A large optical zone intraocular lens based on edge phase technology

By adopting a large optical zone intraocular lens based on edge phase technology in ICL, the phase structure and micro-phase structure are optimized, and the problem of optical interference in traditional ICL in dark field and large pupils is solved, which significantly improves the visual quality of patients.

CN119126408BActive Publication Date: 2025-03-28SHANGHAI JINGWEIER MEDICAL TECHNOLOGY CO
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Patent Information

Application Number
CN202411622861.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-11-14
Publication Date
2025-03-28
Estimated Expiration
2044-11-14

AI Technical Summary

Technical Problem

Traditional ICLs will experience optical interference such as halo and glare in dark field environments, especially in large pupils, reducing the patient's visual quality and life experience.

Method used

A large optical zone intraocular lens based on edge phase technology is adopted. The lens includes a lens optical zone and a plate-type support beam. The lens optical zone is composed of a planar concave lens composed of two optical surfaces. The rear surface is a phase lens with light field modulation capability. By optimizing the phase structure and micro-phase structure, the light field modulation capability is enhanced.

Benefits of technology

It significantly improves the imaging quality of patients in dark environments and large pupils, reduces halo and glare interference, and improves visual quality.

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Abstract

The present invention discloses a large optical zone intraocular lens based on edge phase technology, and specifically relates to the field of intraocular lenses, wherein the intraocular lens comprises an intraocular lens body and a plate-type support haptic; the intraocular lens body comprises a lens optical zone providing light field modulation, the plate-type support haptic is arranged at the edge of the lens optical zone, and the plane where the plate-type support haptic is located forms a certain angle with the plane where the intraocular lens body is located; the lens optical zone comprises a plano-concave lens composed of two optical surfaces, the front surface of the plano-concave lens close to the iris after implantation into the eye is a plane, and the surface of the plano-concave lens close to the natural lens after implantation into the eye is a rear surface; the rear surface is a phase lens with light field modulation capability, and the light field is imaged at the retina through the lens. The invention has the effect of improving the visual quality of dark field.
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Description

Technical Field

[0001] The invention relates to the technical field of artificial lenses, in particular to a large optical zone intraocular lens based on edge phase technology. Background Art

[0002] At present, phakic intraocular lens implantation is a surgical method for correcting myopia in the refractive surgery market, which is on par with excimer laser surgery. It is suitable for all myopia surgery patients, especially those with thin cornea, dry eyes, high myopia of more than 600 degrees, and those with high requirements for visual quality. Implantable myopia lenses are implanted in the ciliary sulcus between the iris and the natural lens of the human eye to treat refractive errors. They have very good therapeutic effects for patients who need to remove the lenses and high myopia. The lenses have good biocompatibility, and their effectiveness and safety have been widely verified.

[0003] The characteristics of the surgery are: no corneal cutting, maintaining the natural corneal shape, the surgery is safe and reversible, the myopic lens can be removed from the human eye at any time, and the visual quality is high. Phakic intraocular lens implantation surgery is the future development trend of refractive surgery. With the further improvement of surgical standardization and corresponding safety, especially in recent years, ICL as a way of myopia correction has been accepted by more and more people. In the future, more people will choose this method to correct myopia. With the emergence of domestic brands, the price of single products will gradually decrease in the future, which will allow more myopic patients to choose this type of product. The proportion of products in myopia correction will gradually increase. It can be foreseen that sales will maintain a high growth trend for a long time in the future.

[0004] However, in a dark field environment, especially when the patient's pupil is relatively large, the traditional technical solution will cause optical interference such as halo and glare in EVO ICL, which reduces the patient's visual quality and life experience. For the vast majority of patients, their adaptability to this product is further prolonged, affecting their confidence in such products. Summary of the invention

[0005] In view of the shortcomings of the prior art, an object of the present invention is to provide an intraocular lens with a large optical zone based on edge phase technology.

[0006] The above object of the present invention is achieved through the following technical solutions:

[0007] An intraocular lens with a large optical zone based on edge phase technology, comprising an intraocular lens body and a plate-type support haptic;

[0008] The intraocular lens body comprises an optical zone of the lens providing light field modulation, the plate-type support haptics are arranged at the edge of the optical zone of the lens, and the plane where the plate-type support haptics are located forms a certain angle with the plane where the intraocular lens body is located;

[0009] The optical zone of the lens includes a plano-concave lens composed of two optical surfaces, the front surface of the plano-concave lens close to the iris after implantation is a plane, and the surface of the plano-concave lens close to the natural lens after implantation is a rear surface;

[0010] The rear surface is a phase lens with light field modulation capability, and the light field is imaged at the retina position through the lens.

