method of an ultrathin zero-spherical-aberration implantable myopia lens.
Background
According to the research report published by the world health organization in 2018, the proportion of myopic eyes in China is higher than that in the world, the myopic population is as high as 6 hundred million, and the myopia of young people is a big problem which troubles modern families. Today, we have mastered a number of methods of correcting myopia. The simplest method is to wear the glasses, and although the glasses are worn effectively, a plurality of situations that the glasses are inconvenient to wear or are not recommended to wear exist in life, for example, near-sighted patients enter a room with normal temperature in a cold environment, and water mist can be generated on the surfaces of the glasses; for example, for athletes engaged in extreme sports, the glasses may be dangerous to slide off. Furthermore, many people prefer to use less obvious corrective measures for aesthetic reasons. Contact lenses have been produced, and although contact lenses look natural when worn, they are inconvenient to use and care, can scratch the cornea when improperly cleaned, and are prone to protein deposits that must be replaced after a period of use. Since the last 90 s, LASIK is well established for correcting vision and eliminating the trouble of wearing glasses or contact lenses for myopia. However, LASIK is not suitable for all people, and is not recommended for patients with central corneal thickness less than 0.5 mm. In addition, another disadvantage of LASIK is that the surgical procedure is not reversible, and the cornea cannot return to its original state after being cut, which has a certain hidden trouble.
The implantable myopia lens sheet has the advantages over the previous correction means, and the greatest advantage is that the implantable myopia lens sheet can be implanted and taken out when needed. However, the lens sheet for myopia can be implanted at the position of the ciliary sulcus of the human eye, and the axial space is relatively narrow. If the gap between the lens sheet and the natural crystalline lens is too small or the lens sheet and the natural crystalline lens are in contact with each other after implantation, a secondary cataract is likely to occur. In chinese patent CN201710010110, wang 26316and so on control the gap between the lens sheet and the natural crystalline lens by the design of the biconcave optical zone. This design, though, increases the clearance relative to the plano-concave spherical optical zone. However, for the same material and under the same clear aperture, the higher the power of the near-sighted lens sheet is, the edge thickness is still thicker (limited to the spherical surface type), and the safety gap between the lens sheet and the natural crystalline lens is difficult to further increase. In US20070162118a1 George et al smoothly chamfers the iris side upper optic and haptic junction to reduce the thickness of the optic edge but sacrifice the size of the active optic.
Meanwhile, implantable myopia lenses on the market are all spherical, such as the ICL of STRRA Surgical company and the PRL of Ehrlich company, which are all designed to be spherical, and the spherical lenses have inherent spherical aberration. Spherical aberration is one of the higher-order aberrations, and has a large influence on the visual quality of the human eye. The cornea of a normal human eye is positively spherical, while the natural lens is negatively spherical, and the two are negatively and positively cancelled. As shown in fig. 5, the total spherical aberration of the whole eye of a human eye is related to the diameter of the pupil, and the total spherical aberration tends to be zero at the pupil diameter of 3 mm; beyond 3mm, the spherical aberration gradually increases. The preferred design of an implantable myopic lens sheet should be zero spherical aberration and not cause spherical aberration variation across the eye beyond the 3mm optic zone.
Disclosure of Invention
In view of the defects of the prior art, the applicant of the invention provides a design of an ultrathin zero-spherical-aberration implantable myopia lens sheet. The optical area has ultrathin axial thickness, increases the safety clearance between the implanted lens and the natural crystalline lens, reduces the risk of after cataract and is convenient for surgical implantation or taking out; and the optical area has zero spherical aberration distribution in the 3mm diameter shaft section, the total eyeball difference change is not caused beyond 3mm, and the natural comfort of postoperative crystal eye imaging is improved.
