WO2023216540A1 - 一种基于相位调制技术的巩膜接触镜 - Google Patents
一种基于相位调制技术的巩膜接触镜 Download PDFInfo
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- WO2023216540A1 WO2023216540A1 PCT/CN2022/131983 CN2022131983W WO2023216540A1 WO 2023216540 A1 WO2023216540 A1 WO 2023216540A1 CN 2022131983 W CN2022131983 W CN 2022131983W WO 2023216540 A1 WO2023216540 A1 WO 2023216540A1
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- contact lens
- scleral
- cornea
- scleral contact
- phase modulation
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- 238000005516 engineering process Methods 0.000 title claims abstract description 22
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Images
Classifications
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- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C7/00—Optical parts
- G02C7/02—Lenses; Lens systems ; Methods of designing lenses
- G02C7/04—Contact lenses for the eyes
-
- G—PHYSICS
- G02—OPTICS
- G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02B27/00—Optical systems or apparatus not provided for by any of the groups G02B1/00 - G02B26/00, G02B30/00
- G02B27/0012—Optical design, e.g. procedures, algorithms, optimisation routines
-
- G—PHYSICS
- G02—OPTICS
- G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02B27/00—Optical systems or apparatus not provided for by any of the groups G02B1/00 - G02B26/00, G02B30/00
- G02B27/0025—Optical systems or apparatus not provided for by any of the groups G02B1/00 - G02B26/00, G02B30/00 for optical correction, e.g. distorsion, aberration
-
- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C7/00—Optical parts
- G02C7/02—Lenses; Lens systems ; Methods of designing lenses
- G02C7/024—Methods of designing ophthalmic lenses
- G02C7/027—Methods of designing ophthalmic lenses considering wearer's parameters
-
- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C7/00—Optical parts
- G02C7/02—Lenses; Lens systems ; Methods of designing lenses
- G02C7/04—Contact lenses for the eyes
- G02C7/047—Contact lens fitting; Contact lenses for orthokeratology; Contact lenses for specially shaped corneae
-
- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
- G02C2202/22—Correction of higher order and chromatic aberrations, wave front measurement and calculation
Definitions
- the present invention relates to the technical field of scleral contact lenses, and in particular to a scleral contact lens based on phase modulation technology.
- Scleral lenses are a specially designed rigid gas-permeable contact lens. They are named for their large diameter, no contact between the lens and the cornea, the lens spanning the entire cornea, the lens landing in the scleral area, and the middle of the cornea being filled with preservative-free saline. . Large-diameter contact lenses allow the lens to be positioned outside the edge of the cornea, making it considered the best way to correct vision for patients with irregular corneas. For the cornea, only wearing scleral lenses has a real gap without any mechanical friction. . Try to avoid any contact between the lens and the cornea, so that the lens spans the cornea like a bridge, as shown in Figure 1. From a technical point of view, these lenses are not contact lenses, at least they do not come into contact with the corneal surface, and the comfort of the cornea is greatly improved, which is one of the biggest advantages of large-diameter contact lenses.
- scleral lenses have become increasingly popular in Europe and the United States. Due to their personalized design, they have certain advantages in the treatment of refractive correction, irregular cornea, and dry eye. According to the diameter of scleral lenses, they can be divided into corneoscleral lenses (diameter 12.5mm-15mm, contacting part of the cornea), mini scleral lenses (diameter 15mm-18mm, completely touching the sclera) and full scleral lenses (18mm-25mm, completely touching the sclera). ), because mini scleral lenses usually have a small tear storage capacity, good oxygen permeability and visual quality, and have a good corneal apex gap, which can reduce mechanical friction on the central cornea.
- Scleral lenses use rigid gas-permeable scleral contact lens materials, that is, through highly oxygen-permeable RGP materials, materials with different oxygen permeability coefficients are gradually improved.
- the current lens materials mainly come from BOSTON, Menicon and CONTAMAC.
- BOSTON material is currently the most used, most commonly used, and most used material in the world. It has high oxygen permeability and moisture content, and has good comfort.
- BOSTON XO2 material has a wetting angle of 38 and an oxygen permeability coefficient of 141. It has a high With Dk value, good dimensional stability and processability, this material has been applied to rigid gas-permeable contact lenses for orthokeratology. Its safety and effectiveness have been verified.
- the clinical application of scleral lenses generally uses try-on lenses and trial-on evaluation technology.
- the main fitting process is: first, perform corneoscleral topography, slit lamp examination, and OCT anterior segment examination. Obtain the sagittal height from the corneal apex to the landing zone and the corresponding sagittal height difference, and select a suitable trial piece for trial fitting evaluation; use a suction stick to hold the lens before wearing it, fill the lens with physiological saline and fluorescein sodium, and instruct the patient to lower his head vertically. Look at the ground, use your hands to open the upper and lower eyelids as much as possible to expose the eyeball. The doctor helps the patient put on the lens and observe whether there are any bubbles under the lens.