[0011] Furthermore, the phase lens is formed by combining (i, j) phase structures in a certain period, and the phase function of the phase lens in a single period is determined according to the following formula (1):

[0012] H i (r) = A i -B i ×tan -1 [-1 / 2+1 / 2cos[π(r 2 -r i1 2 ) / (r j 2 -r i1 2 )]], i = 1...N, N is an integer, j = 1...M, M is an integer; (1)

[0013] In the above formula (1), the vertex of the optical surface is taken as the origin O, the optical axis is taken as the coordinate Z axis, and an arbitrary spatial polar coordinate system is established. r is the radial coordinate, and r i1 is the initial phase coordinate, r j is the end phase coordinate, N is the maximum number of edge phase structures, A i is the reference phase coefficient of the i-th phase structure, B i is the phase modulation amplitude of the i-th phase structure;

[0014] The reference phase coefficient A of the phase lens in the optical zone of the lens ranges from 0 to 100;

[0015] The phase modulation amplitude B of the phase lens in the optical zone of the lens is in the range of 0 to 1;

[0016] The maximum edge phase structure number N of the phase lens in the optical zone of the lens is in the range of 0 to 10;

[0017] H i (r) ranges from 0 to 22.7.

[0018] Furthermore, at least part of the microphase structure has a size in the range of 0.5 to 5 times the incident wavelength.

[0019] Furthermore, the optical zone of the lens is a combined phase-type lens, and the radial width of the optical zone of the lens ranges from 1 mm to 8 mm.

[0020] Furthermore, the range of A is between 0 and 24.

[0021] Furthermore, the range of B is between 0.3 and 0.6.

[0022] Furthermore, the range of N is between 2 and 6.

[0023] Furthermore, the size of the microphase structure is in the range of 0.5 to 2 times the incident wavelength.

[0024] Furthermore, the refractive index of the optical zone of the lens and the plate-type support haptic is 1.4 to 1.6, and the water content is 8% to 60%.

[0025] Furthermore, at least one circular water conducting hole is distributed on the periphery of the optical zone of the lens, and the diameter of the circular water conducting hole ranges from 0.2 to 0.4 mm.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] This patented invention uses edge phase technology for the first time, which greatly improves the imaging quality of patients in dark environments and with large pupils. In the process of optimizing the single-cycle phase structure, this technology continuously adds new micro-phase structures to the edge of the initial micro-phase structure, thereby increasing the details of the micro-structure and the phase modulation capability, thereby ultimately improving the visual quality of the dark field. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A schematic diagram of an intraocular lens based on edge phase technology disclosed in Example 1 of the present invention and implanted in a LeGrand simplified eye model;

[0029] Figure 2 A schematic top view of an intraocular lens based on edge phase technology disclosed in Example 1 of the present invention;

[0030] Figure 3 A schematic side view of an intraocular lens based on edge phase technology disclosed in Example 1 of the present invention;

[0031] Figure 4 An initial phase distribution diagram of a microstructure in a single cycle of an intraocular lens based on edge phase technology disclosed in Example 1 of the present invention;

[0032] Figure 5A distribution diagram of an intraocular lens based on edge phase technology disclosed in Example 2 of the present invention after adding edge phase in a single cycle;

[0033] Figure 6 This is the MTF imaging quality and effect diagram of the intraocular lens of Comparative Example 1 in the LB model eye, with a 5mm aperture and a -16D lens implanted.

[0034] Figure 7 This is a diagram of the MTF imaging quality and effect of an implantable posterior chamber myopic intraocular lens based on marginal phase technology disclosed in Example 1 of the present invention in an LB model eye with a 5mm aperture and -16D lens implanted.

[0035] Figure 8 This is a comparative experimental diagram of the glare of the intraocular lenses of Comparative Example 1 and Example 1 at an aperture of 5 mm in an ISO model eye.

[0036] Fig. 9 : is a comparison diagram of the MTF curves of the intraocular lenses of Comparative Example 1 and Example 1 at an aperture of 5 mm in an ISO model eye.

[0037] Figure numerals: 1. cornea; 2. intraocular lens; 3. natural lens; 4. optical zone of lens; 5. plate support haptic; 6. water guide hole. DETAILED DESCRIPTION

[0038] The present invention is described in detail below in conjunction with embodiments.

