Ortho-k contact lenses and related methods

Abstract

The present disclosure provides a corneal reshaping contact lens (201) and a method of manufacturing such a contact lens (201). The corneal reshaping contact lens (201) disclosed herein comprises a corrective zone (206) for reducing the curvature of a central portion of a cornea, an annular treatment groove (208) for inducing myopic defocus in a peripheral portion of the cornea, and a modulation zone (210) for modulating the myopic defocus induced by the annular treatment groove (208).

Description

Technical Field

[0001] This disclosure relates to orthokeratology contact lenses and methods. In particular (but not exclusively), this disclosure relates to contact lenses used to reshape the cornea of ​​the eye to provide optical correction for myopia and slow its progression. This disclosure also relates to methods of manufacturing such lenses. Background Technology

[0002] Myopia (also referred to as nearsightedness or shortness of vision) is an eye condition that occurs primarily due to elongation of the eye. An uncorrected myopic eye focuses incoming light from distant objects in front of the retina. Once the light enters the eye, it converges at the focal plane in front of the retina, then diverges and defocuses after reaching the retina. As a result, a myopic person cannot focus on distant objects.

[0003] Many people use contact lenses to correct nearsightedness. Regular contact lenses used to correct nearsightedness reduce the convergence of light passing through the lens, causing the image plane to shift onto the retina. Farsighted vision is only improved when using contact lenses, eyeglasses, or reshaping the cornea to reduce the eye + lens power. Furthermore, while regular contact lenses correct mismatches between optical power and eye length, they do not treat the underlying eye size abnormality that forms the basis of nearsightedness.

[0004] Decades ago, it was proposed that undercorrection (i.e., moving the focus toward, but not completely toward, the retina) could slow the progression of myopia in children or young adults. However, this method inevitably results in hyperopic vision, which is inferior to that obtained with fully corrected myopia glasses. Furthermore, it is now doubtful whether undercorrection is effective in controlling myopia development. A more recent method that can simultaneously provide a focused image at the retina and slow the progression of eye growth is the use of glasses with one or more fully corrected areas providing hyperopic vision and one or more undercorrected or intentionally induced myopic defocus areas. This method has been shown to slow the development or progression of myopia in children or young adults while providing good hyperopic vision.

[0005] For eyeglasses with zones that provide myopic defocus, the zone providing full correction for hyperopia is typically referred to as the base power zone, while the zone providing undercorrection is typically referred to as the myopic defocus zone or the add-on power zone (because the refractive power is more positive or less negative than that of the distance zone). The surface of the add-on power zone (usually the anterior surface) has a smaller radius of curvature than that of the distance power zone and therefore provides a more positive or less negative power to the eye. The add-on power zone is designed to focus light in front of (in front of) the retina when the distance-correcting optics focus light at or near the retina.

[0006] The known type of contact lens that reduces the progression of myopia is a bifocal contact lens available under the name MISIGHT (CooperVision), such as... Figure 1As shown in the image. The eyeglasses 100 have a central correction zone 101 and two further annular correction zones 102 and 104. Correction zones 101, 102, and 104 are distance correction zones that provide a stable corrective power or base power across each zone. The eyeglasses also have two annular treatment zones 106 and 108. Each treatment zone 106 and 108 is located between the two correction zones 101, 102, and 104. Treatment zones 106 and 108 provide additional power or myopic astigmatism. The diameters of correction zones 101, 102, and 104 and treatment zones 106 and 108 are clearly defined, and the power provided is stable across each zone. This bifocal eyeglasses differ from bifocal or multifocal contact lenses configured to improve the vision of farsighted individuals in that bifocal eyeglasses are configured with specific optical dimensions so that a suitable individual can use distance correction (i.e., base power) to view both distant and near objects. The treatment zones 106 and 108 of the bifocal glasses with added power are designed to provide myopic defocused images at both near and far viewing distances.

[0007] Although it has been shown that MISIGHT glasses correct myopia and slow the progression of myopia in children (Chamberlain et al., 2019), Optometry and Vision Science , 96(8):556-567; Chamberlain et al. 2022, Optometry and Vision Science , 99(3):204-212), but myopia correction and treatment are only achieved when wearing glasses. An alternative to bifocal contact lenses, which provide optical correction for existing myopia while slowing future progression, is orthokeratology. Studies have shown that wearing orthokeratology lenses overnight produces optical correction for myopia (Mountford et al., 2004, 99(3):204-212), but myopia correction and treatment are only achieved when wearing glasses. Orthokeratology: Principles and Practice (Orthokeratology:principlesandpractice) Butterworth-Heinemann (medical) and can also effectively slow the progression of myopia (Cho et al., 2005). Current eye research (CurrentEyeResearch) 30(1):71 to 80). Orthokeratology lenses (often referred to as "ortho-K" lenses) correct myopia by reshaping the surface of the cornea to modify the curvature of the cornea in a defined area. Thus, orthokeratology lenses give myopic eyes a physical change to improve vision.

[0008] Orthokeratology lenses include a central region defined by a posterior surface, having a low curvature or flat profile designed to flatten the curvature of the cornea. When worn, the central correction region applies pressure or compressive force to the corneal epithelium, causing corneal tissue and / or fluid from the central portion of the cornea to redistribute to the peripheral portion. This redistribution reduces corneal curvature by compressing the cornea at its apex. Because the corneal curvature of a myopic individual is too steep to focus light onto the retina, reducing corneal curvature shifts the focal point of light onto the retina and thus corrects myopia to provide improved hyperopic vision. Examples of orthokeratology lenses are disclosed in U.S. Patent Nos. 6,543,897 and 6,652,095. While these disclose that orthokeratology lenses can correct developed myopia, presbyopia, and / or hyperopia, they do not disclose that such lenses are suitable for treating or slowing the progression of myopia.

[0009] Orthokeratology lenses gradually reshape the cornea and are therefore typically worn overnight. After several hours of wear, the reshaped cornea corrects nearsightedness, and the user can remove the lenses (for example) in the morning. After removal, the cornea retains its new shape for several hours, allowing the user to focus on distant objects without corrective lenses. Therefore, orthokeratology lenses offer advantages over other contact lenses because vision remains corrected even when not wearing glasses. During the day after lens removal, the cornea partially reverts to its original shape. Therefore, users must wear orthokeratology lenses every night to maintain the desired shape of the central cornea.

[0010] In addition to the central correction zone, orthokeratology lenses further include an annular arched region (sometimes referred to as the "reverse curve" or "recovery zone") surrounding the central correction zone. This region is a recess in the posterior surface of the lens that accommodates an increased volume of tissue in the corneal region. The increase in the volume of tissue in the corneal region is caused by the redistribution of corneal tissue and / or fluid from the central correction zone of the lens to the peripheral portion of the cornea, resulting in an increased curvature of the corneal epithelium. Therefore, the annular arched region allows corneal tissue and / or fluid to move away from the central region of the cornea and thus helps to flatten the central portion of the cornea. An inevitable result of the annular arched region is that the redistribution of fluid and tissue to the peripheral portion of the cornea will create a single ring around the central flattened region of the cornea, adding power or causing myopic astigmatism.

[0011] Although orthokeratology lenses have been shown to correct myopia more effectively than MISIGHT lenses, the corrective and power-adding zones induced by orthokeratology lenses are not clearly defined. The correction provided by the corrective zone of orthokeratology lenses is not constant across the central portion of the cornea. Providing a constant power-adding effect across the peripheral annular region of the cornea aligned with the annular arch is also challenging, and the ring of power-adding effect induced in the cornea is often considered an inevitable consequence of central flattening and not a specific design feature of controlled optics. The limited control of induced myopic defocus and the corrective zone in the cornea by orthokeratology lenses currently limits their effectiveness in correcting existing myopia and slowing future progression.

[0012] Another issue with orthokeratology lenses is that the diameter of the central corrective zone of the cornea and the added power provided in the peripheral cornea will vary depending on the amount of correction. Generally, the greater the degree of myopia, the smaller the diameter of the central corrective zone of the cornea induced by the lens's corrective area, and the greater the refractive addition provided in the peripheral cornea by the surrounding annular arch area. This effectively limits the degree of myopia that can be treated with conventional orthokeratology lenses and prevents the treatment from providing a level of control for myopia control. In contrast, regardless of the degree of myopia treated and well controlled, MISIGHT lenses have a constant central corrective zone with a fixed diameter of 3.36 mm and stable myopia control treatment power.

[0013] This disclosure attempts to provide orthokeratology lenses that provide control over the diameter of the central corrective portion of the treated cornea regardless of the level of myopia being treated. Such lenses may further provide a more constant power across the central corrective region of the cornea. Alternatively or additionally, such lenses may provide a clearly defined area of ​​myopic defocus in the treated cornea. Summary of the Invention

[0014] According to a first aspect, this disclosure provides an orthokeratology contact lens for correcting and slowing the progression of myopia, wherein the lens is according to technical solution 1.

[0015] According to a second aspect, this disclosure further provides a method for manufacturing orthokeratology lenses, wherein the method is in accordance with technical solution 10.

[0016] According to a third aspect, this disclosure provides a method for manufacturing orthokeratology contact lenses, wherein the method is in accordance with technical solution 11.

[0017] According to a fourth aspect, this disclosure further provides a method for treating myopia progression, comprising providing eyeglasses according to the first aspect to a subject in need of such eyeglasses, wherein the method is according to technical solution 15.

[0018] Optional but preferred features are stated in the accompanying technical solutions.

[0019] It should be understood that features described with respect to one aspect of this disclosure may be incorporated into other aspects of this disclosure. For example, a method of preparing an orthokeratology contact lens according to this disclosure may be incorporated into any feature described with reference to the orthokeratology contact lens of this disclosure, and vice versa. Attached Figure Description

[0020] Embodiments of this disclosure will now be described by way of example only with reference to the illustrative accompanying drawings, in which:

[0021] Figure 1 This is a plan view of a bifocal lens 100 in the prior art;

[0022] Figure 2A It is along Figure 2B A cross-sectional view of the eyeglasses 201 according to this disclosure, obtained along axis A-A'. The eyeglasses 201 are suitable for treating or slowing the progression of myopia in individuals with relatively high myopia.

[0023] Figure 2B yes Figure 2A The diagram shows a plan view of the eyeglasses 201. The boundary of each central region corresponds to the boundary of the eyeglass region, which is typically defined by the change in curvature of the rear surface 202 of the eyeglasses.

[0024] Figure 3A It is along Figure 3B A cross-sectional view of the eyeglasses 301 according to this disclosure, obtained along axis B-B'. The eyeglasses are suitable for treating or slowing the progression of myopia in individuals with relatively low myopia.

[0025] Figure 3B yes Figure 3A The diagram shows a plan view of the eyeglasses 301. The boundary of each central region corresponds to the boundary of the eyeglass region, which is typically defined by the change in curvature of the rear surface 302 of the eyeglasses.

