CN116880085A

CN116880085A - Contact lens

Info

Publication number: CN116880085A
Application number: CN202310794484.0A
Authority: CN
Inventors: 邓如芝; 刘熠; 蔡勇; 张亮君
Original assignee: Puyan Shanghai Industrial Co ltd; Wenzhou Weixiao Medical Information Technology Co ltd; Shanghai Aikangte Medical Technology Co ltd
Current assignee: Puyan Shanghai Industrial Co ltd; Wenzhou Weixiao Medical Information Technology Co ltd; Shanghai Aikangte Medical Technology Co ltd
Priority date: 2023-06-30
Filing date: 2023-06-30
Publication date: 2023-10-13

Abstract

The present disclosure relates to a contact lens which is easily rotatable in a worn state, comprising: a vision correction zone having a first refractive power based on a prescription of an eyeball and comprising a first correction zone located in a central region of the contact lens; and a vision control zone encircling the first correction zone and having a ring shape, the vision control zone having an equivalent optical power that is positive compared to the first optical power, the vision control zone comprising a first control zone adjacent the first correction zone, a boundary line between the first control zone and the first correction zone being a first inner edge defined by a first inner circle and a first outer circle and reciprocally fluctuating in the circumferential direction of the contact lens, the diameter d of the first inner circle ₁ The method meets the following conditions: d is less than or equal to 2.4mm ₁ The diameter d of the first excircle is less than or equal to 3.6mm ₂ The method meets the following conditions: d, d ₁ +0.2mm≤d ₂ . The contact lens can provide different defocus stimuli over time, thereby achieving a long-term myopia control effect.

Description

Contact lens

Technical Field

The present disclosure relates to the field of ophthalmic devices, and more particularly to a contact lens intended to be worn in front of the human eye to inhibit the development of abnormalities of the lens such as myopia or hyperopia.

Background

Conventional lenses primarily seek vision correction for eyes that already have a refractive error. Such lenses are used as relief to address the defects of the eye. After a person wears such lenses (e.g., single vision lenses), vision inevitably further worsens (e.g., myopia further increases). It is further desirable to be able to actively control refractive errors (e.g., myopia, hyperopia, etc.) to prevent further deterioration of vision. Therefore, a new functional lens with myopia retardation effect is being developed on the basis of the conventional single-lens.

Representative of myopia-slowing-control lenses are peripheral continuous defocus contact lenses, which have a lens peripheral sphere with a higher refractive power than the central zone of the lens. In the existing defocus lens, the area on the contact lens for achieving defocus can be divided into annular defocus design (commonly called "concentric circle" design), progressive addition design, and scattering microlens layout design. In concentric circular designs, the surface of the contact lens is typically provided with 2-8 rings of successive defocus regions of different refractive powers. In progressive addition designs, the refractive power of the contact lens varies progressively in the radial direction. In a diffuse microlens layout design, the surface of the contact lens is regularly provided with microlenses of additional diopters or special focus directions.

There is evidence that these concentric design, progressive addition design contact lenses can actually achieve some retardation control for myopia. After the lenses are commercially popularized and used by more people, researchers and doctors commonly find that the contact lens can obviously slow down the development of the vision disorder in the early use process (most of 1 year) of the patients with the vision disorder. As the years of contact lens wear increase, patients with vision disorder can adapt and compensate the single-form defocus stimulus provided by the contact lens, so that the myopia prevention and control effect of the contact lens is weakened year by year.

There is no clinical data disclosure presently published for a diffuse microlens layout design. Analysis has shown that on the one hand, such contact lenses are more costly to design and are not acceptable to the average consumer because of the more microscopic micro-lenses designed on the surface of contact lenses having smaller dimensions. On the other hand, the duration of the effective action of such contact lenses on the wearer is not known.

Accordingly, there is a need for a contact lens that provides sustained effective myopia inhibition for ametropia patients.

BRIEF SUMMARY OF THE PRESENT DISCLOSURE

In view of the above-mentioned state of the art contact lenses according to the prior art, it is an object of the present disclosure to provide a contact lens capable of permanently suppressing the development of refractive errors of the eye.

This object is achieved by the disclosure of a contact lens of the following form. The contact lens is a contact lens which is easy to rotate in a wearing state, and is characterized in that the contact lens comprises:

the contact lens comprises:

a vision correction zone having a first refractive power based on a prescription for an eye and comprising a first correction zone located in a central region of the contact lens; and

a vision control zone encircling the first correction zone and having a ring shape, the vision control zone having an equivalent optical power that is positive compared to the first optical power, the vision control zone including a first control zone adjacent the first correction zone, the boundary line between the first control zone and the first correction zone being a first inner edge defined by a first inner circle and a first outer circle and reciprocally fluctuating in the circumferential direction of the contact lens, and the diameter d of the first inner circle ₁ The method meets the following conditions:

2.4mm≤d ₁ ≤3.6mm，

diameter d of the first outer circle ₂ The method meets the following conditions:

d ₁ +0.2mm≤d ₂ 。

the best foveal vision of the human eye is the worse the farther the peripheral vision is. For a human eye with a macular area diameter of 2.75mm, the macular area corresponds to a contact lens vision correction area boundary of about 2.8mm. The first correction zone of the present disclosure is set between 2.4mm-3.6mm in consideration of the variability in anatomy of the eyeballs of different patients, thereby ensuring good correction of ametropia of the central vision zone and ensuring clear vision of the user. On the basis, the inner boundary of the first correction zone is set to be in a wave form, and the diameter of the first outer circle is set to be at least 0.2mm larger than that of the first inner circle, so that the defocus index of the first correction zone can be maximized, and the myopia control effect is enhanced. Specifically, the user blinks to drive the contact lens to slightly rotate, and the fluctuation type boundary promotes the defocusing stimulus contacted by the corresponding visual area (retina) of the eye to be changed compared with the defocusing stimulus before, so that the changed defocusing stimulus effect is realized. Because the human eye blinks continuously, the contact lens rotates correspondingly at relatively high frequency, and the corresponding visual area of the eye of the wearer of the contact lens is subjected to continuous out-of-focus stimulus changes, so that the contact lens can bring about a dynamic stimulus effect. Based on this design, the myopia prevention and control effect of the contact lens can last for a longer time.

