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CN109581690B - Lenses, spectacles and methods for obtaining parameters of defocusing amount, fitting of glasses and evaluating effects - Google Patents

Lenses, spectacles and methods for obtaining parameters of defocusing amount, fitting of glasses and evaluating effects Download PDF

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CN109581690B
CN109581690B CN201811592602.5A CN201811592602A CN109581690B CN 109581690 B CN109581690 B CN 109581690B CN 201811592602 A CN201811592602 A CN 201811592602A CN 109581690 B CN109581690 B CN 109581690B
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defocus
lens
cornea
area
amount
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CN109581690A (en
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魏瑞华
王景慧
杜蓓
林伟平
谷天瀑
刘桂华
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TIANJIN MEDICAL UNIVERSITY EYE HOSPITAL
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TIANJIN MEDICAL UNIVERSITY EYE HOSPITAL
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    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04Contact lenses for the eyes
    • G02C7/041Contact lenses for the eyes bifocal; multifocal
    • G02C7/044Annular configuration, e.g. pupil tuned
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C13/00Assembling; Repairing; Cleaning
    • G02C13/003Measuring during assembly or fitting of spectacles
    • G02C13/005Measuring geometric parameters required to locate ophtalmic lenses in spectacles frames
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/024Methods of designing ophthalmic lenses
    • G02C7/027Methods of designing ophthalmic lenses considering wearer's parameters
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00Optical parts
    • G02C7/02Lenses; Lens systems ; Methods of designing lenses
    • G02C7/06Lenses; Lens systems ; Methods of designing lenses bifocal; multifocal ; progressive
    • GPHYSICS
    • G02OPTICS
    • G02CSPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/24Myopia progression prevention

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • General Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • General Health & Medical Sciences (AREA)
  • Geometry (AREA)
  • Eyeglasses (AREA)
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Abstract

The peripheral defocused lens comprises a central optical area, an annular defocused area is arranged outside the central optical area, and the defocused amount of the defocused area changes in the annular direction. At least one of the base arc zone and the reversal arc zone of the orthokeratology lens provided by the application has structural change in the circumferential direction. The method for acquiring the defocus quantity parameter comprises the following steps: collecting defocus amounts of a plurality of sampling points on a user cornea or a dioptric system consisting of a cornea and a lens of a myope, wherein the sampling points are distributed on a plurality of direction angles in a coordinate system taking the center of the cornea as an origin; and obtaining the defocus parameter according to the defocus of the plurality of sample points on the cornea. The application also provides a method for determining the myopia control effect of the orthokeratology lens on the myope according to the defocus quantity parameter.

Description

镜片、眼镜及获取离焦量参数、配镜和评估效果的方法Lenses, spectacles and methods for obtaining parameters of defocus amount, fitting of glasses and evaluating effects

技术领域technical field

本申请涉及近视防控领域,更具体地,涉及一种镜片、眼镜,以及获取离焦量参数的方法、配镜方法和评估近视控制效果的方法。The present application relates to the field of myopia prevention and control, and more particularly, to a lens, glasses, a method for obtaining a defocus amount parameter, a method for fitting glasses and a method for evaluating the effect of myopia control.

背景技术Background technique

近视已经成为一个重大的公共卫生问题,近视眼也成为社会的重大负担。光线在界面的偏折程度,可用屈光力(refractive power)来表达。屈光力取决于两介质的折射率和界面的曲率半径。近视是屈光不正的一种。对于正常眼球,中央和周边的图像都投像在视网膜上。近视眼由于眼球伸长,在调节松弛状态下,平行光线经眼的屈光系统的折射后焦点落在视网膜之前。Myopia has become a major public health problem, and myopia has also become a major burden to society. The degree of deflection of light at the interface can be expressed by refractive power. The refractive power depends on the refractive indices of the two media and the radius of curvature of the interface. Myopia is a type of refractive error. For a normal eye, both central and peripheral images are projected on the retina. Due to the elongation of the eyeball in myopic eyes, in the relaxed state of accommodation, the focus of parallel light rays falls in front of the retina after being refracted by the refractive system of the eye.

近视眼的发展机理仍旧处于激烈的讨论中,已有研究发现诸多控制眼轴增长的手段,包括不同浓度的药物及不同的光学设计镜片。周边离焦理论是美国休斯顿大学眼视光学院Smith教授在上世纪末提出的近视的一个成因。按照屈光学概念,焦点落在视网膜前称为近视性离焦,落在视网膜后面称为远视性离焦。周边离焦理论认为这种视网膜周边的远视性离焦是促进近视眼度数不断增加的主要原因。而视网膜周边的近视性离焦能够减缓眼轴的增长,具有抑制近视发展的效果。The development mechanism of myopia is still under intense discussion, and studies have found many means to control the growth of the eye axis, including different concentrations of drugs and different optical design lenses. Peripheral defocus theory is one of the causes of myopia proposed by Professor Smith from the School of Optometry of the University of Houston at the end of the last century. According to the concept of refractive optics, when the focus falls in front of the retina, it is called myopic defocus, and when it falls behind the retina, it is called hyperopic defocus. Peripheral defocus theory believes that this hyperopic defocusing around the retina is the main reason for the continuous increase in the degree of myopia. The myopic defocusing around the retina can slow down the growth of the eye axis and has the effect of inhibiting the development of myopia.

传统的单光眼镜主要的目的是解决配戴者看远不清的需要,只能矫正眼睛中央黄斑区的离焦。图1所示是单光镜片矫正后的眼睛的视物示意图。中心视力处的物像投影到视网膜上,外围区域的物像却投影到了视网膜的后方,形成远视性离焦。而眼球会进行调节让外围区域的物像投影到视网膜上,这会使眼轴慢慢拉长。所以部分患者在配戴普通近视眼镜后,虽然解决了看远不清的问题,但近视度数仍不断加深。The main purpose of traditional single vision glasses is to solve the wearer's need to see far away, and can only correct the defocus in the central macular area of the eye. Figure 1 is a schematic view of an eye corrected by a single vision lens. The image of the object at the central vision is projected on the retina, but the image of the object in the peripheral area is projected to the back of the retina, forming a hyperopic defocus. The eyeball adjusts so that the image of the peripheral area is projected onto the retina, which causes the axial length of the eye to slowly elongate. Therefore, after some patients wear ordinary myopia glasses, although the problem of blurred vision has been solved, the degree of myopia is still deepening.

周边离焦的新型镜片能减少视网膜周边的远视性离焦,甚至使其变为近视性离焦,以缓解眼轴增长。这种特殊设计的光学镜片可以是角膜塑形镜(如OK镜(OrthoKeratology))、角膜接触镜(包括软性角膜接触镜、硬件角膜接触镜如RGP镜等)或框架眼镜(如棱镜双光框架眼镜、双光框架眼镜、渐进多焦点眼镜等)的镜片。近视眼经周边离焦的镜片矫正后,其中心视力处的物像投影至视网膜上,外围物像投影至视网膜上或投影至视网膜前方,形成近视性离焦效果,如图2所示。有研究发现,周边离焦的角膜接触镜控制近视(即抑制眼轴生长速度)的成功率可以达到30%~40%左右。The new peripheral defocus lens can reduce the hyperopic defocusing around the retina, and even make it myopic defocusing, in order to alleviate the growth of the eye axis. The specially designed optical lenses can be orthokeratology lenses (such as OK lenses (OrthoKeratology)), contact lenses (including soft contact lenses, hardware contact lenses such as RGP lenses, etc.) or frame glasses (such as prism bifocals) Lenses for spectacles, bifocal spectacles, progressive multifocal spectacles, etc.). After the myopia is corrected by the peripheral defocused lens, the image of the object at the central vision is projected onto the retina, and the image of the peripheral object is projected onto the retina or projected to the front of the retina, forming a myopic defocus effect, as shown in Figure 2. Some studies have found that the success rate of contact lenses with peripheral defocus in controlling myopia (ie, inhibiting the growth rate of the eye axis) can reach about 30% to 40%.

角膜塑形镜采用逆几何设计,通过改变角膜形状来达到矫正视力和控制近视发展的目的,控制近视发展的成功率可以达到32%-55%。与框架眼镜和角膜接触镜不同的是,角膜塑形镜仅需夜间佩戴,白天不需要佩戴视力即可达到正常值。角膜塑形镜的设计分为VCT(vision shaping treatment视觉重塑治疗)设计和CRT(corneal refractive therapy角膜屈光矫治)设计。其中VST设计的角膜塑形镜包括基弧区、反转弧区、定位弧区和周弧区。Orthokeratology lens adopts inverse geometric design to correct vision and control the development of myopia by changing the shape of the cornea. The success rate of controlling the development of myopia can reach 32%-55%. Unlike spectacles and contact lenses, orthokeratology lenses only need to be worn at night and do not need to be worn during the day to achieve normal vision. The design of orthokeratology lens is divided into VCT (vision shaping treatment) design and CRT (corneal refractive therapy) design. Among them, the orthokeratology lens designed by VST includes the base arc area, the reverse arc area, the positioning arc area and the peripheral arc area.

角膜接触镜和框架眼镜的镜片中部通常都是屈光力恒定的中央光学区,对于本申请用于近视控制的周边离焦的镜片来说,其中央光学区之外的周边区域的屈光力高于中央光学区,两者的屈光力之差用离焦量表示,以D(度数)为单位。例如,如果用于近视的镜片中央光学区的度数为-2.00D(一般该度数作为镜片的度数),而周边位置有4.5D的离焦量,则该镜片该周边位置的度数是2.5D。如果用于近视的镜片中央光学区的度数为-5.00D,该周边位置的离焦量仍为4.5D,则该镜片该周边位置的度数为-0.50D。The middle of the lenses of contact lenses and frame glasses is usually a central optical zone with constant refractive power. For the peripheral defocus lens used for myopia control in this application, the refractive power of the peripheral area outside the central optical zone is higher than that of the central optical zone. area, the difference between the two refractive powers is expressed by the defocus amount, in D (degrees) as the unit. For example, if the power of the central optical zone of a lens for myopia is -2.00D (usually the power is used as the power of the lens), and the peripheral position has a defocusing amount of 4.5D, the power of the peripheral position of the lens is 2.5D. If the power of the central optical zone of the lens used for myopia is -5.00D, and the defocusing amount of the peripheral position is still 4.5D, the power of the peripheral position of the lens is -0.50D.

周边离焦镜片的离焦量设计与近视控制的效果相关,但是哪些离焦量参数与近视控制(指控制近视发展)相关,以及离焦量参数与近视控制之间关联的机理尚不明确,从而难以有针对性地进行周边离焦镜片的设计和配镜,这影响了周边离焦镜片所能达到的近视控制效果。The design of the defocus amount of the peripheral defocus lens is related to the effect of myopia control, but which defocus amount parameters are related to myopia control (referring to controlling the development of myopia), and the mechanism of the association between the defocus amount parameters and myopia control is still unclear. Therefore, it is difficult to design and match the peripheral defocus lens in a targeted manner, which affects the myopia control effect that the peripheral defocus lens can achieve.

对于角膜塑形镜,其在角膜上所形成的离焦量的大小,目前只有总量的估计。并无与近视控制相关的其他离焦量参数的提出。而且角膜塑形镜的效果的临床预估仍缺乏标准,需要很长时间才能够判断其对于特定近视患者的近视控制效果。这使得角膜塑镜形的应用受到影响。For orthokeratology lenses, the amount of defocus formed on the cornea is currently only an estimate of the total amount. No other defocus parameters related to myopia control were proposed. Moreover, the clinical prediction of the effect of orthokeratology still lacks standards, and it will take a long time to judge its myopia control effect on specific myopic patients. This has affected the application of orthokeratology lenses.

发明内容SUMMARY OF THE INVENTION

以下是对本文详细描述的主题的概述。本概述并非是为了限制权利要求的保护范围。The following is an overview of the topics detailed in this article. This summary is not intended to limit the scope of protection of the claims.

本发明实施例提供了一种周边离焦的镜片,所述镜片包括中央光学区,所述中央光学区外设置有环形的离焦区,所述离焦区的离焦量在环向上存在变化。An embodiment of the present invention provides a peripheral defocus lens, the lens includes a central optical zone, an annular defocus zone is provided outside the central optical zone, and the defocus amount of the defocus zone varies in the annular direction .

本发明实施例提供了一种框架眼镜,包括镜架和两个镜片,其特征在于,所述两个镜片中的至少一个采用如上所述的周边离焦的镜片。An embodiment of the present invention provides a frame glasses, comprising a frame and two lenses, characterized in that, at least one of the two lenses adopts the above-mentioned peripherally defocused lens.

本发明实施例提供了一种角膜塑形镜的镜片,所述镜片包括基弧区、反转弧区和定位弧区,所述基弧区和反转弧区中的至少之一在周向上存在结构变化。An embodiment of the present invention provides a lens for an orthokeratology lens, the lens includes a base arc area, a reverse arc area and a positioning arc area, and at least one of the base arc area and the reverse arc area is in the circumferential direction There are structural changes.

本发明实施例提供了一种获取离焦量参数的方法,包括:在用户裸眼状态下,采集所述用户角膜上多个样点的离焦量,所述样点分布在以角膜中心为原点的坐标系中的多个方向角上;及,根据所述角膜上多个样点的离焦量得到离焦量参数。An embodiment of the present invention provides a method for obtaining a defocus amount parameter, including: in a user's naked eye state, collecting defocus amounts of multiple sample points on the user's cornea, the sample points are distributed with the cornea center as the origin and, according to the defocus amounts of the plurality of sample points on the cornea, the defocus amount parameters are obtained.

本发明实施例提供了一种获取离焦量参数的方法,包括:在近视患者配戴角膜接触镜时,采集所述近视患者角膜和镜片组成的屈光系统上多个样点的离焦量,所述样点分布在以角膜中心为原点的坐标系中的多个方向角上;及,根据所述屈光系统上多个样点的离焦量得到离焦量参数。An embodiment of the present invention provides a method for obtaining a defocus amount parameter, which includes: when a myopic patient wears a corneal contact lens, collecting defocus amounts of multiple samples on a refractive system composed of the cornea and the lens of the myopic patient , the sample points are distributed on a plurality of direction angles in a coordinate system with the cornea center as the origin; and, the defocus amount parameter is obtained according to the defocus amounts of the plurality of sample points on the refractive system.

本发明实施例提供了一种配镜方法,包括:按照如上所述的获取离焦量参数的方法获取近视患者配镜前的裸眼状态下的离焦量参数;及,根据所述离焦量参数为所述近视患者配镜。An embodiment of the present invention provides a method for fitting glasses, comprising: obtaining a parameter of the amount of defocus in the naked eye state of a myopic patient before fitting glasses according to the method for obtaining a parameter of defocusing as described above; and, according to the amount of defocusing The parameters are glasses for the myopic patient.

本发明实施例提供了一种评估近视控制效果的方法,包括:按照如上所述的方法获取近视患者经角膜塑形镜对角膜塑形后的裸眼状态下得到的离焦量参数;及,根据所述离焦量参数确定所述角膜塑形镜对所述近视患者的近视控制效果。The embodiment of the present invention provides a method for evaluating the control effect of myopia, including: obtaining the defocus amount parameter obtained in the naked eye state of the myopic patient after the orthokeratology lens is used for orthokeratology according to the above method; and, according to the method described above. The defocus amount parameter determines the myopia control effect of the orthokeratology lens on the myopic patient.