The technical scheme of the invention is as follows:
an ultrathin zero-spherical-aberration implantable myopia lens sheet comprises an optical area of an optical lens and a plate-shaped supporting loop along the edge of the optical area of the optical lens, wherein the included angle between the plane where the supporting loop is located and the plane where a main body of the optical lens is located is 10-20 degrees, the optical area of the optical lens is a concave-plano-type round lens and consists of two optical surfaces, the front surface (the surface close to an iris after implantation) is a plane, and the back surface (the surface close to a natural crystalline lens after implantation) is a rotationally symmetric free curved surface;
the method for determining the free-form surface comprises the following steps: the method comprises the following steps of establishing an arbitrary space rectangular coordinate system by taking a vertex of an optical surface as an origin O and an optical axis as a coordinate Z axis, wherein an X axis and a Y axis of a horizontal coordinate of the coordinate system are tangent to the optical surface, and a projection curve of a free curved surface on a Y-Z plane has a characterization equation of 5-order polynomial, and the characterization equation is as follows:
z(y)＝p1×y5+p2×y4+p3×y3+p4×y2+p5×y+p6
Wherein Z (Y) is a projection curve expression of the free-form surface on a plane Y-Z of a two-dimensional coordinate system, Y is a vertical distance from any point on the curve to a coordinate Z axis, p1, p2, p3, p4, p5 and p6 are polynomial coefficients, and the polynomial coefficients are obtained by optimization in ZEMAX software;
the optical zone has an ultra-thin axial thickness in the range of 0.2mm to 0.4 mm. Especially at the edge of the optical zone, the thickness of the optical zone edge is reduced by 30 to 80 percent relative to the spherical surface under the same aperture;
after the lens sheet is implanted, the safety gap between the lens and the natural crystalline lens is increased, the risk of after cataract is reduced, and meanwhile, the lens sheet is convenient to implant or take out in an operation;
the optical zone has the distribution characteristic of zero spherical aberration in a 3mm axial section, the optical zone beyond 3mm does not cause the change of the total eyeball aberration (relative to the total spherical aberration before implantation) and does not interfere with the total spherical aberration of an implanted eye;
the diameter of the effective optical area of the optical area is 5.0-6.0mm, and the central thickness of the lens is 0.05-0.2 mm;
the optical area and the support loop of the lens sheet are made of the same material and are integrally formed. The lens sheet is made of hydrophilic polymethacrylate with the refractive index of 1.4-1.6 and the dispersion coefficient of 40-55;
The lens sheet is characterized in that a plurality of small circular holes are formed in the position 2-6mm away from the periphery of the optical area, the diameter of each small circular hole is 0.2-0.6mm, the small circular holes are beneficial to circulation of aqueous humor, and generation of glaucoma is effectively reduced.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly described below.
Fig. 1 is a schematic view of a simulated implantation position of an ultra-thin zero-spherical-aberration implantable myopic lens sheet disclosed in embodiments 1 and 2 of the present invention;
fig. 2 is a schematic front view of an ultra-thin zero-spherical-aberration implantable myopia lens sheet disclosed in embodiments 1 and 2 of the present invention;
fig. 3 is a schematic side view of an ultra-thin zero-spherical-aberration implantable lens for near vision disclosed in embodiment 1 of the present invention;
fig. 4 is a schematic side view of an ultra-thin zero-spherical-aberration implantable lens for myopia according to embodiment 2 of the present invention;
FIG. 5 is a diagram of normal eye spherical aberration with pupil diameter;
fig. 6 is a response curve of full-eye MTF versus spatial frequency after the implantation of the ultrathin zero-spherical-aberration implantable myopic lens sheet disclosed in embodiment 1 of the present invention;
Fig. 7 is a curve of full-eye MTF versus spatial frequency response after implantation simulation of an ultra-thin zero-spherical-aberration implantable lens sheet for myopic eyes as disclosed in embodiment 1 of the present invention;
fig. 8 is a comparison of the cross-sectional profiles of an ultra-thin zero-spherical-aberration implantable myopic lens sheet and an iso-power spherical lens disclosed in embodiment 1 of the present invention;
fig. 9 is a comparison of the cross-sectional profiles of an ultra-thin zero-spherical-aberration implantable myopic lens sheet and an iso-power spherical lens disclosed in embodiment 2 of the present invention;
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention.
Example 1
The design material of example 1 is hydrophilic polymethacrylate, the material refractive index is 1.46, and the abbe number is 45; designing the focal power to be-12D; the design wavelength lambda is 0.546 um; the diameter of the optical zone is 6.0 mm; the center thickness is 0.11 mm.
As shown in fig. 1, in a front view of example 1, example 1 includes an optic zone which is a plano-concave type round lens composed of two optical surfaces, an anterior surface (a surface close to the iris after implantation) which is a flat surface, and a plate-like haptic along the edge of the optic zone, and a posterior surface (a surface close to the natural lens after implantation) which is a rotationally symmetric free-form surface;
The method for determining the free-form surface comprises the following steps: the method comprises the following steps of establishing an arbitrary space rectangular coordinate system by taking a vertex of an optical surface as an origin O and an optical axis as a coordinate Z axis, wherein an X axis and a Y axis of a horizontal coordinate of the coordinate system are tangent to the optical surface, and a projection curve of a free curved surface on a Y-Z plane has a characterization equation of 5-order polynomial, and the characterization equation is as follows:
z(y)＝p1×y5+p2×y4+p3×y3+p4×y2+p5×y+p6
wherein Z (Y) is a projection curve expression of the free-form surface on a plane Y-Z of a two-dimensional coordinate system, Y is a vertical distance from any point on the curve to a Z axis of the coordinate, and p1, p2, p3, p4, p5 and p6 are polynomial coefficients.
