Astigmatism correcting contact lens with smooth edge, spherical and / or aspherical geometric design

Abstract

The invention provides an axisymmetric soft contact lens with aspheric and / or spherical geometric design, which is used for correcting ametropia of eyes.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Application No. 63 / 588,645, filed October 6, 2023, and / or U.S. Application No. 63 / 560,974, filed March 4, 2024, and / or U.S. Application No. 63 / 574,027, filed April 3, 2024, which are incorporated herein by reference in their entirety. Background Technology

[0002] Refractive errors are common eye conditions that occur when the shape of the eye prevents light from focusing directly at the back of the eye, causing blurred vision and other symptoms. Refractive errors include astigmatism, myopia, and / or presbyopia. For individuals with one or more refractive errors, more specialized contact lenses with additional features and correction may be needed to correct these errors.

[0003] Astigmatism is a visual defect in the curvature of the eye that causes blurred vision at both near and far distances. Astigmatism occurs when the cornea or lens has a mismatched curvature (not a spherical curve, but rather a surface that varies in curvature like an egg). This results in blurred vision at all distances (normal, nearsighted, or farsighted vision).

[0004] These types of refractive errors can be corrected with eyeglasses, contact lenses, and / or surgery. People with astigmatic corneas may require a contact lens that corrects different refractive errors along at least two meridians. Furthermore, those with these types of refractive errors who use contact lenses can have many different spherical powers. The power along each meridian, the angle of a particular meridian, and / or the diameter at which the power difference occurs typically vary from person to person.

[0005] Due to the additional fitting standards, a large number of specialized contact lenses that meet the correction standards need to be manufactured and stored. Furthermore, fitting these specialized contact lenses may be more time-consuming than fitting regular contact lenses. Additionally, due to the complexity of refractive errors, current contact lenses may not be suitable for highly satisfactory correction of one or more refractive errors.

[0006] Current treatments for such corneal irregularities using soft contact lenses involve contact lenses with multiple base curves and features that allow for alignment and rotation to the wearer's specific astigmatic axis. Examples include structural elements such as prism weights and dynamic stabilizing elements. These lenses, often referred to as toric lenses, typically require multiple lenses to be manufactured for each optical power difference and angle between the meridions.

[0007] It is generally assumed that opposite meridians have similar curvature, and that a deviation of + / -5 degrees is usually not significant. Therefore, with a step size of 10 degrees, each combination of spherical (ranging from +6.0 D to -6.0 D in 0.25 D steps) and cylindrical power (typically 0.75 D to 2.5 D relative to the spherical) typically requires 18 lens steps to cover the various astigmatisms a patient may have. This results in the production of thousands of different lenses. Therefore, a solution is needed to minimize the number of different contact lenses that must be manufactured and stored.

[0008] To address this challenge, a lens for astigmatism correction was developed. Regardless of its rotation, the lens is designed to remain relatively flat along the flat meridians of the cornea and arch along steep meridians. Maintaining the spherical position of the soft contact lens above the aspherical cornea requires unobstructed fluid flow. While grooves can enhance fluid conductivity, considerations regarding geometry, base curve, transitions between base curves, contour, and the distribution and placement of grooves and openings are crucial for maintaining and improving the lens's comfort and functionality.

[0009] Therefore, solutions are needed to reduce the number of different contact lenses that need to be manufactured and stored, and to improve treatment options for patients with astigmatism or other optical aberrations. Summary of the Invention

[0010] This invention is based on clinical evidence demonstrating that two key elements are required to manufacture lenses that effectively cover astigmatism: fluid exchange and a suitable lens geometry. Certain geometries have been found to allow for optimal coverage, while others do not.

[0011] The lens requires at least one of two elements: a central portion that allows the lens structure to arch over certain parts of the cornea, and a peripheral portion that allows for good fluid exchange through the lens edge; fluid drains outward during blinking and flows inward between blinks. Furthermore, it has been found that combining the geometry with features that enhance fluid entry under the lens (e.g., openings) and / or grooves on the posterior surface that enhance fluid distribution under the lens can improve the lens's coverage performance.

[0012] This invention provides a soft contact lens for correcting refractive errors of the eye. One aspect of the invention includes: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; and wherein the soft contact lens is axially symmetric; wherein the soft continuous lens body has at least a central aspherical portion and a peripheral aspherical portion; wherein the central aspherical portion has a base curve of less than 9 mm at its center and less than 8 mm at its edge; and wherein the peripheral aspherical portion has a base curve of more than 8 mm at its proximal end and more than 8.5 mm at its distal end; wherein at least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and wherein at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0013] In another aspect, the present invention provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; and wherein the soft contact lens is axially symmetric; wherein the soft lens body has at least a central aspherical portion and a peripheral spherical portion; wherein the central aspherical portion has a base curve of less than 9 mm at its center and a base curve of less than 8 mm at its edge; and wherein the peripheral spherical portion has a base curve of greater than 8.5 mm; wherein at least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and wherein at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0014] In another aspect of the invention, a soft contact lens for correcting refractive errors of the eye is provided, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; wherein the soft lens body has at least a central spherical portion and a peripheral aspherical portion; wherein the base curve of the central spherical portion is less than 9 mm; and wherein the peripheral aspherical portion has a base curve greater than 8 mm at its proximal end and a base curve greater than 8.5 mm at its distal end; wherein at least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and wherein at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0015] In another aspect, the present invention provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; wherein the soft lens body has at least a central spherical portion and a peripheral spherical portion; wherein the base curve of the central spherical portion is less than 9 mm; and wherein the peripheral spherical portion has a base curve greater than 8.5 mm; wherein at least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and wherein at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0016] The present invention also provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; and wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; and wherein the soft contact lens is axially symmetric; wherein the soft continuous lens body has at least a central aspheric portion and a peripheral aspheric portion; The central aspherical portion has a base arc of less than 20 mm at its center and a base arc of less than 15 mm at its edge; and the peripheral aspherical portion has a base arc of more than 20 mm at its proximal end and a base arc of more than 5 mm at its distal end. At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0017] The present invention also provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; and wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; and wherein the soft contact lens is axially symmetric; wherein the soft lens body has at least a central aspherical portion and a peripheral spherical portion; The central aspherical portion has a base arc of less than 20 mm at its center and a base arc of less than 15 mm at its edge; and the peripheral spherical portion has a base arc of greater than 5 mm. At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0018] The present invention also provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; and wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; and wherein the soft lens body has at least a central spherical portion and a peripheral aspherical portion; The base arc of the central spherical portion is less than 20 mm; and the base arc of the peripheral aspherical portion is greater than 5 mm at its proximal end and greater than 5 mm at its distal end. At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0019] The present invention also provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body configured to cover the corneal surface of the eye, having an anterior surface and a posterior surface; and wherein the contact lens has a central thickness between about 80 micrometers and about 350 micrometers; and wherein the soft lens body has at least a central spherical portion and a peripheral spherical portion; The base arc of the central spherical portion is less than 20 mm; and the base arc of the peripheral spherical portion is greater than 5 mm. At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0020] The present invention also provides a lens for correcting refractive errors; wherein the lens has a lens body, the lens body having a lens surface and at least one discrete discontinuity within the surface; and wherein the at least one discrete discontinuity transitions on the lens surface through at least one transition radius; and wherein the at least one transition radius has a base curve greater than 1 mm. In some embodiments, the base curve is between about 1 mm and 4 mm. In other embodiments, the base curve is about 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4 mm.