在阅读并理解了附图和详细描述后,可以明白其他方面。Other aspects will become apparent upon reading and understanding of the drawings and detailed description.

附图说明Description of drawings

图1是使用单光镜片对近视矫正时产生的远视性离焦的示意图;Fig. 1 is a schematic diagram of hyperopic defocus generated when using single vision lens to correct myopia;

图2是使用周边离焦镜片时产生的近视性离焦的示意图;Fig. 2 is the schematic diagram of myopic defocus generated when using peripheral defocus lens;

图3A是患者角膜在同一方向角上离焦量随距离变化的示意图;Fig. 3A is a schematic diagram of the change of the defocus amount of the patient's cornea at the same direction angle with distance;

图3B是患者角膜在0~360度范围内mRCRP变化的示意图;Figure 3B is a schematic diagram of the change of mRCRP in the patient's cornea in the range of 0 to 360 degrees;

图4是建立的mRCRP模型中各个分量的示意图;Fig. 4 is the schematic diagram of each component in the established mRCRP model;

图5是最大离焦量Vmax与眼轴增长长度之间的关系的示意图;5 is a schematic diagram of the relationship between the maximum defocus amount Vmax and the length of the eye axis;

图6是近视控制成功率随着Vmax的变化而变化的示意图;Fig. 6 is the schematic diagram that the success rate of myopia control changes with the change of Vmax;

图7A-图7D是mRCRP模型中各分量取值的几种不同情况的示意图;7A-7D are schematic diagrams of several different situations of the values of each component in the mRCRP model;

图8A和图8B是本发明两个示例性实施例的周边离焦镜片的示意图;8A and 8B are schematic diagrams of peripheral defocus lenses of two exemplary embodiments of the present invention;

图9是本发明示例性实施例角膜塑形镜的示意图;9 is a schematic diagram of an orthokeratology lens according to an exemplary embodiment of the present invention;

图10是图9的A-A剖面图;Fig. 10 is the A-A sectional view of Fig. 9;

图11是本发明示例性实施例获取离焦量参数的方法的流程图;11 is a flowchart of a method for obtaining a defocus amount parameter according to an exemplary embodiment of the present invention;

图12是本发明示例性实施例获取离焦量参数的另一方法的流程图;12 is a flowchart of another method for obtaining a defocus amount parameter according to an exemplary embodiment of the present invention;

图13是本发明示例性实施例提供配镜方法的流程图;13 is a flowchart of a method for providing glasses according to an exemplary embodiment of the present invention;

图14是本发明示例性实施例提供评估近视控制效果的方法的流程图;14 is a flow chart of a method for evaluating the effect of myopia control provided by an exemplary embodiment of the present invention;

图15是本发明示例性实施例的计算机设备的示意图。15 is a schematic diagram of a computer device of an exemplary embodiment of the present invention.

具体实施方式Detailed ways

本申请描述了多个实施例,但是该描述是示例性的,而不是限制性的,并且对于本领域的普通技术人员来说显而易见的是,在本申请所描述的实施例包含的范围内可以有更多的实施例和实现方案。尽管在附图中示出了许多可能的特征组合,并在具体实施方式中进行了讨论,但是所公开的特征的许多其它组合方式也是可能的。除非特意加以限制的情况以外,任何实施例的任何特征或元件可以与任何其它实施例中的任何其他特征或元件结合使用,或可以替代任何其它实施例中的任何其他特征或元件。This application describes a number of embodiments, but the description is exemplary rather than restrictive, and it will be apparent to those of ordinary skill in the art that within the scope of the embodiments described in this application can be There are many more examples and implementations. Although many possible combinations of features are shown in the drawings and discussed in the detailed description, many other combinations of the disclosed features are possible. Unless expressly limited, any feature or element of any embodiment may be used in combination with, or may be substituted for, any other feature or element of any other embodiment.

本申请包括并设想了与本领域普通技术人员已知的特征和元件的组合。本申请已经公开的实施例、特征和元件也可以与任何常规特征或元件组合,以形成由权利要求限定的独特的发明方案。任何实施例的任何特征或元件也可以与来自其它发明方案的特征或元件组合,以形成另一个由权利要求限定的独特的发明方案。因此,应当理解,在本申请中示出和/或讨论的任何特征可以单独地或以任何适当的组合来实现。因此,除了根据所附权利要求及其等同替换所做的限制以外,实施例不受其它限制。此外,可以在所附权利要求的保护范围内进行各种修改和改变。This application includes and contemplates combinations with features and elements known to those of ordinary skill in the art. The embodiments, features and elements that have been disclosed in this application can also be combined with any conventional features or elements to form unique inventive solutions as defined by the claims. Any features or elements of any embodiment may also be combined with features or elements from other inventive arrangements to form another unique inventive arrangement defined by the claims. Accordingly, it should be understood that any of the features shown and/or discussed in this application may be implemented alone or in any suitable combination. Accordingly, the embodiments are not to be limited except in accordance with the appended claims and their equivalents. Furthermore, various modifications and changes may be made within the scope of the appended claims.

此外,在描述具有代表性的实施例时,说明书可能已经将方法和/或过程呈现为特定的步骤序列。然而,在该方法或过程不依赖于本文所述步骤的特定顺序的程度上,该方法或过程不应限于所述的特定顺序的步骤。如本领域普通技术人员将理解的,其它的步骤顺序也是可能的。因此,说明书中阐述的步骤的特定顺序不应被解释为对权利要求的限制。此外,针对该方法和/或过程的权利要求不应限于按照所写顺序执行它们的步骤,本领域技术人员可以容易地理解,这些顺序可以变化,并且仍然保持在本申请实施例的精神和范围内。Furthermore, in describing representative embodiments, the specification may have presented methods and/or processes as a particular sequence of steps. However, to the extent that the method or process does not depend on the specific order of steps described herein, the method or process should not be limited to the specific order of steps described. Other sequences of steps are possible, as will be understood by those of ordinary skill in the art. Therefore, the specific order of steps set forth in the specification should not be construed as limitations on the claims. Furthermore, the claims directed to the method and/or process should not be limited to performing their steps in the order written, as those skilled in the art will readily appreciate that these orders may be varied and still remain within the spirit and scope of the embodiments of the present application Inside.

本申请中,角膜塑形镜和角膜接触镜都可以采用透气性硬质材料(RGP,Rigid GasPermeable)的镜片,但属于两种不同类型的眼镜。角膜塑形镜采用逆几何形态设计的镜片,其内表面由多个弧段组成。通过流体力学效应改变角膜几何形态,睡觉时戴在角膜前部,逐步使角膜弯曲度变平、眼轴缩短,白天无需配戴。而角膜接触镜也可以称为隐形眼镜(contact lens),其镜片并不采用逆几何设计,通过配戴在眼球角膜上产生的光学效果来矫正视力或保护眼睛,根据材料的软硬可以包括硬性、半硬性、软性三种。框架眼镜的镜片安装在镜架上,镜片与眼球之间存在距离。In the present application, both the orthokeratology lens and the contact lens can be lenses made of gas permeable hard material (RGP, Rigid Gas Permeable), but they belong to two different types of glasses. Orthokeratology lenses are lenses designed with inverse geometry, the inner surface of which consists of multiple arc segments. The corneal geometry is changed through hydrodynamic effects, and it is worn on the front of the cornea when sleeping, gradually flattening the curvature of the cornea and shortening the axial length of the eye, so there is no need to wear it during the day. Contact lenses can also be called contact lenses. The lenses do not use inverse geometric design. They correct vision or protect the eyes through the optical effects produced by wearing on the cornea of the eye. According to the hardness of the material, it can include rigid , semi-hard, soft three. The lenses of frame glasses are mounted on the frame, and there is a distance between the lenses and the eyeballs.

角膜塑形镜的验配成功的标准之一是形成居中的中央定位,即在角膜上形成均匀的周边离焦。有研究表明,近视屈光不正度越大,形成的周边离焦量越大,近视控制效果相对好。但具体多大,以哪个参数来评估离焦量的大小并没有提及,而且周边离焦量的大小也会受到各种限制,不能做得特别大。这种结论的研究选取的周边离焦的数据范围大,为-1.00~-6.00D。同时,也有研究结论相反,认为周边离焦量大小与近视控制效果并无必然的关系,根据这一研究一般选取的周边离焦数据范围较小。此外,对于角膜接触镜和框架眼镜而言,如果使用周边离焦量过大的镜片,会使患者感觉不适,导致视力、对比敏感度视力下降,且存在制作困难等问题。目前角膜接触镜和框架眼镜的镜片采用的周边离焦设计方案,其近视控制效果低于角膜塑形镜。One of the criteria for successful fitting of orthokeratology lenses is the creation of a centered central positioning, ie, the creation of a uniform peripheral defocus on the cornea. Studies have shown that the greater the refractive error of myopia, the greater the amount of peripheral defocus formed, and the control effect of myopia is relatively good. However, it is not mentioned which parameter is used to evaluate the defocus amount, and the size of the peripheral defocus amount will also be subject to various restrictions, so it cannot be made particularly large. The data range of the peripheral defocusing selected in the research of this conclusion is -1.00 ~ -6.00D. At the same time, there are also research conclusions to the contrary, that the amount of peripheral defocus is not necessarily related to the control effect of myopia. According to this research, the range of peripheral defocus data is generally selected. In addition, for contact lenses and spectacles, if a lens with excessive peripheral defocus is used, the patient will feel uncomfortable, resulting in decreased visual acuity and contrast sensitivity, and there are problems such as difficulty in manufacturing. At present, the peripheral defocusing design scheme adopted by the lenses of contact lenses and spectacles has a lower myopia control effect than orthokeratology lenses.

如果可以更好地解释角膜塑形镜缓解眼轴生长的机制,对角膜塑形镜临床验配将有重大指导意义,同时可以将机制推广至角膜接触镜镜片、框架眼镜镜片的周边离焦设计中。为此,本申请的发明人进行了前瞻性研究,以探讨配戴角膜塑形镜后,角膜的离焦形态及程度等因素对近视患者眼轴生长的影响。If the mechanism of orthokeratology lenses to relieve axial growth can be better explained, it will have great guiding significance for the clinical fitting of orthokeratology lenses, and the mechanism can be extended to the peripheral defocusing design of contact lenses and spectacle lenses. middle. Therefore, the inventors of the present application conducted a prospective study to explore the influence of factors such as corneal defocus shape and degree on the axial growth of myopic patients after wearing orthokeratology lenses.

对于离焦量,目前只有总量的估计或假设塑形术后形成的就是均匀的周边离焦情况。而本申请的发明人经研究发现,由于角膜散光及视网膜的非球面性带来的视网膜不同子午线对离焦的反应不同,患者配戴塑形镜后角膜上形成的周边离焦并不均匀。采用计算周边离焦总量或均值来衡量周边离焦对近视控制的影响是不科学的。对于临床中常出现的-1.00~-5.00D的近视患者,角膜塑形术后周边离焦总量差异不大,但是由于角膜塑形术后角膜上周边离焦分布的不同会造成角膜上的离焦量的最大值(本申请中也将最大值称为极值,角膜上的离焦量最大的位置可以是一个点或多个点,可以集中分布在一起也可以离散地分布在多处)。视网膜对于离焦量的更敏感的不是总量,而是离焦量的极值,也即具有极值敏感性。在周边离焦对近视控制的影响方面,角膜上的最大离焦量的大小比离焦量总量的大小更重要。For the amount of defocus, there are currently only estimates of the total amount or the assumption that a uniform peripheral defocus situation is formed after shaping. However, the inventors of the present application have found through research that different meridians of the retina have different responses to defocus due to corneal astigmatism and asphericity of the retina, and the peripheral defocus formed on the cornea after the patient wears an orthopedic lens is not uniform. It is unscientific to measure the influence of peripheral defocusing on myopia control by calculating the total or average value of peripheral defocusing. For patients with myopia of -1.00~-5.00D, which often occurs in clinical practice, the total amount of peripheral defocusing after orthokeratology is not much different, but the difference in the distribution of peripheral defocusing on the cornea after orthokeratology will cause defocusing on the cornea. The maximum value of the focal amount (the maximum value is also referred to as the extreme value in this application, and the position on the cornea with the maximum defocus amount can be one point or multiple points, which can be distributed together or discretely distributed in multiple places) . The retina is more sensitive to the defocus amount than the total amount, but the extreme value of the defocus amount, that is, it has extreme sensitivity. In the influence of peripheral defocusing on myopia control, the maximum defocusing amount on the cornea is more important than the total defocusing amount.

本申请的发明人对儿童配戴角膜塑形镜后角膜上离焦量与近视控制效果之间的关系进行了实验研究,实验方法如下:The inventor of the present application has carried out an experimental study on the relationship between the amount of defocus on the cornea and the control effect of myopia after children wear orthokeratology lenses. The experimental method is as follows:

将55名8-12岁青少年作为患者入组,患者均无近视控制产品使用历史,无眼表疾病,无影响屈光系统的全身性疾病。患者的散瞳验光满足于-5.50D≤SE≤-1.00D(SE是等效球面镜屈光度),角膜散光≤-1.50D,屈光参差小于1.0D,最佳矫正视力高于20/20。患者经过全面检查后配戴美国欧几里德公司生产的角膜塑形镜(Euclid System Crop.,Herndon,VA),所有患者在下午2-5点间复查;配戴前及一年后分别使用光学相关生物测量仪(Lenstar LS900,Haag-Streit AG,Switzerland)测量角膜生物力学。配戴前及配后四个月使用角膜地形图仪(Oculus,Wetzlar,Germany)检查角膜地形图。每名患者取右眼数据进行统计,采用夏皮罗-威尔克检验法(Schapiro-Wilk test)检验所有数据的正态。使用秩和检验(Ranksum test)方法比较模型中近视控制理想组与不理想组的差异。使用Logistic回归分析方法分析近视控制成功率与离焦量最大值的关系。Fifty-five adolescents aged 8-12 were enrolled as patients. All patients had no history of using myopia control products, no ocular surface diseases, and no systemic diseases affecting the refractive system. The patient's mydriatic refraction satisfied -5.50D≤SE≤-1.00D (SE is equivalent spherical lens diopter), corneal astigmatism ≤-1.50D, anisometropia less than 1.0D, and best corrected visual acuity higher than 20/20. After a comprehensive examination, the patients wore orthokeratology lenses (Euclid System Crop., Herndon, VA) produced by Euclid Company, USA. Corneal biomechanics was measured with an optical correlation biometer (Lenstar LS900, Haag-Streit AG, Switzerland). Corneal topography was checked using a corneal topograph (Oculus, Wetzlar, Germany) before wearing and four months after wearing. The data of the right eye of each patient were taken for statistics, and the normality of all data was tested by the Shapiro-Wilk test. The Ranksum test was used to compare the differences between the ideal and non-ideal myopia control groups in the model. Logistic regression analysis method was used to analyze the relationship between the success rate of myopia control and the maximum defocus amount.