In addition to the dynamic stimulation effect caused by the contact lens being driven to rotate by the blinking of the human eye during the wearing process, the stimulation effect obtained by the wearer during each wearing is different due to the fact that the position (particularly the circumferential position) of the contact lens is not fixed when the contact lens is worn on the eyeball, and the circumferential non-uniformity of the design of the defocused stimulation area of the contact lens is combined.

Preferably, in the front view direction of the contact lens, the first inner edge has at least 2 different radial dimensions in any central angular region of the contact lens of not more than 30 °. Studies have shown that for contact lenses that have not been anti-rotation designed, the angle at which the eye blinks to rotate the contact lens is typically within ±20°. Based on this, the first inner edge of the design ensures that the radial dimension of the first inner edge changes in the rotation range of the contact lens driven by blinks, and ensures the dynamic defocusing stimulation brought by each blink.

Preferably, at least part of the sections of the first inner edge consist of arc segments located on the first inner circle and arc segments located on the first outer circle in the front view direction of the contact lens; and/or

At least a portion of the sections of the first inner edge are composed of a first curve with a central portion concave toward the center of the contact lens or convex toward the center away from the contact lens.

Preferably, the diameter of the first outer circle satisfies: d, d ₂ Less than or equal to 3.6mm, and d ₁ +0.4mm≤d ₂ ≤d ₁ +1.2mm. Thereby facilitating a better balance between the wearer's clear vision requirements and the goal of achieving a larger defocus control area.

Preferably, the first curve is selected from any one of a circular arc, a spline curve, a Bezier curve (Bezier), and a higher order polynomial curve.

Preferably, the first control zone comprises a first outer edge, and the diameter d of the outer circle of the first outer edge ₃ The method meets the following conditions: d, d ₂ +0.8mm≤d ₃ ≤d ₂ +1.4mm. Further, preferably, the first outer edge satisfies: d is less than or equal to 3.8mm ₃ Less than or equal to 5.2mm. On the premise of providing clear vision, the first control area with the size obtains a larger defocus control area, which can ensure more remarkable defocus stimulus and improve myopia control effect.

Preferably, the first outer edge of the first control zone is rounded. The centers of the circles of the first inner circle and the first outer circle are coincident.

Preferably, the first correction zone covers a visual range of not less than 10 ° of the fovea of the eyeball, preferably, the first inner circle corresponds to a 10 ° viewing angle of the fovea. The first control zone should be outside the first correction zone and should be within the corresponding pupillary region, so the first control zone is primarily set at a core sensitivity period of 10 ° -20 ° foveal defocus control from the fovea.

Preferably, the vision correction zone comprises a second correction zone surrounding the first control zone, and the vision control zone comprises a second control zone surrounding the second correction zone.

Preferably, the boundary line of the second control zone and the second correction zone is a second inner edge defined by a third inner circle and a third outer circle and reciprocally fluctuating in the circumferential direction of the contact lens, wherein the diameter d of the third inner circle ₄ The method meets the following conditions: 0.2mm+d ₃ ≤d ₄ 。

Preferably, the second control zone comprises a non-circular second inner edge having a diameter d of the inner circle of the second inner edge ₄ The method meets the following conditions: 0.4mm+d ₃ ≤d ₄ ≤d ₃ +2mm; more preferably, the following is satisfied: 0.5mm+d ₃ ≤d ₄ ≤d ₃ +1.2mm。

Preferably, the diameter d4 satisfies: d is less than or equal to 4.2mm ₄ Less than or equal to 5.6mm; more preferably, the following is satisfied: d is less than or equal to 4.4mm ₄ ≤5.2mm。

Preferably, said second inner edge has at least 2 different radial dimensions in any central angular region of not more than 30 °.

Preferably, in at least part of the central angular region of the contact lens, the second inner edge and the first inner edge are parallel to each other and the circumferential waving tendency of both is synchronized.

Preferably, the diameter d of the outer circle of the second inner edge ₅ The method meets the following conditions:

d ₄ +0.6mm≤d ₅ ≤d ₄ +1.2mm。

preferably, the second control zone includes a second outer edge, and the diameter d of the outer circle of the second outer edge ₆ The method meets the following conditions:

d ₅ +0.6mm≤d ₆ ≤d ₅ +2.6mm；

preferably, the diameter d ₆ The method meets the following conditions:

d ₅ +0.8mm≤d ₆ ≤d ₅ +1.5mm。

preferably, the diameter d of the outer circle of the second outer edge ₆ The method meets the following conditions:

7mm≤d ₆ ≤8.2mm；

preferably, the diameterd ₆ The method meets the following conditions:

7.2mm≤d ₆ ≤8mm。

preferably, the second control zone is in the 15 ° -25 ° visual range of the macular fovea of the eyeball, preferably in the 18 ° -23 ° visual range of the macular fovea of the eyeball.

Preferably, the equivalent optical power of the second control zone is not less than the equivalent optical power of the first control zone.