- the ideal vertex tear film gap is about 300 microns. There will be a slight depression when the edge of the lens lands on the sclera. The thickness of the tear layer is significantly reduced after wearing (120-170 microns). Therefore, the fit evaluation should be carried out half an hour after wearing the glasses.
- the corneal limbus should be 360-degree full of fluorescence when observed under a slit lamp.
- the edge of the lens should not compress the bulbar conjunctival blood vessels.
- the limbus is very important for corneal health, especially because stem cells are responsible for producing new epithelial cells, which are dispersed throughout the cornea.
- the tear fluid between the lens and the limbus is very important for the fragile stem cells in the limbus.
- the positioning area compresses the conjunctiva excessively, the blood in the compressed area of the conjunctiva will not be able to pass through the blood vessels, causing the conjunctival blood vessels under the lens to become white.
- scleral lenses also need to be tilted to help tear circulation.
- the warp angle should not be too high. An excessively high warp angle will increase the foreign body sensation and make it easy to feel uncomfortable when wearing it, affecting the wearing comfort. The warp angle can be adjusted by changing the angle of the positioning area.
- subjective refraction and visual acuity examination after wearing glasses are performed to determine the lens diopter.
- rigid scleral contact lenses have the following unique advantages: (1) High oxygen permeability ensures that the surface of the eye receives sufficient oxygen, which greatly reduces complications compared with ordinary soft lenses. It is one of the safest contact lenses currently worn. 1; (2) It has good shaping effect and good optical performance, ensuring that you get clear vision, even high astigmatism, irregular astigmatism, and aphakia will be well corrected; (3) In addition, the adaptation of scleral lenses The symptoms are quite extensive: general myopia, hyperopia, astigmatism, and anisometropia; especially high myopia, high hyperopia, high astigmatism, and irregular astigmatism; patients with keratoconus or presbyopia, due to various refractive corneal surgeries (such as RK, PRK, LASIK), keratoplasty, corneal diseases (such as corneal trauma, keratitis) causing irregular corneal astigmatism; all those who are unable to give up wearing contact lenses due to various complications caused by wearing contact lenses.
- scleral contact lenses can significantly improve the visual quality of the human eye.
- the tear layer The refractive index is similar to the refractive index of the cornea itself. Therefore, it can significantly reduce the changes in wavefront aberration caused by various defects and deformations on the front surface of the cornea and improve the patient's visual quality.
- due to the current majority of The optical zone of scleral contact lenses is a simple spherical design. Although it improves the visual quality to a certain extent, many patients still experience glare and unclear vision after wearing them, especially when their pupils become enlarged at night.
- the purpose of the present invention is to provide a scleral contact lens based on phase modulation technology.
- a three-dimensional sagittal height distribution model of the front surface of the human cornea is established.
- the human eye optical system after wearing the scleral contact lens is established.
- the rear surface of the scleral lens adopts a spherical design, which mainly matches the curvature radius of the front surface of the human eye.
- the phase modulation function is superimposed on the optical area of the front surface of the scleral lens, and each incident field of view is The specific optical aberration is modulated to achieve the balance or correction of the target aberration.
- the present invention provides a scleral contact lens based on phase modulation technology.
- the inner surface of the scleral contact lens (the surface in contact with the cornea) can be generally divided into three parts from the middle to the outside. Part: middle optical zone D1, transition zone D2 and landing zone D3, the middle optical zone spans the cornea and does not contact the cornea to correct vision; the transition zone connects the optical zone and the landing zone, is located at the edge of the cornea, and is divided into two areas : Edge adaptation area and limbus area. The limbus area is located at the edge of the cornea and maintains a certain gap with the edge of the cornea.
- the edge adaptation area is used to adjust the sagittal height of the scleral lens and compensate for the sagittal height; the landing zone is the load-bearing area of the entire lens. , should be consistent with the curvature of the sclera, and contact the sclera tangentially, so that the scleral contact lens can be well fixed on the sclera, and the landing area forms an angle with the cornea, which is conducive to the exchange of tears.
- the front surface optical zone of the scleral contact lens and the inner surface optical zone of the scleral lens jointly provide optical imaging characteristics.
- the front surface optical zone has a base shape similar to the standard surface type (flat, spherical, quadratic surface) plus Additional phase term defined by Zernike standard coefficients. When light passes through this surface, the additional phase term deviates and increases the optical path of the light. This surface type actually adds phase modulation on the basis of the standard surface type.
- the additional phase of the surface is defined as:
- This phase function describes how to modulate the phase by adding modulation phase at any radial wavelength position based on the standard curved surface.
- the standard surface shape (base shape) of the front surface optical zone of the scleral contact lens adopts a biquadric surface design with higher-order terms, which is expressed by the following formula:
- the surface shape of the front surface optical zone of the scleral contact lens that is, the surface shape distribution after phase modulation, is expressed as:
- the first item is the basal surface profile distribution, which together with the rear surface of the scleral lens provides the optical power of the scleral contact lens.