在本实验中,采用以下方法精准分析通过角膜地形图得到的数据,以确定角膜上的离焦量参数:用Matlab软件确定镜片的定位。以角膜中心为圆心,将角膜等分为36个扇形的区域,每个区域的圆心角为10°,在每个区域中取多个样点,包括一个角膜中心的样点以计算其他样点的离焦量。这些样点可以均匀分布在该区域中,也可以分布在依次间隔10°的36个方向角上,样点越多计算的精度较高。对每一区域,通过角膜地形图可以计算出该区域中所有样点的离焦量,如图3A所示。图中横轴表示该区域上的点距离角膜中心的距离(即径向距离)。纵轴表示该区域上的点的屈光力。图中角膜中心的屈光力是40度,其他点的屈光力减去40即该点的离焦量。取图中最大的离焦量表示该区域的离焦量,记为mRCRP。mRCRP通常出现在角膜塑形镜反转弧区对应的角膜区域。In this experiment, the following method was used to accurately analyze the data obtained by corneal topography to determine the defocus parameter on the cornea: use Matlab software to determine the positioning of the lens. Taking the center of the cornea as the center, the cornea is divided into 36 fan-shaped areas, the central angle of each area is 10°, and multiple sample points are taken in each area, including one sample point at the center of the cornea to calculate other sample points defocus amount. These sample points can be evenly distributed in this area, or can be distributed on 36 directional angles spaced 10° in turn. The more sample points, the higher the calculation accuracy. For each region, the defocus amount of all samples in the region can be calculated from the corneal topography, as shown in Figure 3A. The horizontal axis in the graph represents the distance (ie, radial distance) of the point on the region from the center of the cornea. The vertical axis represents the refractive power of the point on the area. The refractive power of the center of the cornea in the figure is 40 degrees, and the refractive power of other points minus 40 is the defocus amount of that point. Take the largest defocus amount in the figure to represent the defocus amount in this area, denoted as mRCRP. mRCRP usually occurs in the corneal region corresponding to the inversion arc of orthokeratology lenses.

对每一位患者,可以得到36个区域上的36个mPCRP及其对应的角度,如0至10°区域对应的角度可设定为0°(或0°~10°中的另一个值),10°~20°区域对应的角度可以设定为10°(或10°~20°中的另一个值),依此类推。根据该36个mPCRP进行曲线拟合(即选择适当的曲线类型来拟合观测数据,并用拟合的曲线方程分析两变量间的关系),可以得到一条离焦量曲线,称为mPCRP曲线,如图3B所示。图3B中的横轴为方向角,纵轴为mPCRP值,图中的圆圈即36个mPCRP在图中的位置,曲线即为mRCRP曲线。将该离焦量曲线的最大峰值记为Vmax,Vmax即塑形后角膜上的离焦量的最大值,也可称为角膜上的最大离焦量。For each patient, 36 mPCRPs on 36 regions and their corresponding angles can be obtained. For example, the angle corresponding to the region from 0 to 10° can be set to 0° (or another value from 0° to 10°). , the angle corresponding to the area of 10°~20° can be set to 10° (or another value in 10°~20°), and so on. Perform curve fitting according to the 36 mPCRPs (that is, select an appropriate curve type to fit the observed data, and use the fitted curve equation to analyze the relationship between the two variables), and a defocus amount curve, called the mPCRP curve, can be obtained, such as shown in Figure 3B. The horizontal axis in FIG. 3B is the direction angle, the vertical axis is the mPCRP value, the circle in the figure is the position of the 36 mPCRPs in the figure, and the curve is the mRCRP curve. The maximum peak value of the defocus amount curve is recorded as Vmax, and Vmax is the maximum defocus amount on the cornea after shaping, which can also be referred to as the maximum defocus amount on the cornea.

对每一位患者,根据拟合的离焦量曲线可以建立一个精准计算mPCRP的模型:mRCRP=M+F1+F2。具体可采用多元线性回归检测模型,相关因素包括等效球镜,镜片定位,散光和角膜离心率等。R2=0.93±0.06(均值0.94)。在统计学中对变量进行线行回归分析,采用最小二乘法进行参数估计时,R2为回归平方和与总离差平方和的比值,表示总离差平方和中可以由回归平方和解释的比例,这一比例越大,模型越精确,回归效果越显著。For each patient, a model for accurately calculating mPCRP can be established based on the fitted defocus amount curve: mRCRP=M+F1+F2. Specifically, a multiple linear regression detection model can be used, and relevant factors include spherical equivalent lens, lens positioning, astigmatism and corneal eccentricity. R2=0.93±0.06 (mean 0.94). When performing linear regression analysis on variables in statistics, and using the least squares method for parameter estimation, R2 is the ratio of the regression sum of squares to the sum of squares of total deviations, indicating the proportion of the sum of squares of total deviations that can be explained by the sum of squares of regression , the larger the ratio, the more accurate the model and the more significant the regression effect.

请参见图4所示,这个模型包括三部分:M代表平均的屈光力,这个值与患者配戴角膜塑形镜前的初始等效球面镜相关,在图中表示为水平的虚线;F1为一个正弦曲线,可以表示为(Mean*f1*sin(x+phase1)),在360度方向角范围内有一个峰值,F1AmpF2是F1的最大值;F2为一个余弦曲线,可以表示为(Mean*f2*sin(2*x+phase2)),在360度方向角范围内有两个峰值,F2Amp为F2的最大值。研究表明,F1的幅值f1的大小与镜片定位的不对称性(如戴偏等)有关。而F2的峰值f2与角膜散光有关。模型中三部分具体参数的值根据离焦量曲线可以计算得到。三部分叠加得到的即mRCRP曲线,在图中用实线表示。其最大值为Vmax,最小值为Vmin。Please refer to Figure 4. This model consists of three parts: M represents the average refractive power, which is related to the initial equivalent spherical lens before the patient wears orthokeratology lenses, and is represented as a horizontal dashed line in the figure; F1 is a sine The curve, which can be expressed as (Mean*f1*sin(x+phase1)), has a peak in the range of 360 degrees of direction angle, F1AmpF2 is the maximum value of F1; F2 is a cosine curve, which can be expressed as (Mean*f2* sin(2*x+phase2)), there are two peaks in the range of 360 degree direction angle, F2Amp is the maximum value of F2. Studies have shown that the magnitude of F1 amplitude f1 is related to the asymmetry of lens positioning (such as wearing bias, etc.). The peak f2 of F2 is related to corneal astigmatism. The values of the three specific parameters in the model can be calculated according to the defocus amount curve. The mRCRP curve obtained by the superposition of the three parts is represented by a solid line in the figure. The maximum value is Vmax and the minimum value is Vmin.

配戴一年后,对每一位患者测量角膜生物力学,以0.3mm作为判断近视控制是否有效的眼轴增长阈值。结果表明,55名患者中,40名患者得到了有效的近视控制,眼轴一年增长≤0.3mm,15名患者近视控制不理想,眼轴一年增长>0.3mm。将近视控制成功与否的结果与每一名患者的mRCRP曲线结合分析可以发现,患者的mRCRP曲线上Vmax越大,成功率越高。如图5所示,其横轴表示Vmax的大小,纵轴表示眼轴增长的长度,每一圆圈对应一位患者,位于0.3mm线以下的圆圈对应的是近视控制成功的患者,0.3mm线以上的圆圈对应的是近视控制失败的患者。After wearing for one year, corneal biomechanics were measured for each patient, and 0.3 mm was used as the axial growth threshold for judging whether myopia control was effective. The results showed that among the 55 patients, 40 patients achieved effective myopia control, and the annual growth of the eye axis was less than or equal to 0.3mm. Combining the results of myopia control with the mRCRP curve of each patient, it can be found that the larger the Vmax of the patient's mRCRP curve, the higher the success rate. As shown in Figure 5, the horizontal axis represents the size of Vmax, and the vertical axis represents the length of the axial growth. Each circle corresponds to a patient, and the circle below the 0.3mm line corresponds to the patient whose myopia was successfully controlled. The 0.3mm line The circles above correspond to patients who have failed myopia control.

图6所示是Vmax与近视控制成功率的关系曲线,该曲线表明,随着Vmax的增大,近视控制的成功率随之增大(p<0.05)。Vmax≤1.2D时,只有20%的患者成功;Vmax≥3.5D时,有超过50%的患者成功;Vmax≥4.5D,有超过80%的患者成功;Vmax≥5D时,有超过90%的患者成功。根据这种关系,根据这一统计数据,采用Vmax来评估,Vmax≤1.2D时,可以认为近视控制有20%的概率有效;Vmax≥3.5D时,近视控制有50%以上的概率有效;Vmax≥4.5D,近视控制有80%以上的概率有效;Vmax≥5D时,近视控制有90%以上的概率有效。Figure 6 shows the relationship between Vmax and the success rate of myopia control, which shows that with the increase of Vmax, the success rate of myopia control increases (p<0.05). When Vmax≤1.2D, only 20% of patients succeeded; when Vmax≥3.5D, more than 50% of patients succeeded; when Vmax≥4.5D, more than 80% of patients succeeded; when Vmax≥5D, more than 90% of patients succeeded Patient success. According to this relationship, according to this statistical data, Vmax is used to evaluate, when Vmax≤1.2D, it can be considered that myopia control has a 20% probability of being effective; when Vmax≥3.5D, myopia control has a probability of more than 50% effective; Vmax ≥4.5D, the probability of myopia control is more than 80% effective; when Vmax≥5D, the probability of myopia control is more than 90% effective.

上述数据只是示例性的,根据本申请提出的分析方法或类似的方法可以进行更多、范围更广(如不同国家的近视儿童)的试验,根据这些试验的数据统计得到Vmax和近视控制成功率的对应关系等具体数据不一定完全相同,这是正常的现象。The above data are only exemplary, according to the analysis method proposed in this application or similar methods, more tests with a wider range (such as myopia children in different countries) can be carried out, and Vmax and the success rate of myopia control can be obtained statistically according to the data of these tests. The corresponding relationship and other specific data may not be exactly the same, which is a normal phenomenon.

以阈值取为4.5D为例,将为各患者建立的mRCRP曲线与其近视控制是否成功结合分析,还可以发现:Taking the threshold value as 4.5D as an example, the mRCRP curve established for each patient will be combined with myopia control to analyze whether it is successful. It can also be found that:

如果M值较大,虽然mRCRP曲线没有波动,但角膜上各个位置的离焦量可以达到4.5D,如图7A所示,此时依旧可以有效控制近视。If the M value is large, although the mRCRP curve does not fluctuate, the defocus amount of each position on the cornea can reach 4.5D, as shown in Figure 7A, and myopia can still be effectively controlled at this time.

如果M值较小,且mRCRP曲线波动小,角膜上没有任何一点的离焦量可以达到4.5D,如图7B所示,此时没有控制效果。If the value of M is small and the fluctuation of the mRCRP curve is small, the defocus amount at no point on the cornea can reach 4.5D, as shown in Figure 7B, and there is no control effect at this time.

如果M值处于均值,但是mRCRP曲线波动不大,角膜上没有点的离焦量超过4.5,如图7C所示,此时控制效果不好。If the M value is in the mean value, but the mRCRP curve does not fluctuate much, and the defocus amount of no point on the cornea exceeds 4.5, as shown in Figure 7C, the control effect is not good at this time.

如果M较小,但是mRCRP波动较大,角膜上有一部分点的离焦量超过4.5D,如图7D所示,此时控制效果较好。If M is small, but mRCRP fluctuates greatly, and the defocus amount of some points on the cornea exceeds 4.5D, as shown in Figure 7D, the control effect is better at this time.

为患者建立的模型mRCRP=M+F1+F2中,M值与近视的度数有关。对于低中度近视,M值会较低,根据模型,F1和F2的增加会使Vmax增大,提高近视控制效果。所以对于周边离焦对近视控制的影响,申请人提出新的理论:视网膜对周边离焦的极值敏感,不需要所有位置的离焦量相同,只要最大离焦量Vmax足够大,即可有效控制近视。而Vmax越大,近视控制的成功率越高,通过将患者的Vmax与设定的离焦阈值(如3.5D,4.5D)比较,可以有效地评估近视控制效果。此外,研究表明,塑形后的角膜只要有一个点达到离焦阈值即可根据该离焦阈值评估其近视控制的成功率。而在离阈阈值不变的情况下,如果角膜上离焦量达到离焦阈值的区域(可以用对应的圆心角表示)越大,其成功率也会相应提高。In the model mRCRP=M+F1+F2 established for patients, the M value is related to the degree of myopia. For low to moderate myopia, the M value will be lower. According to the model, the increase of F1 and F2 will increase the Vmax and improve the control effect of myopia. Therefore, regarding the influence of peripheral defocusing on myopia control, the applicant proposes a new theory: the retina is sensitive to the extreme value of peripheral defocusing, and it is not necessary to have the same defocusing amount at all positions, as long as the maximum defocusing amount Vmax is large enough, it can be effective Control myopia. The greater the Vmax, the higher the success rate of myopia control. By comparing the patient's Vmax with the set defocus threshold (such as 3.5D, 4.5D), the effect of myopia control can be effectively evaluated. In addition, studies have shown that as long as one point of the shaped cornea reaches the defocus threshold, the success rate of myopia control can be evaluated according to the defocus threshold. Under the condition that the defocusing threshold is unchanged, if the area on the cornea where the defocusing amount reaches the defocusing threshold (which can be represented by the corresponding central angle) is larger, the success rate will also increase accordingly.

虽然上述研究是以角膜塑形镜为源头进行的,但是建立的模型,以及提出的周边离焦的波动性和阈值适用周边离焦镜片的设计。上述理论为镜片设计给出了重要启示:在离焦总量不变的情况下,进行周边离焦的不均匀设计可增大Vmax,对近视控制更为有利。这对无论是框架眼镜还是角膜接触镜的镜片设计都是具有非常重大的指导意义。Although the above research is based on the orthokeratology lens as the source, the established model, and the proposed fluctuations and thresholds of peripheral defocus are suitable for the design of peripheral defocus lenses. The above theory provides important inspiration for lens design: under the condition that the total amount of defocusing remains unchanged, the uneven design of peripheral defocusing can increase Vmax, which is more beneficial to myopia control. This has a very important guiding significance for the lens design of both frame glasses and contact lenses.

此外上述分析表明,为患者建立的模型mRCRP=M+F1+F2中,F1和F2的幅值与近视控制效果也是相关的,F1,F2其中一个值大或者都大,近视控制的成功率更高。容易理解,F1和F2的幅值大,则mRCRP的最大峰值Vmax一般也较大。根据图4可以看出,在F1和F2的幅值不变的情况下,如果F1的一个峰值和F2的两个峰值中的一个在同一方向角上,两者能够叠加起来,则得到的Vmax最大,近视控制效果最好。反之,得到的Vmax就会变小,近视控制效果也会下降。如前所述,F1与配戴的镜片相关,F2与角膜散光相关,那么这就为镜片设计和配戴给出了另一个重要启示:使镜片带来的最大离焦量和角膜上的最大离焦量对准,可以实现极值叠加,将有利于提高近视控制效果。In addition, the above analysis shows that in the model mRCRP=M+F1+F2 established for patients, the amplitudes of F1 and F2 are also related to the effect of myopia control. If one or both of F1 and F2 are larger, the success rate of myopia control is higher. high. It is easy to understand that if the amplitudes of F1 and F2 are large, the maximum peak value Vmax of mRCRP is generally larger. According to Figure 4, it can be seen that under the condition that the amplitudes of F1 and F2 remain unchanged, if one of the peaks of F1 and one of the two peaks of F2 are in the same direction angle, the two can be superimposed, then the obtained Vmax Maximum, myopia control is the best. On the contrary, the obtained Vmax will become smaller, and the control effect of myopia will also decrease. As mentioned earlier, F1 is related to the lens worn, and F2 is related to corneal astigmatism, so this gives another important inspiration for lens design and wearing: the maximum defocus amount brought by the lens and the maximum on the cornea. Aligning the defocus amount can realize the superposition of extreme values, which will help to improve the control effect of myopia.