Preferably, the refractive power of the second control zone increases gradually from inside to outside in the radial direction of the contact lens. The second control area adopts progressive addition design to make the change of refractive power on circumference milder than the abrupt change design of the first control area, on the basis of guaranteeing dynamic stimulation effect, the degree of inadaptation of partial vision sensitive crowd has been reduced for the initial stage is worn to the lens is more easily adapted.

Preferably, the vision control zone further comprises a third control zone surrounding and adjacent to the second control zone, the third control zone having a width selected from 0.8mm to 1.5mm and having a uniform optical power. The uniform diopter of the third control zone ensures defocus area and defocus amount at the periphery of the retina, contributing to the effect of myopia control. Preferably, the inner edge and the outer edge of the third control zone are circular.

Preferably, the outer diameter of the third control zone is greater than 8mm and less than 9mm.

On the basis of the common general knowledge in the field, the above preferred embodiments can be arbitrarily combined to obtain each preferred example of the disclosure.

The contact lens designed by the present disclosure provides continuous dynamic defocus stimulus to the eye, weakening the automatic compensation effect of the eye on defocus stimulus. The conventional physiological blinking action of the user and the taking and driving actions of the contact lens can promote the contact lens to spontaneously rotate, so as to provide different defocusing stimulus for eyes of the user. Therefore, the contact lens can provide long-term and effective myopia prevention and control function for the user.

Drawings

For a better understanding of the above and other objects, features, advantages and functions of the present disclosure, reference should be made to the preferred embodiments illustrated in the accompanying drawings. Like reference numerals refer to like parts throughout the drawings. It will be appreciated by those skilled in the art that the drawings are intended to schematically illustrate preferred embodiments of the present disclosure, and that the scope of the present disclosure is not limited in any way, and that the various components in the drawings are not drawn to scale.

FIG. 1 is a schematic structural view of the front face of a contact lens according to a first preferred embodiment of the present disclosure;

FIG. 2 is a partial schematic view of the contact lens according to FIG. 1;

FIG. 3 is a schematic structural view of the front face of a contact lens of a second preferred embodiment of the present disclosure;

FIG. 4 is a partial schematic view of the contact lens according to FIG. 2;

fig. 5 is a graph of cone and rod cell distribution on the retina.

FIG. 6 is a schematic diagram showing the location of an area on a contact lens where optical simulation is performed.

Fig. 7 is a schematic diagram of MTFs for the regions of fig. 6.

Detailed Description

The disclosed concept of the present disclosure will be described in detail with reference to the accompanying drawings. What has been described herein is merely a preferred embodiment according to the present disclosure, and other ways of enabling the present disclosure based on the preferred embodiment will occur to those skilled in the art, which also fall within the scope of the present disclosure. In the following detailed description, directional terms, such as "upper", "lower", "inner", "outer", "longitudinal", "transverse", etc., are used with reference to the directions described in the drawings. The components of the embodiments of the present disclosure can be positioned in a number of different orientations and the directional terminology is used for purposes of illustration and is in no way limiting.

In this disclosure, the term "contact lens" generally refers to an ophthalmic lens suitable for conformable wear to the anterior surface of a human eye. It will be appreciated that the contact lens provides clinically acceptable eye movements without embedding into the eye ball and causing damage to the eye ball. Contact lenses, also known as contact lenses, may be corneal contact lenses, scleral contact lenses, corneoscleral contact lenses, and the like. Corneal contact lenses are typically landed on the cornea or limbus of a human eye; scleral contact lenses are typically landed on the sclera; corneoscleral contact lenses are typically landed on the limbus or on the limbus and sclera. The contact lens may be a soft contact lens, such as a hydrogel contact lens, a silicone hydrogel contact lens; may be a hard contact lens such as a lens made of a hard material such as polymethyl methacrylate (PMMA), silicone methacrylate (SiMA), etc.; the lens can also be made of soft materials and hard materials.

A front view of the contact lens corresponding to a view angle directly in front of the center of the contact lens. The front surface of the contact lens is the surface facing away from the human eye (referred to as the "outer surface" or "front surface"); the back surface of a contact lens is the surface that contacts the human eye (referred to as the "inner surface" or "back surface").

According to the present disclosure, contact lenses can be generally divided into an optical zone 1 having an optical function and directly affecting human eye vision and non-optical zones 13, 13' not directly affecting human eye vision. The optical zone 1 includes zones 10, 10 'for vision correction, zones 20, 20' for vision control, and the like; the non-optical zones 13, 13' include landing zones for ensuring contact lens wear firmness and tear exchange quality of the inner and outer zones of the contact lens, and edge-lift for ensuring tear exchange quality of the inner and outer zones of the contact lens and wear comfort. Depending on the specific class of contact lenses, the landing zones correspond to respective different regions of the user's eyes. For example, for a scleral contact lens, the landing zone corresponds to the sclera of the eye. The landing zone, the edge-warping, etc. are not the focus of the present document, and will not be described in detail herein, but only the vision correction zone and the vision control zone in the design points of the present document.

The contact lens according to the present disclosure is a contact lens that is easy to rotate in a worn state, and as is known, techniques for ensuring that the contact lens does not rotate as much as possible include Prism Ballast (Prism Ballast), double slide-off (double slide-off), and truncated method (truncated), etc., and such techniques are basically specifically designed at the edge of the contact lens 100. In general, contact lens 100, which has no specific design at the edge, can be rotated by a small amount due to the pressure of the eyelid when the wearer blinks. Studies have shown that contact lens 100 of conventional design typically rotates around the axis of the eye by an angle within + -20 deg. under the condition of blinking of the human eye, by virtue of the compression of the eyelid and the natural rotation of the eye. Since contact lenses of conventional design are kept rotatable, the design of how the contact lens can be rotated about the eye axis is well known and will not be described in detail.