- the next two items are the higher-order aspherical coefficients in the x and y directions.
- the last term is superimposed on the basic surface profile.
- the surface shape distribution of the human cornea is measured with a corneal topograph, and the sagittal height distribution map of the front surface shape of the cornea is obtained.
- the equivalent radius of curvature and cone coefficient are fitted, and the sagittal height difference is measured using Zenico. Sagittal height coefficient expansion:
- the discretely sampled surface shape of the front corneal surface can also be directly converted into a phase plane.
- the conversion method is as follows:
- the sagittal height distribution of the anterior corneal surface is discretized on the two-dimensional xy plane.
- ⁇ y is the sagittal height of the anterior corneal surface at the ⁇ x displacement interval, and the sagittal height distribution can be directly transformed into the phase.
- the imaging optical system of the human eye after wearing the lens is established, and the ray tracing method is used to calculate the retinal defocus distribution when the on-axis field of view and the off-axis field of view are incident, based on multiple retinal positions.
- the size of the weighted sum of the RMS values of the field of view diffuse spots is used as the evaluation function. The smaller the value, the better the imaging quality, that is:
- the scleral contact lens is characterized in that the entire lens is treated with plasma to improve surface hydrophilicity, making it more comfortable to wear, and the plasma power is 10-2000W.
- the refractive index range of the scleral contact lens is between 1.4-1.6, and the oxygen permeability coefficient is (80-200)*10 -11 (cm 2 /s) [mlO 2 /(ml ⁇ mmHg)].
- the total diameter of the scleral contact lens ranges from 12.5mm to 24mm, and the radius of curvature of the rear surface ranges from 6.4mm to 9.2mm.
- the rear surface of the scleral lens is matched with the front surface of the human cornea, and a radius slightly flatter than the average curvature radius of the front cornea surface is used.
- a spherical design is adopted to match the curvature radius of the front surface of the human cornea.
- phase modulation function is superimposed on the optical area of the front surface of the scleral lens to modulate the specific optical aberration of each incident field of view to achieve the balance or correction of the target aberration.
- the raw material used for processing is a highly oxygen-permeable material, which reaches a glassy state at room temperature.
- Diamond single-point turning processing technology is used to turn the front and rear surfaces.
- Single-end polishing removes driveway lines and minor scratches.
- the plasma power is 10-2000W.
- the present invention provides a scleral contact lens based on phase modulation technology.
- the wavefront aberration of the whole eye is personalizedly modulated, and has the following beneficial effects. :
- Figure 1 is a schematic diagram of a human eye wearing a scleral contact lens
- Figure 2 is a schematic structural diagram of a scleral contact lens
- Figure 3 is a light tracing diagram of the human eye with a scleral contact lens
- Figure 4 is a design flow chart of scleral contact lenses based on phase modulation technology
- Figure 8 is a comparison of MTF before and after 6mm pupil, 0 degree field of view modulation
- Figure 9 is a comparison of MTF before and after 5-degree field of view modulation for a 6mm pupil
- Figure 10 is a comparison of MTF before and after -5 degree field of view modulation with a 6mm pupil.
- the inner surface of the scleral contact lens (the surface in contact with the cornea) can be generally divided into three parts from the middle to the outside: the middle optical zone D1, the transition zone D2 and the landing zone.
- the front surface optical area of the scleral contact lens and the inner surface optical area of the scleral lens jointly provide optical imaging characteristics.
- the back surface of the scleral lens is matched with the front surface of the human cornea.
- the radius is flatter than the average curvature radius of the front cornea surface, and a spherical design is adopted to match the curvature radius of the front surface of the human cornea.
- phase modulation function is superimposed on the optical area of the front surface of the scleral lens to modulate the specific optical aberration of each incident field of view to achieve the balance or correction of the target aberration.
- the raw material used for processing is a highly oxygen-permeable material, which reaches a glassy state at room temperature.
- Diamond single-point turning processing technology is used to turn the front and rear surfaces.
- Single-end polishing removes driveway lines and minor scratches.
- the plasma power is 10-2000W.
- the distribution of on-axis and off-axis light in the retina of the human eye is obtained.
- Figure 3 it can be seen that the diopter error of the on-axis point has been obtained.
- Correction the light is focused on the retina, and then the off-axis light is focused in front or behind the retina.
- the Zernike terms of the target modulation are the astigmatism terms Z5 and Z6 of the 6mm pupil, the coma aberration terms Z7 and Z8, and the spherical aberration term Z11.
- coma is very important for patients with keratoconus.
- Obvious aberrations, this example is intended to demonstrate targeted aberration modulation capabilities.
- Figure 5 Comparison of the Zernike coefficient before and after modulation of the central field of view under a 6mm pupil.
- the spherical surface is before modulation and the aspheric surface is after modulation.
- Figure 6 Comparison of the Zernike coefficient before and after modulation of the 5-degree field of view under a 6mm pupil.