为此,本发明示例性的实施例提供了一种周边离焦的镜片,镜片可以是圆形但不是必须如此。如图8A所示,所述镜片1包括中央光学区11,所述中央光学区外设置有环形的离焦区12,所述离焦区的离焦量在环向上存在变化。原则上,离焦量大对于控制近视发展较为有利,但是如果离焦量过大,会造成近视患者的不适,如产生晕眩等反应,还会造成视野受限、视力下降和对比敏感度视力下降等不利影响。通过离焦量在环向上的变化,在最大离焦量不变的情况下,可以将部分离焦区的离焦量减少,从而在保证近视控制效果的同时,减轻这些不利影响。To this end, exemplary embodiments of the present invention provide a peripheral defocus lens, which may but need not be circular. As shown in FIG. 8A , the lens 1 includes a central optical zone 11 , an annular defocus zone 12 is disposed outside the central optical zone, and the defocus amount of the defocus zone varies in the annular direction. In principle, a large amount of defocus is more beneficial to control the development of myopia, but if the amount of defocus is too large, it will cause discomfort for myopic patients, such as dizziness and other reactions, as well as limited visual field, decreased visual acuity and contrast sensitivity vision. adverse effects such as decline. Through the change of the defocus amount in the annular direction, under the condition that the maximum defocus amount remains unchanged, the defocus amount of a part of the defocus area can be reduced, so as to ensure the control effect of myopia and reduce these adverse effects.

在图8A所示的示例性实施例中,所述镜片1的中央光学区11为圆形的定焦区,所述镜片1包括一个以镜片中心(图中的“O”点)为圆心的圆环状的离焦区。但本申请不局限于此,镜片也可以包括多个以镜片中心为圆心的圆环状的离焦区,如图8B所示,镜片1包括两个圆环状的离焦区12a,12b,作为示例性的,图中该两个离焦区12a,12b之间间隔设置,中间也可以是离焦量为0的定焦区。在其他实施例中,可以设置更多的离焦区。存在多个离焦区中,可以只有部分离焦区在环向上存在变化,即只要有一个离焦区在环向上存在变化,即落入本申请的覆盖范围。In the exemplary embodiment shown in FIG. 8A , the central optical zone 11 of the lens 1 is a circular fixed focal zone, and the lens 1 includes a center of the lens (the “O” point in the figure) as the center of the circle. Circular defocused area. However, the present application is not limited to this, and the lens may also include a plurality of annular defocus areas with the center of the lens as the center of the circle. As shown in FIG. 8B , the lens 1 includes two annular defocus areas 12a and 12b, As an example, the two defocus areas 12a and 12b in the figure are spaced apart, and the middle may also be a fixed focus area with a defocus amount of 0. As shown in FIG. In other embodiments, more defocus regions may be provided. In the presence of multiple defocus regions, only part of the defocus regions may vary in the annular direction, that is, as long as there is a variation in the annular direction of one defocus region, it falls within the scope of coverage of the present application.

本申请离焦区的形状并不一定是圆环,也可以是椭圆环或其他非标准的环状结构。离焦区中某个点的位置可以用该点在以镜片中心为圆心的坐标系上的方向角和径向距离来表示。径向距离指该点到镜片中心的距离。图8A中,定义0°方向角指向右侧,图8A中P点的方向角表示为α。所述离焦区的离焦量在环向上存在变化,也即离焦区的离焦量在360度方向角范围内存在变化,换言之,在方向角从0至360°变化时,离焦区中该方向角上的离焦量存在变化。该变化可以是渐变,在360°范围内存在一个或两个或更多个峰值。也可以存在突变如阶梯式的跃变,本申请对此不做局限。在同一离焦区的一个方向角上,径向距离不同的点的离焦量也可以存在波动,此时可以用该方向角上的离焦量的最大值表示该离焦区在该方向角上的离焦量。The shape of the defocusing zone in the present application is not necessarily a circular ring, but can also be an elliptical ring or other non-standard annular structures. The position of a point in the out-of-focus zone can be represented by the azimuth angle and radial distance of the point on a coordinate system with the center of the lens as the center of the circle. Radial distance refers to the distance from the point to the center of the lens. In FIG. 8A , it is defined that the orientation angle of 0° points to the right, and the orientation angle of point P in FIG. 8A is denoted as α. The defocus amount of the defocus area varies in the ring direction, that is, the defocus amount of the defocus area varies within a 360-degree direction angle range, in other words, when the direction angle changes from 0 to 360°, the defocus area There is a change in the amount of defocus at this direction angle in . The change can be gradual, with one or two or more peaks present over 360°. There may also be sudden changes such as stepped transitions, which are not limited in this application. At one direction angle of the same defocus area, the defocus amount of points with different radial distances may also fluctuate. In this case, the maximum value of the defocus amount on the direction angle can be used to represent the defocus area at the direction angle. defocus amount on .

从镜片的径向来看,存在一个离焦区时,离焦量随径向距离的增大可以有一个上升、下降的变化。存在多个离焦区时,可以有多次上升、下降的过程。离焦区外的区域的离焦量可以小于离焦区或者等于0,也可以等于或大于离焦区,例如,离焦量随径向距离的增大。在最后一个离焦区上升之后可以保持不变或者继续增大。From the radial point of view of the lens, when there is a defocus zone, the defocus amount can have a rise and a fall with the increase of the radial distance. When there are multiple defocused areas, there can be multiple rising and falling processes. The defocus amount of the area outside the defocus area may be smaller than the defocus area or equal to 0, and may also be equal to or greater than the defocus area, for example, the defocus amount increases with the radial distance. It can remain unchanged or continue to increase after the last defocus zone rises.

在图8A所示的示例性实施例中,所述镜片包括指示标志13,所述指示标志用于指示所述离焦区中离焦量最大的位置处的方向角。所述离焦量最大的位置可以是一个点或包括多个点的一个区域,如果有多个位置离焦量最大,可以选择一个位置来指示,或者每一个位置分别使用一个指示标志13来指示。所述指示标志可以与镜片一体成形,或附着在所述镜片上,或嵌入在所述镜片内。例如,所述指示标志可以是镜片上的一凸起或一凹槽,或者贴在镜片相应位置的标志物,或者镜片中的标志物甚至气泡。虽然图8A中的示例中,指示标志13是向上的箭头,但指示标志的形状也可以是条状、点状或其他任意的符号等等。指示标志可以直接指示离焦区中离焦量最大的位置,如图中的箭头用于指示离焦区中离焦量最大的位置出现在90°方向角上。离焦区中离焦量最大的位置是一个区域时,一般可以指示该区域的中心位置的方向角,但允许有偏差,不影响使用就可以。指示标志也可以间接的方式来指示离焦量最大的位置,如指向其相反方向,等等。在镜片上有了指示标志之后,可以方便近视患者在配戴时(特别是配戴角膜接触镜时),根据该指示标志将镜片离焦量最大的位置与角膜上离焦量最大的位置对准,实现镜片和角膜上的离焦量进行极值叠加,以使两者构成的屈光系统的最大离焦量尽可能达到最大,从而提高近视控制的效果。角膜上离焦量主要是角膜散光带来的,其离焦量最大的位置一般出现在90°方向角和270°方向角附近。其准确位置可以通过检测确定。In the exemplary embodiment shown in FIG. 8A , the lens includes an indicator mark 13 for indicating the direction angle at the position where the defocus amount is the largest in the out-of-focus zone. The position with the largest defocus amount can be a point or an area including multiple points. If there are multiple positions with the largest defocus amount, a position can be selected to indicate, or each position can be indicated by an indicator 13 respectively. . The indicator can be integrally formed with the lens, or attached to the lens, or embedded in the lens. For example, the indicator can be a protrusion or a groove on the lens, or a marker attached to the corresponding position of the lens, or a marker in the lens or even a bubble. Although in the example in FIG. 8A , the indicator mark 13 is an upward arrow, the shape of the indicator mark may also be a bar, a dot, or any other symbols and the like. The indicator mark can directly indicate the position with the largest defocus amount in the defocused area. The arrow in the figure is used to indicate that the position with the largest defocus amount in the defocused area appears on the 90° direction angle. When the position with the largest defocus amount in the defocus area is an area, the direction angle of the center position of the area can generally be indicated, but deviations are allowed, which does not affect the use. The indicator can also indicate the position of the largest defocus amount in an indirect way, such as pointing in the opposite direction, and so on. After there is an indicator mark on the lens, it is convenient for myopic patients to align the position with the largest defocus amount on the cornea according to the indicator mark when wearing a contact lens (especially when wearing a contact lens). Accurate, realize the extreme value superposition of the defocus amount on the lens and the cornea, so that the maximum defocus amount of the refractive system formed by the two is as large as possible, so as to improve the effect of myopia control. The defocus amount on the cornea is mainly caused by corneal astigmatism, and the position with the largest defocus amount generally occurs near the 90° direction angle and the 270° direction angle. Its exact location can be determined by inspection.

本发明示例性的实施例中,所述离焦区中离焦量的最大值与最小值的之差不小于1D或2D或3D或4D或5D。这个差值反映了离焦区中离焦量波动的幅度,可以根据离焦阈值、镜片度数、患者的耐受度等因素来选择。In an exemplary embodiment of the present invention, the difference between the maximum value and the minimum value of the defocus amount in the defocus area is not less than 1D or 2D or 3D or 4D or 5D. This difference reflects the amplitude of the fluctuation of the defocus amount in the defocus area, and can be selected according to factors such as the defocus threshold, the power of the lens, and the patient's tolerance.

本发明一示例性实施例中,所述镜片为角膜接触镜的镜片,所述离焦区位于以镜片中心为圆心、内直径3mm~4mm、外直径5~8mm的一圆环形区域内。在本发明另一示例性实施例中,所述镜片为框架眼镜的镜片,所述离焦区位于以镜片中心为圆心、内直径6mm~8mm、外直径8~12mm的一圆环形区域内。对于镜片来说,离焦区需要排除镜片上的中央光学区以及对近视控制影响很小或无影响的区域如投射光线不能有效进入瞳孔的区域。有些框架眼镜将镜片边缘的离焦量做得很大,但在上述区域的离焦量并不大,并不具有好的近视控制效果。因而在设计和计算镜片离焦区的离焦量时,需按照上述设定的离焦区域的范围进行设计和计算,以达到有效的近视控制效果。需要说明的是,上述圆环形区域内除离焦区外,还可以包括中央光学区和离焦区的外部区域。In an exemplary embodiment of the present invention, the lens is a contact lens, and the defocus area is located in an annular area with the center of the lens as the center of the circle, with an inner diameter of 3 mm to 4 mm and an outer diameter of 5 to 8 mm. In another exemplary embodiment of the present invention, the lens is a lens of frame glasses, and the defocus area is located in an annular area with the center of the lens as the center, an inner diameter of 6 mm to 8 mm, and an outer diameter of 8 to 12 mm . For lenses, the defocus zone needs to exclude the central optical zone on the lens and areas that have little or no effect on myopia control, such as areas where the projected light cannot effectively enter the pupil. Some frame glasses have a large defocus amount at the edge of the lens, but the defocus amount in the above area is not large, and it does not have a good myopia control effect. Therefore, when designing and calculating the defocus amount of the defocus area of the lens, it is necessary to design and calculate according to the range of the defocus area set above, so as to achieve an effective myopia control effect. It should be noted that, in addition to the out-of-focus area, the above-mentioned annular area may also include a central optical area and an outer area of the de-focused area.

本发明一示例性实施例中,所述镜片为角膜接触镜的镜片,所述离焦区包括任意位置离焦量不小于2D或2.5D或3D或3.5D或4D或4.5D或5D或5.5D的高焦区。在本发明另一示例性实施例中,所述镜片为框架眼镜的镜片,所述离焦区包括任意位置离焦量不小于2.5D或3D或3.5D或4D或4.5D或5D或5.5D或6D的高焦区。In an exemplary embodiment of the present invention, the lens is a contact lens lens, and the defocus zone includes a defocus amount at any position that is not less than 2D or 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5 D's high focal area. In another exemplary embodiment of the present invention, the lens is a lens of frame glasses, and the defocus zone includes a defocus amount at any position that is not less than 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5D Or the high focal area of 6D.

在本申请中,高焦区是离焦区中用于达成期望的近视控制效果的区域,可以设定一个离焦阈值,将离焦区中任意位置离焦量不小于该离焦阈值的区域判定为高焦区。本申请中,一个点也视为一种特殊的区域。框架眼镜的镜片与眼球有一定距离,镜片上的离焦量所能发挥的效用小于角膜接触镜,因而在确定高焦区时,在其他条件相同时可以选择较高一些的阈值。In this application, the high-focus area is the area used to achieve the desired myopia control effect in the de-focus area. A de-focus threshold can be set, and the defocus amount of any position in the de-focus area is not less than the de-focus threshold. Determined as a high focal area. In this application, a point is also regarded as a special area. The lens of frame glasses has a certain distance from the eyeball, and the defocus amount on the lens can play a smaller role than that of contact lenses. Therefore, when determining the high focal area, a higher threshold can be selected when other conditions are the same.

在一个示例中,用于确定高焦区的离焦阈值可以选择对应的近视控制成功率在50%以上的离焦阈值如上述的3.5D、4D、4.5D等等。由于配戴眼镜后,可以将镜片的离焦量与患者角膜的离焦量进行极值叠加,使得镜片和角膜组成的屈光系统的最大离焦量大于镜片的最大离焦量,因而在镜片设计时,设计的高焦区的离焦量也可以小于3.5D。具体的离焦阈值的选择可以根据预期的近视控制成功率、患者的角膜散光情况、患者对镜片的配适情况、患者对高离焦量的耐受度、清晰视野的大小、患者近视的度数等等因素来综合考虑。In an example, the defocus threshold used to determine the high focal area may be selected from a corresponding defocus threshold with a success rate of myopia control above 50%, such as the above-mentioned 3.5D, 4D, 4.5D and so on. After wearing glasses, the defocus amount of the lens and the defocus amount of the patient's cornea can be superimposed on the extreme value, so that the maximum defocus amount of the refractive system composed of the lens and the cornea is greater than the maximum defocus amount of the lens, so in the lens When designing, the defocus amount of the designed high focal area can also be less than 3.5D. The selection of the specific defocus threshold can be based on the expected success rate of myopia control, the patient's corneal astigmatism, the patient's fit of the lens, the patient's tolerance to high defocus, the size of the clear field of view, and the degree of myopia of the patient. and other factors to be considered comprehensively.

就图8A所示的实施例来说,所述高焦区包括所述离焦区中设置的一个环段121,但也可以两个以上的环段。另外,高焦区的形状也可以是点状或其他的形状。本申请对此并不局限。For the embodiment shown in FIG. 8A , the high focus area includes one ring segment 121 provided in the defocus area, but it can also have more than two ring segments. In addition, the shape of the high focal region can also be a point shape or other shapes. This application is not limited to this.