Hereinafter, for the same portions of the respective examples, such as data for restricting the boundary line size, etc., it can be understood with reference to fig. 1, 2 and their related expressions, and examples other than fig. 1, 2 will not be repeated for the common portions.

The related concepts of the disclosure are described below with reference to the specific drawings.

As described above in connection with fig. 1, a contact lens 100 according to the present disclosure includes an optical zone 1 and a non-optical zone 13, the optical zone 1 being composed of a vision correction zone 10 and a vision control zone 20. Wherein the vision correction zone 10 in the optical zone 1 has a first refractive power based on the prescription of the eye and comprises a first correction zone 11 located in the central region of the contact lens 100 and a second correction zone 12 located radially outward of the first correction zone. The vision correction area 10 is intended to correct any one or more of myopia, hyperopia, astigmatism, etc. of the eye, in addition to which the vision correction area 10 may have 0 diopters. With a vision correction area 10 of 0 diopters, the contact lens 100 of the present disclosure serves to inhibit the risk of future myopia in the associated wearer. In general, based on the contact lens 100 of the present disclosure, a child or child with insufficient presbyopia reserves can fit the contact lens 100 of the 0 diopter vision correction zone 10.

The vision control area 20 surrounds the first correction area 11 and is annular. It should be noted that, the "annular" herein does not refer to a circular ring alone, but refers to other annular forms. In addition, the interruption of the vision control zone at the local microscopic level in the annulus is also a "annular vision control zone" that the present disclosure seeks to protect. Also, as described below, the vision control area 20, which is made up of a plurality of annular subregions, is also the "annular vision control area" sought to be protected by the present disclosure.

The equivalent optical power of vision control area 20 is positive compared to the first optical power, i.e., the equivalent optical power of vision control area 20 has a positive add power. Regarding equivalent optical power D _E This can be expressed as follows:

wherein D in the formula _i Representing diopter of a sub-region having a single diopter, A _i Representing the area in the front view of a sub-region having a single diopter.

For myopes, the first refractive power is negative, and the equivalent refractive power of vision control area 20 may be either positive or negative, depending on the magnitude of the absolute value of the negative power of the first refractive power. In general, the absolute value of the first optical power is small, and the equivalent optical power of vision control area 20 is positive power or 0 °. The absolute value of the first refractive power is large, and the equivalent refractive power of the vision control area 20 is negative.

Referring to the example shown in fig. 1, in this example, in the front view direction, the vision control area 20 includes a first control area 21, a second control area 22, and a third control area 23, which are sequentially arranged in the radial direction of the contact lens 100. In connection with fig. 1 and the description above, in this example, the contact lens 100 is arranged with the first correction zone 11, the first control zone 21, the second correction zone 12, the second control zone 22, and the third control zone 23 in that order from the inside to the outside in the radial direction.

In connection with fig. 2, wherein fig. 2 shows the first correction zone 11 and the first control zone 21 of fig. 1. The boundary line between the first control zone 21 and the first correction zone 11, the first inner edge S11. In connection with the enlarged partial view of the contact lens 100 shown in fig. 2, the first inner edge S11 is a saw-tooth like curve defined by a first inner circle C11 and a first outer circle C12 and reciprocally oscillating in the circumferential direction of the contact lens 100.

It should be noted that, although the above description uses the "radial direction", the "radial direction" is merely a vertical direction with respect to the circumferential direction, and is expressed as a direction extending from the middle to the outer edge of the contact lens 100, and does not necessarily imply the potential meaning of "the contact lens 100 is circular-face-shaped". The contact lens 100 of the present disclosure may be of other non-circular shapes, such as elliptical, and saddle-shaped shapes. Unless otherwise specified, "planar" in the present disclosure refers to a shape defined by the outer edges of the contact lens 100 as a whole or a localized area of the contact lens 100, as viewed along a normal direction to the localized center of the contact lens 100. For example, the example representation of contact lens 100 above being a circular-shaped facet: after the contact lens 100 is worn, the contact lens 100 is generally circular as viewed by a third party from the front of the wearer.

By "the boundary line fluctuates reciprocally in the circumferential direction of the contact lens 100" it is meant that the boundary line has different distances from the center of the contact lens 100 at different positions in the circumferential direction of the contact lens 100, and the distances are in the form of a distribution of the fluctuation reciprocally. The first inner edge S11 may be of any form under the condition that "defined by the first inner circle and the first outer circle and reciprocally fluctuates in the circumferential direction of the contact lens" is satisfied. For example, in one example shown in fig. 1, the first inner edge S21 is formed by alternating arc segments on the first inner circle C21 and arc segments on the first outer circle C22. In another example shown in fig. 3, the first inner edge S21 is a concave curve (see the relevant expression "first curve" below) with a multi-segment middle recessed toward the center of the contact lens 100. The concave curve may also be replaced by a convex curve with a multi-segment middle protruding away from the center of the contact lens 100. In other examples not shown, the first inner edge may also be in the form of a plurality of straight or non-straight lines that are joined to one another, wherein the non-straight lines may be arcs or in the form of straight and arcuate segments joined together. The non-straight line may furthermore be a circular arc, a spline Curve, a Bezier Curve (Bezier Curve), a higher order polynomial Curve. The first inner edge may be formed of a plurality of line segments different from each other, and specifically may be formed by combining any of the plurality of circular arc segment curves, concave curves, convex curves, straight lines, or any non-straight lines, which are joined to each other as described above.