[0026] Figure 4A This is a cross-sectional view of the eyeglasses 401 according to this disclosure in use. The eyeglasses 401 are placed on the surface of the cornea 414. For simplicity, the adjustment area of ​​the eyeglasses is not shown. Arrows indicate the compressive force applied to the cornea 414 by the central correction area 406 of the eyeglasses 401, and thus the flow of fluid and / or tissue from the central portion of the cornea 414 to the peripheral portion of the cornea 414;

[0027] Figure 4B This is a cross-sectional view of the surface profile of cornea 414 before and after treatment. The dashed lines indicate the... Figure 4AThe surface profile of the cornea 414 before treatment with eyeglasses 401. Thick lines show the area of ​​the cornea 414 with a modified surface profile after treatment with eyeglasses 401. Compared to the pre-treatment profile of the cornea 414, the post-treatment cornea 414 has a flatter, less curved central portion and a raised, more curved peripheral portion;

[0028] Figure 5 yes Figure 4A A cross-sectional view of the eyeglasses 401, showing the areas of the eyeglasses 401 (correction area 406, annular treatment groove 408, and fitting area 412). The dimensions (width, curvature, depth, asphericity, and symmetry) of these areas are adjustable to control the movement of corneal tissue and / or fluid and thus induce a specific contour in the cornea to be treated, as shown. For simplicity, the adjustment areas of the eyeglasses 401 are not shown. Arrows indicate the movement of fluid and / or tissue within the cornea 414;

[0029] Figure 6 yes Figure 4A A cross-sectional view of the eyeglasses 401, showing the dimensions of the adjustable annular treatment recess 408. For simplicity, the adjustment area of ​​the eyeglasses 401 is not shown. Changes in the width of the annular treatment recess 408 are indicated on the left-hand side of the eyeglasses 401. Changes in the tilt or asphericity of the annular treatment recess 408 are indicated on the right-hand side of the eyeglasses. Arrows indicate the movement of fluid and / or tissue within the cornea 414;

[0030] Figure 7 yes Figure 4A A cross-sectional view of the eyeglasses 401, showing other dimensions of the adjustable annular treatment recess 408. For simplicity, the adjustment area of ​​the eyeglasses 401 is not shown. Changes in the curvature and tilt of the annular treatment recess 408 are indicated on the left-hand side of the eyeglasses 401. Changes in the position of the annular treatment recess 408 are indicated on the right-hand side of the eyeglasses 401. Arrows indicate the movement of fluid and / or tissue within the cornea 414;

[0031] Figure 8 yes Figure 4A A cross-sectional view of eyeglasses 401, showing the dimensions of the adjustable adjustment area 410. Changes in curvature and width of the adjustment area 410 are indicated on the left-hand side of eyeglasses 401. Changes in asphericity and symmetry of the adjustment area 410 are indicated on the right-hand side of eyeglasses 401. Arrows indicate the movement of fluids and / or tissues within the cornea;

[0032] Figure 9 It is a method 500 for manufacturing eyeglasses according to the present disclosure.

[0033] Figure 10 This is another method 600 for manufacturing eyeglasses according to this disclosure. Detailed Implementation

[0034] According to a first aspect of this disclosure, an orthokeratology contact lens is provided. The orthokeratology contact lens is used to correct, treat, or slow the progression of myopia by reshaping a portion of the cornea in a myopic eye. The lens has a posterior surface for contacting the portion of the cornea to be reshaped. The posterior surface of the lens includes a correction region for reducing the curvature of the central portion of the cornea. The correction region is defined by a first segment of the posterior surface having a radius of curvature of 6 mm or greater. The posterior surface of the lens also includes an annular treatment groove for inducing myopic astigmatism in the peripheral portion of the cornea. The annular treatment groove extends radially outward from the periphery of the correction region and is defined by a second segment of the posterior surface having a radius of curvature smaller than that of the first segment, wherein the radius of curvature of the second segment defining the annular treatment groove is configured to induce at least +1D of myopic astigmatism in the peripheral portion of the cornea. The posterior surface of the lens also includes an accommodation region for adjusting the myopic astigmatism induced by the annular treatment groove. The adjustment area extends radially outward from the periphery of the annular treatment groove and is defined by a third segment of the rear surface having a radius of curvature ranging from 4.5 mm to 15 mm.

[0035] According to a second aspect, a method for manufacturing an orthokeratology contact lens for correcting and treating myopia by reshaping a portion of the cornea of ​​a myopic eye is disclosed. The orthokeratology lens may be a lens according to the first aspect of this disclosure. The method includes forming a posterior surface of the lens for contact with a portion of the cornea to be reshaped. The method includes forming a first segment of the posterior surface, wherein the first segment defines a correction area and has a radius of curvature of 6 mm or greater. The method further includes forming a second segment of the posterior surface extending radially outward from the periphery of the correction area. The second segment defines an annular treatment groove and has a radius of curvature smaller than that of the first segment. The radius of curvature of the second segment causes the annular treatment groove to be configured to induce at least +1D myopic astigmatism in the peripheral portion of the cornea. The method further includes forming a third segment of the posterior surface extending radially outward from the periphery of the annular treatment groove. The third segment defines an accommodation area and has a radius of curvature in the range of 4.5 mm to 15 mm. The first, second, and third segments of the posterior surface of the lens may be formed sequentially or simultaneously using the methods disclosed herein.

[0036] As used herein, the term "contact lens" or simply "glasses" refers to a lens that can be placed on the anterior surface of the eye. Orthokeratology contact lenses are a type of contact lens whose properties and characteristics will be described herein. It should be understood that this contact lens will provide clinically acceptable on-ocular movement and will not adhere to a person's eye. Contact lenses are in the form of corneal lenses (e.g., lenses that rest on the cornea of ​​the eye).

[0037] According to this disclosure, the eyeglasses are orthokeratology contact lenses (also referred to as "Ortho-K lenses"). It should be understood that, unless otherwise specified, reference to "eyeglasses" according to this disclosure refers to orthokeratology lenses. Conventional contact lenses correct myopia by reducing the convergence of light before it reaches the eye from a distant object, thus shifting the focal point onto the retina. Therefore, conventional contact lenses must be worn on the cornea to improve vision. In contrast, orthokeratology lenses according to this disclosure alter the optical properties of the eye itself by gradually changing or reshaping the surface contour of the subject's cornea during continuous wear. This reshaping of the corneal surface contour provides temporary optical correction for myopia.

[0038] The disclosed orthokeratology lenses apply continuous pressure to selected locations on the cornea during wear to reshape the cornea into a desired surface profile. More specifically, the orthokeratology contact lenses are worn on the cornea and primarily reshape the corneal epithelium by altering the distribution of fluids and / or tissues within the epithelium. It should be understood that reference fluids and / or tissues refer to any organic or physiological material in the corneal epithelium that can be moved by compressive forces applied to the surface of the cornea. For example, the fluid in the corneal epithelium may comprise an aqueous solution of water and solutes commonly found in the cornea, and may also comprise a dispersion of organic materials commonly found in the cornea in the aqueous solution. Tissues may refer to cells or cell clusters commonly found in the cornea. The orthokeratology lenses according to this disclosure reshape the cornea of ​​the eye such that a cornea having a radius of curvature that converges light before it reaches the eye from a distant object is reshaped into a cornea having a radius of curvature that reduces the convergence of light from distant objects, allowing light to focus onto the retina. Mechanisms by which corneal fluids and / or tissues can be redistributed are disclosed herein. After the orthokeratology contact lens is removed from the contact point with the cornea, the reshaped surface contour of the cornea can be maintained. This reshaped surface contour can be maintained for an extended period after lens removal, allowing for visual acuity to be maintained for several hours, such as up to 5 hours, 8 hours, 12 hours, or 16 hours, or even a day or several days. Therefore, the optical correction provided by the orthokeratology lens remains in the cornea even after lens removal.

[0039] The orthokeratology lenses disclosed herein are for the correction and treatment of myopia. It should be understood that myopia correction refers to altering the optical properties of the eye to reduce or eliminate the degree of myopia, resulting in sufficient vision without the need for corrective devices (e.g., conventional contact lenses or eyeglasses). For example, an eye with myopia between -0.25D and -15D may experience a myopia reduction of at least 0.25D, at least 0.5D, or preferably at least 0.75D after wearing lenses according to this disclosure. Orthokeratology lenses can be worn nightly for one week to achieve myopia refractive error correction sufficient to eliminate the need for conventional corrective devices such as contact lenses or eyeglasses. Preferably, myopia correction results in the eye no longer being myopic, so that hyperopia does not require external vision correction (e.g., wearing eyeglasses or conventional contact lenses). Myopia can be corrected by the lenses reducing the curvature of at least a central portion of the cornea. This can be achieved by orthokeratology lenses according to the mechanism described herein. It should be understood that myopia correction in the central portion of the cornea is necessary to correct distance vision. However, the peripheral portion of the cornea may remain uncorrected or even have increased myopia (“myopic astigmatism”) without interfering with distance vision. For example, orthokeratology lenses according to this disclosure can correct myopia in the central portion of the cornea while undercorrecting or adding positive power in the peripheral portion. This undercorrection or addition of positive power in the peripheral portion can be described as introducing myopic astigmatism into the eye.

[0040] It should be understood that reference treatment for myopia implies slowing the progression of myopia. Treatment for myopia can lead to a pause or reversal in the progression of myopia. This can be particularly beneficial for children, as myopia typically worsens with age. Orthokeratology lenses can be used to prevent myopia from developing in subjects at risk of developing it. Without wishing to be bound by theory, it can be considered that introducing myopic defocus into the peripheral region of the cornea through lenses according to this disclosure can slow the progression of myopia or prevent its occurrence. The annular treatment groove of the orthokeratology lenses disclosed herein can induce myopic defocus in the cornea through the mechanisms disclosed herein.

[0041] The disclosed orthokeratology contact lenses may be rigid contact lenses made of rigid materials. The lenses may be rigid gas-permeable lenses. Orthokeratology lenses may be made of polymethyl methacrylate (PMMA) or copolymers of fluoromethyl acrylate and styrene-siloxane, copolymers of fluoropolysiloxane acrylate compounds, copolymers of polysiloxane acrylate compounds and fluoromethyl acrylate compounds. Examples of suitable lens materials include materials having the following US Adopted Names (USAN): tisilfocon A, tolofocon A, paflufocon A, paflufocon B, and paflufocon C. It should be understood that rigid lenses can be particularly effective in redistributing corneal fluid and / or tissue in the corneal epithelium because the rigid structure can impose compressive forces on the corneal surface sufficient to displace fluid and / or tissue from one area of ​​the cornea to another.

[0042] The term "eyeglass body" can be used to refer to the bulk of an eyeglass and can be used particularly to refer to a segment of an eyeglass defined by its front and rear surfaces. The eyeglass body can be formed of multiple eyeglass layers. A "eyeglass layer" refers to an area of ​​eyeglass material forming at least one segment of the eyeglass body. If multiple eyeglass layers are present, each eyeglass layer will have a thickness less than the thickness of the eyeglass body. The eyeglass body optionally includes eyeglass layers attached to at least one other layer. For example, multiple layers (e.g., at least two or at least three eyeglass layers) can be stacked to form the eyeglass body. If multiple eyeglass layers are present, the eyeglass layers can be formed of the same or different materials. At least two of the eyeglass layers can optionally be formed of the same material and at least one eyeglass layer can be formed of an alternative material. If the eyeglass body includes multiple eyeglass layers, then distinguishable boundaries can exist between each layer. For example, the eyeglass body can be formed by curing a bulk material to form a first layer and then laying other materials on top of the first layer (which are then cured to form a second layer). If the first and second layers are formed of different materials, then obviously, there are boundaries where the chemical composition of the materials changes between the layers. If the first and second lens layers are formed of the same material, then different physical properties may exist between the layers, such as different optical properties or crystallinity at the boundaries between the lens layers. It should be understood that when eyeglasses consist of more than one lens layer, the rear surface of the eyeglasses refers to the rear surface of the bottommost layer (i.e., the layer that contacts the eye when worn). When eyeglasses consist of multiple layers, the front surface of the eyeglasses should be understood as the front surface of the topmost layer (i.e., the layer furthest from the eye when worn). The eyeglass body may be formed from a single lens layer. It should be understood that if the eyeglass body is formed from a single lens layer, then the bulk material forming the eyeglass body will be homogeneous, such that there are no distinguishable boundaries between the regions of the bulk material forming the eyeglass body. When the eyeglass body is formed from a single lens layer, the lens layer forms the entire eyeglass body; in this case, the terms "lens layer" and "eyeglass body" are used interchangeably. A single lens layer can form the entire eyeglass.