本发明一示例性实施例中,所述高焦区落入一个或两个或三个以上的扇形区域内,所述扇形区域以镜片中心为圆心,且圆心角之和不大于30°或60°或90°或120°或150°。上述高焦区落入的扇形区域的两个边为镜片中心与高焦区中方向角最大和最小的两个点的两条连线。当有多个扇形区域时,该多个扇形区域可以在离焦区中均布如关于镜片中心成中心对称,或关于中央光学区的直径成轴对称,但不局限于此。高焦区落入的扇形区域的圆心角之和越小,说明镜片上其他离焦量较小的区域(也可以称为低焦区)较大,有利于提高配戴的舒适度,扩大清晰视野、减少高离焦量对视力的影响。In an exemplary embodiment of the present invention, the high focal area falls within one or two or more than three fan-shaped areas, the fan-shaped areas take the center of the lens as the center, and the sum of the central angles is not greater than 30° or 60° ° or 90° or 120° or 150°. The two sides of the fan-shaped area into which the high focal area falls are the two connecting lines between the center of the lens and the two points with the largest and smallest direction angles in the high focal area. When there are multiple sector-shaped regions, the multiple sector-shaped regions may be evenly distributed in the defocus zone, such as being centrally symmetric about the center of the lens, or axisymmetric about the diameter of the central optical zone, but not limited thereto. The smaller the sum of the central angles of the fan-shaped areas that the high focal area falls into, the smaller the other areas on the lens with less defocus (also known as the low focal area) are larger, which is conducive to improving wearing comfort and expanding clarity. Field of view, reducing the impact of high defocus on vision.

本发明一示例性实施例中,所述离焦区包括一个或两个或三个以上的高焦区,所述高焦区所在环段相对镜片中心的圆心角之和不小于5°或15°或30°或45°或60°。图8A所示的示例中,镜片1中有一个高焦区,其所在环段相对镜片中心的圆心角为θ。上述圆心角之和越大,表示高焦区在视野中的比例较大,有利于近视控制,但会减少清晰视野。高焦区对应的圆心角可以表示为高焦区中方向角最大和最小的两个点到镜片中心的两条连线的夹角。In an exemplary embodiment of the present invention, the defocus area includes one or two or more high focal areas, and the sum of the central angles of the ring segment where the high focal areas are located relative to the center of the lens is not less than 5° or 15° ° or 30° or 45° or 60°. In the example shown in FIG. 8A , there is a high focal area in the lens 1, and the central angle of the ring segment where it is located relative to the center of the lens is θ. The larger the sum of the above-mentioned central angles, the larger the proportion of the high focal area in the field of view, which is conducive to the control of myopia, but will reduce the clear field of view. The central angle corresponding to the high focal area can be expressed as the angle between the two connecting lines from the two points with the largest and smallest direction angles in the high focal area to the center of the lens.

上述两个示例性实施例中分加对高焦区对应的圆心角的最大值和最小值进行了限制,在实际配镜时可以根据患者的情况选择一个合适的值。In the above-mentioned two exemplary embodiments, the maximum and minimum values of the central angle corresponding to the high focal area are limited by the addition and addition, and an appropriate value can be selected according to the patient's condition during the actual fitting of glasses.

本发明一示例性实施例中,所述离焦区包括在所述镜片外表面形成的以下结构中的一种或任意组合:In an exemplary embodiment of the present invention, the defocus zone includes one or any combination of the following structures formed on the outer surface of the lens:

离焦量渐变的曲面;A surface with a gradual defocus amount;

定焦区域;及fixed focus area; and

点状凸起。Dotted bulges.

在一个示例中,所述离焦区包括在所述镜片外表面形成的离焦量渐变的曲面。在一个示例中,所述离焦区包括在所述镜片外表面形成的多个定焦区域(区域内离焦量恒定),多个定焦区域的离焦量不同,多个定焦区域之间呈台阶状跃变。在一个示例中,所述离焦区包括在所述镜片外表面部分区域(如圆心角为90度的环段内)形成的点状凸起,所述点状凸起构成了离焦区中的高焦区。In one example, the out-of-focus area includes a curved surface with a gradual de-focus amount formed on the outer surface of the lens. In one example, the defocus area includes a plurality of fixed focus areas formed on the outer surface of the lens (with a constant defocus amount within the area), the defocus amounts of the multiple fixed focus areas are different, and the distance between the multiple fixed focus areas is different. There is a step-like transition. In one example, the out-of-focus area includes point-like protrusions formed in a partial area of the outer surface of the lens (eg, in a ring segment with a central angle of 90 degrees), and the point-like protrusions constitute the center of the out-of-focus area. high focal area.

上述结构也可以组合起来,例如,在一个示例中,所述离焦区包括在所述镜片外表面形成的一个或多个定焦区域,该定焦区域可以构成高焦区的一部分但不局限于此,其他区域采用离焦量渐变的曲面结构。在一个示例中,所述离焦区包括在所述镜片外表面形成的离焦量渐变的曲面,其中包括一个或多个高焦区,而在至少一个高焦区中还设置有一个或多个点状凸起,通过这种复合结构可以在高焦区取得更大的Vmax值。等等。在镜片外表面形成离焦量渐变的曲面时可能会带来部分像散,但一定程度的像散是可以接受的,有利于近视控制。The above structures can also be combined, for example, in one example, the defocusing area includes one or more fixed-focus areas formed on the outer surface of the lens, and the fixed-focus area may constitute a part of the high-focus area but is not limited to Here, other areas adopt a curved surface structure with gradual defocus amount. In one example, the defocus area includes a curved surface with gradual defocus amount formed on the outer surface of the lens, which includes one or more high focal areas, and at least one high focal area is further provided with one or more high focal areas. A point-like protrusion, through this composite structure, a larger Vmax value can be obtained in the high focal area. and many more. Partial astigmatism may be caused when the outer surface of the lens forms a curved surface with gradual defocus amount, but a certain degree of astigmatism is acceptable, which is beneficial to the control of myopia.

本发明一示例性实施例中,所述离焦区的离焦量在0~360°方向角上形成一个峰值,所述峰值不小于2D或2.5D或3D或3.5D或4D或4.5D或5D或5.5D;在本发明另一示例性实施例中,所述离焦区的离焦量在0~360°方向角上形成相互间隔120°~240°的两个峰值,其中第一个峰值不小于2D或2.5D或3D或3.5D或4D或4.5D或5D或5.5D,第二个峰值与第一个峰值相等,或者小于第一个峰值。上述只有一个峰值的情况,相当于在镜片上设计了用于产生上述模型中F1的结构,而有两个峰值的情况,相当于在镜片上设计了用于产生上述模型中F2的结构,是将原本角膜散光产生的离焦变化应用到镜片设计上。因为人的角膜散光大部分情况下都出现在以90°方向角和270°方向角为中心的范围内(正负45°左右),上述两个峰值及其间隔角度的设计,有助于实现镜片和角膜的离焦量的极值叠加,产生更大的Vmax值,扩大高焦区在视野中的范围,达到更好的近视控制效果。In an exemplary embodiment of the present invention, the defocus amount of the defocus area forms a peak at a direction angle of 0 to 360°, and the peak value is not less than 2D or 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5D; in another exemplary embodiment of the present invention, the defocus amount of the defocus area forms two peaks separated from each other by 120° to 240° at a direction angle of 0 to 360°, wherein the first The peak is not less than 2D or 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5D, the second peak is equal to the first peak, or is smaller than the first peak. The above case with only one peak is equivalent to designing a structure on the lens to generate F1 in the above model, and the case of having two peaks is equivalent to designing a structure on the lens to generate F2 in the above model, it is Apply the defocus changes originally produced by corneal astigmatism to the lens design. Because human corneal astigmatism mostly occurs in the range centered on the 90° direction angle and the 270° direction angle (plus or minus 45°), the design of the above two peaks and their interval angles is helpful to achieve The extreme value of the defocus amount of the lens and the cornea is superimposed, resulting in a larger Vmax value, expanding the range of the high focal area in the field of view, and achieving better myopia control effect.

本发明上述实施例的周边离焦的镜片,采用了离焦量在环向变化的结构以及有利于镜片、角膜离焦量极值叠加的结构等新的结构设计,可以达到更好的近视控制效果。The peripheral defocus lens of the above-mentioned embodiment of the present invention adopts a new structure design such as a structure in which the defocus amount changes in the circumferential direction and a structure that is conducive to the superposition of the extreme value of the lens and cornea defocus amount, which can achieve better myopia control. Effect.

本发明一示例性实施例中,还提供了一种框架眼镜,包括镜架和两个镜片,所述两个镜片中的至少一个采用如上所述的任一周边离焦的镜片。在一个示例中,所述镜片中的离焦区包括一个高焦区,所述高焦区位于镜片中心的上方或下方。在另一示例中,所述镜片中的离焦区包括两个高焦区,其中一个位于镜片中心的上方,另一个位于镜片中心的下方;其中,所述高焦区指所述离焦区中任意位置离焦量不小于2.5D或3D或3.5D或4D或4.5D或5D或5.5D或6D的区域。本申请中,如果通过镜片中心的向上的垂直线穿过该高焦区,则认为该高焦区位于镜片中心的上方,如果通过镜片中心的向下的垂直线穿过该高焦区,则认为该高焦区位于镜片中心的下方。将高焦区设置在镜片中心的上方和/或下方,也是因为考虑到人的角膜散光大部分情况下都出现在以90°方向角和270°方向角为中心的范围内(正负45°左右),这种设置有助于实现镜片和角膜的离焦量的极值叠加。对于少部分人的角膜散光会出现在其他的角度上,可以通过制造、选择高焦区设计在其他角度上的镜片来满足这部分人的需求。In an exemplary embodiment of the present invention, there is also provided a framed spectacles, comprising a frame and two lenses, at least one of the two lenses adopts any of the above-mentioned peripherally defocused lenses. In one example, the out-of-focus zone in the lens includes a high-focus zone above or below the center of the lens. In another example, the defocus area in the lens includes two high focal areas, one of which is located above the center of the lens and the other is located below the center of the lens; wherein the high focal area refers to the defocused area The defocus amount in any position is not less than 2.5D or 3D or 3.5D or 4D or 4.5D or 5D or 5.5D or 6D area. In this application, if an upward vertical line passing through the center of the lens passes through the high focal zone, the high focal zone is considered to be located above the center of the lens, and if a downward vertical line passing through the center of the lens passes through the high focal zone, then This high focal zone is considered to be below the center of the lens. The high focal zone is set above and/or below the center of the lens, also because it is considered that human corneal astigmatism occurs in the range centered on the 90° azimuth and 270° azimuth (plus or minus 45°) in most cases. left and right), this setting helps to achieve the extreme superposition of the defocus amount of the lens and the cornea. For a small number of people, corneal astigmatism will appear at other angles, and the needs of these people can be met by manufacturing and selecting lenses with high focal areas designed at other angles.

以上是对于周边离焦镜片的设计,本申请还将上述理论应用到角膜塑形镜镜片的设计上,从而提供了一种角膜塑形镜的镜片2,如图9和图10所示,所述镜片包括基弧区(即中央光学区)21、反转弧区22、定位弧区23和周弧区24,其中,所述基弧区21和反转弧区22中的至少之一在周向上存在结构变化。这里的周向变化,指在以镜片中心为圆心的0~360度方向角范围内存在结构变化。角膜塑形镜本身并不直接矫正视力,而是通过对角膜塑形间接矫正视力并抑制近视发展。传统的设计是基于使角膜变形为基弧面的形状来达到离焦的目的。而本实施例通过基弧区或反转弧区的特殊设计促使塑形后的角膜在周向上存在波动,能够达到预期的最大离焦量。The above is the design of the peripheral defocus lens, the application also applies the above theory to the design of the orthokeratology lens, thereby providing a lens 2 of the orthokeratology lens, as shown in FIG. 9 and FIG. The lens includes a base arc area (ie, the central optical area) 21, a reverse arc area 22, a positioning arc area 23 and a peripheral arc area 24, wherein at least one of the base arc area 21 and the reverse arc area 22 is in the There are structural changes in the circumferential direction. The circumferential change here means that there is a structural change in the angular range of 0 to 360 degrees with the center of the lens as the center of the circle. Orthokeratology does not directly correct vision itself, but indirectly corrects vision and inhibits the development of myopia through orthokeratology. The traditional design is based on deforming the cornea into the shape of the basal arc to achieve the purpose of defocusing. However, in this embodiment, through the special design of the base arc region or the reversed arc region, the shaped cornea has fluctuations in the circumferential direction, and the expected maximum defocus amount can be achieved.

本发明一示例性实施例中,所述反转弧区包括至少两个环段,图中示出了两个,其中一个环段221的高度大于其他环段222,见图10示出的图9镜片的A-A剖面,角膜塑形扣合在角膜3上,反转弧区的第一环段221处的高度大于其他环段222处的高度。增大弧段的高度可以提高该位置角膜变形的空间,有利于提高塑形后角膜上对应位置处的离焦量。本发明另一示例性实施例中,也可以将反转弧区设置为在周向上高度渐变的非球面形状,使角膜上对应于反转弧区的位置在塑形后发生离焦量的周向变化,产生更好的近视控制效果。另外,反转弧区还可以做加宽设计,如在保证定位稳定的情况下,将反转弧区的宽度从常规的1mm~2mm增大到1.2mm到2.2mm或更大。反转弧区的宽度增大,有助于提高反转弧区对应角膜位置的离焦量。对于基弧区,在保证视力矫正达到要求的情况下,也可以采用非对称的结构设计以达到使塑形后角膜在周向上发生离焦量变化的效果。In an exemplary embodiment of the present invention, the reversal arc region includes at least two ring segments, two of which are shown in the figure, wherein the height of one ring segment 221 is greater than that of the other ring segments 222 , as shown in FIG. 10 . 9 In the A-A section of the lens, the orthokeratology is fastened on the cornea 3, and the height of the first ring segment 221 in the reversal arc region is greater than the height of the other ring segments 222. Increasing the height of the arc segment can increase the space for corneal deformation at this position, which is beneficial to increase the defocus amount at the corresponding position on the cornea after shaping. In another exemplary embodiment of the present invention, the reversal arc region can also be set as a highly gradual aspheric shape in the circumferential direction, so that the position on the cornea corresponding to the inversion arc region is defocused after shaping. direction change, resulting in better control of myopia. In addition, the reversal arc area can also be widened. For example, under the condition of ensuring stable positioning, the width of the reversal arc area can be increased from the conventional 1mm to 2mm to 1.2mm to 2.2mm or more. The width of the reversal arc area is increased, which helps to increase the defocus amount corresponding to the corneal position of the reversal arc area. For the base arc area, under the condition that the vision correction meets the requirements, an asymmetric structural design can also be used to achieve the effect of changing the defocus amount of the cornea in the circumferential direction after shaping.

因为对离焦量与近视控制的关联尚不明确,在之前的实践中,只考虑过获取角膜上的离焦总量。根据本申请提出的上述离焦与近视控制的新的理论,本发明实施例提供了以下获取离焦量参数的方法,以能够获取到与近视控制关联的离焦量参数用于配镜等场合。Because the relationship between the amount of defocus and myopia control is unclear, in previous practice, only the amount of defocus on the cornea was considered. According to the above-mentioned new theory of defocusing and myopia control proposed in this application, the embodiment of the present invention provides the following method for obtaining the defocusing amount parameter, so that the defocusing amount parameter associated with the myopia control can be obtained and used in occasions such as glasses matching .