[0021] As used herein, the terms “corner groove” and “smooth transition” are used interchangeably. Furthermore, “transition radius” and “rounded corner” as well as “radialized edge” are used interchangeably herein.

[0022] Features such as discrete discontinuities (e.g., grooves and openings) have edges that serve as transitions between the front or back surface of the lens and the discrete discontinuity. These edges have geometries that can affect lens function and / or comfort. To improve comfort when contacting the lens, such edges can be radiusd, which softens the transition from the lens surface to the feature geometry. Without radiusd edges, the feature may have sharp angles (e.g., apexes), which can irritate the eyelids and / or cornea. Radialized edges can distribute the pressure of the lens on the eye over a wider area and allow the lens to move or move over it, thus minimizing friction with the cornea and / or eyelids. These radiusd edges can be uniform along the entire edge of the discrete discontinuity or have one or more different radii along the edge of the discrete discontinuity (e.g., a larger radius along the vertical meridian relative to eyelid movement). These edges can have a radius of curvature that gradually changes along the length of the groove. These radiusd edges can facilitate improved fluid flow through the opening. These radiusd edges can facilitate fluid flow along the groove.

[0023] The angular edges can have a range from 1.0 mm to 4.0 mm or greater. In some cases, these radiusized edges can have a range from 0.5 mm to 8.0 mm or less. In some cases, these radiusized edges can have radii of curvature of 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm.

[0024] When fitting contact lenses, the number of base curves of the cornea should be considered. Contact lenses may also have several base curves to fit the cornea; one number reflecting the combination of base curves is the EBC (Equivalent Base Curve).

[0025] The equivalent base curve (EBC) refers to the concept of matching the base curve of a contact lens to the curvature of the cornea to ensure proper wear. This is crucial for comfort, visual quality, and eye health. The EBC reflects the equivalent value of all base curves in a single parameter. Lenses with several (more than one) base curves and lenses with their equivalent base curve (EBC) have the same sagitta from bottom to top, and therefore the same total curvature. The EBC value of a lens is calculated as follows: EBC = ((Rbc ＊ Abc) + (Rpc ＊ Apc)) / (Abc + Apc) Rbc = Center base arc radius (mm) Abc = Area of ​​the central base arc (%) Rpc = Radius of the peripheral base arc (mm) Apc = Peripheral base arc area (%) For example, a lens with the following variables has an calculated EBC of 8.57 [EBC = ((7.86)] ＊ 0.51) + (9.32 ＊ 0.49)) / (0.51+0.49)]

[0026]

[0027] In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is between about 8.3 mm and 8.8 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.3 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.8 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.4 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.5 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.6 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.7 mm. In some embodiments, the lens body has an equivalent base curve (EBC), wherein the EBC is about 8.8 mm.

[0028] When referring to "soft contact lenses," it should be understood to include thin lenses that are placed directly on the surface of the eye and are made of soft, flexible polymers, such as silicone, silicone hydrogels, and hydrogels. The Young's modulus of such flexible polymers is typically less than 5 mPa.

[0029] When referring to "a soft, continuous lens body configured to cover the corneal surface of the eye", it should be understood that the soft contact lens has a shape and form that covers the basic corneal surface of the eye and has a front surface (the surface of the lens that does not directly contact the surface of the eye) and a rear surface (the surface of the lens that at least partially contacts the surface of the eye).

[0030] When it is mentioned that the contact lens has a center thickness between about 80 micrometers and about 350 micrometers, it should be understood that the thickness of the lens may be uniform or non-uniform in portions and regions of the lens of the present invention. In some embodiments, the center thickness is at least about 80 micrometers. In some other embodiments, the center thickness is about 350 micrometers. In other embodiments, the center thickness is approximately 80, 85, 90, 95, 100, 110, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235, 240, 245, 250, 255, 260, 265, 270, 275, 280, 285, 290, 295, 300, 305, 310, 315, 320, 325, 330, 335, 340, 345, or 350 micrometers.

[0031] When referring to the soft lens body having at least a central portion and a peripheral portion, it should be understood to refer to a central portion of the lens beginning at the center of the lens, and an outermost peripheral portion surrounding the central portion and ending at the edge of the lens. In some embodiments, there may be an additional portion between the central and peripheral portions. In some embodiments, the central portion is aspherical (having a radius of curvature that varies from the center to the edge of the portion). In other embodiments, the central region is spherical (having a uniform radius of curvature from the center to the edge of the portion). In some embodiments, the peripheral portion is aspherical (having a radius of curvature that varies from the proximal to the distal end of the portion). In other embodiments, the peripheral region is spherical (having a uniform radius of curvature from the proximal to the distal end of the portion). In some embodiments, the central portion is aspherical and the peripheral portion is aspherical. In some embodiments, the central portion is aspherical and the peripheral portion is spherical. In some embodiments, the central portion is spherical and the peripheral portion is aspherical. In some embodiments, the central portion is spherical and the peripheral portion is spherical.

[0032] When referring to a "discrete discontinuity," it should be understood as a portion of the surface of the lens of the present invention having isolated and distinct gaps or truncated portions. In some embodiments, the discrete discontinuity may be selected from channels, openings, grooves, openings, slits, thin portions, or any combination thereof. In some embodiments, the discrete discontinuity is on the front surface of the lens of the present invention. In other embodiments, the discrete discontinuity is on the rear surface of the lens of the present invention. In a further embodiment, the discrete discontinuity is positioned from the front surface to the rear surface of the lens of the present invention. In other embodiments, the discrete discontinuity is positioned from the rear surface to the front surface of the lens of the present invention.

[0033] In some embodiments, the contact lens for correcting refractive errors may have a continuum. In some embodiments, the continuum does not have a joint (e.g., a hinge). In some embodiments, the continuum comprises a substantially uniform material, substantially uniform rigidity, substantially uniform tensile modulus, substantially uniform tensile stress, or substantially similar cross-sectional thickness at and near the transition, substantially uniform refractive index, or a combination thereof.

[0034] In some embodiments, a continuum refers to a lens having little or no difference in thickness, modulus, and / or rigidity at or near the transition. In some embodiments, a continuum refers to a substantially smooth surface along one or more axes or lines from the center of the lens to the periphery of the lens.

[0035] In some embodiments, the refractive error of the eye is selected from refractive errors of the eye, corneal irregularities, astigmatism, coma, second-order and higher-order aberrations of the eye, and any combination thereof.

[0036] In some implementations, the lens is not axially symmetric.

[0037] In some embodiments, the lens may be a single-curve lens, a double-curve lens, a triple-curve lens, or a multi-curve lens.

[0038] In some embodiments, the flexible lens body includes at least one discrete discontinuity selected from channels, openings, grooves, openings, slits, thin portions, or any combination thereof.

[0039] In some embodiments, the soft contact lens has a Young's modulus of <4 MPa.

[0040] In some embodiments, the refractive error is astigmatism. In some embodiments, the refractive error is an optical aberration of the cornea.

[0041] In some embodiments, the lens body has at least one discrete discontinuity, which is at least one opening passing between the front and rear surfaces.

[0042] In some embodiments, the soft lens body has a front surface, a rear surface, and at least one opening passing between the front and rear surfaces; in some embodiments, the at least one opening is located adjacent to the lacrimal meniscus of the eye.