[0043] When viewed in a plane, orthokeratology contact lenses are generally circular and have a diameter ranging from 8 mm to 25 mm. The diameter of the lens can optionally be in the range of 8 mm to 15 mm.

[0044] The orthokeratology contact lens according to this disclosure has an anterior surface and an opposing posterior surface. When the contact lens is positioned on the eye, the anterior surface faces away from the eye and may have a generally convex shape. When the contact lens is positioned on the eye, the posterior surface is oriented towards the eye. The posterior surface may have a generally concave shape. The posterior surface of the lens contacts the cornea of ​​the eye. It should be understood that when the lens is worn, at least a major portion of the posterior surface may contact the surface of the cornea, for example, at least 50%, at least 75%, or at least 90%. The contact between the posterior surface of the lens and the cornea allows the lens to reshape the surface of the cornea as described herein.

[0045] The posterior surface of orthokeratology lenses includes a correction zone. The correction zone is the area on the posterior surface of the lens that reduces the curvature of the central portion of the cornea when the lens is worn. The lenses are configured such that the correction zone is positioned over the pupil of the eye when the lenses are in use. When viewed in a plane, the correction zone is preferably positioned around the center of the lens along its central axis. The correction zone is aligned with the central portion of the cornea to be treated. When viewed in a plane, the correction zone is preferably substantially circular.

[0046] The correction zone is defined by a first segment of the posterior surface with a radius of curvature greater than that of the central portion of the cornea. It should be understood that the larger the radius of curvature, the flatter the correction zone.

[0047] The eyeglasses are configured such that, when worn, the corrective area contacts the apex of the cornea, and the central portion of the cornea is flattened due to compression because the central area has a flatter or more gently curved profile than the apex. Therefore, the corrective area is configured to correct hyperopia in nearsighted individuals by flattening or reducing the curvature of the central portion of the treated cornea. Without being bound by theory, it can be considered that the corrective area reduces the curvature of the central portion of the cornea by displacing epithelial fluid and / or tissue from the central portion to the central portion of the cornea. When orthokeratology lenses are worn, the central portion of the cornea will be at least partially molded or influenced by at least a portion of the corrective area of ​​the lens. Therefore, the topology of the central portion of the cornea will be flatter after wearing the lenses than before.

[0048] To correct refractive errors in nearsightedness, the central portion of the cornea needs to be flattened or less curved. The minimum radius of curvature required for the corrective zone of the eyeglasses can be approximated to the radius of curvature required to correct low myopia (e.g., -0.25D). Eyes with higher degrees of myopia will require greater flattening and therefore must have a corrective zone with a radius of curvature larger than that required for lower myopia. Therefore, the maximum radius of curvature of the corrective zone can be approximated to the radius of curvature required to correct high myopia (e.g., -15D).

[0049] The correction area is defined by a first segment of the posterior surface of the eyeglasses having a radius of curvature of 6 mm or greater (e.g., 7 mm or greater, or 8 mm or greater). The correction area may also be defined by a first segment of the posterior surface of the eyeglasses having a radius of curvature less than 15 mm, less than 12 mm, or less than 10 mm. The radius of curvature of the correction area may range from 6 mm to 15 mm, from 6 mm to 12 mm, from 6 mm to 10 mm, from 6 mm to 9.5 mm, from 7 mm to 9.5 mm, from 7 mm to 9 mm, from 8 mm to 8.5 mm, from 8.8 mm to 9.3 mm, from 6 mm to 6.8 mm, or from 6.8 mm to 15 mm. When treating individuals with relatively low myopia (e.g., those with -1.0D myopia), a correction area containing a radius of curvature ranging from 7 mm to 9.5 mm is advantageous. When treating individuals with relatively high myopia (e.g., -4.0D or greater), it is advantageous to provide a correction zone defined by a portion of the posterior surface of the eyeglasses having a radius of curvature ranging from 6.8mm to 15mm.

[0050] The overcorrection zone provides additional correction beyond what is needed to correct myopia. This overcorrection considers the gradual reversal of the cornea's contour to its untreated state during a day when glasses are not worn. For example, an overcorrection of approximately -0.75D can be induced by the overcorrection zone to allow the central portion of the cornea to partially revert to its natural, more curved state when glasses are not worn. This overcorrection is called the Jessen factor. Overcorrection can be greater than -0.5D, -1D, or -2D. Overcorrection prolongs the period during which the cornea will maintain focus on distance vision when glasses are not worn. Overcorrection also increases the volume of fluid and / or cells moving into the peripheral portion of the cornea because the central portion of the cornea becomes flatter. This can help control the amount of myopic astigmatism induced by the annular treatment notch, as a larger volume of fluid and / or cells redistributes within the cornea.

[0051] The correction area may have a diameter greater than 1 mm, greater than 2 mm, or greater than 3 mm. The correction area may have a diameter less than 8 mm, less than 6 mm, less than 5 mm, or less than 4 mm. The correction area may have a diameter in the range of 1 mm to 8 mm, 2 mm to 6 mm, more preferably 2.5 mm to 5.5 mm, and most preferably in the range of 3 mm to 4 mm. In a preferred embodiment, the correction area has a diameter of approximately 3 mm, for example, approximately 3.36 mm.

[0052] The correction area may be defined by a first segment of the posterior surface of a spherical eyeglass. Alternatively, the correction area may be defined by a first segment of the posterior surface of an aspherical eyeglass. It should be understood that an aspherical profile is a profile in which the radius of curvature across a segment of the posterior surface corresponding to the diameter of the correction area is not constant. For example, the radius of curvature at the center of the correction area may be greater than the radius of curvature at either end of the correction area. Alternatively, the radius of curvature at the center of the correction area may be smaller than the radius of curvature at either end of the correction area. The radius of curvature may increase toward the edge of the correction area. Alternatively, the radius of curvature may decrease toward the edge of the correction area. An aspherical correction area can advantageously achieve a more constant base power across the central portion of the cornea because the degree of flattening can decrease with the radial distance from the apex of the cornea. The correction area may optionally be defined by a first segment of the posterior surface configured to treat astigmatism. For example, the profile of the posterior surface of the correction area may be toroidal.

[0053] The posterior surface of the eyeglasses further includes an annular treatment groove extending radially outward from the periphery of the corrective area. The eyeglasses are configured such that, when in use, the annular treatment groove, together with the corrective area, aligns with the pupil of the eye. When viewed in a plane, the central corrective area is centered on the central axis of the eyeglasses and surrounded by the annular treatment groove. When worn, the annular treatment groove aligns with the peripheral portion of the cornea to be treated. When viewed in a plane, the annular treatment groove is preferably substantially circular.

[0054] The annular treatment groove induces myopic astigmatism in the peripheral portion of the cornea and is defined by a second segment of the posterior surface with a radius of curvature smaller than that of the first segment (i.e., the correction zone) of the posterior surface. Because the radius of curvature of the annular treatment groove is smaller than that of the correction zone, the annular treatment groove is more curved and provides additional power to the treated cornea. It should be understood that the shorter the radius of curvature of the second segment of the posterior surface of the eyeglass, the more curved the annular treatment groove and the greater the added power. The annular treatment groove is formed in the posterior surface of the eyeglass, which is a concave surface.

[0055] When the glasses are in use, the annular treatment groove accommodates the increased thickness and curvature of the peripheral portion of the cornea. This increased thickness / curvature is caused by increased pressure within the central region of the cornea (caused by the corrective zone of the glasses), leading to a redistribution of fluid and / or tissue to the peripheral portion. It should be understood that the corneal surface exhibits a profile influenced by the contour of the posterior surface of the glasses, as the corneal surface is compressed to at least partially conform to the shape of the posterior surface. Therefore, the peripheral portion of the cornea aligned with the annular treatment groove will be shaped by the annular treatment groove and will have added (convex) curvature when the glasses are worn. This shaping of the peripheral portion of the cornea adds a positive power or myopic defocus to the cornea. The annular treatment groove controls the shape of the peripheral portion of the cornea providing myopic defocus in the treated eye. It should be understood that the shape of the peripheral portion of the cornea may not necessarily match the shape of the annular treatment groove; for example, when wearing glasses, the peripheral portion of the cornea may only partially fill the annular treatment groove.

[0056] The corrective zone of the eyeglass alters the curvature of the central cornea and provides power to the central portion of the cornea by flattening said zone. The annular treatment groove provides undercorrection for hyperopia or intentionally induces myopic astigmatism in the cornea. The radius of curvature of the second segment of the peripheral portion of the eyeglass will cause the annular treatment groove to induce at least +1D of myopic astigmatism in the peripheral portion of the treated cornea, exceeding the power obtained from flattening the central portion of the cornea. It should be understood that diopter (D) is a unit of measurement for the refractive power of eyeglasses and is a common term in the field. The added power provided by the annular treatment groove in the peripheral portion of the cornea can be at least +1.5D, at least +2.0D, at least +4.0D, at least +6.0D, at least +8.0D, or at least +12.0D, exceeding the power obtained from flattening the central portion of the cornea. The added power provided by the annular treatment groove in the peripheral portion of the cornea can be less than +12.0D, less than +8.0D, or less than +6.0D. For example, the added power provided by the annular treatment groove in the peripheral portion of the cornea can be at least +1.0D but less than +12.0D. This is achieved by controlling the curvature of the annular treatment groove. The annular treatment groove can also contribute to creating a uniformly corrected area in the central portion of the cornea by accommodating at least some fluid and / or tissue displaced from the central portion of the cornea. As will be disclosed herein, the width, depth, curvature, and position of the annular treatment groove can affect the amount of redistributed fluid and / or tissue accommodated in the peripheral portion of the cornea.

[0057] The annular treatment notch induces myopic astigmatism in the peripheral portion of the cornea by allowing less flattening of the corneal curvature, maintaining an unflattened state, or increasing the curvature of the peripheral portion of the cornea positioned below the annular treatment notch when wearing glasses. The radius of curvature of the annular treatment notch is selected based on the desired degree of flattening or curvature increase in the peripheral portion of the cornea. The peripheral portion of the cornea is not fully corrected for distance vision. Therefore, intentional undercorrection or myopic astigmatism is introduced into the cornea in the peripheral portion. Where one does not wish to be bound by theory, it can be considered that induced myopic astigmatism in the peripheral portion of the cornea promotes a slowing of myopia progression. The dimensions of the annular treatment notch can be modified to control the amount of induced myopic astigmatism and the location of the cornea in which astigmatism will be induced.