- the spherical surface is before modulation and the aspheric surface is after modulation.
- Figure 7 Comparison of the Zernike coefficient before and after modulation of the 10-degree field of view under a 6mm pupil.
- the spherical surface is before modulation and the aspheric surface is after modulation.
- a corneal topograph was used to test the basic parameters of the personalized human eye, and a human eye model was established.
- the front surface of the cornea was fitted with a spherical average curvature radius.
- the aspheric surface refers to the average curvature radius of the front surface of the human cornea obtained by using the corneal topography map.
- the Zenico polynomial is expanded to obtain the final surface distribution model, after ray tracing and modulation compensation. After obtaining the Zenico aberration value, the aberration distribution of different fields of view before and after modulation is shown in Figure 5- Figure 7. It can be clearly seen that the aberration has been significantly reduced before and after modulation, reaching the phase modulation purposes.
- Figures 8 to 10 are the MTF comparison diagrams before and after modulation of the 0-degree field of view, the 5-degree field of view, and the -5-degree field of view under the 6mm pupil. It can be seen that since the aberration has been significantly reduced, the corresponding field of view The modulation transfer function (MTF) has also been significantly improved.
- MTF modulation transfer function
- phase modulation function can be directly superimposed on the optical area of the front surface of the scleral lens, it facilitates later lathe processing and molding.
- This phase modulation technology can specifically modulate and compensate the actual detected human eye aberrations. Has wider adaptability and universality.
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Abstract
本发明提出的一种基于相位调制技术的巩膜接触镜，通过将调制/解调相位叠加在巩膜接触镜前表面的光学面上，个性化的调制全眼的波前像差，使其满足设计时对人眼波前像差的要求，精确地补偿患者角膜前表面的各种波前畸变，大幅度地提高患者的视力水平和视觉质量。
Description