[0043] In some embodiments, the at least one opening is configured to be positioned adjacent to the lacrimal meniscus to facilitate the flow of tears from there to the free volume, from the anterior surface of the lens body to the posterior surface of the lens body and to the free volume.

[0044] In some embodiments, the lacrimal meniscus is one or more of the superior and / or inferior lacrimal meniscus of the eye.

[0045] In some embodiments, at least one opening is configured to be positioned adjacent to the lacrimal meniscus to facilitate tear flow to the free volume when the lens body is applied to the corneal surface when the eyelids are open, regardless of the orientation of the lens body relative to the lacrimal meniscus.

[0046] In some embodiments, the at least one opening is configured to be positioned adjacent to the lacrimal meniscus to facilitate tear flow to the free volume.

[0047] In some embodiments, at least one opening is configured to be located adjacent to the tear duct meniscus at a distance of about 0.0 mm to about 4.0 mm. In some embodiments, at least one opening is configured to be located adjacent to the tear duct meniscus at a distance of about 0.0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4.0 mm.

[0048] In some embodiments, the at least one opening is located at a distance of approximately 3 mm to approximately 9 mm from the center of the lens body. In some embodiments, the at least one opening is located at approximately 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, or 5.7 mm from the center of the lens body. At the following points: 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, and 9.0 mm.

[0049] In some embodiments, the soft contact lens and / or lens body includes a plurality of openings.

[0050] In some implementations, multiple openings are evenly distributed around the center of the flexible lens body.

[0051] In some embodiments, the plurality of openings are non-uniformly distributed around the center of the soft lens body.

[0052] In some implementations, multiple openings are distributed circumferentially.

[0053] In some embodiments, the plurality of openings are radially distributed.

[0054] In some embodiments, the plurality of openings are spaced approximately 1 mm apart. In some embodiments, the plurality of openings are spaced > 1 mm apart.

[0055] In some embodiments, the plurality of openings are distributed along at least one meridian of the flexible lens body.

[0056] In some embodiments, the plurality of openings are radially distributed over a radius of about 3 mm to about 9 mm. In some embodiments, the plurality of openings are radially distributed over radii of about 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0 mm.

[0057] In some embodiments, the plurality of openings are located at a distance of approximately 3 mm to approximately 9 mm from the center of the soft lens body. In some embodiments, the plurality of openings are located at a distance of approximately 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, or 9.0 mm from the center of the soft lens body.

[0058] In some implementations, multiple openings are distributed along the length of the flexible lens body.

[0059] In some embodiments, the cross-sectional area of ​​the at least one opening is approximately 0.0001 mm. 2 Approximately 1mm 2 In some embodiments, the cross-sectional area of ​​the at least one opening is approximately 0.0001, 0.0005, 0.001, 0.0015, 0.002, 0.0025, 0.0030, 0.0035, 0.0040, 0.0045, 0.0050, 0.0055, 0.0060, 0.0065, 0.0070, 0.0075, 0.0080, 0.0085, 0.0090, 0.0095, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1.0 mm. 2 .

[0060] In some embodiments, the at least one opening has a circular cross-sectional area. In some embodiments, the at least one opening has an elliptical cross-sectional area. In some embodiments, a portion of the cross-sectional area of ​​the at least one opening is circular.

[0061] In some embodiments, the central portion extends from the center of the lens to a radius of approximately 3 mm to 9.0 mm. In some embodiments, the central portion extends from the center of the lens to a radius of approximately 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, or 9.0 mm.

[0062] In some embodiments, the peripheral portion extends from a radius of approximately 3 mm to 12.0 mm from the center of the lens. In some embodiments, the peripheral portion extends from a radius of approximately 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 10.5, 11.0, 11.5, or 12.0 mm from the center of the lens.

[0063] In some embodiments, at least one opening is located at a distance of about 3 mm to about 9.0 mm from the center of the lens body.

[0064] In some embodiments, the at least one opening may include a plurality of openings.

[0065] In some embodiments, the plurality of openings are circumferentially distributed.

[0066] In some embodiments, the plurality of openings are radially distributed.

[0067] In some embodiments, the plurality of openings are distributed along at least one meridian of the flexible lens body.

[0068] In some embodiments, the plurality of openings are distributed along two meridians of the soft lens body, wherein the angle between them is between 45 and 135 degrees.

[0069] This disclosure generally relates to eye vision and treatments for providing improved vision. While specific mention is made of coverings such as soft contact lenses for vision correction, embodiments of this disclosure may include additional uses and applications, such as correcting refractive errors of the eye, such as astigmatism.

[0070] In one aspect, this disclosure provides a soft contact lens for correcting refractive errors of the eye. In some embodiments, the soft contact lens includes a soft, continuous lens body configured to cover the corneal surface of the eye. In some embodiments, the soft, continuous lens body has a front surface, a rear surface, and at least one opening. In some embodiments, at least a portion of the rear surface of the soft, continuous lens body is configured to be suspended above the corneal surface when placed on it, thereby forming a free volume between the rear surface of the soft, continuous lens body and the corneal surface. In some embodiments, at least a portion of the free volume is configured to be filled with fluid to form a tear film lens on the corneal surface for correcting refractive errors of the eye.

[0071] In some embodiments, at least a portion of the soft continuous lens body is suspended higher above the corneal surface compared to another portion of the soft continuous lens body. In some embodiments, at least a portion of the soft continuous lens body is suspended above the corneal surface, while another portion of the soft continuous lens body is attached to the corneal surface.

[0072] The at least portion of the soft continuous lens body may include a first portion of the soft continuous lens body suspended above the corneal surface, and a different second portion suspended above the corneal surface that is higher, lower, or the same as the first portion of the soft continuous lens body.

[0073] In some embodiments, the flexible continuous lens body has a uniform Young's modulus. In some embodiments, the flexible continuous lens body has a Young's modulus of about 0.1 MPa to about 4 MPa.

[0074] In some embodiments, the refractive error originates from one or more of the following: corneal irregularities, first-order aberrations—spherical aberration, second-order aberrations of the eye—astigmatism, or higher-order aberrations—such as coma and cloverleaf aberration. In some embodiments, the refractive error is astigmatism of the eye.

[0075] In another aspect, this disclosure provides a soft contact lens for correcting astigmatism in the eye. In some embodiments, the soft contact lens includes a soft, continuous lens body configured to cover the corneal surface of the eye.

[0076] In some embodiments, the flexible continuous lens body has a front surface, a rear surface, and at least one opening.

[0077] In some embodiments, the soft continuous lens body has a uniform Young's modulus of about 0.1 MPa to about 4 MPa.

[0078] In some embodiments, at least a portion of the posterior surface of the soft continuous lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby creating a free volume between the posterior surface of the soft continuous lens body and the corneal surface.

[0079] In some implementations, at least a portion of the free volume is configured to be filled with fluid to form a tear lens on the corneal surface for correcting astigmatism of the eye.