[0058] At the annular treatment groove, along the thickness direction of the eyeglasses, the eyeglasses include the groove and a residual portion of the eyeglass material having a surface defining the closed end of the groove. The surface defining the closed end of the groove is a second segment of the rear surface of the eyeglasses. The second segment of the rear surface of the eyeglasses has a curvature that defines the groove.

[0059] The depth of the groove is defined as the distance from the open end of the groove (i.e., the back surface that would exist if the groove were not present) to the closed end of the groove (i.e., the surface of the eyeglass material that defines the end of the groove). One or more grooves may have a depth between 3% and <100% of the thickness of the residual portion of the eyeglass material; for example, the groove may have a depth between 10% and 80%, 20% and 60%, or 30% and 50% of the thickness of the residual portion.

[0060] The radius of curvature of the second segment of the posterior surface of the eyeglasses defining the annular treatment groove can be in the range of 5.5 mm to 12 mm, for example, in the range of 6.5 mm to 12.0 mm, 7.5 mm to 9.0 mm, 8.0 mm to 9.0 mm, 5.5 mm to 8.5 mm, 7.5 mm to 8.5 mm, or 8.5 mm to 9.5 mm. The curvature of the second segment of the posterior surface of the eyeglasses defining the annular treatment groove can be selected depending on the curvature of the correction area. For example, when the radius of curvature of the first segment of the posterior surface of the eyeglasses defining the correction area is in the range of 8.0 mm to 8.5 mm, the radius of curvature of the second segment of the posterior surface of the eyeglasses defining the annular treatment groove can be in the range of 7.7 mm to 8.2 mm. When the radius of curvature of the first segment of the posterior surface of the eyeglasses defining the correction area is in the range of 8.8 mm to 9.3 mm, the radius of curvature of the second segment of the posterior surface of the annular treatment groove can be in the range of 8.3 mm to 8.8 mm. The flatter (less curved) the correction area, the greater the amount of corneal fluid and / or tissue that will be displaced through the eyeglass, and the more curved the annular treatment groove may be required. Alternatively, in individuals with relatively high myopia, the correction area can be flatter than for those with low myopia, but because the surface profile of the peripheral portion of the pre-treated cornea is already highly curved, the annular treatment groove can have a radius of curvature equal to or even smaller than the radius of curvature of the peripheral portion of the pre-treated cornea to protect or flatten the peripheral portion to achieve the desired myopic defocus. The radius of curvature of the second portion of the posterior surface of the eyeglass defining the annular treatment groove will be smaller than the radius of curvature of the first portion of the posterior surface of the eyeglass defining the correction area.

[0061] The annular treatment recess may have a width ranging from 0.5 mm to 5.5 mm, or from 1 mm to 4 mm (e.g., from 1 mm to 2 mm). It should be understood that because the treatment recess is annular, the width can be defined as the distance between the outer periphery of the inner edge of the recess and the outer edge of the recess along the direction of travel from the center of the eyeglass to the edge of the eyeglass (when viewed in a plane).

[0062] The annular treatment groove can be symmetrical or asymmetrical, meaning the groove is defined by a second segment of the posterior surface of the eyeglass with a symmetrical or asymmetrical profile. The annular treatment groove can be defined by a second segment of the posterior surface of the eyeglass that is spherical. Alternatively, the annular treatment groove can be defined by a second segment of the posterior surface of the eyeglass that is aspherical. The shape of the groove can impart a specific optical power to the portion of the cornea aligned with the groove of the eyeglass. The annular treatment groove can be asymmetrical, such that the portion of the annular treatment groove positioned closest to the correction area has a smaller radius of curvature than the portion positioned further away from the correction area. It should be understood that this asymmetrical profile tilts the annular treatment groove toward the correction area. Alternatively, the annular treatment groove can be asymmetrical, such that the portion of the annular treatment groove positioned closest to the correction area has a larger radius of curvature than the portion positioned further away from the correction area. It should be understood that this asymmetrical profile tilts the annular treatment groove away from the correction area. The tilting of the annular treatment groove can help guide tissue and / or fluid toward or away from the central portion of the cornea aligned with the correction area. The radius of curvature of the annular treatment groove can depend on the radius of curvature of the correction area.

[0063] The eyeglasses further include an accommodative area extending radially outward from the periphery of the annular treatment groove. Therefore, it should be understood that, when viewed in a plane, the accommodative area is also annular or substantially annular and centered on the central axis of the eyeglasses. The accommodative area regulates myopic astigmatism induced by the annular treatment groove and the central correction area in the peripheral portion of the cornea. The accommodative area regulates the increased curvature of the cornea in the peripheral portion due to increased intracorneal pressure caused by the redistribution of fluids and / or tissues toward the peripheral portion, and controls the movement of fluids and / or tissues from the far periphery of the cornea to the peripheral portion of the cornea aligned with the annular treatment groove, as will be explained herein. The accommodative area may additionally or alternatively contribute to achieving a central portion of the cornea with a uniform power across its diameter. For example, the accommodative area may act as an additional groove for accommodating the increased curvature of the cornea in the peripheral portion caused by increased intracorneal pressure caused by the redistribution of fluids and / or tissues toward the peripheral portion. The accommodative area may be positioned outside the visual field to avoid interfering with the user's vision. When the eyeglasses are in use, the accommodative area may not overlap with the pupil of the eye.

[0064] The accommodation region has a radius of curvature defined by a third segment of the posterior surface of the eyeglasses, which provides a power ranging from a radius of curvature greater than 12 diopters to a radius of curvature less than 12 diopters of the correction region. For example, the third segment of the posterior surface of the eyeglasses defining the accommodation region may have a radius of curvature providing a power ranging from 0 to 12 diopters greater than the correction region, from 0 to 8 diopters greater than the correction region, or from 0 to 4 diopters greater than the correction region. Alternatively, the third segment of the posterior surface of the eyeglasses defining the accommodation region may have a radius of curvature providing a power ranging from 0 to 12 diopters less than the correction region, from 0 to 8 diopters less than the correction region, or from 0 to 4 diopters less than the correction region.

[0065] The radius of curvature of the third segment of the posterior surface of the eyeglasses defining the accommodation area can be in the range of 4.5 mm to 15 mm, for example, from 4.5 mm to 12 mm, from 7 mm to 15 mm, or from 7 mm to 9 mm. The accommodation area can have a width in the range of 0.5 mm to 5.5 mm, or from 1 mm to 4 mm, for example, a width in the range of 1 mm to 2 mm. The radius of curvature of the third segment can be equal to the radius of curvature of the second segment defining the correction area.

[0066] The radius of curvature of the third section can be greater than the radius of curvature of the second section that defines the correction area, for example, at least 0.9 mm greater.

[0067] The radius of curvature of the third segment may be smaller than the radius of curvature of the second segment defining the correction area, for example, at least 0.9 mm smaller. It should be understood that because the adjustment area is annular, its width can be defined as the distance between the outer periphery of the inner edge of the adjustment area and the outer edge of the area along the direction of travel from the center of the glasses to the edge of the glasses (when viewing the glasses in a plane).

[0068] The adjustment area can be symmetrical, i.e., defined by a third segment of the rear surface of the eyeglasses with a symmetrical profile. The adjustment area can also be asymmetrical, i.e., defined by a third segment of the rear surface of the eyeglasses with an asymmetrical profile. The adjustment area can be defined by a third segment of the rear surface of the eyeglasses that is spherical. Alternatively, the adjustment area can be defined by a third segment of the rear surface of the eyeglasses that is aspherical. The shape of the adjustment area can impart a specific optical power in the eyeglasses. The adjustment area can be asymmetrical such that the portion of the adjustment area positioned closest to the annular treatment groove has a smaller radius of curvature than the portion positioned further away from the annular treatment groove. It should be understood that this asymmetrical profile tilts the adjustment area toward the annular treatment groove and the correction area. Alternatively, the adjustment area can be asymmetrical such that the portion of the adjustment area positioned closest to the annular treatment groove has a larger radius of curvature than the portion positioned further away from the annular treatment groove. It should be understood that this asymmetrical profile tilts the adjustment area away from the annular treatment groove and the correction area. This can help guide tissue and / or fluid toward or away from the portion of the cornea aligned with the circular treatment notch, as needed. The radius of curvature of the adjustment zone may depend on the radius of curvature of the correction zone.

[0069] In some embodiments, the radius of curvature of the accommodation region is smaller than that of the correction region. In such embodiments, the accommodation region can be used to accommodate fluid and / or tissue displaced by the correction region that is not contained by the annular treatment recess of the eyeglass. This can be particularly advantageous when the degree of myopia being corrected is relatively high (e.g., -4.00D myopia). In this example, a relatively large amount of planarization of the central portion of the cornea is required, and therefore a large volume of tissue and / or fluid is displaced through the correction region of the eyeglass. The volume of displaced tissue and / or fluid can be greater than that required to induce the desired myopic astigmatism in the peripheral portion of the cornea. It is desirable to avoid the accumulation of excessive displaced tissue and / or fluid in the peripheral portion of the cornea, as this would induce an additional power beyond what is required in said area of ​​the cornea. To help achieve the desired amount of myopic astigmatism in the peripheral portion of the cornea within a well-defined area, the accommodation region can act as a reservoir for accommodating excess displaced tissue and / or fluid. In this case, the accommodation region is the area of ​​the eyeglass into which the curvature of the cornea extends. Therefore, the accommodation region in this embodiment can be considered as a second groove and can have any features disclosed relative to the annular treatment groove. The accommodation region in this embodiment can induce a second myopic defocus into the cornea.

[0070] Orthokeratology lenses optionally include a correction region defined by a first segment of the posterior surface of the lens having a radius of curvature ranging from 6.8 mm to 15.0 mm, and a third segment of the posterior surface defining the correction region having a radius of curvature ranging from 4.5 mm to 15 mm and smaller than the radius of curvature of the first segment of the posterior surface defining the correction region. The radius of curvature of a second segment of the posterior surface defining the annular treatment groove is optionally ranging from 6.5 mm to 12.0 mm, provided that the radius of curvature is smaller than the radius of curvature of the correction region. The radius of curvature of the third segment of the posterior surface defining the correction region is optionally smaller than the radius of curvature of the second segment defining the annular treatment groove. For example, when the radius of curvature of the first segment of the posterior surface of the eyeglasses defining the correction area is in the range of 8.8 mm to 9.3 mm, the radius of curvature of the second segment of the posterior surface defining the annular treatment groove can be in the range of 8.3 mm to 8.8 mm, and the radius of curvature of the third segment of the posterior surface defining the accommodation area can be in the range of 7.9 mm to 8.4 mm. This eyeglasses are particularly effective in correcting and treating high myopia, such as at least -4.0D.

[0071] In some embodiments, the radius of curvature of the accommodation region is greater than or equal to the radius of curvature of the correction region. In such embodiments, the accommodation region can be used to guide fluid and / or tissue displaced through the correction region toward a portion of the cornea aligned with the annular treatment groove of the eyeglass. This can be particularly advantageous when the degree of myopia being corrected is relatively low (e.g., -1.0D myopia). In this example, a relatively small amount of flattening of the central portion of the cornea is required, and therefore a small volume of tissue and / or fluid is displaced through the correction region of the eyeglass. To ensure that the annular treatment groove can induce sufficient myopic defocus in the peripheral portion of the cornea, a larger (flatter) radius of curvature of the accommodation region can help guide tissue and / or fluid toward the area of ​​the cornea aligned with the correction region. When the accommodation region is relatively flat, it may not act as a reservoir in which the cornea can expand, and thus inhibits the movement of fluid and / or tissue from the central and / or peripheral portions of the cornea toward the area aligned with the accommodation region.