如图11所示,本发明一示例性实施例提供了一种获取离焦量参数的方法,包括:As shown in FIG. 11 , an exemplary embodiment of the present invention provides a method for obtaining a defocus amount parameter, including:

步骤110,在用户裸眼状态下,采集所述用户角膜上多个样点的离焦量,所述样点分布在以角膜中心为原点的坐标系中的多个方向角上;Step 110, in the user's naked eye state, collect the defocus amounts of a plurality of sample points on the user's cornea, and the sample points are distributed on a plurality of direction angles in a coordinate system with the cornea center as the origin;

角膜上离焦量的采集可以使用角膜地图仪实现,角膜地形图仪是一种通过电脑辅助,从而呈现角膜表面曲率映像的新型设备,可以生成角膜地形图。根据角膜地形图可以计算出在角膜上选择的样点的离焦量。The acquisition of the defocus amount on the cornea can be realized using a corneal mapper, a new type of equipment that presents the curvature image of the corneal surface with the aid of a computer, and can generate a corneal topography map. According to the corneal topography, the defocus amount of the selected spot on the cornea can be calculated.

步骤120,根据所述角膜上多个样点的离焦量得到离焦量参数。Step 120, obtaining a defocus amount parameter according to the defocus amounts of the multiple sample points on the cornea.

本发明一示例性实施例中,所述在所述用户裸眼状态下,是指在近视患者配镜前的裸眼状态下,得到的所述离焦量参数用于为所述近视患者配镜;在本发明另一示例性实施例中,所述在所述用户裸眼状态下,是指在近视患者经角膜塑形镜对角膜塑形后的裸眼状态下,得到的所述离焦量参数用于评估所述近视患者配戴角膜塑形镜后的近视控制效果。本实施例所述近视患者配戴的角膜塑形镜可以是本发明实施例的角膜塑形镜,也可以是其他的角膜塑形镜如传统的角膜塑形镜。In an exemplary embodiment of the present invention, in the naked eye state of the user, it means that the defocus amount parameter obtained in the naked eye state before the myopia patient is fitted with glasses is used for fitting glasses for the myopic patient; In another exemplary embodiment of the present invention, in the naked eye state of the user, it refers to the defocus amount parameter obtained in the naked eye state of the myopic patient after corneal orthokeratology is performed by an orthokeratology lens. To evaluate the myopia control effect of the myopic patients after wearing orthokeratology lenses. The orthokeratology lens worn by the myopic patient in this embodiment may be the orthokeratology lens of the embodiment of the present invention, or may be other orthokeratology lenses such as traditional orthokeratology lenses.

本发明一示例性实施例中,所述离焦量参数包括以下参数中的一种或任意组合:In an exemplary embodiment of the present invention, the defocus amount parameter includes one or any combination of the following parameters:

所述角膜上多个样点的离焦量;the amount of defocus of a plurality of sample points on the cornea;

所述角膜上的最大离焦量;the maximum amount of defocus on the cornea;

所述角膜上的最大离焦量所在的位置信息;position information on the cornea where the maximum defocus amount is located;

所述角膜上的最大离焦量和设定的一个或多个离焦阈值的比较结果;the comparison result of the maximum defocus amount on the cornea and the set one or more defocus thresholds;

有效离焦区域的有无、数量、大小和位置中的一种或多种信息;One or more of the presence, quantity, size and location of the effective defocus area;

其中,所述角膜上的最大离焦量根据所述角膜上多个样点的离焦量确定,所述有效离焦区域指所述角膜上任意位置离焦量不小于对应的离焦阈值的区域,所述离焦阈值不小于3.5D或4D或4.5D或5D或5.5D。Wherein, the maximum defocus amount on the cornea is determined according to the defocus amounts of a plurality of sample points on the cornea, and the effective defocus area refers to the area where the defocus amount at any position on the cornea is not less than the corresponding defocus threshold. area, the defocus threshold is not less than 3.5D or 4D or 4.5D or 5D or 5.5D.

在一示例中,根据所述角膜上多个样点的离焦量确定所述角膜上的最大离焦量,包括:In an example, determining the maximum defocus amount on the cornea according to the defocus amounts of a plurality of sample points on the cornea, including:

将所述角膜上多个样点的离焦量的最大值作为所述角膜上的最大离焦量。如果样点够多,这种方式也有较高的精确度。此时所述角膜上的最大离焦量所在的位置信息就是具有该最大离焦量的样点的位置信息;或者The maximum defocus amount on the cornea is taken as the maximum defocus amount on the cornea. This method also has higher accuracy if there are enough samples. At this time, the position information of the maximum defocus amount on the cornea is the position information of the sample point with the maximum defocus amount; or

根据所述多个方向角中每一方向角上的样点的离焦量确定每一方向角上离焦量的最大值;根据每一方向角上离焦量的进行曲线拟合得到0°~360°方向角上的离焦量曲线;将所述离焦量曲线的最大峰值确定为所述角膜上的最大离焦量。The maximum value of the defocus amount at each direction angle is determined according to the defocus amount of the sample point at each direction angle in the plurality of direction angles; according to the curve fitting of the defocus amount at each direction angle, 0° is obtained Defocus amount curve at a direction angle of ~360°; the maximum peak value of the defocus amount curve is determined as the maximum defocus amount on the cornea.

除了以上方法外,在一示例中,所述角膜上的多个样点均布在周膜上,也可以根据所述多个样点进行曲面拟合,将拟合得到的曲面的最大峰值作为所述角膜上的最大离焦量。对于具体计算方式本申请不做局限。In addition to the above methods, in an example, multiple sample points on the cornea are evenly distributed on the peripheral membrane, and surface fitting can also be performed according to the multiple sample points, and the maximum peak value of the fitted surface can be used as the The maximum amount of defocus on the cornea. This application does not limit the specific calculation method.

对于角膜上的样点的选取,可以有不同的方式。例如,可以在至少18个等间隔的方向角上选择样点,每一方向角上采集至少3个样点的离焦量。又如,也可以在360个等间隔的方向角上,每一方向角上采集至少50个样点的离焦量。具体可以根据实际需要如测量精度的要求来设定。There are different ways to select the sample points on the cornea. For example, the sample points may be selected at at least 18 equally spaced azimuth angles, and the defocus amount of at least 3 sample points may be collected on each azimuth angle. For another example, the defocus amount of at least 50 sample points can also be collected at 360 equally spaced directional angles, and at each directional angle. Specifically, it can be set according to actual needs such as measurement accuracy requirements.

本发明一示例性实施例还提供了一种获取离焦量参数的方法,如图12所示,包括:An exemplary embodiment of the present invention also provides a method for obtaining a defocus amount parameter, as shown in FIG. 12 , including:

步骤210,在近视患者配戴角膜接触镜时,采集所述近视患者角膜和镜片组成的屈光系统上多个样点的离焦量,所述样点分布在以角膜中心为原点的坐标系中的多个方向角上;Step 210, when the myopic patient wears the corneal contact lens, collect the defocus amounts of multiple sample points on the refractive system composed of the cornea and the lens of the myopic patient, and the sample points are distributed in a coordinate system with the center of the cornea as the origin on multiple directional angles in;

上述屈光系统上多个样点的离焦量也可以使用角膜地图仪或类似的检测设备来检测得到。本实施例屈光系统上多个样点的离焦量是指屈光系统前表面上多个样点的离焦量。The defocus amounts of the multiple sample points on the above-mentioned refractive system can also be detected by using a corneal map or similar detection equipment. The defocus amount of the plurality of sample points on the refractive system in this embodiment refers to the defocus amount of the plurality of sample points on the front surface of the refractive system.

步骤220,根据所述屈光系统上多个样点的离焦量得到离焦量参数。Step 220: Obtain a defocus amount parameter according to the defocus amounts of multiple sample points on the refractive system.

本步骤得到的离焦量参数是所述屈光系统上的离焦量参数。The defocus amount parameter obtained in this step is the defocus amount parameter on the refractive system.

本实施例中的所述角膜接触眼镜可以使用本申请周边离焦的镜片,也可以不使用本申请周边离焦的镜片。The corneal contact lenses in this embodiment may use the lenses with the peripheral defocus of the present application, or may not use the lenses with the peripheral defocus of the present application.

本发明一示例性实施例中,得到的所述离焦量参数包括以下参数中的一种或任意组合:In an exemplary embodiment of the present invention, the obtained defocus amount parameter includes one or any combination of the following parameters:

所述屈光系统上的最大离焦量;the maximum amount of defocus on the refractive system;

所述屈光系统上的最大离焦量和设定的一个或多个离焦阈值的比较结果;The comparison result of the maximum defocus amount on the refractive system and the set one or more defocus thresholds;

其中,所述屈光系统上的最大离焦量根据所述屈光系统上多个样点的离焦量确定,所述离焦阈值不小于3.5D或4D或4.5D或5D或5.5D。确定屈光系统上的最大离焦量的方法可以参照上文确定角膜上的最大离焦量的方法,这里不再赘述。Wherein, the maximum defocus amount on the refractive system is determined according to the defocus amounts of multiple sample points on the refractive system, and the defocus threshold is not less than 3.5D or 4D or 4.5D or 5D or 5.5D. For the method of determining the maximum defocus amount on the refractive system, reference may be made to the method for determining the maximum defocus amount on the cornea above, which will not be repeated here.

在一示例中,设定一个离焦阈值,例如用于判断近视控制是否成功的阈值,如4.5D,而在另一示例中,则设定多个离焦阈值如3.5D和4.5D或更多个,将最大离焦量与多个离焦阈值比较,可以更精确地表示最大离焦量所在的区间,对近视控制的有效性进行定量的评估。In one example, a defocusing threshold is set, such as a threshold for judging whether myopia control is successful, such as 4.5D, while in another example, multiple defocusing thresholds are set such as 3.5D and 4.5D or more. More than one, comparing the maximum defocus amount with a plurality of defocus thresholds can more accurately represent the interval where the maximum defocus amount is located, and quantitatively evaluate the effectiveness of myopia control.

本发明一示例性实施例中,根据所述屈光系统上多个样点的离焦量得到的离焦量参数包括:根据所述多个样点的离焦量确定有效离焦区域的有无,数量、大小和位置中的一种或多种信息,其中,所述有效离焦区域指所述屈光系统上任意位置离焦量不小于对应的离焦阈值的区域,所述离焦阈值不小于3.5D或4D或4.5D或5D或5.5D。In an exemplary embodiment of the present invention, the defocus amount parameter obtained according to the defocus amounts of multiple sample points on the refractive system includes: determining the effective defocus area according to the defocus amounts of the multiple sample points None, one or more information in quantity, size and position, wherein, the effective defocus area refers to the area where the defocus amount at any position on the refractive system is not less than the corresponding defocus threshold, and the defocus area The threshold is not less than 3.5D or 4D or 4.5D or 5D or 5.5D.

本实施例中,根据对应的离焦阈值的不同,有效离焦区域可以有一种或多种,不同的有效离焦区域是采用不同的离焦阈值判断得到的。例如,可以有对应于离焦阈值3.5D的有效离焦区域,对应于离焦阈值4.5D的有效离焦区域,等等。同一种有效离焦区域的数量可以有一个或多个。存在有效离焦区域,就说明屈光系统上的最大离焦量大于该有效离焦区域对应的离焦阈值,再结合有效离焦区域的大小信息,可以对近视控制有效性进行更为精细的评估。有效离焦区域的大小信息可以用该有效离焦区域对应的圆心角的大小,或者有效离焦区域的面积等来表示。除了大小信息外,还可以结合有效离焦区域的其他信息如具体位置信息,结合统计分析得到的这些位置信息与近视控制有效性的关联性进行精细评估。In this embodiment, according to different corresponding defocus thresholds, there may be one or more effective defocus areas, and different effective defocus areas are determined by using different defocus thresholds. For example, there may be an effective out-of-focus area corresponding to a defocus threshold of 3.5D, an effective out-of-focus area corresponding to a defocus threshold of 4.5D, and so on. The number of the same effective defocus area can be one or more. There is an effective defocus area, which means that the maximum defocus amount on the refractive system is greater than the defocus threshold corresponding to the effective defocus area. Combined with the size information of the effective defocus area, the effectiveness of myopia control can be more refined. Evaluate. The size information of the effective out-of-focus area can be represented by the size of the central angle corresponding to the effective out-of-focus area, or the area of the effective out-of-focus area. In addition to the size information, other information of the effective defocus area, such as specific position information, can also be combined with the correlation between these position information obtained by statistical analysis and the effectiveness of myopia control for fine evaluation.

本发明一示例性实施例中,所述近视患者配戴的眼镜为角膜接触镜,所述角膜接触镜使用如本发明实施例所述的任一镜片,所述镜片包括一指示标志,所述指示标志用于指示所述镜片的离焦区中离焦量最大的位置;在采集所述屈光系统上多个样点的离焦量之前,所述方法还包括:根据所述镜片的指示标志,对所述镜片的配戴角度进行校准,使所述镜片的离焦区中离焦量最大的位置对准所述近视患者角膜上的最大离焦量所在的位置。因为近视患者配戴时,应先进行校准以取得好的近视控制效果,因而在测量离焦量参数之前也需要进行上述校准,有利于获得更为准确的数据。位置的校准可以是在镜片中心与角膜中心对准后,将镜片以镜片中心与角膜中心的连线为轴旋转一个角度来实现。In an exemplary embodiment of the present invention, the glasses worn by the myopic patient are contact lenses, the contact lenses use any of the lenses described in the embodiments of the present invention, and the lenses include an indicator mark, the The indication mark is used to indicate the position with the largest defocus amount in the defocus area of the lens; before collecting the defocus amounts of the multiple sample points on the refractive system, the method further includes: according to the indication of the lens mark, and calibrate the wearing angle of the lens, so that the position with the largest defocus amount in the defocus area of the lens is aligned with the position on the cornea of the myopic patient where the maximum defocus amount is located. Because myopia patients should perform calibration first to obtain a good myopia control effect, the above calibration should also be performed before measuring the defocus parameter, which is beneficial to obtain more accurate data. The calibration of the position can be realized by rotating the lens by an angle with the line connecting the center of the lens and the center of the cornea as the axis after the center of the lens is aligned with the center of the cornea.

在获取上述离焦量参数后,得到的所述离焦量参数用于评估所述近视患者配戴所述角膜接触镜的近视控制效果,例如评估患者配戴传统的周边离焦的角膜接触镜对近视控制的效果,如果效果不佳可以及时更换其他镜片如本申请周边离焦的镜片。After obtaining the above defocus amount parameter, the obtained defocus amount parameter is used to evaluate the myopia control effect of the myopic patient wearing the contact lens, for example, evaluating the patient wearing a traditional peripheral defocus contact lens For the effect of myopia control, if the effect is not good, other lenses can be replaced in time, such as the peripheral defocus lens of the present application.