[0080] In some embodiments, the anterior surface of the soft continuous lens body is axisymmetric. In some embodiments, the anterior surface includes an anterior curvature profile. In some embodiments, the anterior curvature profile is axisymmetric. In some embodiments, the posterior surface of the soft continuous lens body is axisymmetric. In some embodiments, the posterior surface includes a posterior curvature profile. In some embodiments, the posterior curvature profile is axisymmetric. In some embodiments, the soft continuous lens body also includes a lens volume. In some embodiments, the lens volume is axisymmetric. In some embodiments, when in a neutral state, the lens does not provide cylindrical power. In some embodiments, when placed on the lens, the lens corrects refractive errors or optical aberrations of the eye regardless of the lens's orientation relative to the eye's meridian. In some embodiments, the lens corrects refractive errors or optical aberrations of the eye without rotation to the eye. In some embodiments, the optical aberrations of the eye are first-order aberrations or spherical aberrations. In some embodiments, the optical aberrations of the eye are second-order aberrations or cylindrical aberrations. In some embodiments, the optical aberrations are third-order aberrations or coma.

[0081] In some embodiments, the lens is made of a single material. In some embodiments, the lens is made of a single material that consistently has the same mechanical properties. In some embodiments, the lens is made of a single polymer material. In some embodiments, the lens is made of hydrogel, silicone hydrogel, or silicone. In some embodiments, the lens is made of a single material selected from diacetone acrylamide, N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, methacrylic acid, methyl methacrylate, N-carboxyvinyl ester, N-vinylpyrrolidone, poly[dimethylsiloxane]bis[silylbutanol]bis[vinylcarbamate], phosphorylcholine, tris(trimethylsiloxy)silylpropyl vinylcarbamate, tris(hydroxymethyl)aminomethane, siloxane, or polyvinylpyrrolidone.

[0082] In some embodiments, the soft continuous lens body has a strength of approximately 1.25E+04 MPa. ＊ cubic micrometer (MPa) ＊ µm 3 (approximately 5.00E+08 MPa) ＊ µm 3 The rigidity range.

[0083] In some embodiments, the soft continuous lens body includes one or more optical regions and / or one or more non-optical regions. In some embodiments, each of the one or more optical regions is independently defined by the ratio between the radius of curvature at the rear surface and the radius of curvature at the front surface. In some embodiments, each of the one or more optical regions independently provides different optical powers to the eye. In some embodiments, the one or more optical regions are multiple optical regions. In some embodiments, the one or more optical regions are simultaneously visible or segmented. In some embodiments, the one or more simultaneously visible optical regions are either concentric (concentric circles with different curvatures) or aspherical (having varying curvature on the lens surface rather than a uniform spherical shape).

[0084] In some implementations, the lens is a bifocal or multifocal lens.

[0085] In some embodiments, the diameter of the one or more optical regions is from about 4 millimeters ("mm") to about 15 mm.

[0086] In some embodiments, the radius of curvature at the rear surface of the one or more optical regions is about 7 mm to about 9 mm. In some embodiments, the radius of curvature at the front surface of the one or more optical regions is about 5.5 mm to about 11.5 mm. In some embodiments, the ratio of the radii of curvature at the rear and front surfaces of the one or more optical regions is about 3:5 to about 2:1.

[0087] In some implementations, the soft continuous lens body has multiple base arcs between the central base arc and the peripheral base arcs.

[0088] In some embodiments, the radius of curvature at the rear surface of the central spherical portion is less than 9 mm. In some embodiments, the central spherical portion is divided into sections of approximately 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, and 9.0 mm. In some embodiments, the radius of curvature at the rear surface of the peripheral spherical portion is greater than 8.5 mm. In some embodiments, the peripheral spherical surface is divided into approximately 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11... 8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 20.0, 20.1, 20.2, 20.3, 2 0.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21.0, 21.1, 21.2, 21.3, 21.4, 21.5, 21.6, 21.7, 21.8, 21.9, 22.0mm.

[0089] In some embodiments, the peripheral spherical portion has a reverse base arc between 15.0 and 25 mm. In some embodiments, the peripheral spherical portion has diameters of 15.0, 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, and 17. 2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6, 18.7, 18.8, 18.9, 19.0, 19.1, 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8 19.9, 20.0, 20.1, 20.2, 20.3, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21.0, 21.1, 21.2, 21.3, 21.4, 21.5, 21.6, 21.7, 21.8, 21.9, 22.0, 22.1, 22.2, 22.3, 22.4, 22 0.5, 22.6, 22.7, 22.8, 22.9, 23.0, 23.1, 23.2, 23.3, 23.4, 23.5, 23.6, 23.7, 23.8, 23.9, 24.0, 24.1, 24.2, 24.3, 24.4, 24.5, 24.6, 24.7, 24.8, 24.9, and 25 mm of reverse base arc.

[0090] In some embodiments, the radius of curvature of the rear surface of the central aspherical portion is less than 9 mm at its center and has a base arc of less than 8 mm at its edge. In some embodiments, the central aspherical portion has a radius of curvature of approximately 9, 8.9, 8.8, 8.7, 8.6, 8.5, 8.4, 8.3, 8.2, 8.1, 8, 7.9, 7.8, 7, 7.6, 7.5, 7.4, 7.3, 7.2, 7.1, 7, 6.9, 6.8 mm at its center. In some embodiments, the central aspherical portion has a radius of curvature of approximately 8.0, 7.9, 7.8, 7, 7.6, 7.5, 7.4, 7.3, 7.2, 7.1, 7, 6.9, 6.8, 6.7, 6.6, 6.5, 6.4, 6.3 mm at its edge. In some embodiments, the central aspherical portion is divided into any combination of the central aspherical portion at its center and the central aspherical portion at its edge.

[0091] In some embodiments, the radius of curvature of the rear surface of the peripheral aspherical portion is greater than 8.0 mm at its proximal end and greater than 8.5 mm at its distal edge. In some embodiments, the radius of curvature of the peripheral aspherical portion at its proximal end is approximately 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, or 11. 7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 1 5.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6 ,18.7,18.8,18.9,19.0,19.1,19.2,19.3,19.4,19.5,19.6,19.7,19.8,19.9,20.0,20.1,20.2,20.3, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21.0, 21.1, 21.2, 21.3, 21.4, 21.5, 21.6, 21.7, 21.8, 21.9, 22.0mm.

[0092] In some embodiments, the peripheral aspherical portion has a distal end with approximate 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, or 11. 7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 1 5.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, 16.0, 16.1, 16.2, 16.3, 16.4, 16.5, 16.6, 16.7, 16.8, 16.9, 17.0, 17.1, 17.2, 17.3, 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 18.0, 18.1, 18.2, 18.3, 18.4, 18.5, 18.6 ,18.7,18.8,18.9,19.0,19.1,19.2,19.3,19.4,19.5,19.6,19.7,19.8,19.9,20.0,20.1,20.2,20.3, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 21.0, 21.1, 21.2, 21.3, 21.4, 21.5, 21.6, 21.7, 21.8, 21.9, 22.0mm.

[0093] In some implementations, the peripheral aspherical portion is divided into any combination of the peripheral aspherical portion at its proximal end and the peripheral aspherical portion at its distal end.

[0094] In some embodiments, the flexible continuous lens body has a uniform thickness throughout the optical region. In some embodiments, the flexible continuous lens body has a non-uniform thickness throughout the optical region. In some embodiments, the center thickness of the flexible continuous lens body in the optical region is from about 80 micrometers ("µm") to about 350 µm. In some embodiments, the flexible continuous lens body also includes an axisymmetric lens volume. In some embodiments, the flexible continuous lens body also includes a non-axisymmetric lens volume.

[0095] In some embodiments, the non-optical region begins at a distance of approximately 1.5 mm to approximately 14 mm from the center. In some embodiments, the diameter of the optical region is approximately 3 mm to approximately 12 mm.