本申请要求于2022年5月9日提交中国专利局、申请号为202210500567.X、发明名称为“一种基于相位调制技术的巩膜接触镜”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
本发明涉及巩膜接触镜技术领域，特别是涉及一种基于相位调制技术的巩膜接触镜。
巩膜镜是一种特殊设计的硬性透气性接触镜，因镜片直径大、镜片与角膜不接触、镜片横跨整个角膜、镜片在巩膜区着陆以及角膜中间填充不含防腐剂的生理盐水而得名。大直径接触镜使镜片定位落在角膜边缘之外，使它被认为是矫正不规则角膜患者视力之最佳方法，对于角膜而言，配戴巩膜片才有真的空隙，无任何机械性摩擦、尽量避免镜片和角膜的任何接触，使镜片像一座桥梁跨越在角膜上，如图1所示。从技术方面来说，这些镜片不是接触镜，至少没有与角膜表面接触，角膜的舒适性得到大幅的提高，这是大直径接触镜最大的优势之一。
近年来，巩膜镜在欧美日渐盛行，因其个性化的设计，对于屈光矫正、不规则角膜、干眼的治疗具有一定的优势。按照巩膜镜的直径分类，可以分为角巩膜镜(直径12.5mm-15mm，接触部分角膜)、迷你巩膜镜(直径15mm-18mm，完全接触巩膜)以及全巩膜镜(18mm-25mm，完全接触巩膜)，由于迷你巩膜镜的泪水储存量通常少，具有良好的透氧性和视觉质量，同时拥有较好的角膜顶点空隙，可减少在中央角膜上的机械性摩擦。
巩膜镜使用硬性透气性巩膜接触镜材料，即通过高透氧的RGP材料，逐渐改进形成具有不同透氧系数的材料。目前的镜片材料主要来自BOSTON、Menicon和CONTAMAC。BOSTON材质是目前全球用量最大、使用最普遍、使用人数最多的材料，透氧与湿润度都较高，舒适度也不错，其中BOSTON XO2材料，湿润角38，透氧系数为141，具有较高Dk值、良好的尺寸稳定性以及可加工性，该材料已经应用到角膜塑形用硬性透气性接触镜，其安全性和有效性已经得到了验证，其高的透氧性和平衡的可加工性，成为制备巩膜镜的理想材料。巩膜镜需要使用高Dk材料，并且镜片与角膜间隙中的泪液不应过多，以防止缺氧。研究表明，目前并没有研究证实佩戴现代巩膜镜会导致角膜缺氧。
巩膜镜临床应用一般采用试戴片，用试戴评估技术，主要的验配过程是：首先进行角巩膜地形图，裂隙灯检查，OCT眼前节检查。获得角膜顶点到着陆区的矢高以及相应的矢高差，选择合适的试戴片进行试戴评估；配戴前用吸棒托住镜片，镜片中滴满生理盐水和荧光素钠，嘱患者低头垂直看向地面，用自己的双手尽量撑开上下眼睑暴露出眼球，医生帮助患者戴上镜片，并观察有无气泡在镜片下，如果有气泡应取出重新配戴。配戴巩膜镜时镜片活动度几乎为零，也几乎没有泪液交换。理想的顶点泪膜间隙300微米左右，镜片边缘着陆巩膜上会有轻微压陷，佩戴后泪液层厚度明显降低(120—170微米)，因此配适评估在戴镜半小时以后进行。评估镜片与角膜间的泪液厚度，可以使用裂隙灯，利用光切片法以45度角观察镜片下的泪液厚度(可选择性使用荧光染色)。裂隙灯下观察角膜缘应为360度荧光充盈，避免镜片与角膜缘直接接触，镜片边缘对球结膜血管无 压迫。角膜缘部对于角膜健康十分重要，尤其干细胞负责产生新的上皮细胞，这些新的上皮细胞会分散到整个角膜。镜片和角膜缘部间的泪液，对于角膜缘部脆弱的干细胞是非常重要的，验配时尽量确保角膜缘部有100微米左右的空间，建议在验配时使用OCT来做为辅助工具，从中央顶点到角膜缘部精确地评估各位置应保留的泪液厚度，提升验配的精准度。
评估镜片定位弧在球结膜上所施予的压力也是非常重要的。如果定位区过度紧压结膜，结膜受压区域的血液将无法通过血管，使得镜片下的结膜血管白化。此外，巩膜镜也需要翘角帮助泪液循环。然而翘角不宜过高，过高的翘角会使异物感增加，配戴起来容易感到不舒服，影响配戴舒适度。可通过改变定位区角度来调整翘角。最后进行戴镜后的主觉验光与视力检查，确定镜片屈光度。
总的来说，硬性巩膜接触镜有如下独特优势：(1)高透氧性能保证眼睛表面获得充足的氧份，较之普通软镜大大减少并发症，是目前配戴最安全的隐形眼镜之一；(2)它成形效果好，具有良好的光学性能，保证您获得清晰的视力，即使是高度散光、不规则散光、无晶体眼也会获得良好的矫正；(3)另外巩膜镜的适应症相当广泛：一般的近视、远视、散光、屈光参差；尤其是高度近视、高度远视、高度散光、不规则散光；圆锥角膜或老花患者，因各种屈光性角膜手术(如RK、PRK、LASIK)、角膜移植术、角膜病(如角膜外伤、角膜炎)而导致角膜不规则散光者；所有因配戴角膜接触镜导致各种并发症而不适应而又无法放弃隐形眼镜的配戴者。
相比于软镜和框架眼镜，巩膜接触镜之所以能够明显地提升人眼的视觉质量，关键原因在于角膜前表面和巩膜镜后表面之间形成了一层几百微 米的泪液层，泪液层的折射率和角膜本身的折射率相近，因此，可以显著降低由于角膜前表面各种缺陷和变形所带来的的波前像差的改变，提高患者的视觉质量，但是，由于目前大多数的巩膜接触镜光学区都是简单的球面设计，虽然在一定程度上改善了视觉质量，但是很多患者在佩戴后，尤其是夜间瞳孔变大的情况下，还是会出现眩光，视物不清晰的情况，主要的原因是巩膜镜配戴的患者，一般情况下，角膜的情况都比较差，存在不规则的散光或者规则的高度散光，有的甚至还有慧差，三叶草等高阶像差，这些高阶像差的存在，大大限制了患者视觉质量的进一步提升。因此，急需开发一种基于相位调制技术的巩膜接触镜以解决上述技术问题。