[0039] Example 1

[0040] A large optical zone intraocular lens based on edge phase technology disclosed in Example 1 of the present invention comprises an intraocular lens body and a plate-type support haptic;

[0041] The intraocular lens body includes an optical zone of the lens for providing light field modulation, and the plate-type support haptic is arranged at the edge of the optical zone of the lens, and the plane where the plate-type support haptic is located forms a certain angle with the plane where the intraocular lens body is located;

[0042] The optical zone of the lens includes a plano-concave lens composed of two optical surfaces. The front surface of the plano-concave lens close to the iris after implantation is a plane, and the surface of the plano-concave lens close to the natural lens after implantation is a rear surface.

[0043] The rear surface is a phase lens with light field modulation capability, and the light field is imaged at the retina through the lens.

[0044] Figure 1The light field distribution state of a large optical zone intraocular lens based on edge phase technology disclosed in Example 1 of the present invention in the LeGrand simplified eye model is shown. The simplified eye model is used to describe the optical properties of the cornea 1. The parameters of the entire eye model are shown in Table 1. An implantable myopic intraocular lens 2 is inserted in front of the natural lens 3. The front surface is set as a plane, and the rear surface is a phase lens surface. The parameters of the entire combined system are shown in Table 2. The material of the intraocular lens 2 of Example 1 is hydrophilic polymethacrylate, the material refractive index is 1.442, the Abbe number is 50; the designed optical focal length is -16D; the designed wavelength λ is 0.546um; the optical zone diameter is 6.0mm; and the center thickness is 0.13mm.

[0045] In some optional implementations of some embodiments, at least one circular water guide hole is distributed around the optical zone of the lens, and the diameter of the circular water guide hole ranges from 0.2 to 0.4 mm. In embodiment 1, the diameter of the circular water guide hole is 0.2 mm.

[0046] Figure 2 and Figure 3 They are respectively a top view and a side view of the intraocular lens of Example 1. As can be seen from the figure, the hole in the center of the optical zone is mainly responsible for the circulation and flow of aqueous humor, and the two holes in the haptic angle play a role in distinguishing the front and back sides of the lens. In order to ensure better aqueous humor flow at the edge of the iris, four water guide holes 6 are added to better ensure that the aqueous humor flows more smoothly after the pupil is enlarged. As can be seen from the side view, the slope of the plate haptic basically presents a certain angle with the chamber angle, ensuring that the haptic of the lens does not contact the iris tissue of the human eye, and the haptic angle is inserted into the tissue near the ciliary sulcus, which plays a role in fixing the artificial lens.

[0047] Table 1 Le Grand simplified eye model parameters

[0048]

[0049] Table 2 Model parameters after implantation of intraocular lens

[0050]

[0051] In some optional implementations of some embodiments, within a certain period of the phase structure of the optical zone of the lens, (i, j) phase structures are combined to form a phase lens, wherein the phase function of the phase lens within a single period is determined according to the following formula (1):

[0052] H i (r) = A i -B i ×tan -1 [-1 / 2+1 / 2cos[π(r 2 -r i1 2) / (r j 2 -r i1 2 )]], i = 1...N, N is an integer, j = 1...M, M is an integer; (1)

[0053] In the above formula (1), the vertex of the optical surface is taken as the origin O, the optical axis is taken as the coordinate Z axis, and an arbitrary spatial polar coordinate system is established. r is the radial coordinate, and r i1 is the initial phase coordinate, r j is the end phase coordinate, N is the maximum number of edge phase structures, A i is the reference phase coefficient of the i-th phase structure, B i is the phase modulation amplitude of the i-th phase structure; i refers to the phase structure, j refers to the end point of the phase structure; H i (r) refers to the phase function with respect to the radial coordinate r;

[0054] The maximum phase difference of the i-th phase structure is determined by the following formula, where RI icl is the refractive index of the phase-changing lens, RI aqueous is the refractive index of the surrounding medium, the aqueous humor:

[0055] Phase_wave i =H i (r)×(RI icl -RI aqueous ) / 0.546

[0056] In order to enable the phase lens to provide a certain refractive power, within a single cycle, it is necessary to calculate the reference phase coefficient and modulation amplitude of the i-th microstructure through an optimization algorithm, so that it can simultaneously meet the high refractive efficiency and refractive power as well as the ability to correct some other aberrations. At the same time, it is necessary to continuously add new microphase structures to the edge of the original microphase structure during the optimization, that is, continuously increase the number of i, and continuously iterate to finally achieve the desired purpose. In some optional implementations of some embodiments, the reference phase coefficient A of the phase lens in the optical zone of the lens is in the range of 0 to 100, preferably, A is in the range of 0 to 24. The phase modulation amplitude B of the phase lens is in the range of 0 to 1, preferably, B is in the range of 0.3 to 0.6. H i(r) ranges from 0 to 22.7, preferably from 0 to 5. Some microphase structure sizes are in the range of 0.5 to 5 times the incident wavelength, preferably, the microphase structure size is in the range of 0.5 to 2 times the incident wavelength, reflecting obvious vector light field characteristics; in some optional implementations of some embodiments, the maximum edge phase structure number N of the phase lens in the optical zone of the lens ranges from 0 to 10, preferably, N ranges from 2 to 6. In some optional implementations of some embodiments, the refractive index of the optical zone of the lens and the plate-type support haptic is 1.4 to 1.6, and the water content is 8% to 60%. In some optional implementations of some embodiments, the optical zone of the lens is a combined phase lens, and the radial width of the optical zone of the lens ranges from 1 mm to 8 mm.

[0057] The phase function (I-type phase) of the phase lens of Example 1 in a single cycle is as follows: Figure 4 As shown, the maximum number N of edge phase structures of the phase lens is 1.

[0058] The difference between Example 2 and Example 1 is that the maximum edge phase structure number N of the phase lens is 1. The phase function (type II phase) of the phase lens of Example 2 in a single cycle is as follows: Figure 5 As shown,

[0059] Figure 4 Type I phase is a continuous phase distribution. The smoothly rising phase distribution and the gradually decreasing phase distribution are not symmetrical, which makes it convenient for the light incident on the edge to have relatively high energy at a specified position, increases the degree of freedom, and plays a role in targeted energy adjustment.

[0060] Figure 5 It is based on the Type I phase distribution. By continuously iteratively adding Type I phase to the edge of Type I phase, a spatially discrete phase distribution structure is continuously formed at the edge of a single period, that is, a Type II phase distribution structure is constructed. The phase height and symmetry of the superimposed phase structure can be freely adjusted and set. The adjustment ability of a single Type I phase is limited, and the degree of freedom is only reflected in the depth direction. After constructing Type II phase distribution within a single period, the energy intensity and distribution state of the incident light incident on the area can be more flexibly controlled.

[0061] Comparative Example

[0062] Comparative Example 1 uses the EVO ICL intraocular lens currently available on the market.

[0063] Detection Methods

[0064] Curing performance test

[0065] 1. MTF imaging quality and effect picture test

[0066] Figure 6 This is the MTF imaging quality and effect diagram of the Le Grand model eye with a 5mm aperture and EVO ICL-16D lens (Comparative Example 1) implanted. Figure 6 It can be seen that when the Le Grand model eye is used for simulation, the aperture is also increased to 5mm to simulate the state of a dark environment. The MTF is at low frequency, about 10lp / mm, and there is an obvious depression. This position corresponds exactly to the area where the human eye has the most sensitive contrast sensitivity, which will make the patient feel very obvious visual interference. From the point diagram on the right, it can be seen that there is a circle of obvious halo around the strong light spot in the center. This explains why patients, especially those with high myopia, have obvious halo interference after implanting the EVO ICL. The light at the center point can be well focused on the retina to form a clearer image, but the peripheral light cannot provide refractive power due to the limitation of the effective optical zone, thus forming a focus in front of the retina, causing visual interference.

[0067] Figure 7 This is the MTF imaging quality and effect diagram of the Le Grand model eye with a 5mm aperture and SEAT ICL-16D lens (Example 1) implanted. Figure 7 It can be seen that when the Le Grand model eye is used for simulation, the aperture is also increased to 5mm to simulate the state of a dark environment. The MTF does not show a depression at low frequencies. Therefore, after implanting such an intraocular lens, it is conceivable that there will be no visual interference such as halos. It can be seen from the point diagram that there is no obvious halo around the strong center, and the light in the center and the periphery is very well focused on the retina. The actual imaging optical path diagram also proves this. Therefore, due to the introduction of edge phase technology, not only visual interference is greatly reduced, but also visual quality is improved.