[0072] Orthokeratology lenses optionally include a correction region defined by a first segment of a posterior surface having a radius of curvature ranging from 7 mm to 9.5 mm, and a second segment of the posterior surface defining an annular treatment groove having a radius of curvature ranging from 5.5 mm to 8.5 mm, provided that the radius of curvature is smaller than that of the central correction region. The radius of curvature of the accommodation region is optionally in the range of 7.0 mm to 15 mm, and the radius of curvature of the third segment is greater than that of the second segment defining the annular treatment groove. The radius of curvature of the accommodation region may be greater than or equal to that of the correction region. For example, when the radius of curvature of the first segment of the posterior surface defining the correction region is in the range of 8.0 mm to 8.5 mm, the radius of curvature of the second segment of the posterior surface defining the annular treatment groove may be in the range of 7.7 mm to 8.2 mm, and the radius of curvature of the third segment of the posterior surface defining the accommodation region may be in the range of 8.0 mm to 8.5 mm. These glasses are particularly effective in correcting and treating low myopia, such as approximately -1.0D.

[0073] The accommodative region can be positioned within the posterior surface of the eyeglass, tilted toward or away from the center of the corrective region. It should be understood that this tilt can be achieved by creating an asymmetrical profile in a third segment of the posterior surface of the eyeglass. The accommodative region can be asymmetrical such that the portion of the accommodative region positioned closest to the annular treatment groove has a smaller radius of curvature than the portion positioned further away from the annular treatment groove. It should be understood that this asymmetrical profile tilts the accommodative region toward both the annular treatment groove and the corrective region. Alternatively, the accommodative region can be asymmetrical such that the portion of the accommodative region positioned closest to the annular treatment groove has a larger radius of curvature than the portion positioned further away from the annular treatment groove. It should be understood that this asymmetrical profile tilts the accommodative region away from both the annular treatment groove and the corrective region. The direction of tilt of the accommodative region can be selected based on the desired flow direction of tissues and / or fluids in the cornea. For example, in eyeglasses designed to treat low myopia (e.g., -1.0D myopia), the accommodative region can be tilted away from both the annular treatment groove and the corrective region. This arrangement guides corneal fluid and / or tissue toward the portion of the cornea bounded by the annular treatment groove and the correction area, and / or prevents fluid and / or tissue from moving toward the outer region of the cornea bounded by the mating area. In this arrangement, more fluid and / or tissue is available for alignment with the annular treatment groove and / or the correction area, which can help achieve the desired corneal contour in these areas. In glasses designed to treat high myopia (e.g., -4.0D myopia), the accommodation area may be tilted toward the annular treatment groove and the correction area. This guides corneal fluid and / or tissue toward the outer region of the cornea bounded by the mating area and / or away from the portion of the cornea bounded by the annular treatment groove and the correction area. If the accommodation area is tilted toward the annular treatment groove and the correction area, then corneal fluid and / or tissue guided from the central portion of the cornea can be guided toward the outer region of the cornea that can be aligned with the mating area. This arrangement also prevents corneal tissue and / or fluid from flowing back from the outer region of the cornea toward the central region. This configuration in the eyeglasses allows excess corneal fluid and / or tissue to be guided away from the annular treatment groove, thus enabling control of the desired myopic defocus in the peripheral portion of the eyeglasses.

[0074] The eyeglasses according to this disclosure may optionally include an adjustment region directly adjacent to the annular treatment groove, i.e., the outer periphery of the annular treatment groove defines the boundary between the annular treatment groove and the adjustment region. Therefore, the treatment groove may be adjacent to the adjustment region. At the boundary between the adjacent adjustment region and the annular treatment groove, there may be a sharp, discontinuous increase or decrease in the radius of curvature, depending on the relative radius of curvature addition of the annular treatment groove and the adjustment region, respectively.

[0075] The radius of curvature of the adjustment area can be equal to the radius of curvature of the annular treatment groove. In this embodiment, the adjustment area and the annular treatment groove can be separated within the eyeglasses, such that there is a clear definition between the end point of one area and the beginning point of another. For example, a portion of the rear eyeglasses having a radius of curvature equal to the radius of curvature of the adjustment area can separate the annular treatment groove from the adjustment area.

[0076] One or more other regions may be located between the annular treatment recess and the correction region. Such regions may guide tissue and / or fluid toward the peripheral portion of the cornea positioned below the annular treatment recess when the eyeglass is in use. For example, the region may have properties similar to the accommodation region described herein, except that it is located on the opposite side of the treatment recess, i.e., it is aligned with the inner and outer peripheries of the annular treatment recess. Alternatively, such regions may deflect tissue and / or fluid away from the portion of the cornea positioned below the annular treatment recess when the eyeglass is in use. For example, the region may have properties similar to the annular treatment recess.

[0077] The rear surface of the eyeglass may optionally further include a mating region for securing the eyeglass to the cornea, wherein the mating region extends radially outward from the periphery of the accommodation region. Therefore, the eyeglasses according to this disclosure may include a mating region for stabilizing the eyeglasses.

[0078] The accommodating region is the portion of the eyeglass outside the visual field; therefore, when the eyeglass is in use, the accommodating region is not aligned with the pupil of the eye, but rather lies outside the peripheral portion of the cornea. When viewed in a plane, the accommodating region is centered on the central axis of the eyeglass and surrounds the accommodation region. When viewed in a plane, the accommodating region is preferably substantially circular. The accommodating region does not have optical properties but serves to anchor the eyeglass to the eye during use. This helps prevent the eyeglass from moving or sliding on the eye during use. The accommodating region optionally has a radius of curvature approximating the radius of curvature of the portion of the eye to be treated. The accommodating region may have multiple regions, each with a different radius of curvature. Each region may have a radius of curvature ranging from 8 mm to 12 mm (preferably from 8.5 mm to 10.5 mm), for example, a radius of curvature of about 9 mm. The accommodating region may be rigid so that it does not flex or deform under the pressure of fluid redistributed within the cornea. In this way, the accommodating region helps guide fluid / cells to the region of the cornea aligned with the annular region. The mating area may optionally have a radius of curvature larger than the portion of the cornea aligned with the mating area when the eyeglasses are in use. In this way, the mating area can apply additional pressure to the eye (e.g., additional pressure to the side of the cornea by the mating area). This can advantageously redistribute corneal tissue and / or fluid toward the center of the cornea, which is preferred in eyeglasses designed to treat relatively low myopia. Alternatively, the mating area may have a radius of curvature larger than the portion of the cornea aligned with the mating area when the eyeglasses are in use. This mating area will be more curved than the portion of the cornea it aligns with and therefore the mating area may not apply additional pressure to the cornea. This allows the eye to expand in the area aligned with the mating area (i.e., the side of the cornea), which is preferred in eyeglasses designed to treat relatively high myopia. The mating area may have a width of at least 1 mm, or at least 2 mm, or at least 4 mm. The mating area may have a width not exceeding 9 mm, not exceeding 7 mm, or not exceeding 5 mm. For example, the mating area may have a width in the range of 1 mm to 7 mm (e.g., 1.5 mm). It should be understood that, because the mating area is annular, the width can be defined as the distance between the outer periphery of the inner edge of the mating area and the outer edge of the mating area along the direction of travel from the center of the eyeglass to the edge of the eyeglass (when viewing the eyeglass in a plane).

[0079] The glasses may optionally include an edge lift. An edge lift helps the user lift the glasses from the cornea.

[0080] The method for forming orthokeratology lenses according to this disclosure may include any of the features stated above.

[0081] The orthokeratology lens according to this disclosure can optionally reshape the corneal contour to mimic the core properties of the MISIGHT contact lens. Specifically, the lens can provide a corneal contour including a central correction zone (the central portion of the already flattened cornea) with a diameter of 3.30 mm to 3.40 mm and a lifting peripheral portion (the peripheral portion of the cornea with increased curvature or myopic astigmatism) providing an additional +2.0D power and optionally having a diameter of 1.40 mm to 1.50 mm.

[0082] Eyeglasses can be formed by a casting molding process, a spin casting molding process, or a milling and turning process, or a combination thereof. Those skilled in the art will understand that casting molding refers to molding eyeglasses by placing eyeglass forming material between a female mold having a concave eyeglass component forming surface and a male mold having a convex eyeglass component forming surface.

[0083] The manufacturing method may include forming a female mold having a concave eyeglass forming surface and a male mold having a convex eyeglass forming surface. The method may include filling the gap between the female and male molds with bulk eyeglass material. The method may further include curing the bulk eyeglass material to form eyeglasses. It should be understood that the rear and front surfaces of the eyeglasses will conform to the concave and convex surfaces and the mold, and therefore the contour of the eyeglass surface is controlled by the contour of the mold surface.

[0084] At least one of the annular treatment groove and adjustment region can be formed in the spectacle layer by milling, etching, or lasering the groove or region into the spectacle layer. The spectacle body having a rear surface can be formed first without (e.g.) the annular treatment groove and adjustment region being in a mold. After the annular treatment groove and adjustment region are formed, the rear surface of the spectacle body can form the rear surface of the spectacle. The spectacle body can have a substantially uniform radius of curvature across the rear surface. The radius of curvature across the entire rear surface can be equal to the radius of curvature of the correction region. The method then includes forming a second segment of the rear surface defining the annular treatment groove and / or a third segment of the rear surface defining the adjustment region, and removing portions of the spectacle body using milling, etching, or lasering. In this manner, after forming the spectacle body, portions of the spectacle body can be removed using milling, etching, or lasering to form the desired spectacle having the rear surface according to the present disclosure. This technique can be used to change the curvature of a segment or multiple segments of the rear surface of the spectacle body and thus create an annular treatment groove or adjustment region on the rear surface. The resulting spectacle will have the rear surface according to the present disclosure.

[0085] Alternatively or additionally, at least one of the annular treatment groove and the adjustment region can be formed in the lens layer using a mold. The surface of the mold may optionally define at least one of the following: a first segment defining the rear surface of the corrective region, a second segment defining the rear surface of the annular treatment groove, and a third segment defining the rear surface of the lens's adjustment region. The mold may define the corrective region of the lens, and the annular treatment groove and the adjustment region may be formed by another process disclosed herein (e.g., milling, etching, or laser). The mold may include one or more protrusions for defining at least one of the corrective region, the annular treatment groove, or the adjustment region. The shape and curvature of the protrusions will define the radius of curvature of the segment of the lens's rear surface defining the annular treatment groove or the adjustment region.

[0086] At least one of the annular treatment recess and adjustment area can be formed, either additionally or alternatively, by holding the eyeglasses in place while pressing an impression forming arm into the rear surface of the eyeglasses. This can be performed multiple times, with impression arms of different diameters used to form impressions of different sizes on the rear surface of the eyeglasses. The shape and curvature of the impression forming arm will define the radius of curvature of the segment of the rear surface of the eyeglasses that defines the annular treatment recess or adjustment area.

[0087] Those skilled in the art will understand that the order of steps set forth in the methods of the first aspect or any other aspect of this disclosure is not limited to the order presented.

[0088] According to a third aspect of this disclosure, there is a method for manufacturing orthokeratology contact lenses.