在本发明一示例性实施例中,所述离焦量参数包括所述角膜上的最大离焦量,或者所述角膜上的最大离焦量和设定的一个离焦阈值的比较结果;所述根据所述离焦量参数确定近视控制效果,包括:根据所述离焦量参数判断所述角膜上的最大离焦量是否不小于所述离焦阈值,如是,确定近视控制效果为有效,如否,确定近视控制效果为无效;或者In an exemplary embodiment of the present invention, the defocus amount parameter includes a maximum defocus amount on the cornea, or a comparison result between the maximum defocus amount on the cornea and a set defocus threshold; The determining the myopia control effect according to the defocus amount parameter includes: judging whether the maximum defocus amount on the cornea is not less than the defocus threshold according to the defocus amount parameter, and if so, determining that the myopia control effect is effective, If not, determine that the myopia control effect is ineffective; or

所述离焦量参数包括所述角膜上的最大离焦量,或者所述角膜上的最大离焦量和设定的多个离焦阈值的比较结果;所述根据所述离焦量参数确定近视控制效果,包括:根据所述离焦量参数判断所述角膜上的最大离焦量是否不小于一个或多个离焦阈值,如是,根据所述一个或多个离焦阈值中最大的一个离焦阈值查找对应的近视控制成功率,根据所述近视控制成功率确定近视控制效果。The defocus amount parameter includes a maximum defocus amount on the cornea, or a comparison result between the maximum defocus amount on the cornea and a plurality of set defocus thresholds; the defocus amount parameter is determined according to the defocus amount parameter. Myopia control effect, including: judging whether the maximum defocus amount on the cornea is not less than one or more defocus thresholds according to the defocus amount parameter, and if so, according to the largest one or more defocus thresholds The defocus threshold is used to find the corresponding myopia control success rate, and the myopia control effect is determined according to the myopia control success rate.

在本发明一示例性实施例中,所述离焦量参数至少包括有效离焦区的有无和大小信息;所述根据所述离焦量参数确定近视控制效果,包括:如所述角膜上存在有效离焦区域,则根据所述有效离焦区域对应的离焦阈值和所述有效离焦区域的大小信息查找对应的近视控制成功率,根据所述近视控制成功率确定近视控制效果。In an exemplary embodiment of the present invention, the defocus amount parameter includes at least information on the presence or absence of an effective defocus area and size; the determining the myopia control effect according to the defocus amount parameter includes: If there is an effective defocus area, the corresponding myopia control success rate is searched according to the defocus threshold corresponding to the effective defocus area and the size information of the effective defocus area, and the myopia control effect is determined according to the myopia control success rate.

上述实施例中,所述根据所述近视控制成功率确定近视控制效果,包括:直接使用所述近视控制成功率来表示近视控制效果;或者,判断所述近视控制成功率是否不小于预期的成功率,如果是,确定近视控制效果为有效,如否,确定近视控制效果为无效。In the above embodiment, determining the myopia control effect according to the myopia control success rate includes: directly using the myopia control success rate to represent the myopia control effect; or, judging whether the myopia control success rate is not less than an expected success rate. If yes, determine that the myopia control effect is valid, if not, determine that the myopia control effect is invalid.

本发明一示例性实施例还提供了一种配镜方法,如图13所示,包括:An exemplary embodiment of the present invention also provides a method for dispensing glasses, as shown in FIG. 13 , including:

步骤310,按照本发明上述实施例所述的任一方法获取近视患者配镜前的裸眼状态下的离焦量参数;Step 310, according to any method described in the above-mentioned embodiments of the present invention, obtain the defocus amount parameter of the myopic patient under the naked eye state before the glasses are fitted;

步骤320,根据所述离焦量参数为所述近视患者配镜。Step 320, according to the defocus amount parameter, the myopia patient is fitted with glasses.

上述配镜可以是从已制造的眼镜中选择到一副合适的眼镜,也可以是为近视患者设计一款个性化的新的眼镜。所述眼镜可以使用本申请的周边离焦镜片,也可以使用传统的周边离焦的镜片。The above-mentioned glasses can be a pair of suitable glasses selected from the manufactured glasses, or a new personalized glasses designed for myopic patients. The glasses may use the peripheral defocus lens of the present application, or may use the conventional peripheral defocus lens.

本发明一示例性实施例中,所述离焦量参数包括所述角膜上的最大离焦量及其所在的位置信息;根据所述离焦量参数为所述近视患者配镜,包括:为所述近视患者选配周边离焦的角膜接触镜或框架眼镜的镜片,使得所述近视患者角膜上的最大离焦量与所述镜片相应位置的离焦量对位叠加后,得到的和不小于设定的离焦阈值,其中,所述离焦阈值不小于3.5D或4D或4.5D或5D或5.5D,离焦阈值具体可以根据所希望的近视抑制效果和患者的耐受度等选定一个。角膜接触镜的镜片是与角膜直接贴合的,对位前需将镜片中心与角膜中心对准。对框架眼镜,镜片与角膜有一定距离,对位前可以将镜片中心与角膜对准,其他位置的对应关系可以参照原有的规则。In an exemplary embodiment of the present invention, the defocus amount parameter includes the maximum defocus amount on the cornea and its position information; according to the defocus amount parameter, fitting glasses for the myopic patient includes: The myopic patient selects a peripheral defocused contact lens or lenses of frame glasses, so that after the maximum defocus amount on the cornea of the myopia patient is aligned and superimposed with the defocus amount at the corresponding position of the lens, the obtained sum is not Less than the set defocus threshold, wherein, the defocus threshold is not less than 3.5D or 4D or 4.5D or 5D or 5.5D, and the defocus threshold can be selected according to the desired myopia suppression effect and the patient's tolerance. Set one. The lens of the contact lens is directly attached to the cornea, and the center of the lens needs to be aligned with the center of the cornea before alignment. For frame glasses, there is a certain distance between the lens and the cornea. Before alignment, the center of the lens can be aligned with the cornea. The corresponding relationship of other positions can refer to the original rules.

本发明一示例性实施例中,所述离焦量参数包括所述角膜上多个样点的离焦量信息;根据所述离焦量参数为所述近视患者配镜,包括:为所述近视患者选配周边离焦的角膜接触镜或框架眼镜的镜片,使得所述近视患者配戴所述镜片时,所述角膜上的离焦量与所述镜片相应位置的离焦量对位叠加后,至少存在有效离焦区域且所述有效离焦区域的大小满足要求,其中,所述有效离焦区域指任意位置离焦量不小于对应的离焦阈值的区域,所述离焦阈值不小于3.5D或4D或4.5D或5D或5.5D,具体可以根据所希望的近视抑制效果和患者的耐受度等选定一个离焦阈值。In an exemplary embodiment of the present invention, the defocus amount parameter includes defocus amount information of a plurality of sample points on the cornea; fitting glasses for the myopic patient according to the defocus amount parameter includes: Myopic patients can choose contact lenses or spectacle lenses with peripheral defocus, so that when the myopic patient wears the lenses, the defocus amount on the cornea and the defocus amount at the corresponding position of the lens are aligned and superimposed. After that, there is at least an effective defocus area and the size of the effective defocus area meets the requirements, wherein the effective defocus area refers to an area where the defocus amount at any position is not less than the corresponding defocus threshold, and the defocus threshold is not equal to If it is less than 3.5D or 4D or 4.5D or 5D or 5.5D, a defocus threshold can be selected according to the desired myopia suppression effect and the patient's tolerance.

在一个示例中,所述有效离焦区域的大小满足要求,包括:所述有效离焦区域满足以下一个或多个条件:In an example, the size of the effective defocus area meets the requirements, including: the effective defocus area satisfies one or more of the following conditions:

所述有效离焦区域所在环段相对镜片中心的圆心角不小于一角度阈值,所述角度阈值是不小于5°或15°或30°或45°或60°的一设定值;The central angle of the ring segment where the effective defocus area is located relative to the center of the lens is not less than an angle threshold, and the angle threshold is a set value not less than 5° or 15° or 30° or 45° or 60°;

所述有效离焦区域的面积之和不小于设定的面积阈值。The sum of the areas of the effective out-of-focus areas is not less than the set area threshold.

本发明一示例性实施例中,所述镜片采用本发明实施例所述的任一镜片;进行所述对位叠加之前,所述方法还包括:对所述镜片的配戴角度进行校准(可以在软件中完成),使所述镜片的离焦区中离焦量最大的位置对准所述近视患者角膜上的最大离焦量所在的位置。在叠加前先对准,可以得到更为准确的离焦数据,减少所需的最大离焦量的值。In an exemplary embodiment of the present invention, the lens adopts any lens described in the embodiment of the present invention; before performing the alignment and stacking, the method further includes: calibrating the wearing angle of the lens (may be Completed in the software), the position with the largest defocus amount in the defocus zone of the lens is aligned with the position where the maximum defocus amount is located on the cornea of the myopic patient. By aligning before stacking, more accurate defocus data can be obtained, reducing the value of the required maximum defocus amount.

本发明一示例性实施例中,所述方法还包括:获取所述近视患者的瞳孔的直径;为所述近视患者选配框架眼镜或角膜接触镜的镜片,其中,根据所述瞳孔的直径确定所述镜片的中央光学区的直径,瞳孔的直径越大,则确定的所述镜片的中央光学区的直径越大。此处是根据患者的瞳孔大小进行个性化的设计。例如,可以将瞳孔的直径分为5个大小不同的等级,而将镜片的中央光学区的直径也分为5个大小不同的等级。如果瞳孔的直径是最小的一级,则选择中央光学区的直径是最小一级的镜片,如果瞳孔的直径是最大的一级,则选择中央光学区的直径是最大一级的镜片。依此类推。在其他示例中,瞳孔的直径所分等级和镜片所分等级的数量并不需要相等。而且瞳孔的直径也可以不分等级,直接将瞳孔直径划分为多个区间,每个区间对应一种镜片中央光学区的直径,也是可以的。In an exemplary embodiment of the present invention, the method further includes: acquiring the diameter of the pupil of the myopic patient; matching frame glasses or contact lenses for the myopic patient, wherein the diameter of the pupil is determined according to the diameter of the pupil. The diameter of the central optical zone of the lens, the larger the diameter of the pupil, the larger the diameter of the central optical zone of the lens is determined. Here is a personalized design based on the patient's pupil size. For example, the diameter of the pupil can be divided into 5 grades of different sizes, and the diameter of the central optical zone of the lens can also be divided into 5 grades of different sizes. If the diameter of the pupil is the smallest order, the lens with the diameter of the central optic zone is the smallest order, and if the diameter of the pupil is the largest order, the lens with the diameter of the central optic zone is the largest order. So on and so forth. In other examples, the number of pupil diameters graded and the lenses graded need not be equal. Moreover, the diameter of the pupil can also be divided into multiple sections without any grades, and each section corresponds to the diameter of the central optical zone of the lens, which is also possible.

目前判断一个角膜塑形镜对患者近视控制是否有效,需要测量配戴角膜塑形镜一年后眼轴的变化,而且评估主要是针对角膜塑形镜的定位及视力。这需要非常多的时间,对于控制无效的患者可能会耽误了采用其他方法进行有效治疗的时机。At present, to judge whether an orthokeratology lens is effective in controlling myopia, it is necessary to measure the change of the eye axis after wearing the orthokeratology lens for one year, and the evaluation mainly focuses on the positioning and vision of the orthokeratology lens. This takes a lot of time and may delay the use of other modalities for effective treatment in patients with ineffective control.

为此,本发明一示例性实施例提供了一种使用离焦量评估近视控制效果的方法,如图14所示,包括:To this end, an exemplary embodiment of the present invention provides a method for evaluating the control effect of myopia by using the defocus amount, as shown in FIG. 14 , including:

步骤410,按照如本发明上述实施例所述的任一方法获取近视患者经角膜塑形镜对角膜塑形后的裸眼状态下得到的离焦量参数;Step 410, according to any method described in the above-mentioned embodiments of the present invention, obtain the defocus amount parameter obtained in the naked eye state of the myopic patient after orthokeratology lens orthokeratology;

步骤420,根据所述离焦量参数确定所述角膜塑形镜对所述近视患者的近视控制效果。Step 420: Determine the myopia control effect of the orthokeratology lens on the myopia patient according to the defocus amount parameter.

本发明一示例性实施例中,所述离焦量参数包括所述角膜上的最大离焦量,或者所述角膜上的最大离焦量和设定的一个离焦阈值的比较结果;所述根据所述离焦量参数确定近视控制效果,包括:根据所述离焦量参数判断所述角膜上的最大离焦量是否不小于所述离焦阈值,如是,确定近视控制效果为有效,如否,确定近视控制效果为无效;或者In an exemplary embodiment of the present invention, the defocus amount parameter includes a maximum defocus amount on the cornea, or a comparison result between the maximum defocus amount on the cornea and a set defocus threshold; the Determining the myopia control effect according to the defocus amount parameter includes: judging whether the maximum defocus amount on the cornea is not less than the defocus threshold according to the defocus amount parameter, and if so, determining that the myopia control effect is effective, such as No, determine that the myopia control effect is invalid; or

所述离焦量参数包括所述角膜上的最大离焦量,或者所述角膜上的最大离焦量和设定的多个离焦阈值的比较结果;所述根据所述离焦量参数确定近视控制效果,包括:根据所述离焦量参数判断所述角膜上的最大离焦量是否不小于一个或多个离焦阈值,如是,根据所述一个或多个离焦阈值中最大的一个离焦阈值查找对应的近视控制成功率,根据所述近视控制成功率确定近视控制效果。离焦阈值对应的近视控制成功率可以根据相应的实验数据统计得到并保存起来。The defocus amount parameter includes a maximum defocus amount on the cornea, or a comparison result between the maximum defocus amount on the cornea and a plurality of set defocus thresholds; the defocus amount parameter is determined according to the defocus amount parameter. Myopia control effect, including: judging whether the maximum defocus amount on the cornea is not less than one or more defocus thresholds according to the defocus amount parameter, and if so, according to the largest one or more defocus thresholds The defocus threshold is used to find the corresponding myopia control success rate, and the myopia control effect is determined according to the myopia control success rate. The success rate of myopia control corresponding to the defocus threshold can be obtained and saved according to the corresponding experimental data.

本发明一示例性实施例中,所述离焦量参数至少包括有效离焦区的有无和大小信息(没有有效离焦区时,大小信息等是空信息);所述根据所述离焦量参数确定近视控制效果,包括:如所述角膜上存在有效离焦区域,则根据所述有效离焦区域对应的离焦阈值和所述有效离焦区域的大小信息查找对应的近视控制成功率,根据所述近视控制成功率确定近视控制效果。离焦阈值和有效离焦区域的大小信息对应的近视控制成功率可以根据相应的实验数据统计得到并保存起来。如果离焦量参数中包括对应不同离焦阈值的多个有效离焦区域,可以查找到多个近视控制成功率,从中选择一个用于确定近视控制效果。例如,根据对应最大离焦阈值的有效离焦区域及其大小信息查找近视控制成功率,使用查找到的近视控制成功率确定近视控制效果,但本申请不局限于此。还可以是将根据多个有效离焦区域及其大小信息查找到的近视控制成功率综合考虑,如取最大值,或均值,或最小值来确定近视控制效果,本申请对此不做局限。In an exemplary embodiment of the present invention, the defocus amount parameter includes at least information on the presence or absence of an effective defocus area and size information (when there is no effective defocus area, the size information and the like are empty information); Quantitative parameters to determine the myopia control effect, including: if there is an effective defocus area on the cornea, searching for the corresponding myopia control success rate according to the defocus threshold corresponding to the effective defocus area and the size information of the effective defocus area , and the myopia control effect is determined according to the myopia control success rate. The success rate of myopia control corresponding to the defocus threshold and the size information of the effective defocus area can be obtained and saved according to the corresponding experimental data. If the defocus amount parameter includes multiple effective defocus regions corresponding to different defocus thresholds, multiple myopia control success rates can be found, and one of them can be selected to determine the myopia control effect. For example, the myopia control success rate is searched according to the effective defocus area corresponding to the maximum defocus threshold and its size information, and the myopia control effect is determined using the found myopia control success rate, but the present application is not limited thereto. It is also possible to comprehensively consider the myopia control success rate found according to multiple effective defocus areas and their size information, such as taking a maximum value, an average value, or a minimum value to determine the myopia control effect, which is not limited in this application.