[0096] In some embodiments, at least one opening is located in an optical region. In some embodiments, at least one opening is located in a non-optical region. In some embodiments, at least one opening is located in both an optical region and a non-optical region. In some embodiments, at least one opening is located on the front surface of the lens. In some embodiments, at least one opening is located on the rear surface of the lens. In some embodiments, at least one opening is located on both the front and rear surfaces. In some embodiments, the lens body further includes at least one of a channel, opening, groove, aperture, slit, thin portion, or any combination thereof. In some embodiments, the lens body further includes a channel. In some embodiments, the lens body further includes a channel further configured to allow fluid to flow in and out of the free volume. In some embodiments, the lens body further includes a groove. In some embodiments, the lens body further includes a groove further configured to reduce mechanical deformation of the continuous lens body. In some embodiments, the lens body further includes an opening. In some embodiments, the lens body further includes an opening further configured to allow fluid to flow in and out of the free volume. In some embodiments, the opening is configured to indirectly allow fluid to flow in and out of the free volume via a channel connection. In some embodiments, at least a portion of the flexible continuous lens body is configured to conform to the corneal surface of the eye, forming a deformation of the continuous lens body. In some embodiments, the lens body is further configured to substantially prevent deformation from being transmitted to the non-conforming portions of the flexible continuous lens body.

[0097] In some implementations, the lens has no protrusions extending from the rear surface.

[0098] In some implementations, the diameter of the lens is from about 8 mm to about 17 mm.

[0099] In some embodiments, the free volume between the posterior surface of the soft continuous lens body and the corneal surface has a total volume of about 0.001 microliters ("µL") to 10µL.

[0100] In some embodiments, when the continuous lens body is disposed on the corneal surface, at least one sector from the center of the soft continuous lens body to its peripheral edge is configured to be suspended above the corneal surface to form at least a portion of the free volume. In some embodiments, when the continuous lens body is disposed on the corneal surface, any one of the at least one sector of the soft continuous lens body is capable of being suspended above the corneal surface to form at least a portion of the free volume.

[0101] On the other hand, this disclosure provides a method for correcting refractive errors of the eye using the soft contact lenses of this disclosure.

[0102] In another aspect, this disclosure provides a method for forming a tear lens using the soft contact lens of this disclosure. In some embodiments, applying the soft contact lens of this disclosure to the eye results in the formation of a tear lens with an asymmetrical volume distribution. In some embodiments, the asymmetrical volume distribution corrects for one or more of corneal irregularities, coma, astigmatism, or higher-order aberrations of the eye. In some embodiments, in the asymmetrical volume distribution, the volume of a first tear lens sector differs from the volume of a second tear lens sector that is opposite in diameter to or adjacent to the first tear lens sector. In some embodiments, the difference in volume between the first and second tear lens sectors corrects for coma of the eye.

[0103] The soft contact lenses described herein offer an advantage over many commercially available toric contact lenses that cover astigmatism and coma. While such toric lenses can provide different refractive powers between meridians, they may not provide different refractive powers within the same meridian. In contrast, the soft contact lenses described herein can have multiple sectors, each with a different tear lens volume beneath it, and each sector, combined with the tear lens portion directly behind it, can provide different refractive powers. As further discussed, the soft contact lenses described herein can cover astigmatism and coma independently of rotational orientation, whereas such toric lenses require a specific rotational orientation to cover astigmatism.

[0104] In another aspect, this disclosure provides a method for correcting refractive errors of the eye, comprising the steps of: providing optical correction to the subject's eye through an optical region of a soft contact lens and a free volume between the posterior surface of the lens and the corneal surface when positioned on the eye. In some embodiments, at least one discontinuity of the soft contact lens allows tear fluid to flow into the free volume to form a tear lens over the ocular abnormality, thereby correcting the refractive error of the eye.

[0105] In another aspect, this disclosure provides a method for forming a tear lens, comprising the steps of: applying a soft contact lens having a continuum to the eye to form a free volume between the posterior surface of the continuum and the corneal surface of the eye. In some embodiments, at least one discontinuity of the soft contact lens allows tear fluid to flow into the free volume to form a tear lens over an ocular abnormality, thereby correcting the refractive error of the eye.

[0106] In some implementations, the soft contact lens is applied to the eye in any orientation, such that the lens corrects the eye’s refractive error, regardless of the lens’s orientation relative to the eye’s meridian.

[0107] In some embodiments, the soft contact lens has a pressure of approximately 1.25E+04 mPa. ＊ µm 3 Approximately 5.00E+08 mPa ＊ µm 3 The rigidity range.

[0108] In some implementations, the refractive error originates from one or more of corneal irregularities, coma, astigmatism, or higher-order aberrations of the eye.

[0109] In some implementations, refractive error is astigmatism of the eye.

[0110] In some implementations, the front and / or rear surfaces of the lens are axially symmetric.

[0111] In some implementations, the optical region of the lens has a uniform thickness.

[0112] In some implementations, the optical region of the lens has a non-uniform thickness.

[0113] In some implementations, the soft contact lens is made of a single material.

[0114] Additional aspects and advantages of this disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. As will be appreciated, the disclosure is capable of other and different embodiments, and certain details thereof can be modified in various obvious ways without departing from the disclosure. Therefore, the drawings and descriptions should be considered illustrative in nature and not restrictive. Attached Figure Description

[0115] The subject matter considered to be of the present invention is particularly pointed out and explicitly claimed in the concluding section of the specification. However, the present invention, with regard to its organization and operation methods, as well as its objects, features, and advantages, can be best understood by referring to the following detailed description taken in conjunction with the accompanying drawings, wherein: Figure 1 Cylindrical correction (cylindrical masking, paired N= [6]) of the two lenses compared in Example 5 is shown.

[0116] Figure 2 The comfort scores (comfort, pair N = [6]) of the two lenses compared in Example 5 are shown.

[0117] Figure 3A and 3B The aspherical (3A) and spherical (3B) lens designs of the present invention are shown.

[0118] Figure 4A and4B The performance and comfort of the aspherical (4A) and spherical (4B) lenses of the present invention are shown.

[0119] Figure 5 The comfort level of each lens described in Table 2 of Example 8 is shown.

[0120] Figure 6 The reduction in cylindrical area for each lens described in Table 2 of Example 8 is shown.

[0121] Figure 7 The effect of EBC on the comfort and instability of the lens of the present invention is shown.

[0122] It should be understood that, for the sake of simplicity and clarity, the elements shown in the accompanying drawings are not necessarily drawn to scale. For example, the dimensions of some elements may be enlarged relative to others for clarity. Furthermore, reference numerals may be repeated in the drawings where deemed appropriate to indicate corresponding or similar elements. Detailed Implementation

[0123] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the invention. However, those skilled in the art will understand that the invention can be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the invention.

[0124] In the following detailed description, reference is made to the accompanying drawings, which form a part thereof. In the drawings, like symbols generally denote like components unless the context otherwise requires. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the scope of the subject matter presented herein. It will be readily understood that aspects of this disclosure, as illustrated in the general description and drawings herein, can be arranged, substituted, combined, separated, and designed in a variety of different configurations, all of which are expressly contemplated herein.

[0125] Although certain embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the appended claims is not limited to any particular embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process can be performed in any suitable order and are not necessarily limited to any particular order of disclosure. Various operations may be described sequentially as a plurality of discrete operations, which aids in understanding certain embodiments; however, the order of description should not be construed as implying that these operations are sequentially related. Furthermore, the structures, systems, and / or devices described herein may be embodied as integrated components or separate components.