[0089] The eyeglasses include a rear surface with multiple segments, each segment having a radius of curvature, wherein a first segment defines the correction area of ​​the eyeglasses, a second segment defines the annular treatment groove of the eyeglasses, and a third radius segment defines the adjustment area of ​​the eyeglasses.

[0090] The method includes selecting the radius of curvature of each segment by:

[0091] i) Select the radius of curvature of the first segment, wherein the radius of curvature of the first segment is at least 6 mm.

[0092] ii) Select the radius of curvature of the second segment, wherein the radius of curvature of the second segment is smaller than the radius of curvature of the first segment; and

[0093] iii) Select the radius of curvature of the third segment, wherein the radius of curvature of the third segment is in the range of 4.5 mm to 15 mm; and,

[0094] iv) manufacture eyeglasses such that the rear surface has multiple segments having the radii of curvature selected in steps i), ii) and iii).

[0095] It should be understood that any feature of the first or second aspect of this disclosure may be combined with the third aspect of this disclosure. For example, the method according to the third aspect can be used to manufacture eyeglasses according to the first aspect. The corrective region, annular treatment groove, and adjustment region of the third aspect may have any features described relative to the first or second aspect of this disclosure. Furthermore, the method of the third aspect of this disclosure may include any feature of the second aspect of this disclosure. For example, the eyeglasses may be formed in a mold. At least one of the annular treatment groove and adjustment region may optionally be formed by milling.

[0096] A fourth aspect of this disclosure is a method for treating the progression of myopia, comprising providing eyeglasses according to this disclosure to a subject in need of them. It should be understood that the subject is a person with myopia and the method includes treating the person's myopia. The subject may be under 25 years of age. The subject may be under 20 years of age or under 15 years of age. The subject may be under 12 years of age. Orthokeratology eyeglasses according to this disclosure are particularly advantageous for treating myopia in children under 12 years of age. In children under 12 years of age, myopia is undeveloped and only mild, and therefore easily slowed or prevented from progressing or worsening. Use of orthokeratology eyeglasses according to this disclosure is particularly effective in preventing the development of myopia or at least slowing the progression of myopia in subjects with a family history of myopia (i.e., genetic predisposition).

[0097] Methods for treating myopia progression may include reshaping a subject's cornea by fitting eyeglasses according to this disclosure onto the subject's cornea. The method corrects myopia so that the subject has clear distance vision when the eyeglasses are removed from the eye. The method can induce myopic astigmatism in the peripheral region of the cornea, as described herein. For example, the method can induce myopic astigmatism of at least +1D, at least +1.5D, at least +2D, at least +4D, at least +6D, or at least +8D in the cornea. The radius of the corrected region of the cornea and the radius of the myopic astigmatic region of the cornea can be defined by the corrected region of the eyeglasses and the treatment groove, respectively. For example, the corrected region in eyeglasses with a diameter of about 3 mm can induce a correction of about 3 mm in diameter in the central portion of the cornea.

[0098] After being fitted to the subject's eye, the glasses can be worn for a period of time sufficient to reshape the cornea to conform to the shape of the glasses, or at least substantially conform to the shape of the glasses. For example, the glasses can be worn for at least 5 hours or at least 8 hours. The glasses are preferably worn overnight while the subject sleeps, allowing the cornea of ​​the eye to be reshaped when the subject does not need their vision. After the cornea has been reshaped to have a contour substantially identical to the posterior surface of the glasses, the glasses can be removed. The corneal reshaping can last for several hours, such as at least 5 hours, at least 8 hours, or at least 12 hours. Therefore, the subject's distance vision is enhanced compared to the eye's natural state (i.e., the subject's vision before treatment with the glasses). After the glasses are removed from the eye, no compressive force is applied to the cornea, and therefore the cornea will return to its natural state. The glasses can be worn again to reshape the cornea once more. Therefore, the subject can wear the glasses nightly and remove them during the day.

[0099] This disclosure attempts to control the location and refractive characteristics of myopic astigmatism generated in the peripheral portion of the cornea by corrective flattening of the central portion of the cornea. Alternatively, this disclosure attempts to control the size and curvature of the corrective central portion of the cornea. This can be achieved by using the annular treatment groove and accommodation area in the orthokeratology lenses described herein.

[0100] According to the present disclosure, orthokeratology contact lenses 201 ( Figure 2A This device is suitable for correcting and treating relatively high myopia (e.g., -4D myopia). The glasses 201 are configured to be worn on the cornea of ​​the eye (not shown). The glasses 201 include a posterior surface 202 and an anterior surface 204. A first segment of the posterior surface 202 defines a central correction region 206. The first segment of the posterior surface 202 defining the central correction region 206 has a radius of curvature smaller than that of the cornea. A second segment of the posterior surface 202 defines an annular treatment groove 208. The annular treatment groove 208 is defined by the second segment of the posterior surface having a radius of curvature smaller than that of the correction region 206. A third segment of the posterior surface 202 defines an accommodation region 210. The accommodation region 210 is defined by the third segment of the posterior surface having a radius of curvature smaller than that of the correction region 206 and smaller than that of the annular treatment groove 208. A mating region 212 is located at the periphery of the glasses. The mating region 212 helps to stabilize the glasses 201 to the eyes during use. The mating region 212 may have a continuous radius of curvature across its width, or it may have multiple radii of curvature across its width.

[0101] Glasses 201 include four concentric regions ( Figure 2BEach region is centered on the axis of the eyeglasses 201. The central portion of the eyeglasses 201 is the correction region 206. The annular treatment groove 208 extends radially outward from the periphery of the correction region 206. The adjustment region 210 is adjacent to the annular treatment groove 208. The outermost region of the eyeglasses 201 is the fitting region 212.

[0102] Orthokeratology contact lenses 301 ( Figure 3A This is suitable for correcting and treating relatively low myopia (e.g., -1D myopia). The glasses 301 are configured to be worn on the cornea of ​​the eye (not shown). The glasses 301 include a posterior surface 302 and an anterior surface 304. A first segment of the posterior surface 302 defines a central correction region 306. The first segment of the posterior surface 302 defining the correction region 306 has a radius of curvature smaller than that of the cornea to be treated (not shown). Because the glasses are suitable for treating relatively low myopia, the correction region 306 is comparable to... Figure 2A The correction area 206 shown is more curved or less flat. A second segment of the posterior surface 302 defines an annular treatment groove 308. The annular treatment groove 308 is defined by a second segment of the posterior surface 302 having a radius of curvature smaller than that of the correction area 306. A third segment of the posterior surface 302 defines an adjustment area 310. The adjustment area 310 is defined by a third segment of the posterior surface 302 of the eyeglasses 301 having a radius of curvature equal to that of the correction area 306 and greater than that of the annular treatment groove 308. Therefore, with... Figure 2A Compared to the glasses 201 shown in the article, Figure 3A The glasses 301 shown have a relatively flat adjustment area 310. A mating area 312 is located on the periphery of the glasses. The mating area 312 helps to stabilize the glasses 301 to the eyes during use. The mating area 312 may have a continuous radius of curvature across its width, or it may have multiple radii of curvature across its width.

[0103] Glasses 301 include four concentric regions ( Figure 3B Each region is centered on the axis of the eyeglasses 301. The central portion of the eyeglasses 301 is the correction region 306. The annular treatment groove 308 extends radially outward from the periphery of the correction region 306. The adjustment region 310 is adjacent to the annular treatment groove 308. The outermost region of the eyeglasses 301 is the fitting region 312.

[0104] In use, the orthokeratology contact lens 401 is placed on the cornea to be treated (414). Figure 4A(Only the uppermost surface of the cornea 414 is shown; it should be understood that the uppermost surface of the cornea includes the epithelial layer 416). The correction area 406 is aligned with the central portion of the cornea 414, which contains the apex of the surface of the cornea 414. The annular treatment recess 408 is aligned with the peripheral portion of the surface of the cornea 414. For simplicity, the adjustment area is not shown on the surface of the cornea. Figure 4A It is shown in the middle but positioned between the annular treatment groove 408 and the mating area 412. Figure 4A Different shades are used to indicate different areas of the glasses.

[0105] The structure of the corneal epithelium 416 of the cornea 414 means that the epithelium 416 of the cornea 414 is flexible and moldable. The structure and physiological function of the corneal epithelium allow its thickness to be altered by applying continuous pressure. Fluid and / or tissue (and other organic materials commonly found in the eye) of the corneal epithelium 416 can be redistributed from one region of the cornea 414 to another by applying pressure to the surface of the cornea 414. Because the radius of curvature of the correction area 406 of the spectacle 401 is smaller than the radius of curvature of the cornea 414 to be treated, the correction area 406 contacts at least a central portion of the cornea 414 and applies pressure or compressive force (such as by) to the apex of the cornea 414. Figure 4A (As indicated by the central vertical arrow in the image). This causes fluid and / or tissue of the corneal epithelium 416 to be forced into the peripheral portion of the cornea 414, as in... Figure 4A The image is shown by arrows radiating from the center of the cornea 414. The annular treatment recess 408 is aligned with the peripheral portion of the cornea 414 and provides space within the cornea 414 as cells / fluid redistribute from the central region of the cornea 414 to the peripheral portion.

[0106] The surface contour of corneal 414 before treatment (dashed line) differs from the surface contour of corneal 414 after treatment (thick line). Figure 4B Therefore, the redistribution of fluid and / or cells in the epithelial layer 416 of the cornea 414 can reduce or increase corneal curvature and thus optical power. The central portion of the cornea 414 aligned with the correction zone 406 has been flattened, or is less curved in the treated cornea 414 than before treatment. Because the central portion of the treated cornea 414 is less curved, the focal point of light reflected from distant objects will be centered on the retina rather than in front of it, thus correcting visual acuity. In contrast, the peripheral portion of the cornea 414 adjacent to the annular treatment notch 408 is an elevated portion or a portion of the treated cornea 414 that is more curved than before treatment. Because the peripheral portion of the cornea 414 is more curved than the central portion after treatment, a positive power is induced relative to the baseline power of the central portion. This added power or myopic defocus zone in the peripheral portion of the eyeglass is considered to slow or limit the progression of myopia.

[0107] Even when the glasses 401 are removed from the eye, the shape of the corrected cornea 414 is maintained. The shape of the cornea 414 will relax back to its uncorrected or pre-treatment state over time. When the shape of the cornea 414 returns to its uncorrected state to the point that it impairs distance vision, the glasses 410 can be placed back on the cornea 414 to reshape the contour of the cornea 414 once again.