在本发明上述示例性实施例中,所述根据所述近视控制成功率确定近视控制效果,包括:直接使用所述近视控制成功率来表示近视控制效果;或者,判断所述近视控制成功率是否不小于预期的成功率,如果是,确定近视控制效果为有效,如否,确定近视控制效果为无效。In the above exemplary embodiment of the present invention, the determining the myopia control effect according to the myopia control success rate includes: directly using the myopia control success rate to represent the myopia control effect; or, judging whether the myopia control success rate is It is not less than the expected success rate. If it is, it is determined that the myopia control effect is valid, if not, it is determined that the myopia control effect is invalid.

在本发明一示例性实施例中,所述近视控制效果的评估在所述近视患者配戴角膜塑形镜后的2周内或1个月内或3个月内或6个月内进行。In an exemplary embodiment of the present invention, the evaluation of the myopia control effect is carried out within 2 weeks or within 1 month or within 3 months or within 6 months after the myopia patient wears the orthokeratology lens.

区别于以往的评估方法,本发明上述实施例提供了一种使用离焦量参数来评估近视控制有效性的方法。而且在较短的时间内就可以预判角膜塑形镜对该患者是否有效,提高临床效率,避免耽误患者病情选择其他控制近视的手段。本申请提供了一种新的角膜塑形镜评估标准,具有重要的意义。Different from the previous evaluation methods, the above-mentioned embodiment of the present invention provides a method for evaluating the effectiveness of myopia control by using the defocus amount parameter. Moreover, in a relatively short period of time, it is possible to predict whether the orthokeratology lens is effective for the patient, improve the clinical efficiency, and avoid delaying the patient's condition to choose other means of controlling myopia. This application provides a new evaluation standard for orthokeratology lenses, which is of great significance.

本发明上述实施例的获取离焦量参数的方法、配镜方法和评估近视控制效果的方法,均可以使用计算机设备来实现。如图15所示,所述计算机设备包括处理器50、存储器60及存储在所述存储器60上并可在所述处理器50上运行的计算机程序,所述处理器50执行所述计算程序时实现如本发明上述实施例所述的任一方法的处理。The method for obtaining the defocus amount parameter, the method for fitting glasses, and the method for evaluating the control effect of myopia in the above-mentioned embodiments of the present invention can all be implemented by using computer equipment. As shown in FIG. 15, the computer device includes a processor 50, a memory 60, and a computer program stored on the memory 60 and executable on the processor 50, when the processor 50 executes the computing program The processing of any of the methods described in the above embodiments of the present invention is implemented.

本发明一示例性实施例还提供了一种计算机可读存储介质,其上存储有计算机程序,所述计算机程序被处理器执行时实现如本发明上述实施例所述的任一方法的处理。An exemplary embodiment of the present invention further provides a computer-readable storage medium on which a computer program is stored, and when the computer program is executed by a processor, implements the processing of any of the methods described in the foregoing embodiments of the present invention.

本领域普通技术人员可以理解,上文中所公开方法中的全部或某些步骤、系统、装置中的功能模块/单元可以被实施为软件、固件、硬件及其适当的组合。在硬件实施方式中,在以上描述中提及的功能模块/单元之间的划分不一定对应于物理组件的划分;例如,一个物理组件可以具有多个功能,或者一个功能或步骤可以由若干物理组件合作执行。某些物理组件或所有物理组件可以被实施为由处理器,如中央处理器、数字信号处理器或微处理器执行的软件,或者被实施为硬件,或者被实施为集成电路,如专用集成电路。这样的软件可以分布在计算机可读介质上,计算机可读介质可以包括计算机存储介质(或非暂时性介质)和通信介质(或暂时性介质)。如本领域普通技术人员公知的,术语计算机存储介质包括在用于存储信息(诸如计算机可读指令、数据结构、程序模块或其他数据)的任何方法或技术中实施的易失性和非易失性、可移除和不可移除介质。计算机存储介质包括但不限于RAM、ROM、EEPROM、闪存或其他存储器技术、CD-ROM、数字多功能盘(DVD)或其他光盘存储、磁盒、磁带、磁盘存储或其他磁存储装置、或者可以用于存储期望的信息并且可以被计算机访问的任何其他的介质。此外,本领域普通技术人员公知的是,通信介质通常包含计算机可读指令、数据结构、程序模块或者诸如载波或其他传输机制之类的调制数据信号中的其他数据,并且可包括任何信息递送介质。Those of ordinary skill in the art can understand that all or some of the steps in the methods disclosed above, functional modules/units in the systems, and devices can be implemented as software, firmware, hardware, and appropriate combinations thereof. In a hardware implementation, the division between functional modules/units mentioned in the above description does not necessarily correspond to the division of physical components; for example, one physical component may have multiple functions, or one function or step may be composed of several physical components Components execute cooperatively. Some or all physical components may be implemented as software executed by a processor, such as a central processing unit, digital signal processor or microprocessor, or as hardware, or as an integrated circuit, such as an application specific integrated circuit . Such software may be distributed on computer-readable media, which may include computer storage media (or non-transitory media) and communication media (or transitory media). As is known to those of ordinary skill in the art, the term computer storage media includes both volatile and nonvolatile implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data flexible, removable and non-removable media. Computer storage media include, but are not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disk (DVD) or other optical disk storage, magnetic cartridges, magnetic tape, magnetic disk storage or other magnetic storage devices, or may Any other medium used to store desired information and which can be accessed by a computer. In addition, communication media typically embodies computer readable instructions, data structures, program modules, or other data in a modulated data signal such as a carrier wave or other transport mechanism, and can include any information delivery media, as is well known to those of ordinary skill in the art .

Claims (18)

1. A method of obtaining defocus parameters, comprising:
in a naked eye state of a user, acquiring defocus amounts of a plurality of sampling points on a cornea of the user, wherein the sampling points are distributed on a plurality of direction angles in a coordinate system taking the center of the cornea as an origin;
obtaining defocus parameters according to defocus of a plurality of sample points on the cornea, wherein the defocus parameters are used for fitting a lens for a myope or evaluating the myopia control effect of the myope after wearing a cornea shaping lens, and the defocus parameters comprise one or any combination of the following parameters:
a maximum defocus on the cornea;
position information of a maximum defocus on the cornea;
the maximum defocus amount on the cornea and one or more set defocus threshold values;
one or more of the presence, number, size and position of the effective defocus area;
the maximum defocus on the cornea is determined according to the defocus of the plurality of sample points on the cornea, the effective defocus area refers to an area where the defocus at any position on the cornea is not less than a corresponding defocus threshold, and the defocus threshold is not less than 3.5D, 4D, 4.5D, 5D, or 5.5D.
2. The method of claim 1, wherein:
determining the maximum defocus amount on the cornea according to the defocus amounts of a plurality of sample points on the cornea, wherein the method comprises the following steps:
taking the maximum value of the defocus amounts of the plurality of sample points on the cornea as the maximum defocus amount on the cornea; or
Determining the maximum value of the defocusing amount of each direction angle according to the defocusing amount of the sample point of each direction angle in the plurality of direction angles; performing curve fitting according to the defocusing amount on each direction angle to obtain a defocusing amount curve on the direction angle of 0-360 degrees; and determining the maximum peak value of the defocus curve as the maximum defocus on the cornea.
3. The method of claim 1 or 2, wherein:
in the naked eye state of the user, the defocusing amount parameter is obtained in the naked eye state before glasses fitting of a myope, and the obtained defocusing amount parameter is used for glasses fitting of the myope; or
In the naked eye state of the user, the defocusing amount parameter obtained in the naked eye state of a myope after the cornea of the myope is shaped by the corneal shaping lens is used for evaluating the myopia control effect of the myope after the myope wears the corneal shaping lens.
4. A method of obtaining defocus parameters, comprising:
when a myope wears a corneal contact lens, acquiring defocus amounts of a plurality of sampling points on a dioptric system consisting of the cornea and a lens of the myope, wherein the sampling points are distributed on a plurality of direction angles in a coordinate system taking the center of the cornea as an origin;
obtaining a defocus parameter according to defocus of a plurality of sample points on the dioptric system, wherein the defocus parameter is used for evaluating the myopia control effect of the myope wearing the corneal contact lens, and the defocus parameter comprises one or any combination of the following parameters:
a maximum defocus amount on the dioptric system;
the comparison result of the maximum defocus amount on the dioptric system and one or more set defocus thresholds;
determining the existence, the quantity, the size and the position of an effective defocusing area according to the defocusing amount of the plurality of sample points;
the maximum defocus amount on the dioptric system is determined according to defocus amounts of a plurality of sample points on the dioptric system, and the defocus threshold value is not less than 3.5D, 4D, 4.5D, 5D or 5.5D;
the effective defocus area refers to an area where the defocus amount at any position on the dioptric system is not less than the corresponding defocus threshold.
5. The method of claim 4, wherein:
the glasses worn by the myope are corneal contact lenses, the lenses of the corneal contact lenses comprise a central optical area, an annular defocus area is arranged outside the central optical area, defocus of the defocus area varies in the annular direction, and the lenses further comprise an indicating mark for indicating the position of the lens with the largest defocus in the defocus area;
before the defocus amounts of a plurality of sample points on the dioptric system are collected, the method further comprises the following steps: and calibrating the wearing angle of the lens according to the indication mark of the lens, so that the position with the maximum defocus amount in the out-of-focus area of the lens is aligned with the position with the maximum defocus amount on the cornea of the myope.
6. A method of fitting a lens, comprising:
acquiring a defocus parameter of a myope in an naked eye state before fitting according to the method of claim 1 or 2;
and fitting the glasses for the myope according to the defocus quantity parameter.
7. The method of claim 6, wherein:
the defocus parameter comprises the maximum defocus on the cornea and the position information of the maximum defocus;
fitting a pair of glasses for the myope according to the defocus quantity parameter, comprising: and selecting peripheral out-of-focus lenses of contact lenses or frame glasses for the myope, wherein the sum of the maximum out-of-focus on the cornea of the myope and the out-of-focus at the corresponding position of the lenses is not less than a set out-of-focus threshold value after overlay, wherein the out-of-focus threshold value is not less than 3.5D or 4D or 4.5D or 5D or 5.5D.
8. The method of claim 6, wherein:
the defocus parameter comprises defocus information of a plurality of sample points on the cornea;
fitting a pair of glasses for the myope according to the defocus quantity parameter, comprising: and selecting a peripheral out-of-focus lens of a contact lens or frame glasses for the myope, so that when the myope wears the lens, after the out-of-focus amount on the cornea is superposed with the out-of-focus amount at the corresponding position of the lens in an alignment manner, at least an effective out-of-focus area exists and the size of the effective out-of-focus area meets the requirement, wherein the effective out-of-focus area refers to an area with the out-of-focus amount at any position not less than a corresponding out-of-focus threshold value, and the out-of-focus threshold value is not less than 3.5D or 4D or 4.5D or 5.
9. The method of claim 8, wherein:
the size of the effective defocusing area meets the requirement, and the method comprises the following steps: the effective defocus area satisfies one or more of the following conditions:
the central angle of the ring section where the effective defocusing area is located relative to the center of the lens is not less than an angle threshold value, and the angle threshold value is a set value which is not less than 5 degrees, 15 degrees, 30 degrees, 45 degrees or 60 degrees;
the sum of the areas of the effective defocusing areas is not less than a set area threshold.
10. The method of claim 7 or 8, wherein:
the lens comprises a central optical area, an annular out-of-focus area is arranged outside the central optical area, the out-of-focus amount of the out-of-focus area changes in the annular direction, and the lens further comprises an indicating mark for indicating the position with the largest out-of-focus amount in the out-of-focus area of the lens;
before the performing the overlay, the method further includes: and calibrating the wearing angle of the lens, so that the position with the maximum defocus amount in the out-of-focus area of the lens is aligned with the position with the maximum defocus amount on the cornea of the myope.
11. The method of claim 6, wherein the method further comprises:
acquiring the diameter of the pupil of the myope;
and selecting a lens of a frame glasses or a corneal contact lens for the myope, wherein the diameter of the central optical area of the lens is determined according to the diameter of the pupil, and the larger the diameter of the pupil is, the larger the diameter of the determined central optical area of the lens is.
12. A computer device comprising a memory, a processor and a computer program stored on the memory and executable on the processor, characterized in that the processor implements the process of the method according to any one of claims 1 to 11 when executing the computer program.
13. A computer device for assessing the effects of myopia control, comprising a memory, a processor and a computer program stored on the memory and executable on the processor, wherein the processor when executing the computer program implements the processes of:
acquiring defocus parameters obtained by a myope in an naked eye state after the cornea of the myope is shaped by a keratoplasty mirror according to the method of claim 1 or 2;
and determining the myopia control effect of the corneal shaping mirror on the myope according to the defocus quantity parameter.
14. The computer device of claim 13, wherein:
the defocus parameter comprises the maximum defocus on the cornea or the comparison result of the maximum defocus on the cornea and a set defocus threshold; the method for determining the myopia control effect according to the defocus quantity parameter comprises the following steps: judging whether the maximum defocus amount on the cornea is not smaller than the defocus threshold value or not according to the defocus amount parameter, if so, determining that the myopia control effect is effective, and if not, determining that the myopia control effect is ineffective; or
The defocus parameter comprises the maximum defocus on the cornea or the comparison result of the maximum defocus on the cornea and a plurality of set defocus threshold values; the method for determining the myopia control effect according to the defocus quantity parameter comprises the following steps: and judging whether the maximum defocus amount on the cornea is not less than one or more defocus threshold values according to the defocus amount parameter, if so, searching for a corresponding myopia control success rate according to the maximum defocus threshold value in the one or more defocus threshold values, and determining a myopia control effect according to the myopia control success rate.
15. The computer device of claim 13, wherein:
the defocus amount parameters at least comprise the existence and size information of an effective defocus area;
the method for determining the myopia control effect according to the defocus quantity parameter comprises the following steps: if the cornea has the effective out-of-focus area, searching the corresponding myopia control success rate according to the out-of-focus threshold corresponding to the effective out-of-focus area and the size information of the effective out-of-focus area, and determining the myopia control effect according to the myopia control success rate.
16. The computer device of claim 14 or 15, wherein:
the determining of the myopia control effect according to the myopia control success rate comprises:
directly using the myopia control success rate to represent a myopia control effect; or
And judging whether the success rate of the myopia control is not less than the expected success rate, if so, determining that the myopia control effect is effective, and if not, determining that the myopia control effect is ineffective.
17. The computer device of any of claims 13 to 15, wherein:
the myopia control effect is assessed within 2 weeks or within 1 month or within 3 months or within 6 months of the myope wearing the keratoplastic lens.
18. A computer-readable storage medium, on which a computer program is stored, which, when being executed by a processor, carries out the processing of the method according to any one of claims 1 to 11.
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