[0126] For the purpose of comparing the various implementations, certain aspects and advantages of these implementations have been described. Not all of these aspects or advantages can necessarily be achieved by any particular implementation. Thus, for example, various implementations may be carried out in a manner that achieves or optimizes one or more advantages taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0127] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. As used herein, the singular forms “a,” “an,” and “described” include plural references unless the context clearly indicates otherwise. Unless otherwise stated, any reference to “or” herein is intended to cover “and / or.” It will be further understood that, when used in this specification, the terms “comprising” and / or “including” specify the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated to “ / ”.

[0128] Spatial relative terms such as “below,” “under,” “lower,” “above,” and “upper” are used herein for convenience in describing the relationship of one element or feature to another, as illustrated in the figures. It will be understood that spatial relative terms are intended to cover different orientations of the device in use or operation, other than those shown in the figures. For example, if the device in the figures were flipped, an element described as “below” or “under” other elements or features would be oriented as “above” other elements or features. Thus, the exemplary term “below” can cover both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Similarly, unless otherwise specified, the terms “up,” “down,” “vertical,” “horizontal,” etc., used herein are for illustrative purposes only.

[0129] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element, without departing from the teachings of this disclosure.

[0130] Throughout this specification and the appended claims, unless the context otherwise requires, the word “comprising” and its variations such as “including” and “comprise” mean that various components may be used together in a method and article of manufacture (e.g., a composition and apparatus that includes a device and a method). For example, the term “comprising” will be understood to imply the inclusion of any stated element or step, but does not exclude any other element or step.

[0131] Whenever the terms "at least," "greater than," or "greater than or equal to" precede the first value in a series of two or more values, the terms "at least," "greater than," or "greater than or equal to" apply to each value in the series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0132] Whenever the terms “not more than,” “less than,” “less than or equal to,” or “at most” precede the first value in a series of two or more values, the terms “not more than,” “less than,” “less than or equal to,” or “at most” apply to each value in the series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0133] When a numerical value is described as a range, it will be understood that such disclosure includes disclosures of all possible subranges within that range, as well as specific numerical values ​​that fall within that range, whether or not a specific numerical value or a specific subrange is explicitly stated.

[0134] As used herein in the specification and claims, including in the examples, and unless expressly stated otherwise, all figures may be interpreted as if prefixed with the words “about” or “approximately,” even if the term is not explicitly stated. When describing size and / or location, the phrase “about” or “approximately” may be used to indicate that the described value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have values ​​of + / - 0.1%, + / - 1%, + / - 2%, + / - 5%, + / - 10%, etc., of the stated value (or range of values). Any numerical value given herein should also be understood to include about or approximately that value, unless the context otherwise indicates. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range described herein is intended to include all subranges contained therein. It is also understood that when a value is disclosed as “less than or equal to”, “greater than or equal to” and possible ranges between values ​​are also disclosed, as would be appropriately understood by one of skill in the art. For example, if the value “X” is disclosed, then “less than or equal to X” and “greater than or equal to X” (e.g., where X is a numerical value) are also disclosed. It is also understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and start points, as well as a range of any combination of data points. For example, if specific data point “10” and specific data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, equal to 10 and 15 are considered disclosed, as are the values ​​between 10 and 15. It is also understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0135] Many features of this disclosure are described in relation to the anatomy of a subject's eye. The eye comprises several tissues that allow the subject to see. The subject can be an animal. The subject can be a human, such as a patient. The cornea is the anterior region of the eye, transparent in a healthy eye, and refracts light to form an image on the retina. The retina is the posterior region of the eye, sensing the light on which the image is formed and transmitting signals from the image to the brain. The cornea comprises the outer layer of tissue, the epithelium, which protects the underlying tissues of the cornea, such as Bowman's membrane, the stroma, and nerve fibers extending into the stroma and Bowman's membrane. A healthy eye includes a tear film set on the epithelium. The tear film smooths out minute irregularities in the epithelium to provide an optically smooth surface. The tear film is essentially shaped by the underlying epithelium, stroma, and Bowman's membrane (if present). The tear film contains fluid, primarily water, but also includes additional components such as mucins and lipids. Numerous nerve fibers in the cornea provide sensation to facilitate blinking, which can be achieved by covering the cornea with the tear film. The nerve fibers also sense pain, which causes subjects to generally avoid trauma to the cornea and to avoid direct contact between objects and the cornea.

[0136] The embodiments described herein can be used to treat the eye using one or more covers in various ways. The covers may include contact lenses. The covers may be soft contact lenses. The covers and / or contact lenses may be able to mask astigmatism and can be used to treat astigmatism. Such contact lenses may include one or more contact lenses that mask astigmatism. Contact lenses may be available in various versions. The covers may include one or more soft lenses that can be worn normally. In some cases, contact lenses may be used for long-term vision correction and extended wear. Contact lenses may be used to treat astigmatism. In other examples, covers and / or contact lenses may be used in combination after surgery or to improve outcomes and / or recovery.

[0137] Unlike toric soft contact lenses, which require stabilization to position the corrective cylinder on the proper axis, the lenses of this disclosure typically do not require stabilization. Therefore, the lenses of this disclosure may not have mechanisms for stabilizing the rotation of the lens to a specific cylinder of the eye. Furthermore, the lenses of this disclosure may not have orientation features or markings for stabilizing the rotation of the lens to a specific cylinder of the eye (e.g., non-color markings within or on the contact lens body, one or more truncations at the peripheral edge of the contact lens body, asymmetrical shapes of the contact lens body, etc.). For example, the lenses of this disclosure may not include prism weight (thickness differences on the lens profile that determine the rotational orientation of the lens) or peripheral weight (i.e., flange weight). Additionally, the lenses of this disclosure may not have non-prism weight features, such as thin zones, double-strip-off, or dynamic stabilization.

[0138] In some implementations, soft contact lenses can correct or cover refractive errors of the eye. Refractive errors may include one or more of corneal irregularities, coma, astigmatism, or higher-order aberrations of the eye.

[0139] In some embodiments, the soft contact lens can correct (i.e., mask) the refractive error or aberration of the eye by at least about 20%, 30%, 40%, 50%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or more. In some embodiments, the optical aberration of the eye is a first-order aberration or spherical aberration. In some embodiments, the optical aberration of the eye is a second-order aberration or cylindrical aberration. In some embodiments, the optical aberration is a third-order aberration or coma.

[0140] In some implementations, soft contact lenses can correct (i.e., mask) astigmatism by at least about 20%, 30%, 40%, 50%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or more. For example, soft contact lenses can mask astigmatism up to 1D. In some examples, soft contact lenses can also mask astigmatism up to 2D. In other examples, soft contact lenses can also mask astigmatism up to 3D. Soft contact lenses can mask astigmatism by an amount within the range defined by any two of the foregoing values.

[0141] In some cases, correcting refractive errors or aberrations of the eye includes covering a diameter of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, or larger on the corneal surface. In some examples, covering refractive errors or aberrations of the eye includes covering a diameter of approximately 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or smaller on the corneal surface. The refractive error or aberration of the eye can have an area within the range defined by any two of the foregoing values. For example, the refractive error or aberration of the eye can have an area between approximately 9 mm and approximately 8 mm of the central diameter of the cornea.