In ZEMAX software, a Liou-Brennan eye model was constructed. Liou-Brennan eye model parameters As shown in Table 1, the front surface of the natural crystalline lens is inserted into an implantable myopic lens sheet, the front surface is set to be a plane, and the back surface is expressed by an Extended multinomial surface type Extended polymial.
TABLE 1 Liou-Brennan eye model parameters
The polynomial coefficients of example 1 were obtained by optimizing variables such as Z (4,0), EFL, edge thickness, etc. at different diaphragms:
p1＝0.00021743；
p2＝-0.0016067；
p3＝0.0041546；
p4＝0.026013；
p5＝0.0031607；
p6＝0.000031458。
after the optimization is finished, a simulated MTF curve of the embodiment 1 is obtained in ZEMAX software, and as shown in FIG. 6, the MTF of 100lp/mm is 0.60 under the pupil diameter of 3.0 mm; MTF at 4.6mm pupil diameter of 100lp/mm was 0.44; at a pupil diameter of 6.0mm, the MTF at 100lp/mm was 0.20.
Table 2 shows the axial thickness contrast and safety gap between the ultra-thin zero-spherical-aberration implantable myopic lens sheet disclosed in embodiment 1 of the present invention and the equal-focal-power spherical lens at different pupil diameters;
table 2 example 1 axial thickness comparison
As can be seen from table 2, the axial thickness of example 1 is smaller and the safety gap is larger for the same pupil diameter than for the isopower spherical lens. Particularly at 6.0mm, the axial thickness is reduced by 43.3%. Note: the safety gap analysis was analyzed using the ISO crystalline eye model in fig. 1.
Fig. 8 is a cross-sectional view of a comparison between an ultrathin zero-spherical-aberration implantable myopic lens sheet disclosed in embodiment 1 of the present invention and an isofocal spherical lens, wherein a dotted line represents the isofocal spherical lens, and it can be seen that the axial thickness of embodiment 1 is much smaller than the spherical thickness.
Table 3 shows the total eyeball aberration contrast of the ultra-thin zero-spherical-aberration implantable myopic lens disclosed in embodiment 1 of the present invention before and after implantation, and after implantation of the spherical lens with equal focal power under different pupil diameters,
table 3 example 1 Total Difference of the eyes
As can be seen from table 3, example 1 had zero total spherical aberration at a pupil diameter of 3mm after implantation, and did not cause total spherical aberration change at pupil diameters other than 3 mm. After the spherical lens with the same focal power is implanted, the total eyeball difference changes obviously.
Example 2
The design material of example 2 is hydrophilic polymethacrylate, the material refractive index is 1.46, and the abbe number is 45; the design focal power is-18D; the design wavelength lambda is 0.546 um; the diameter of the optical zone is 5.5 mm; the center thickness is 0.11 mm.
As shown in fig. 1, in a front view of example 2, example 2 comprises an optic zone which is a plano-concave type round lens consisting of two optical surfaces, an anterior surface (a surface close to the iris after implantation) which is a plane surface, and a posterior surface (a surface close to the natural lens after implantation) which is a rotationally symmetric free-form surface, and a plate-like haptic along the edge of the optic zone;
the method for determining the free-form surface comprises the following steps: the method comprises the following steps of establishing an arbitrary space rectangular coordinate system by taking a vertex of an optical surface as an origin O and an optical axis as a coordinate Z axis, wherein an X axis and a Y axis of a horizontal coordinate of the coordinate system are tangent to the optical surface, and a projection curve of a free curved surface on a Y-Z plane has a characterization equation of 5-order polynomial, and the characterization equation is as follows:
z(y)＝p1×y5+p2×y4+p3×y3+p4×y2+p5×y+p6
wherein Z (Y) is a projection curve expression of the free-form surface on a plane Y-Z of a two-dimensional coordinate system, Y is a vertical distance from any point on the curve to a Z axis of the coordinate, and p1, p2, p3, p4, p5 and p6 are polynomial coefficients.
In ZEMAX software, a Liou-Brennan eye model was constructed. Liou-Brennan eye model parameters are shown in Table 1, where the front surface of the natural lens is inserted into an implantable myopic lens sheet, the front surface is set to be a plane, and the back surface is represented by an Extended multinomial surface type.