This non-circular configuration of the first inner edge S11 is to ensure that after rotation of the contact lens 100, at least a portion of the optical power of the optic area of the contact lens 100 corresponding to the cone cells (or rod cells) is different, thereby producing different defocus stimuli to the eye. Furthermore, this fluctuating design of the control zone boundary line, which provides a longer boundary, may thus produce a good boundary stimulus effect (see the simulation effect of the boundary line between the first control zone 21 and the first correction zone 11 described below in connection with fig. 6-7).

With reference to fig. 1, 2, wherein fig. 2 shows the first correction zone 11 and the first control zone 21 of the example of fig. 1, for defining a diameter d of a first inner circle C11 of the first inner edge S11 ₁ Setting an arbitrary value within the range of 2.4mm-3.6 mm; diameter d of first outer circle C12 ₂ Is set to be at least 0.2mm larger than the diameter of the first inner circle C11.

In the diameter d of the first inner circle C11 ₁ The diameter d of the first inner circle C11 is set within the range of 2.4mm-3.6mm ₁ The diameter projected onto the retina is the same or slightly larger than the diameter of the macular area. Taking a wearer with 24mm eye axis length and 2.8mm macula radius as an example, the diameter of the lens projected onto the central area of the lens is 2.8mm according to the simplified optical model of the eye. According to the present disclosure, the diameter d of the first inner circle C11 may be ₁ The first inner circle may cover the corresponding vision zone of the yellow spot zone for ensuring vision when the contact lens sags by gravity a partial distance, set to a dimension slightly larger than the diameter of the yellow spot zone, for example 2.9mm or 3 mm. In general, according to the present disclosure, the diameter of the first inner circle C11 is substantially 0-0.2 mm greater than the diameter of the projected area of the macular region on the contact lens.

In previous studies, it was shown that after a wearer wears contact lens 100 without a specific design on the rim, the squeezing action of the eyelid on contact lens 100 during blinking causes it to rotate, and the angle of rotation of contact lens 100 about the eye axis is within ±20°. In view of this, many conventional studies have focused on how to reduce the rotation of the contact lens 100, and designs such as Prism Ballast (Prism Ballast), double slide-off (double slide-off), and cut-off (cut) have been proposed as described above. For relevant designs see the disclosure of CN109937376A, US20210208423A1, et al.

In view of this, the present disclosure proposes a different concept, specifically, the contact lens 100 of the present disclosure maintains the original characteristic of being easily rotated by blink to an internal angle of ±20°, while performing the following design: in any central angular region of the contact lens 100 of not more than 30 °, the first inner edge S11 of the contact lens 100 has at least 2 different radial dimensions. That is, the radial dimension of the first inner edge S11 changes at least once in an arbitrary central angle region corresponding to not more than 30 °.

In the example of fig. 1, the diameter of the first inner edge S11 varies 2 or 3 times in the region of the central angle of 30 °. It will be appreciated that when the 30 ° central angular region corresponds to a certain continuous arc of the first inner edge S11, the first edge varies 3 times in total over both ends of the segment of arc or first curve and over the main body portion of the segment of arc or first curve.

Referring to fig. 3 and 4, in this example, the first inner circle and the first outer circle C21 and C22 related to the first inner edge S21 have the same size ranges as 1 and 2, and are not described herein.

In the example of fig. 3, 4, unlike the example of fig. 1, 2, the diameter of the first inner edge S21 varies continuously (i.e., with or without a number of variations) over a central angular region of 30 °.

Diameter d of first outer circles C12, C22 of first inner edges S11, S21 of first control areas 21, 21' in FIGS. 1-4 ₂ Is set to not more than 3.6mm and has a diameter d ₂ Is arranged to satisfy: d, d ₁ +0.4mm≤d ₂ ≤d ₁ After +1.2mm, the maximum unit defocus area variable generated by blinking or the like to rotate the contact lens 100, 100' is 1.8mm ² /rad-0.88mm ² Between/rad.

The first inner circles C11, C21 and the first outer circles C12, C22 defining the first inner edges S11, S21 may be of concentric design, in which case the wearer may not be required to center the contact lenses 100, 100' when they are worn.

To ensure visual quality, the first correction zone should be arranged to cover a 10 ° visual range of the fovea of the eye, preferably the first inner circle corresponds to a 10 ° viewing angle of the fovea.

For the first outer edges S12, S22 defining the outer boundary of the first control zone 21, 21', the outer boundary is defined by a second outer circle, wherein the diameter d of the outer circle ₃ Is set to satisfy the following conditions: d, d ₂ +0.8mm≤d ₃ ≤d ₂ +1.4mm, where d ₃ Is the diameter of the second outer circle. Preferably, the first outer edges S12, S22 satisfy: d is less than or equal to 3.8mm ₃ Less than or equal to 5.2mm. The first outer edges S12, S22 preferably take the form of circles as shown in fig. 1-4. The first control zone 21 of the above-described dimensions achieves a larger defocus control zone that ensures more pronounced defocus irritation and improves myopia control, provided that it provides clear vision. Diameter d of second outer circle ₃ May be arranged to correspond to a 15 visual of the fovea of the wearer. Referring to fig. 5, rod cells are most abundant at the 15 ° position of the fovea of the wearer's macula. On the premise of providing clear vision, the first control area with the size obtains a larger defocus control area, which can ensure more remarkable defocus stimulus and improve myopia control effect. As can be seen from the distribution of the retinal cone cells and the rod cells shown in fig. 5, since the rod cells are relatively sensitive to the strong and weak response of light, the contact lens 100 can ensure that the first control region 21 can bring effective defocus control to the wearer in both bright and dark environments when the outer boundary of the first control region 21 is set at the above-mentioned position, thereby achieving myopia control.