有鉴于此，特提出本发明。
发明内容
本发明的目的是提供一种基于相位调制技术的巩膜接触镜，首先建立人眼角膜前表面三维矢高分布模型，其次基于经典的LB人眼模型，建立配戴巩膜接触镜后的人眼光学系统模型，再次，巩膜镜后表面采用球面设计，主要匹配人眼前表面曲率半径，最后，针对全眼实际存在的波前像差，叠加相位调制函数在巩膜镜前表面光学区，对各个入射视场的特定光学像差进行调制，实现目标像差的平衡或者矫正。
针对现有技术存在的上述问题，本发明提供了一种基于相位调制技术的巩膜接触镜，所述巩膜接触镜的内表面(与角膜接触的面)从中间向外总体上可以分为三个部分：中间光学区D1、过渡区D2和着陆区D3，中间光学区横跨角膜，且不与角膜接触，以矫正视力； 过渡区连接光学区和着陆区，位于角膜边缘，分为两个区域：边缘适配区和角膜缘区，角膜缘区，位于角膜边缘，与角膜边缘保持一定的间隙，边缘适配区用于调整巩膜镜的矢高以及矢高的补偿；着陆区是整个镜片承重的区域，要与巩膜的弧度一致，切向与巩膜接触，使得巩膜接触镜能够很好地固定在巩膜上，着陆区与角膜形成夹角，利于泪液的交换。
所述巩膜接触镜的前表面光学区与巩膜镜内表面光学区共同提供光学成像特性，前表面光学区有一个与标准面面型(平面、球面、二次曲面)相似的基底外形再加上由泽尼克标准系数定义的附加相位项。当光线通过该面型时附加相位项发生偏离并使光线的光程增加。这种面型实际上是在标准面型的基础上增加了相位调制，面的附加相位定义为：
该相位函数描述了在标准曲面的基础上，通过在任意径向波长位置，增加调制相位，起到对相位的调制作用。所述巩膜接触镜的前表面光学区的标准面型(基底外形)采用带有高次项的双二次曲面设计，由下式进行表达：
其中，
除了基底半径之外，在X和Y方向上圆锥系数高次项系数都可 以不同，α
i和β
i分别是x方向和y方向高次非球面系数，双二次曲面允许直接指定Rx、Ry、Kx和Ky。
所述巩膜接触镜的前表面光学区的面型，即经过相位调制之后的面型分布表达为：
第一项是基底面型分布，与巩膜镜后表面一起提供了巩膜接触镜的光焦度，随后两项是x方向和y方向的高次非球面系数，最后一项是叠加在基础面型之上的相位调制项。
所述巩膜接触镜，人眼角膜的面型分布用角膜地形图仪进行测量，得到角膜前表面面型的矢高分布图，拟合出等效曲率半径和圆锥系数，矢高差值用泽尼可矢高系数展开：
所述的巩膜接触镜，角膜前表面的离散采样的面型也可以直接转换成相位面，转换的方式如下：
对角膜前表面的矢高分布进行二维xy平面上离散化，Δy是角膜前表面矢高面在Δx位移间隔的矢高，可以直接将矢高分布进行相位的转化。
所述巩膜接触镜在模拟佩戴后，建立戴镜后人眼成像光学系统，采用光线追迹法，计算轴上视场和轴外视场入射时，视网膜离焦分布情况，以视网膜位置多个视场弥散斑RMS值的加权之和的大小作为评价函数，其值越小代表成像质量越好，即：
所述的巩膜接触镜，其特征在于整体采用等离子处理，提升表面亲水性，佩戴更舒适，等离子功率为10-2000W。
所述的巩膜接触镜，其折射率范围在1.4-1.6之间，透氧系数在(80-200)*10
-11(cm
2/s)[mlO
2/(ml×mmHg)]。
所述的巩膜接触镜，其总直径范围在12.5mm-24mm之间，后表面曲率半径在6.4mm-9.2mm之间。
设计方法：
(1)采用角膜地形图仪得到人眼角膜前后表面曲率，厚度，前房深度等信息，最关键的是可以个性化的得到人眼角膜的非球面系数Q。
(2)由角膜地形图仪得到的角膜前表面的矢高分布数据，建立人眼角膜前表面矢高分布模型，采用拟合算法，得到实际表面矢高减去拟合矢高的差值，对残差进行泽尼可多项式展开，最终得到前表面矢高的表达式。
(3)将角膜前表面矢高转换成相位分布数据，导入个性化人眼模型中，建立完整的包括实际角膜前表面的个性化的人眼模型。
(4)基于个性化的人眼模型，建立配戴巩膜接触镜后的人眼光学 系统模型，建立轴上和不同轴外光线，进行光线追迹。
(5)巩膜镜后表面与人眼角膜的前表面进行匹配，取比角膜前表面平均曲率半径稍微平一点的半径，采用球面设计，匹配人眼角膜前表面曲率半径。
(6)通过个性化人眼光线追迹，得到全眼不同瞳孔情况下的波前像差分布特性和幅度，根据患者的实际需求，给出针对性相位调制和补偿的像差值；
(7)针对全眼实际存在的波前像差，叠加相位调制函数在巩膜镜前表面光学区，对各个入射视场的特定光学像差进行调制，实现目标像差的平衡或者矫正。
(8)确定最终巩膜镜前表面面型轮廓。
(9)车床、抛光加工。加工用的原料为高透氧材料，常温下材料达到玻璃态，采用金刚石单点车加工技术，车加工前后表面。经过单头抛光去除车道纹路和细微划痕。