The polynomial coefficients for example 2 were obtained by optimizing variables such as Z (4,0), EFL, edge thickness under different masks:
p1＝0.001602；
p2＝-0.012006；
p3＝0.029727；
p4＝0.006876；
p5＝0.010538；
p6＝-0.00022072。
after the optimization is finished, a simulated MTF curve of the embodiment 2 is obtained in ZEMAX software, and as shown in FIG. 6, the MTF of 100lp/mm is 0.56 under the pupil diameter of 3.0 mm; at a pupil diameter of 4.0mm, the MTF at 100lp/mm is 0.53; at a pupil diameter of 5.5mm, the MTF at 100lp/mm was 0.23.
Table 4 shows the axial thickness contrast and safety gap between the ultrathin zero-spherical-aberration implantable myopic lens sheet disclosed in embodiment 2 of the present invention and the spherical lens with equal focal power at different pupil diameters;
table 4 example 2 axial thickness comparison
As can be seen from table 4, the axial thickness of example 2 is small relative to the isopower spherical lens and the safety gap is large relative to the isopower spherical lens for the same pupil diameter. Particularly at 5.5mm, the axial thickness is reduced by 78.1%. Note: the safety gap analysis was analyzed using the ISO crystalline eye model in fig. 1.
Fig. 9 is a cross-sectional view of an ultra-thin zero-spherical-aberration implantable lens sheet for a myopic eye disclosed in embodiment 2 of the present invention, which is compared with an isofocal spherical lens in appearance, and a dotted line represents the isofocal spherical lens, and it can be seen that the axial direction of embodiment 2 is much smaller than the spherical thickness.
Table 5 shows the total difference of the eyes before and after the implantation of the ultra-thin zero-spherical-aberration implantable myopia lens disclosed in the invention example 2, and after the implantation of the spherical lens with equal focal power under different pupil diameters,
table 5 example 2 total ocular aberration comparison
As can be seen from table 5, example 2, after implantation, had a total spherical aberration of zero at a pupil diameter of 3mm, and did not cause a total spherical aberration change at pupil diameters other than 3 mm. After the spherical lens with the same focal power is implanted, the total eyeball difference changes obviously.
Claims (6)
1. An ultrathin zero-spherical-aberration implantable myopia lens sheet comprises an optical area of the lens and a plate-shaped supporting loop along the edge of the optical area of the lens, wherein an included angle between the plane where the supporting loop is located and the plane where a lens main body is located is 10-20 degrees, the optical area of the lens is a plano-concave circular lens and consists of two optical surfaces, the surface close to an iris after implantation is a front surface, the front surface is a plane, the surface close to a natural crystalline lens after implantation is a rear surface, the rear surface is a rotationally symmetric free curved surface, the optical area has ultrathin axial thickness, the axial thickness range is 0.2mm-0.4mm, the edge of the optical area is reduced by 30% -50% relative to a spherical surface under the same aperture;
The method for determining the free-form surface comprises the following steps: the method comprises the following steps of establishing an arbitrary space rectangular coordinate system by taking a vertex of an optical surface as an origin O and an optical axis as a coordinate Z axis, wherein an X axis and a Y axis of a horizontal coordinate of the coordinate system are tangent to the optical surface, and a projection curve of a free curved surface on a Y-Z plane has a characterization equation of 5-order polynomial, and the characterization equation is as follows:
z(y)＝p1×y5+p2×y4+p3×y3+p4×y2+p5×y+p6
wherein Z (Y) is a projection curve expression of the free-form surface on a plane Y-Z of a two-dimensional coordinate system, Y is a vertical distance from any point on the curve to a coordinate Z axis, p1, p2, p3, p4, p5 and p6 are polynomial coefficients, and the polynomial coefficients are obtained by optimization in ZEMAX software.
2. The lens sheet of claim 1, wherein implantation increases the safety clearance between the lens and the natural crystalline lens, reduces the risk of posterior cataract, and facilitates surgical implantation or removal.
3. The lens sheet according to claim 1, wherein the optical zone has a zero spherical aberration distribution characteristic in a 3mm axial section, and the optical zone other than the 3mm axial section causes no change in total spherical aberration with respect to before implantation and has no interference with total spherical aberration of an implanted eye.
4. The lens sheet of claim 1, wherein the optical zone has an effective optical zone diameter of 5.0 to 6.0mm and a central thickness of 0.05 to 0.2 mm.
5. The lenticular sheet of claim 1, wherein the optical zone and the haptics are integrally formed of the same material, and the lenticular sheet is made of hydrophilic polymethacrylate having a refractive index of 1.4-1.6 and an abbe number of 40-55.
6. The lens sheet of claim 1, wherein a plurality of circular holes are formed at 2-6mm of the periphery of the optical zone, the diameter of each circular hole is 0.2-0.6mm, and the presence of each circular hole facilitates the flow of aqueous humor and effectively reduces glaucoma.
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