[0108] According to this disclosure, the dimensions of the diameter, width, curvature, and shape of each of the spectacle correction area, the annular treatment groove, and the accommodation area can be adjusted to influence the induced surface profile in the treated cornea. For example, the diameter of the spectacle correction area will affect the diameter of the central portion of the flattened cornea. It is desirable to provide a standard diameter of the central portion of the flattened cornea among all myopic individuals treated with the spectacle according to this disclosure. This can be achieved by selecting the diameter of the spectacle correction area that will induce correction of the same diameter of the central portion of the cornea across all myopic individuals being treated; for example, the diameter of the central portion of the cornea corrected by the spectacle correction area may be about 3 mm. The diameter of the correction area can be selected depending on the degree of myopia to be treated. For example, spectacle for treating low myopia may have a correction area with a smaller diameter than the correction area for spectacle for treating higher myopia. However, the radius of curvature of the spectacle correction area will vary between spectacles depending on the degree of myopia being treated, as higher myopia requires greater flattening. Generally, the greater the amount of myopia to be corrected, the flatter the correction zone (i.e., the larger the radius of curvature of the correction zone). The annular treatment groove of the eyeglass always has a curvature greater than that of the central correction zone of the eyeglass to provide added power to the cornea. The width and shape of the radius of curvature of the annular treatment groove can be adjusted for each eyeglass based on the radius of curvature of the correction zone. Similarly, the function of the accommodative zone of the eyeglass also depends on the size of the correction zone, and therefore, the size of this zone will vary with the curvature of the correction zone or the amount of myopia to be corrected. As explained herein, the accommodative zone can be a groove for accommodating corneal volume during treatment, or alternatively, the accommodative zone can be a flatter, sloping area for reducing or promoting volume accommodating the peripheral portion of the cornea aligned with the annular treatment groove of the eyeglass. The greater the power difference between the correction zone and the annular treatment groove, the flatter the accommodative zone can be (i.e., the larger the radius of curvature of the accommodative zone). For example, the power difference between the accommodative zone and the annular treatment groove can be +1D, +1.5D, +2D, +2.5D, +3D, +3.5D, +4D, +4.5D, +5D, +5.5D, +6D, +6.5D, or +7D. It should be understood that the power difference refers to the difference in power induced in the central portion of the cornea aligned with the accommodative zone and the peripheral portion of the cornea aligned with the annular treatment groove. The accommodative zone has a radius of curvature such that sufficient epithelial fluid and / or tissue are distributed to the peripheral portion of the cornea to induce the desired myopic astigmatism. When the power difference between the accommodative zone and the annular treatment groove is large, the amount of epithelial tissue and / or fluid displaced through the accommodative zone may be insufficient, and therefore the amount of tissue and / or fluid directed toward the peripheral portion of the cornea is insufficient to induce the desired myopic astigmatism. Alternatively, virtually all transdisplaced fluid and / or tissue may need to be directed to the peripheral portion of the cornea aligned with the treatment recess, and therefore transdisplaced tissue and / or fluid movement toward the periphery of the cornea should be avoided.Therefore, when the power difference between the corrective area and the annular treatment groove of the eyeglass is large, a flatter accommodative area is expected to guide tissue and / or fluid toward the peripheral portion of the cornea aligned with the annular treatment groove. Conversely, when the power difference between the corrective area and the annular treatment groove is small, sufficient fluid and / or tissue can be guided to the peripheral portion of the cornea aligned with the annular treatment groove. In this case, the accommodative area is expected to be a groove for accommodating excess translocated fluid and / or tissue. Therefore, when the power difference between the corrective area and the annular treatment groove of the eyeglass is small, a more curved accommodative area (i.e., groove) is expected to guide tissue and / or fluid toward the peripheral portion of the cornea aligned with the annular treatment groove. It should be understood that "adjustment," "variation," or similar terms for the size of the area of ​​the eyeglass reference does not refer to changing the size of the eyeglass after its formation, but rather to the ability to design the eyeglass by selecting from a variety of sizes and then manufacture the eyeglass according to the selected size. Reference will now be made. Figures 5 to 8 The various adjustable sizes are described. Arrows in the figures indicate the movement of fluid and / or tissue within the cornea according to the contours of the correction zone, the annular treatment groove, and the accommodation zone. The following embodiments relate to eyeglasses suitable for inducing +2D myopic astigmatism in the peripheral portion of the cornea. It should be understood that eyeglasses according to this disclosure can be designed to induce myopic astigmatism less than or greater than +2D in the peripheral portion of the eyeglasses. The dimensions of the correction zone, the annular treatment groove, and the accommodation zone will be selected depending on the desired myopic astigmatism induced in the peripheral portion of the eyeglasses, as described herein.

[0109] Certain areas and contours of the eyeglasses 401 can be modified to induce specific optical contours in the cornea. Figure 5 ).for Figure 5 The left and right sides of the eyeglasses 401 illustrate different contours of the areas of the eyeglasses, but it should be understood that this only illustrates various dimensions of the modifiable areas. It should be understood that eyeglasses according to this disclosure may include areas of uniform size across all meridians of the eyeglasses. The diameter of the central corrective region 406 of the eyeglasses 401 may be made smaller or larger depending on the desired diameter of the central portion of the cornea 414 to be flattened. The curvature of the corrective region 406 may also be modified depending on the amount of myopia to be corrected. For example, a flatter or less curved central corrective region 406 may be effective for treating high myopia (e.g., -4.0D) and a more curved central corrective region 406 may be effective for treating low myopia (e.g., -1.0D). The shape of the central corrective region 406 may also be modified. For example, the central corrective region 406 may be symmetrical, or it may be asymmetrical. The shape of the corrective region 406 may be aspherical. An aspherical contour may particularly advantageously provide a more uniform contour across the central portion of the corrected cornea. In a similar manner, the annular treatment groove 408 and the adjustment area ( Figure 5The shape, diameter, and width (not shown) can also be modified. Furthermore, the dimensions of the mating region 412 can be modified to control the redistribution of fluid and / or tissue in the corneal epithelium 416. For example, the curvature of the mating region 412 can be made steeper or flatter. It should be understood that in Figure 5 In the lens 401, the left side has a steeper mating region 412 that is steeper than the corneal surface contour 414. The steeper mating region 412 pushes the side of the cornea 414 to move fluid toward the center of the cornea 414. The right side of the lens 401 exhibits a less steep mating region 412 than the cornea 414. The less steep mating region 412 allows the cornea 414 to expand laterally, and thus the fluid and / or tissue of the corneal epithelium 416 is redistributed away from the center of the cornea 414 toward the side of the cornea 414. The mating region 412 may include multiple areas, each with a different radius of curvature. Therefore, the pressure applied by this area of ​​the lens can be more precisely controlled.

[0110] The size of the annular treatment recess in the eyeglasses can be modified. (Reference) Figure 6 The width change of the annular treatment groove 408 is indicated on the left-hand side of the eyeglasses 401 (numbers are marked only on the left-hand side). The tilt or asphericity change of the annular treatment groove 408 is indicated on the right-hand side of the eyeglasses 401. The annular treatment groove 408 may tilt towards the central correction area 406, or it may tilt away from the central correction area 406. The tilt of the annular treatment groove 408 can be used to control the flow direction of tissue and / or fluid in the epithelial layer 416 of the cornea 414. For example, when the annular treatment groove 408 is tilted away from the central correction area 406, it can prevent the tissue and / or fluid in the epithelial layer 416 from moving towards the periphery of the cornea 414. This can be advantageously used to treat low myopia. Conversely, when the annular treatment groove 408 is tilted towards the central correction area 406, it can promote the movement of tissue and / or fluid in the epithelial layer 416 towards the periphery of the cornea 414. This can be advantageously used to treat high myopia.

[0111] Other dimensions of the annular treatment groove can also be adjusted. Figure 7 For simplicity, the accommodation area of ​​the glasses 401 is not shown. The curvature change of the annular treatment groove 408 (numbered only on the right-hand side) is indicated on the left-hand side of the glasses 401. The curvature of the annular treatment groove 408 affects the induced myopic astigmatism in the cornea 414. The smaller the radius of curvature of the annular treatment groove 408 (the more curved the annular treatment groove 408), the greater the increase in the curvature of the cornea 414 caused by the redistribution of fluid and / or tissue in the epithelial layer 416 accommodated within the annular treatment groove 408. The positional change of the annular treatment groove 408 is indicated on the right-hand side of the glasses 401. The position of the annular treatment groove 408 determines the position of the induced myopic astigmatism in the cornea 414.

[0112] The size of adjustment area 410 can also be adjusted. (Reference) Figure 8 The curvature and width changes of the accommodation region 410 (numbers are only marked on the right side) are indicated on the left side of the eyeglasses 401. The curvature of the accommodation region 410 affects the curvature of the cornea 414 in the area aligned with the accommodation region 410. The asphericity and tilt changes of the accommodation region 410 are indicated on the right side of the eyeglasses 401. Arrows indicate the movement of fluid and / or tissue within the epithelial layer 416 of the cornea 414. When the accommodation region 410 is concave, the movement of fluid and / or tissue within the cornea 414 is directed toward the accommodation region 410. When the accommodation region 410 is flatter, the movement of fluid and / or tissue within the cornea 414 is directed toward the annular treatment recess 408 ( Figure 8 (The dashed arrow in the image). The tilt of the adjustment area 410 can also affect the direction of fluid and / or tissue movement in the epithelial layer 416 of the cornea 414.

[0113] Method 500 for manufacturing eyeglasses according to this disclosure Figure 9 The method includes forming an eyeglass with a rear surface in a first step 501. This step may include forming an eyeglass body with a rear surface. The rear surface of the eyeglass body is then modified in subsequent steps to form the rear surface of the eyeglass according to the present disclosure. The method includes step 502: forming a correction region defined by a first segment of the rear surface. The method includes step 503: forming an annular treatment groove defined by a second segment of the rear surface. The method includes step 504: forming an adjustment region defined by a third segment of the rear surface. Steps 502 (forming the correction region), 503 (forming the annular treatment groove), and 504 (forming the adjustment region) may be performed simultaneously while forming the eyeglass or eyeglass body is in step 501. For example, the eyeglass may be formed in a mold that has been shaped to form a rear surface of the eyeglass having multiple curvatures, wherein a first segment of the rear surface has a curvature defining the correction region, a second segment of the rear surface has a curvature defining the annular treatment groove, and a third segment of the surface has a curvature defining the adjustment region. Alternatively, steps 502 (forming the correction region), 503 (forming the annular treatment groove), and 504 (forming the adjustment region) may be performed sequentially (and in any order). For example, the method may include forming the eyeglasses or eyeglass body in step 501 in the absence of at least one of the annular treatment groove or adjustment region. In this context, the rear surface of the eyeglasses or eyeglass body may have a radius of curvature equal to the radius of curvature of the correction region across substantially all of its surfaces. Step 503 (forming the annular treatment groove) or step 504 (forming the adjustment region) may then be performed by milling to correct a segment or multiple segments of the rear surface of the eyeglasses or eyeglass body, such that the segments have radii of curvature defining at least one of the annular treatment groove and adjustment region according to the present disclosure.

[0114] Method 600 for manufacturing eyeglasses according to this disclosure is shown. Figure 10 The eyeglasses have a rear surface comprising multiple segments, each segment having a radius of curvature. A first segment of the rear surface defines the correction area of ​​the eyeglasses, a second segment defines an annular treatment groove, and a third segment defines the adjustment area. The method includes step 601: selecting the radius of curvature of the first segment of the rear surface of the eyeglasses. The radius of curvature of the first segment is at least 6 mm. The method includes step 603: selecting the radius of curvature of the second segment of the rear surface of the eyeglasses. The radius of curvature of the second segment is smaller than that of the first segment. The method includes step 605: selecting the radius of curvature of the third segment of the rear surface of the eyeglasses. The radius of curvature of the third segment is in the range of 4.5 mm to 15 mm. The method 600 finally includes step 607: manufacturing the eyeglasses such that the rear surface comprises multiple segments having the radii of curvature selected in steps 601, 603, and 605.

[0115] Although this disclosure has been described and illustrated with reference to specific embodiments, those skilled in the art will understand that this disclosure itself leads to many different variations not specifically described herein.