(10)经等离子处理，提升表面亲水性，佩戴更舒适，等离子功率为10-2000W。
本发明提供的一种基于相位调制技术的巩膜接触镜，通过将调制/解调相位叠加在巩膜接触镜前表面的光学面上，个性化的调制全眼的波前像差，具有如下有益效果：
1.满足设计时对人眼波前像差的要求。
2.精确地补偿患者角膜前表面的各种波前畸变。
3.大幅度地提高患者的视力水平和视觉质量。
说明书附图
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为人眼配戴巩膜接触镜的示意图；
图2为巩膜接触镜的结构示意图；
图3为巩膜接触镜的人眼光线追击图；
图4为基于相位调制技术的巩膜接触镜的设计流程图；
图5在6mm瞳孔下，中心视场调制前后泽尼可系数比较，球面是调制前和非球面是调制后；
图6在6mm瞳孔下，5度视场调制前后泽尼可系数比较，球面是调制前和非球面是调制后；
图7在6mm瞳孔下，10度视场调制前后泽尼可系数比较，球面是调制前和非球面是调制后；
图8是6mm瞳孔，0度视场调制前后MTF比较；
图9是6mm瞳孔，5度视场调制前后MTF比较；
图10是6mm瞳孔，-5度视场调制前后MTF比较。
下面结合具体实施例和附图对本发明做进一步说明，以助于理解本发明的内容。
实施例1
如图2所示，为巩膜接触镜的结构示意图，巩膜接触镜的内表面(与角膜接触的面)从中间向外总体上可以分为三个部分：中间光学区D1，过渡区D2和着陆区D3，所述巩膜接触镜的前表面光学区与巩膜镜内表面光学区共同提供光学成像特性。
所述巩膜接触镜的制备步骤如下，设计流程图如图4所示：
(1)采用角膜地形图仪得到人眼角膜前后表面曲率，厚度，前房深度等信息，最关键的是可以个性化的得到人眼角膜的非球面系数Q。
(2)由角膜地形图仪得到的角膜前表面的矢高分布数据，建立人眼角膜前表面矢高分布模型，采用拟合算法，得到实际表面矢高减去拟合矢高的差值，对残差进行泽尼可多项式展开，最终得到前表面矢高的表达式。
(3)将角膜前表面矢高转换成相位分布数据，导入个性化人眼模型中，建立完整的包括实际角膜前表面的个性化的人眼模型。
(4)基于个性化的人眼模型，建立配戴巩膜接触镜后的人眼光学系统模型，建立轴上和不同轴外光线，进行光线追迹，如图3所示。
(5)巩膜镜后表面与人眼角膜的前表面进行匹配，取比角膜前表面平均曲率半径平一点的半径，采用球面设计，匹配人眼角膜前表面曲率半径。
(6)通过个性化人眼光线追迹，得到全眼不同瞳孔情况下的波前像差分布特性和幅度，根据患者的实际需求，给出针对性相位调制和补偿的像差值。
(7)针对全眼实际存在的波前像差，叠加相位调制函数在巩膜镜前表面光学区，对各个入射视场的特定光学像差进行调制，实现目标像差的平衡或者矫正。
(8)确定最终巩膜镜前表面面型轮廓，车床、抛光加工。加工用的原料为高透氧材料，常温下材料达到玻璃态，采用金刚石单点车加工技术，车加工前后表面。经过单头抛光去除车道纹路和细微划痕。
(9)经等离子处理，提升表面亲水性，佩戴更舒适，等离子功率为10-2000W。
结果分析与讨论：
采用光线追击软件，结合已经建立的个性化的人眼模型，得到了人眼轴上和轴外光线在视网膜的分布情况，如图3所示，可以看出，轴上点的屈光度误差已经得到矫正，光线聚焦在视网膜上，然后轴外光线聚焦在视网膜的前方或者后方，目标调制的泽尼可项数分别是6mm瞳孔的散光项Z5和Z6，慧差项Z7和Z8以及球差项Z11，对于巩膜镜的患者来说，即便是在轴上视场，也会存在由于角膜不规则和变形带来的散光项和慧差项，对于轴外光线，慧差对于圆锥角膜的患者是非常明显的像差，本实例旨在体现针对性的像差调制能力。
图5在6mm瞳孔下，中心视场调制前后泽尼可系数比较，球面是调制前和非球面是调制后。
图6在6mm瞳孔下，5度视场调制前后泽尼可系数比较，球面是调制前和非球面是调制后。
图7在6mm瞳孔下，10度视场调制前后泽尼可系数比较，球面是调制前和非球面是调制后。
采用角膜地形图仪测试得到个性化人眼的基本参数，建立了人眼模型，角膜前表面用拟合的球面平均曲率半径，经过光线追迹之后，得到不同视 场下的像差分布情况，为了便于比较，统一采用6mm瞳孔，此时人眼像差差异比较明显，非球面指的是采用角膜地形图得到的人眼角膜前表面的平均曲率半径，经过拟合后，对剩余的矢高进行泽尼可多项式展开，得到最终的面型分布模型，光线追迹和调制补偿后。得到泽尼可像差值，不同视场在调制前后的像差分布情况由图5-图7所示，可以明显看出，像差在调制前后都有了比较明显的减小，达到了相位调制的目的。
图8-图10分别是6mm瞳孔下，0度视场、5度视场、-5度视场调制前后MTF比较图，可以看出，由于像差有了明显的降低，因此对应视场的调制传递函数(MTF)也有了明显的提升。
由于相位调制函数可以直接叠加在巩膜镜前表面光学区之上，因此，方便了后期车床加工和成型，这一相位调制的技术，可以针对性地对实际检测的人眼像差进行调制补偿，具有更加广泛的适应性和普适性。