The second correction zone 12, 12' and the first correction zone 11, 11' located outside the first control zone 21, 21' optionally employ the same diopter.

The second control zone 22, 22 'located outside the second correction zone 12, 12' serves to further increase the defocus area of the lens. The boundary line (second inner edges S13, S23) between the second control zone 22, 22 'and the second correction zone 12, 12' is defined by a third inner circle and a third outer circle and fluctuates reciprocally in the circumferential direction of the contact lens 100. The reciprocating shape design of the second inner edges S13, S23 can be referred to as the description about the first inner edge S11, which can also be a circular arc segment, a straight line segment, other arc, etc., and will not be described herein.

The spacing between the second inner edges S13, S23 of the second control zones 22, 22 'and the first outer edges S12, S22 of the first control zones 21, 21' is not less than 0.2mm to ensure that the second correction zone 12 between the first control zone 21 and the second control zone 22 is capable of forming a complete image. Based on this, the diameter d of the third inner circle of the second inner edges S13, S23 ₄ Should satisfy 0.2mm+d ₃ ≤d ₄ . Preferably, the following should be satisfied: 0.4mm+d ₃ ≤d ₄ ≤d ₃ +2mm; more preferably, the following is satisfied: 0.5mm+d ₃ ≤d ₄ ≤d ₃ +1.2mm。

On the basis of this, a specific diameter d of the third inner circle defining the second inner edge ₄ May be set depending on the pupil diameter of the wearer under normal illumination conditions. In particular, the diameter of the third inner circle is preferably set to be 0.2mm-0.4mm smaller than the test pupil diameter of the corresponding wearer (under normal white light conditions). The contact lens thus designed allows two dynamic defocus stimuli to be achieved within the pupillary region of the wearer (one caused by the boundary of the first control zone and the first correction zone and the other caused by the boundary of the second control zone and the second correction zone).

In studies on primates, primates were found to be relatively sensitive to defocus stimuli within 20 ° of the center of the macula, and myopia control effects due to defocus design were relatively pronounced. To this end, in the contact lenses 100, 100 'of the present disclosure, the second inner edges S13, S23 are at least partially located within a 20 ° field of view of the center of the wearer' S macula. For example, in particular, the second inner edges S13, S23 preferably oscillate reciprocally about a central line of sight (which may be understood as circular) corresponding to any angle in the range 18 ° -22 ° of the fovea of the wearer. More preferably, the central line of the 20 ° visual angle boundary line of the fovea of the wearer is reciprocally fluctuated. Based on this, the diameter d of the inner circle of the second inner edges S13, S23 ₄ The following should be satisfied:

4.2mm≤d ₄ ≤5.6mm；

preferably, the following is satisfied:

4.4mm≤d ₄ ≤5.2mm。

it should be understood that d ₄ The value of d is a value ranging from 4.2mm to 5.6mm ₄ Take the value 4mm+d ₃ To d ₃ Values in the +2mm range are not mutually contradictory. When d ₄ When the values of (2) satisfy both conditions, it can be ensured that the second correction zone 12, 12 'forms a clear image while the boundary of the second control zone 22, 22' enters the defocus stimulus-sensitive zone.

1-4, in the illustrated example, the respective segments of the first inner edges S11, S21 on the first control zones 21, 21 'and the second inner edges S13, S23 on the second control zones 22, 22' are parallel to each other and the circumferential waving trend of the two is the same. At this time, the distance between the respective corresponding circumferential positions of the first inner edges S11, S21 and the second inner edges S13, S23 is constant at each radial position. It will be appreciated that the first inner edge S11 on the first control zone 21, 21' and the second inner edge S13, S23 on the second control zone 22 may also take the form of designs in which the partial segments are parallel to each other and the circumferential waving trend of both is the same.

For the purpose of giving more boundary stimulation to the retina, for a third outer circle of the outer world defining the second inner edges S13, S23, the diameter d thereof ₅ The priority is set to satisfy: d, d ₄ +0.6mm≤d ₅ ≤d ₄ +1.2mm, diameter d of the third outer circle of the contact lens in the case of pupil diameter of 2.5-3.1mm ₅ Is set to be between 5 and 6.2 mm. Under normal bright environment, user's pupil is around 3mm, and the third excircle of this size can get into the pupil area, guarantees to have two annular defocusing areas in the pupil area to the lens moves the in-process in the eyeball, and the retina can receive more boundary stimulus, reduces the adaptation and shows, reinforcing myopia effect.

Preferably, the second control zone 22, 22' includes a second outer edge S14, S24, and the diameter d of the outer circle of the second outer edge S14, S24 ₆ The method meets the following conditions: d, d ₅ +0.6mm≤d ₆ ≤d ₅ +2.6mm; more preferably, diameter d ₆ The method meets the following conditions: d, d ₅ +0.8mm≤d ₆ ≤d ₅ +1.5mm。

Preferably, the second outer edges S14, S24Diameter d of the outer circle of (2) ₆ The method meets the following conditions:

7mm≤d ₆ ≤8.2mm；

preferably, diameter d ₆ The method meets the following conditions:

7.2mm≤d ₆ ≤8mm。

the second control zone 22, 22' is preferably arranged in the visual range of 15-25 of the fovea of the eye, more preferably in the visual range of 18-23 of the fovea of the eye. So as to ensure that the second control zone 22 is located substantially within the defocus irritation responsive zone of the fovea of the wearer's macula.