[0068] 2. Glare contrast experiment

[0069] Figure 8 This is a glare comparison test diagram of EVO ICL (Comparative Example 1) and SEAT ICL (Example 1) in an ISO model eye with an aperture of 5mm. The experimental test uses a standard ISO eye model. In order to test the dark environment, the test aperture is 5mm, and the refractive power of the lens is -16D. It can be seen from the figure that it is very close to the theoretical simulation. For EVO ICL, there are several very obvious halos around the central bright spot, while for SEAT ICL, there is no aperture around, and the focus is very clear. This also proves from one aspect that the implantable intraocular lens based on edge phase technology has greatly improved the glare interference at night.

[0070] 3. Comparison of MTF curves

[0071] Fig. 9 This is a comparison chart of the MTF curves of EVO ICL (Comparative Example 1) and SEAT ICL (Example 1) in the ISO model eye with an aperture of 5 mm. Different from the theoretical simulation, this is the result of actual measurement using a standard ISO eye model with an aperture of 5 mm, which is also used to simulate a dark environment. The MTF curve is a very effective tool for evaluating visual quality. As can be seen from the figure, an obvious depression can be seen at the low-frequency position of the EVO ICL, which is completely consistent with the theoretical simulation. This is also one of the reasons for the halo. However, for the SEAT ICL, the curve is very smooth and there is no mutation.

[0072] The above is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention. It should be pointed out that for ordinary technicians in this technical field, some improvements and modifications without departing from the principle of the present invention should also be regarded as the protection scope of the present invention.

Claims

1. A large optical zone intraocular lens based on edge phase technology, characterized in that: The intraocular lens comprises an intraocular lens body and a plate-type support haptic; The intraocular lens body comprises an optical zone of the lens providing light field modulation, the plate-type support haptics are arranged at the edge of the optical zone of the lens, and the plane where the plate-type support haptics are located forms a certain angle with the plane where the intraocular lens body is located; The optical zone of the lens includes a plano-concave lens composed of two optical surfaces, the front surface of the plano-concave lens close to the iris after implantation is a plane, and the surface of the plano-concave lens close to the natural lens after implantation is a rear surface; The rear surface is a phase lens with light field modulation capability, and the light field is imaged at the retina through the lens; The phase lens is formed by combining (i, j) phase structures in a certain period, and the phase function of the phase lens in a single period is determined according to the following formula (1): H i (r) = A i -B i ×tan -1 [-1 / 2+1 / 2cos[π(r 2 -r i1 2 ) / (r j 2 -r i1 2 )]], i = 1...N, N is an integer, j = 1...M, M is an integer; (1) In the above formula (1), the vertex of the optical surface is taken as the origin O, the optical axis is taken as the coordinate Z axis, and an arbitrary spatial polar coordinate system is established. r is the radial coordinate, and r i1 is the initial phase coordinate, r j is the end phase coordinate, N is the maximum number of edge phase structures, A i is the reference phase coefficient of the i-th phase structure, B i is the phase modulation amplitude of the i-th phase structure; i refers to the phase structure, j refers to the end point of the phase structure; H i (r) refers to the phase function with respect to the radial coordinate r; The reference phase coefficient A of the phase lens in the optical zone of the lens ranges from 0 to 100; The phase modulation amplitude B of the phase lens in the optical zone of the lens is in the range of 0.3 to 0.6; The maximum edge phase structure number N of the phase lens in the optical zone of the lens is in the range of 2 to 6; H i (r) ranges from 0 to 22.

7.

2. The large optical zone intraocular lens based on edge phase technology according to claim 1, characterized in that: The size of at least part of the microphase structure is in the range of 0.5 to 5 times the incident wavelength.

3. The large optical zone intraocular lens based on edge phase technology according to claim 1, characterized in that: The optical zone of the lens is a combined phase type lens, and the radial width of the optical zone of the lens ranges from 1 mm to 8 mm.

4. The large optical zone intraocular lens based on edge phase technology according to claim 1, characterized in that: The range of A is between 0 and 24.

5. The large optical zone intraocular lens based on edge phase technology according to claim 1, characterized in that: The size of the microphase structure is in the range of 0.5 to 2 times the incident wavelength.

6. The large optical zone intraocular lens based on edge phase technology according to claim 1, characterized in that: The refractive index of the lens optical zone and the plate-type support haptic is 1.4-1.6, and the water content is 8%-60%.

7. The large optical zone intraocular lens based on edge phase technology according to claim 1, characterized in that: At least one circular water conducting hole is distributed on the periphery of the optical zone of the lens, and the diameter of the circular water conducting hole ranges from 0.2 to 0.4 mm.

Citation Information

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