本文中应用了具体个例对发明构思进行了详细阐述，以上实施例的说明只是用于帮助理解本发明的核心思想。应当指出，对于本技术领域的普通技术人员来说，在不脱离该发明构思的前提下，所做的任何显而易见的修改、等同替换或其他改进，均应包含在本发明的保护范围之内。
Claims (10)
- 一种基于相位调制技术的巩膜接触镜，其特征在于，所述巩膜接触镜的内表面，即与角膜接触的面，从中间向外总体上分为三个部分：中间光学区、过渡区和着陆区；所述光学区横跨角膜，且不与角膜接触，以矫正视力；所述过渡区，连接光学区和着陆区，位于角膜边缘，分为两个区域：边缘适配区和角膜缘区，角膜缘区，位于角膜边缘，与角膜边缘保持间隙；边缘适配区用于调整巩膜镜的矢高以及矢高的补偿；所述着陆区是整个镜片承重的区域，要与巩膜的弧度一致，是切向与巩膜接触，使得巩膜接触镜能够很好地固定在巩膜上，着陆区与角膜形成夹角，利于泪液的交换。
- 根据权利要求1所述的一种基于相位调制技术的巩膜接触镜，其特征在于，巩膜接触镜的前表面光学区与巩膜镜内表面光学区共同提供光学成像特性，前表面光学区有一个与标准面面型(平面、球面、二次曲面)相似的基底外形再加上由泽尼克标准系数定义的附加相位项，当光线通过该面型时附加相位项发生偏离并使光线的光程增加，这种面型实际上是在标准面型的基础上增加了相位调制，面的附加相位定义为：这里，N为级数中泽尼克系数的个数，A i为泽尼克多项式中的系数，ρ为归一化的径向光线坐标值，ψ为光线的角度坐标值，D是衍射级次，该相位函数描述了在标准曲面的基础上，通过在任意径向波长位置，增加调制相位，起到对波前的调制作用，A i是以波长为单位，λ对应2π的相位移动，是极坐标系中波面分布。
- 根据权利要求2所述的一种基于相位调制技术的巩膜接触镜，其特征在于，巩膜接触镜的前表面光学区的标准面型(基底外形)采用带有高次项的双二次曲面设计，由下式进行表达：其中，除了基底半径之外，在X和Y方向上圆锥系数高次项系数都可以不同，α i和β i分别是x方向和y方向高次非球面系数，双二次曲面允许直接指定Rx、Ry、Kx和Ky。
- 根据权利要求3所述的一种基于相位调制技术的巩膜接触镜，其特征在于，巩膜接触镜的前表面光学区的面型，即经过相位调制之后的面型分布为：第一项是基底面型分布，与巩膜镜后表面一起提供了巩膜接触镜的光焦度，随后两项是x方向和y方向的高次非球面系数，最后一项是叠加在基础面型之上的相位调制项。
- 根据权利要求4所述的一种基于相位调制技术的巩膜接触镜，其特征在于，人眼角膜的面型分布用角膜地形图仪进行测量，得到角膜前表面面型的矢高分布图，拟合出等效曲率半径和圆锥系数，矢高差值用泽尼可 矢高系数展开：其中，k是角膜前表面最佳拟合曲面的圆锥系数，c是曲率半径的倒数，N是泽尼可项数，B i是泽尼可系数值，ρ为归一化的径向光线坐标值，ψ为光线的角度坐标值。
- 根据权利要求5所述的一种基于相位调制技术的巩膜接触镜，其特征在于，角膜前表面的离散采样的面型直接转换成相位面，转换的方式如下：对角膜前表面的矢高分布进行二维xy平面上离散化，Δy是角膜前表面矢高面在Δx位移间隔的矢高，可以直接将矢高分布进行相位的转化。
- 根据权利要求6所述的一种基于相位调制技术的巩膜接触镜，其特征在于，巩膜接触镜在模拟佩戴后，建立戴镜后人眼成像光学系统，采用光线追迹法，计算轴上视场和轴外视场入射时，视网膜离焦分布情况，以视网膜位置多个视场弥散斑RMS值的加权之和的大小作为评价函数，其值越小代表成像质量越好，即：其中：S i是加权系数，RMS i是i视场的弥散斑RMS值，T是参与计算的视场的总数。
- 根据权利要求7所述的一种基于相位调制技术的巩膜接触镜，其特 征在于，整体采用等离子处理，提升表面亲水性，佩戴更舒适，等离子功率为10-2000W。
- 根据权利要求8所述的一种基于相位调制技术的巩膜接触镜，其特征在于，其折射率范围在1.4-1.6之间，透氧系数在(80-200)*10 -11(cm 2/s)[mlO 2/(ml×mmHg)]。
- 根据权利要求9所述的一种基于相位调制技术的巩膜接触镜，其特征在于，其总直径范围在12.5mm-24mm之间，后表面曲率半径在6.4mm-9.2mm之间。
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| US20210181529A1 (en) * | 2017-12-06 | 2021-06-17 | Eyebright Medical Technology (Beijing) Co., Ltd. | Orthokeratology lens and method for making orthokeratology lenses |
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