The equivalent optical power of the second control zone 22, 22 'may be set to be greater than the equivalent optical power of the first control zone 21, 21'. In one example, the optical power of the second control zone 22, 22 'increases gradually from inside to outside in the radial direction of the contact lens 100, 100'. The starting power of the second control zone 22, 22 'may be the first power of the vision correction zone 10, 10', or a slightly greater power than the first power. The second control area adopts progressive addition design to make the change of refractive power on circumference milder than the abrupt change design of the first control area, on the basis of guaranteeing dynamic stimulation effect, the degree of inadaptation of partial vision sensitive crowd has been reduced for the initial stage is worn to the lens is more easily adapted.

In another example, the diopters of the second control zone 22, 22 'are of non-progressive design, in particular, the second control zone 22, 22' is of a single optical power, or a limited number of multiple optical powers. In the case where the second control zone 22, 22 'employs a plurality of optical powers, different optical powers may be employed in different regions of the second control zone 22, 22' in the circumferential and/or radial directions.

The vision control zone 20 further includes a third control zone 23, 23' surrounding and adjacent to the second control zone 22, the third control zone 23, 23' having a width selected from 0.8mm to 1.5mm, and the third control zone 23, 23' having a uniform optical power. The uniform diopter of the third control zone ensures defocus area and defocus amount at the periphery of the retina, contributing to the effect of myopia control.

The inner and outer edges of the third control zone 23, 23' may be of circular design. The outer diameter of the third control zone 23 may be set to be greater than 8mm and less than 9mm.

Referring to the second preferred embodiment of fig. 3, 4, the boundary lines (first inner edge S11, second inner edge S13, S23) of the respective control zone and correction zone in this embodiment are continuous smooth curves. In comparison with the first embodiment shown in fig. 1, the boundary lines (first inner edge S21, second inner edge S23) of this form are relatively less different in the front view direction of the contact lens 100 to the visual sense of the wearer during the rotation of the contact lens 100', and are easier for the patient to adapt to the initial wear.

The number of first curves of each of the central portions of fig. 3, 4, which are concave toward the center of the contact lens 100', is selected to be 6, and in fact, the number of first curves may be any number not less than 3, preferably, the number is selected from any one of 5 to 8. The angle at which the eye blinks to rotate the contact lens is generally within + -20 deg.. Based on this, the first inner edge S11 of the first control zone 21 in the form of a polygon of 5-8 first curves ensures that the edge position of the first correction zone 11 (first control zone 21) has the greatest diopter change area and ensures the greatest dynamic defocus stimulus area within the range of rotation of the contact lens 100 driven by the blink.

In this embodiment, the contact lens 100 has a substantially circular face-type pattern, alternatively, the contact lens 100 may also be a face-type having a rectangular, square or other contoured shape.

The optical effects of contact lenses according to the present disclosure are described below in connection with simulation data. See MTF (Modulation Transfer Function ) illustrated in fig. 6-7, wherein the simulation set conditions for MTF are as follows: and (3) taking an object point as infinity, calculating a lens refraction wave surface at each position by adopting a space ray tracing method, and obtaining the MTF of each corresponding region by combining fast Fourier transform. The optical design of a monolithic contact lens is illustrated in fig. 1. Wherein, the diameter of the first inner circle is 3mm, the diameter of the first outer circle is 3.4mm, and the diameter of the second outer circle is 4.8mm. For ease of illustration, the MTF shown in FIGS. 6A-6C is the location on the contact lens of an elliptical area with a major axis of 0.3mm and a minor axis of 0.1 mm. In fig. 6A, the entire ellipse is located in a convex sector of the first control area, whose minor axis forms an angle of 15 ° with the vertical, which is simply referred to as area a for convenience of description; in fig. 6B, the minor axis of the ellipse is located radially of the vertical position of the contact lens, the left half of the ellipse is located in the first control zone, and the right half is located in the first correction zone, which is simply referred to as zone B for ease of description; in fig. 6C, the entire ellipse is located in a convex sector of the first correction zone, with its minor axis at an angle of 15 ° to the vertical, which is simply referred to as zone C for ease of description. The position of the ellipse in the contact lens can be seen schematically in fig. 6A-6C.

As can be seen from the views of fig. 7A to 7C, in general, the MTF of the region a to the region C sequentially increases, and as the spatial frequency increases, the MTF value difference between the region a and the region C becomes larger. The MTF of region a at high frequency (13.5 lp/mm (line pair/mm) or more) will decrease below 0.2, which corresponds to the original focus design of the region, with blurred imaging of the corresponding region of the retina. Comparing fig. 7B with fig. 7A and fig. 7C, it can be seen that the MTF value of the region B corresponding to fig. 7B shows a significant fluctuation distribution at the edge positions corresponding to the first correction region and the first control region, and the corresponding region of the retina actually has poor imaging quality. By combining the characteristic of the reciprocal fluctuation of the boundary line of the first correction area and the first control area, the imaging quality of the boundary area has a significant difference in the spatial viewing angle orientation, and a dynamic visual stimulation effect under a dynamic visual field can be formed. Therefore, effectively increasing the length of the boundary line S11 will be advantageous for improving the dynamic stimulus action.

The scope of protection of the present disclosure is limited only by the claims. Those skilled in the art, having the benefit of the teachings of this disclosure, will readily recognize alternative constructions to the disclosed structures as viable alternative embodiments, and may combine the disclosed embodiments to create new embodiments that fall within the scope of the appended claims.

Description of the drawings:

contact lens: 100. 100'.