[0142] In some cases, astigmatism correction includes covering a diameter of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, or larger on the corneal surface. In some examples, covering astigmatism includes covering a diameter of approximately 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or smaller on the corneal surface. The astigmatic area can be within the range defined by any two of the foregoing values. For example, the astigmatic area can be between approximately 9 mm and approximately 8 mm in diameter at the center of the cornea.

[0143] In some cases, compared to soft toric contact lenses or other conventional contact lenses, soft contact lenses can reduce SKU demand by at least approximately 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 99%, or more. In other cases, compared to soft toric contact lenses or other conventional contact lenses, soft contact lenses can reduce SKU demand by up to approximately 99%, 95%, 90%, 80%, 70%, 60%, 50%, or less. For example, the soft contact lenses described herein can reduce SKU demand by up to approximately 95%. Contact lenses can reduce SKU demand by an amount within the range defined by any two of the foregoing values.

[0144] In some implementations, soft contact lenses can also reduce the fitting or appointment time required with eye care professionals, or the number of appointments until the final lens fitting is determined.

[0145] Example 1: Comparison of lenses with BC of 8.06 and BC of 7.86. The J1 lens with a central BC of 7.86mm is compared with the J1 lens with a central BC of 8.06mm (central thickness 300um, transitioning to peripheral BC at R=5.2mm, peripheral BC=9.32).

[0146] The comparison results were in comfort, function, and visual acuity (VA). Lenses with a center curve of 7.86mm were found to have better correction and better comfort (center thickness 300µm, peripheral).

[0147] Table 1:

[0148] Example 2: Aspheric lenses with a central aspheric design (central BC from 9.05 to 8.0, central thickness = 300u and 250u) and a relatively steep peripheral aspheric surface (BC 8.1-8.5mm) were made of silicone hydrogel. The lenses were tested on 10 subjects (250u) and N=8 (300u). Both groups showed an average cylindrical correction of less than 0.25 diopters and an average comfort score of 7.8 (out of 10) – thus finding this geometry to be both non-functional and uncomfortable.

[0149] Example 3: Aspheric lenses with a peripheral aspheric curvature of 8.1-8.5 (relatively steep) and a central aspheric curvature ranging from flat to steep (8.55 -> 7.35, average 7.85, similar to corneal curvature) failed to correct the cylindrical surface.

[0150] Example 4: Hydrogel, featureless lens, flat periphery—works and demonstrates that a flat periphery can contact fluids. A lens made of hydrogel with a center thickness of 200u, a spherical center curve of 8.6mm, and a peripheral inverse base curve of 19.8mm was tested in 5 subjects, showing an average cylindrical correction of 0.62 diopters and a comfort score of 9.7 (out of 1-10)—the flat periphery can contact fluids.

[0151] Example 5: Two designs were compared among 6 participants. Figure 1 and Figure 21. An aspherical lens having an aspherical central design (central curve 9.05->8.0mm, central thickness = 300u) and a relatively steep aspherical periphery of 8.1->8.5mm. 2. An aspherical lens having an aspherical central design (central curve 9.05->8.0mm, central thickness = 300u) and a relatively flat aspherical periphery of 8.8->9.2mm. Lens 2 performs well, better covers astigmatism, and is more comfortable. The average cylindrical correction is -0.87 diopters, and the comfort rating is 9.3 (out of 1-10) – the flat periphery of 8.8->9.2mm allows for fluid contact, and it is functional and comfortable.

[0152] Table 2: Summary of Experiments 3-5

[0153] Example 6: The effect of sphericity on performance. Two designs with identical materials, fabrication, characteristics, and EBC (equivalent base sphere) were compared in 5 subjects (designs as follows). Figure 3A and 3B (As shown): Lens 1. An aspherical lens having an aspherical center design (center curve 9.05->8.0mm, center thickness = 300u) and an aspherical periphery of 8.5->8.0mm. Lens 2. An aspherical lens having a spherical center design (center curve 8.05mm, center thickness = 300u) and a spherical periphery of 9.32mm. The average cylindrical correction of the aspherical design is -0.6 diopters, and that of the spherical design is -0.96 diopters. Both designs have a comfort rating of 8.9 (out of 1-10) – the spherical design is functionally superior to the aspherical design, while the comfort is the same. Figure 4A and 4B ).

[0154] Example 7: The effect of circumferential rounded corners at a radius of 5.2 mm (transition to the peripheral curve). 74 subjects wearing corrective astigmatism lenses with the smallest transition rounded corner (0.2 mm base curve, direction opposite to the lens curve) were compared to 32 subjects wearing lenses of the same design but with a smoother transition (30 mm base curve, direction opposite to the lens curve). The mean comfort score for the 0.2 mm rounded corner was 8 (on a comfort scale of 1-10), while the mean comfort score for the 30.0 mm rounded corner was 9.2. In a paired retrospective comparison (with only 22 subjects who had worn both 0.2 mm and 30 mm rounded corners), the mean comfort score for the 0.2 mm rounded corner was 8.2 (on a comfort scale of 1-10), while the mean comfort score for the 30.0 mm rounded corner was 9.1.

[0155] Example 8:Five subjects were examined to evaluate the comfort and effectiveness of astigmatism-correcting contact lenses with different designs. The lenses examined were: a control lens with radial angular grooves (to evaluate radial and circumferential effects), a control lens with circumferential annular grooves (to evaluate radial and circumferential effects and serve as a control for the circumferential direction with a radiusization transition), and three lenses with different levels of radiusization transition: narrow, medium, and wide. The results are summarized in Table 2 below. Figure 5 and Figure 6 The comfort level is shown for each lens described in Table 2 below. Figure 5 ) and reduction in cylinder area ( Figure 6 ).

[0156] Table 2: Lenses of Example 8

[0157] Conclusion: Circumferential contact lenses with a radius transition exhibit better tolerance. A radius transition greater than 3.5mm does not appear to add further comfort due to effect saturation. The optimal point between comfort and function is approximately 3.5mm.

[0158] Example 9: Instability Experiment. Nineteen eyes from nineteen subjects with astigmatism (range -0.75D to -1.75D) were examined to investigate the effect of EBC (mean curvature of the lens) on cylindrical corrective performance, comfort, and stability (stability defined as no immediate improvement or deterioration of visual acuity after blinking). Contact lenses made of silicone hydrogel were manufactured. All manufactured lenses had a center thickness of 300u and a diameter of 14.5mm. The lenses had different curvatures, with an EBC base curve ranging from 7.98 to 8.85mm. EBC was modified by altering the transition point between the central and peripheral curvatures (the central curvature being steeper than the peripheral curvature).

[0159] Instability exceeding 20% ​​was defined as unstable. The cylindrical correction range was -0.75D to -0.92D, with no significant difference between different EBCs, and all EBCs had a comfort score of 8 or higher (1-10). Figure 7 The effect of EBC on the comfort and instability of the lens of the present invention is shown.

[0160] Conclusion: The results indicate that when the EBC changes from a geometrical match between the lens and cornea to a "flat mismatch" or a "steep mismatch," a mismatch volume is formed and becomes susceptible to blinking. The optimal EBC range was found to be 8.41 to 8.7 mm.

[0161] Although certain features of the invention have been described and illustrated herein, many modifications, substitutions, alterations, and equivalents will now occur to those skilled in the art. Therefore, it should be understood that the appended claims are intended to cover all such modifications and alterations that fall within the true spirit and scope of the invention.