[0116] Example

[0117] Exemplary orthokeratology lenses according to this disclosure will now be presented. The following examples relate to lenses suitable for inducing +2D myopic astigmatism in the peripheral portion of the cornea. It should be understood that lenses according to this disclosure can be designed to induce myopic astigmatism of less than or greater than +2D in the peripheral portion of the lens. The dimensions of the correction zone, the annular treatment groove, and the accommodation zone will be selected depending on the desired myopic astigmatism induced in the peripheral portion of the lens, as described herein.

[0118] Example 1 - Correction and Treatment of Low Myopia

[0119] In the first example, orthokeratology lenses were designed to fit individuals with low myopia who have a correction of -1.00D.

[0120] Assuming a nominal corneal power of 42D (8.03mm) and a refractive error of -1.00DS, the following parameters are calculated for each region of the eyeglasses according to Example 1.

[0121] Region 1 (Corrected Region): The basic visual zone radius (BOZR) required for the central corrected region = 42D (nominal corneal power) ±1.00 (correction for myopia) ±0.75 (Jason factor) = 40.25D. This is related to the radius of curvature of 8.39mm. The diameter of the central zone is selected as 3.36mm.

[0122] Region 2 (Annular Treatment Groove): To provide an additional 2.00D, Region 2 must have a curvature of 40.25D + 2D = 42.25D. This is related to a radius of curvature of 7.99mm. The width of Region 2 is selected to be 1.4mm.

[0123] Region 3 (Adjustment Region): The radius of curvature for Region 3 is set to 8.39 mm. The width of Region 3 is set to 1 mm.

[0124] Region 4 (Matching Region): 0.0mm to 0.9mm flatter than the BOZR in Region 1, i.e., 9.29mm. The width is 1.5mm.

[0125] Region 5 (Matching Region): 0.0mm to 0.9mm flatter than the BOZR in Region 1, i.e., 9.29mm. The width is 1.5mm.

[0126] The diameter and curvature of regions 4 and 5 (fitting regions) can vary with the corneal eccentricity. These regions are used to stabilize the eyeglasses on the cornea.

[0127] Region 6 (edge ​​lift) has a radius of 0.1 mm. The edge lift is the outermost part of the eyeglass that does not touch the cornea when the glasses are worn.

[0128] For correcting low myopia, less fluid and / or cellular tissue needs to be displaced from the central corrective region of the cornea compared to higher myopia, thus requiring less corneal flattening. In the eyeglasses according to Example 1, region 3 (accommodative region) has a radius of curvature greater than that of region 2 (annular therapeutic groove). Without being bound by theory, it can be assumed that region 3 can guide the displaced fluid and / or cells to the region of the cornea bounded by region 2. This can produce a greater positive curvature and a greater added power in the region of the cornea bounded by region 2. The power in the corneal region bounded by region 2 is desired to have an added power at least +2D greater than that in the region of the cornea bounded by the corrective region (region 1).

[0129] Example 2 - People with high myopia

[0130] In the second example, orthokeratology lenses were designed to correct and treat high myopia of -4.00D.

[0131] Assuming a nominal corneal power of 42D (8.03mm) and a refractive error of -4.00DS, the following parameters are calculated for each region of the eyeglasses according to Example 2.

[0132] Region 1 (Corrected Zone): The basic visual zone radius (BOZR) required for the central corrected zone = 42D (nominal corneal power) ± 4.00 (correction for myopia) ± 0.75 (Jason factor) = 37.25D. This is related to a radius of curvature of 9.06 mm (i.e., a larger radius of curvature for Region 1 than that required for the low myopia patient in Example 1). The diameter of the central corrected zone was selected as 3.36 mm.

[0133] Region 2 (Annular Treatment Groove): To provide an additional 2.00D, Region 2 must have a curvature of 37.25D + 2D = 39.25D. This is related to a radius of curvature of 8.6mm. The width of Region 2 is selected to be 1.4mm.

[0134] Region 3 (Adjustment Region): The radius of curvature of Region 3 is selected as 8.18 mm. The width of Region 3 is selected as 1 mm.

[0135] Region 4 (Matching Region): 0.0mm to 0.9mm flatter than the BOZR in Region 1, i.e., 9.96mm. The width is 1.5mm.

[0136] Region 5 (Matching Region): 0.0mm to 0.9mm flatter than the BOZR in Region 1, i.e., 9.96mm. The width is 1.5mm.

[0137] The diameter and curvature of regions 4 and 5 (fitting regions) can vary with the corneal eccentricity. These regions are used to stabilize the eyeglasses on the cornea.

[0138] Region 6 (edge ​​lift) has a radius of 0.1 mm. The edge lift is the outermost part of the eyeglass that does not touch the cornea when the glasses are worn.

[0139] To correct high myopia, more central corneal flattening must occur than in low myopia. This results in a larger volume of cells and / or tissue shifting from the central correction zone. This shift of cells and / or tissue to the peripheral corneal region typically results in a myopia treatment zone greater than +2D due to the need to accommodate a large volume of tissue and / or fluid within the inverted curvature. However, to control the diameter of the myopia treatment zone and limit the refractive shift to the desired range of +2D, region 3 (accommodation zone) has a steeper curvature than region 2 (annular treatment groove). Without being bound by theory, region 3 can be considered as a well or reservoir for excess tissue and / or fluid shifted through the correction zone (region 1) that cannot be accommodated by the annular treatment groove (region 2).

[0140] Although in this example the curvature of the annular treatment groove and adjustment area is modified to achieve the desired added power in the peripheral portion of the cornea, the diameter of the annular treatment groove and adjustment area may be modified, either additionally or alternatively, to control the amount of fluid and / or tissue contained in the peripheral portion of the cornea.

[0141] When references are made in the foregoing description to elements or components having known, obvious, or foreseeable equivalents, such equivalents are incorporated herein as individually stated. The true scope of this disclosure should be determined with reference to the claims, which should be construed as covering any such equivalents. The reader should also understand that integers or features of this disclosure described as preferred, advantageous, convenient, or similar are optional and do not limit the scope of the independent claims. Furthermore, it should be understood that while such optional elements or features may be advantageous in some embodiments of this disclosure, they may not be desired and therefore may not be present in other embodiments.

Claims

1. An orthokeratology contact lens for correcting and slowing the progression of myopia by reshaping a portion of the cornea in a myopic eye; The eyeglasses have a rear surface for contacting the portion of the cornea to be reshaped. The rear surface includes: A correction region for reducing the curvature of the central portion of the cornea, the correction region being defined by a first segment of the posterior surface having a radius of curvature; An annular treatment groove for inducing myopic astigmatism in the peripheral portion of the cornea, wherein the annular treatment groove extends radially outward from the periphery of the correction area and is defined by a second segment of the posterior surface having a radius of curvature smaller than that of the first segment, and wherein the radius of curvature of the second segment is such that the annular treatment groove is configured to induce at least +1 D of myopic astigmatism in the peripheral portion of the cornea and less than +12 D of myopic astigmatism in the peripheral portion of the cornea; and, An adjustment region for adjusting the myopic defocus induced by the annular treatment groove, wherein the adjustment region extends radially outward from the periphery of the annular treatment groove and is defined by a third segment of a rear surface having a radius of curvature. The orthokeratology contact lens mentioned above is based on (i) or (ii), wherein: (i) The radius of curvature of the first segment of the rear surface of the eyeglasses defining the correction area is in the range of 8.8 mm to 9.3 mm; and, The radius of curvature of the second segment of the rear surface of the eyeglasses defining the annular treatment groove is in the range of 8.3 mm to 8.8 mm, provided that the radius of curvature of the second segment is smaller than the radius of curvature of the first segment of the rear surface. The radius of curvature of the third segment of the rear surface of the eyeglasses defining the adjustment area is in the range of 7.9 mm to 8.4 mm, provided that the radius of curvature of the third segment is smaller than the radius of curvature of the first segment of the rear surface; and, The radius of curvature of the third segment of the rear surface is smaller than the radius of curvature of the second segment of the rear surface; (ii) The radius of curvature of the first segment of the rear surface of the eyeglasses defining the correction area is in the range of 8.0 mm to 8.5 mm; and, The radius of curvature of the second segment of the rear surface of the eyeglasses defining the annular treatment groove is in the range of 7.7 mm to 8.2 mm, provided that the radius of curvature of the second segment is smaller than the radius of curvature of the first segment; and, The radius of curvature of the third segment of the rear surface of the eyeglasses defining the adjustment area is in the range of 8.0 mm to 8.5 mm, wherein the radius of curvature of the third segment is greater than the radius of curvature of the second segment defining the annular treatment groove; and, The radius of curvature of the adjustment region is greater than the radius of curvature of the correction region.

2. The orthokeratology lens according to claim 1, wherein the corrective area has a diameter ranging from 1 mm to 8 mm.

3. The orthokeratology lens according to claim 1, wherein the corrective area has a diameter ranging from 2.5 mm to 5.5 mm.

4. The orthokeratology lens according to any of the preceding claims, wherein at least one of the annular treatment groove and the adjustment region has a width ranging from 0.5 mm to 5.5 mm.

5. The orthokeratology lens according to any one of claims 1 to 3, wherein at least one of the annular treatment groove and the adjustment region has a width ranging from 1 mm to 2 mm.

6. The orthokeratology lens according to any one of claims 1 to 3, wherein the correction area is defined by a first segment of the rear surface of the aspheric lens.

7. The orthokeratology lens according to any one of claims 1 to 3, wherein at least one of the second segment of the rear surface of the lens defining the annular treatment groove or the third segment of the rear surface of the lens defining the adjustment region has an asymmetrical profile.

8. The orthokeratology lens according to any one of claims 1 to 3, wherein the rear surface of the lens further includes a mating region for stabilizing the lens to the cornea, wherein the mating region extends radially outward from the periphery of the adjustment region.

9. A method of manufacturing an orthokeratology contact lens according to any one of claims 1 to 8, wherein the lens is used to correct and treat myopia by reshaping a portion of the cornea of ​​a myopic eye, wherein the method comprises forming the posterior surface of the lens by: The first segment forming the rear surface, wherein the first segment defines the correction area of ​​the eyeglasses and has a radius of curvature as defined in claim 1; A second segment is formed on the posterior surface extending radially outward from the periphery of the correction area, wherein the second segment defines the annular treatment groove and has a radius of curvature smaller than that of the first segment, and wherein the radius of curvature of the second segment is defined as claimed in claim 1 and such that the annular treatment groove is configured to induce myopic astigmatism of at least +1 D and less than +12 D in the peripheral portion of the cornea; and, A third segment is formed on the rear surface extending radially outward from the periphery of the annular treatment groove, wherein the third segment defines the adjustment region and has the radius of curvature as defined in claim 1.

10. The method of claim 9, wherein the method comprises first forming the eyeglasses without at least one of the annular treatment groove or the adjustment region, and then forming a second segment of the rear surface defining the annular treatment groove or a third segment of the rear surface defining the adjustment region by changing the curvature of a portion of the rear surface of the eyeglasses through milling.

11. The method of claim 9 or 10, wherein the method includes forming the eyeglasses in a mold, wherein the surface of the mold defines at least one of: a first segment defining the rear surface of the corrective region; a second segment defining the rear surface of the annular treatment groove; and a third segment defining the rear surface of the adjustment region of the eyeglasses.

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