Vision correction zone: 10. 10'.

First correction zone: 11. 11'.

Second correction zone 12: 12. 12'.

Vision control zone: 20. 20'.

A first control region: 21. 21'.

A second control region: 22. 22'.

Third control region: 23. 23'.

First inner edge: s11 and S21.

A first inner circle: c11 and C21.

First excircle: c12 and C22.

First outer edge: s12 and S22.

Second inner edge: s13, S23.

Second outer edge: s14, S24.

Outer edge of the third control zone: s15 and S25.

Claims

1. A contact lens that is easily rotatable in a worn state, the contact lens comprising:

2.4mm≤d ₁ ≤3.6mm，

d ₁ +0.2mm≤d ₂ 。

2. a contact lens according to claim 1, wherein: in the front view direction of the contact lens, the first inner edge has at least 2 different radial dimensions in any central angular region of the contact lens of no more than 30 °.

3. A contact lens according to claim 2, wherein: at least a portion of the first inner edge, in a front view direction of the contact lens, is composed of an arc segment located on the first inner circle and an arc segment located on the first outer circle; and/or

4. A contact lens according to claim 1, wherein: the diameter of the first outer circle satisfies:

d ₂ less than or equal to 3.6mm, and d ₁ +0.2mm≤d ₂ ≤d ₁ +1.2mm。

5. A contact lens according to claim 3, wherein:

the first curve is selected from any one of an arc, a spline curve, a Bezier curve and a higher order polynomial curve.

6. The contact lens of any one of claims 1-5, wherein:

the first control zone comprises a first outer edge, and the outer boundary of the first outer edge is defined by a second outer circle, and the diameter d of the second outer circle ₃ The method meets the following conditions:

d ₂ +0.8mm≤d ₃ ≤d ₂ +1.4mm。

7. the contact lens of claim 6, wherein: the first outer edge satisfies: d is less than or equal to 3.8mm ₃ ≤5.2mm。

8. The contact lens of claim 6, wherein: the first outer edge of the first control zone is rounded.

9. The contact lens of claim 8, wherein: the centers of the circles of the first inner circle and the first outer circle are coincident.

10. A contact lens according to claim 1, wherein: the first correction zone covers a visual range of not less than 10 ° of the fovea of the eyeball, preferably the first inner circle corresponds to a 10 ° viewing angle of the fovea.

11. The contact lens of claim 6, wherein: the vision correction zone includes a second correction zone surrounding the first control zone, and the vision control zone includes a second control zone surrounding the second correction zone.

12. A contact lens according to claim 11, wherein: the boundary line between the second control zone and the second correction zone is a second inner edge defined by a third inner circle and a third outer circle and reciprocally fluctuating in the circumferential direction of the contact lens, wherein the diameter d of the third inner circle ₄ The method meets the following conditions:

0.2mm+d ₃ ≤d ₄ 。

13. a contact lens according to claim 12, wherein: diameter d of the third inner circle ₄ The method meets the following conditions: 0.4mm+d ₃ ≤d ₄ ≤d ₃ +2mm；

Preferably, the following is satisfied: 0.5mm+d ₃ ≤d ₄ ≤d ₃ +1.2mm。

14. A contact lens according to claim 13, wherein: the diameter d4 satisfies: d is less than or equal to 4.2mm ₄ ≤5.6mm；

Preferably, the following is satisfied: d is less than or equal to 4.4mm ₄ ≤5.2mm。

15. A contact lens as set forth in claim 14 wherein: the second inner edge has at least 2 different radial dimensions in any central angular region of no more than 30 °.

16. A contact lens as set forth in claim 15 wherein: in at least part of the central angular region of the contact lens, the second inner edge and the first inner edge are parallel to each other and the circumferential waving tendency of both is synchronized.

17. The contact lens of any one of claims 12-16, wherein: diameter d of the third outer circle ₅ The method meets the following conditions:

d ₄ +0.6mm≤d ₅ ≤d ₄ +1.2mm。

18. a contact lens as set forth in claim 17 wherein: the second control zone includes a second outer edge, and the outer boundary of the second outer edge is defined by a fourth outer circle having a diameter d ₆ The method meets the following conditions:

d ₅ +0.6mm≤d ₆ ≤d ₅ +2.6mm；

preferably, the diameter d ₆ The method meets the following conditions:

d ₅ +0.8mm≤d ₆ ≤d ₅ +1.5mm。

19. the contact lens of claim 18, wherein the diameter d of the fourth outer circle ₆ The method meets the following conditions: d is 7mm or less ₆ ≤8.2mm；

Preferably, the diameter d ₆ The method meets the following conditions: d is more than or equal to 7.2mm ₆ ≤8mm。

20. A contact lens according to claim 11, wherein: the second control zone is in the visual range of 15 ° -25 ° of the macular fovea of the eyeball, preferably in the visual range of 18 ° -23 ° of the macular fovea of the eyeball.

21. A contact lens according to claim 11, wherein: the equivalent optical power of the second control zone is not less than the equivalent optical power of the first control zone.

22. A contact lens as set forth in claim 21 wherein: in the radial direction of the contact lens, the refractive power of the second control zone gradually increases from inside to outside.

23. A contact lens according to claim 11, wherein: the vision control zone further includes a third control zone surrounding and adjacent to the second control zone, the third control zone having a width selected from 0.8mm-1.5mm and having a uniform optical power.

24. The contact lens of claim 23 wherein the inner and outer edges of the third control zone are rounded.

25. The contact lens of claim 24, wherein the outer diameter of the third control zone is greater than 8mm and less than 9mm.