Claims

1. A soft contact lens for correcting refractive errors of the eye, comprising: A soft, continuous lens body, configured to cover the corneal surface of the eye, having an anterior and a posterior surface; and The contact lens has a center thickness between about 80 micrometers and about 350 micrometers; and The soft contact lens described therein is axially symmetric; The soft continuous lens body described therein has at least a central aspherical portion and a peripheral aspherical portion; The central aspherical portion has a base arc of less than 9 mm at its center and a base arc of less than 8 mm at its edge; and The peripheral aspherical portion has a base arc greater than 8 mm at its proximal end and a base arc greater than 8.5 mm at its distal end; At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

2. A soft contact lens for correcting refractive errors of the eye, comprising: A soft, continuous lens body, configured to cover the corneal surface of the eye, having an anterior and a posterior surface; and The contact lens has a center thickness between about 80 micrometers and about 350 micrometers; and The soft contact lens described therein is axially symmetric; The soft lens body described therein has at least a central aspherical portion and a peripheral spherical portion; The central aspherical portion has a base arc of less than 9 mm at its center and a base arc of less than 8 mm at its edge; and The peripheral spherical portion has a base arc greater than 8.5 mm; At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

3. A soft contact lens for correcting refractive errors of the eye, comprising: A soft, continuous lens body, configured to cover the corneal surface of the eye, having an anterior and a posterior surface; and The contact lens has a center thickness between about 80 micrometers and about 350 micrometers; and The soft contact lens described therein is axially symmetric; The soft lens body described therein has at least a central spherical portion and a peripheral aspherical portion; The base arc of the central spherical portion is less than 9 mm; and The peripheral aspherical portion has a base arc greater than 8 mm at its proximal end and a base arc greater than 8.5 mm at its distal end; At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

4. A soft contact lens for correcting refractive errors of the eye, comprising: A soft, continuous lens body, configured to cover the corneal surface of the eye, having an anterior and a posterior surface; and The contact lens has a center thickness between about 80 micrometers and about 350 micrometers; and The soft contact lens described therein is axially symmetric; The soft lens body described therein has at least a central spherical portion and a peripheral spherical portion; The base arc of the central spherical portion is less than 9 mm; and The peripheral spherical portion has a base arc greater than 9 mm; At least a portion of the posterior surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, thereby forming a free volume between the posterior surface of the soft lens body and the corneal surface; and at least a portion of the free volume is configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

5. The soft contact lens according to any one of claims 1-4, wherein the refractive error of the eye is selected from corneal irregularity, coma, astigmatism, higher-order aberrations of the eye, and any combination thereof.

6. The soft contact lens according to any one of claims 1-5, wherein the soft lens body includes at least one discrete discontinuity selected from channels, openings, grooves, openings, slits, thin portions or any combination thereof.

7. The soft contact lens according to any one of claims 1-6, having a Young's modulus of <4 MPa.

8. The soft contact lens according to claims 1-9, wherein the refractive error is astigmatism.

9. The soft contact lens according to claims 1-9, wherein the refractive error is an optical aberration of the eye.

10. The soft contact lens of claim 6, wherein the discrete discontinuity is at least one opening passing between the front and rear surfaces.

11. The soft contact lens according to any one of claims 1-10, wherein the soft lens body has a front surface, a rear surface and at least one opening passing through between the front surface and the rear surface; wherein the at least one opening is located adjacent to the lacrimal meniscus of the eye.

12. The soft contact lens of claim 11, wherein the at least one opening is configured to be positioned adjacent to the lacrimal meniscus of the eye to facilitate tear flow therefrom to the free volume, from the anterior surface of the lens body to the posterior surface of the lens body and to the free volume.

13. The soft contact lens of claim 12, wherein the lacrimal meniscus is one or more of the superior and / or inferior lacrimal meniscus of the eye.

14. The soft contact lens of claim 12, wherein the at least one opening is configured to be positioned adjacent to the lacrimal meniscus to promote tear flow to the free volume when the lens body is applied to the corneal surface when the eyelid is open, regardless of the orientation of the lens body relative to the lacrimal meniscus.

15. The soft contact lens of claim 12, wherein the at least one opening is configured to be positioned adjacent to the lacrimal meniscus to facilitate tear flow to the free volume.

16. The soft contact lens of claim 12, wherein the at least one opening is configured to be positioned adjacent to the lacrimal meniscus at a distance of about 0.0 mm to about 4 mm.

17. The soft contact lens according to claim 10, wherein the at least one opening is located at a distance of about 3 mm to about 9 mm from the center of the lens body.

18. The soft contact lens according to claim 10, comprising a plurality of openings.

19. The soft contact lens of claim 18, wherein the plurality of openings are uniformly distributed around the center of the soft lens body.

20. The soft contact lens of claim 18, wherein the plurality of openings are non-uniformly distributed around the center of the soft lens body.

21. The soft contact lens of claim 18, wherein the plurality of openings are circumferentially distributed.

22. The soft contact lens of claim 18, wherein the plurality of openings are radially distributed.

23. The soft contact lens of claim 18, wherein the plurality of openings are spaced about 1 mm apart from each other.

24. The soft contact lens of claim 18, wherein the plurality of openings are distributed along at least one meridian of the soft lens body.

25. The soft contact lens of claim 18, wherein the plurality of openings are radially distributed over a radius of about 3 mm to about 8 mm.

26. The soft contact lens of claim 18, wherein the plurality of openings are located at a distance of about 3 mm to about 9 mm from the center of the soft lens body.

27. The soft contact lens of claim 18, wherein the plurality of openings are distributed along the length of the soft lens body.

28. The soft contact lens of claim 10, wherein the length of the at least one opening is from about 40 µm to about 600 µm.

29. The soft contact lens according to claim 10, wherein the cross-sectional area of ​​the at least one opening is from about 0.0001 mm² to about 1 mm².

30. The soft contact lens of claim 10, wherein the at least one opening has a circular cross-sectional area.

31. The soft contact lens of claim 1, wherein the central portion extends from the center of the lens to a radius of approximately 3 mm to 7.5 mm.

32. The soft contact lens of claim 1, wherein the peripheral portion extends from a radius of about 3 mm to 8 mm from the center of the lens.

33. The soft contact lens according to claim 10, wherein the at least one opening is located at a distance of about 3 mm to about 8 mm from the center of the lens body.

34. The soft contact lens according to claim 10, wherein the at least one opening comprises a plurality of openings.

35. The soft contact lens of claim 18, wherein the plurality of openings are circumferentially distributed.

36. The soft contact lens of claim 18, wherein the plurality of openings are radially distributed.

37. The soft contact lens of claim 18, wherein the plurality of openings are distributed along at least one meridian of the soft lens body.

38. The soft contact lens of claim 18, wherein the plurality of openings are distributed along two meridians of the soft lens body, wherein the angle between them is between 45 and 135 degrees.

39. A lens for correcting refractive errors; wherein the lens has a lens body, the lens body having a lens surface and at least one discrete discontinuity within the surface; and wherein the at least one discrete discontinuity is transitioned on the lens surface by at least one transition radius; and wherein the at least one transition radius has a base curve greater than 1 mm.

40. The lens of claim 39, wherein the lens body has an equivalent base curve (EBC), wherein the EBC is between about 8.3 mm and 8.8 mm.

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