Astigmatism-correcting contact lenses with smooth edges and spherical and / or aspherical geometric designs

Abstract

The present invention provides axially symmetric soft contact lenses having aspherical and / or spherical geometric designs for use in correcting refractive errors of the eye.

Description

Technical Field

[0001] Cross-Reference to Related Applications This application claims the benefit of U.S. Application No. 63 / 588,645 filed on October 6, 2023, and / or U.S. Application No. 63 / 560,974 filed on March 4, 2024, and / or U.S. Application No. 63 / 574,027 filed on April 3, 2024, all of which are hereby incorporated by reference in their entirety into the present specification.

Background Art

[0002] Refractive error is a common ocular condition that occurs when the shape of the eye prevents light from being directly focused on the back of the eye, resulting in, among many other symptoms, blurred vision. Refractive errors include astigmatism, myopia, and / or presbyopia. For individuals with one or more refractive errors, more specialized contact lenses with additional features and corrections may be required to correct the one or more refractive errors.

[0003] Astigmatism is a visual defect in the curvature of the eye that results in blurred distance vision and near vision. Astigmatism occurs when either the cornea or the crystalline lens has mismatched curvatures (instead of having a single spherical curvature, the surface varies in its curvature like the shape of an egg). This results in blurred vision at all distances (normal, near, or far vision).

[0004] Such refractive errors may be corrected by eyeglasses, contact lenses, and / or surgery. A person with an astigmatic cornea may require contact lenses that correct different refractive errors in at least two meridians. Furthermore, a person with such refractive errors and using contact lenses may have many different spherical optical powers. The optical power in each meridian, the angle of a particular meridian, and / or the diameter at which an optical power difference occurs often varies from individual to individual.

[0005] Due to additional fitting criteria, a wide variety of specialized contact lenses that meet the corrective standards need to be manufactured and stored. In addition, fitting these specialized contact lenses can take longer than fitting conventional contact lenses. Furthermore, due to the complexity of refractive errors, current contact lenses may not be suitable for correcting one or more refractive errors to a high degree of satisfaction.

[0006] Current treatments for such corneal irregularities using soft contact lenses include contact lenses with multiple base curves and features that allow alignment and rotation to a specific astigmatism axis for the wearer. Examples include structural elements such as prism ballasts and dynamic stabilization elements. These lenses, commonly referred to as toric lenses, often require the manufacture of multiple lenses for each power difference and angle between meridians.

[0007] Opposing meridians are generally assumed to have similar curvature, and a + / - 5 degree shift is usually not very noticeable. Therefore, using 10-degree axial steps, 18 lens steps are typically required for each spherical (ranging from +6.0D to -6.0D in 0.25D steps) and cylindrical power combination (typically 0.75D to 2.5D relative to the spherical) to cover the various astigmatisms a patient may have. This results in the manufacture of thousands of different lenses. Therefore, a solution is needed to minimize the number of individual contact lenses that must be manufactured and stored.

[0008] To address this challenge, astigmatism-correcting lenses were developed. These lenses are designed to remain relatively flat on flat meridians of the cornea, regardless of their rotation, and to remain vaulted on steep meridians. Maintaining the spherical position of a soft contact lens on an aspherical cornea requires unobstructed fluid flow. While grooves can enhance fluid conductivity, considerations regarding the geometric shape, base curve, transitions between base curves, profile, and the distribution and position of grooves and fenestrations are essential to maintaining and improving the comfort and functionality of the lens.

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

[0010] This invention is based on clinical evidence indicating that two key elements are required to create lenses that effectively mask astigmatism: fluid exchange and appropriate lens geometry. It has been found that certain geometric shapes allow for optimal masking, while others do not.

[0011] The lens requires at least one of the following two elements: a central portion that allows the lens structure to be vaulted over a portion of the cornea, and a peripheral portion that allows for good fluid exchange through the edge of the lens, outward when blinking occurs and inward between blinks. In addition, it has been found that combining the geometric shape with features that enhance fluid penetration under the lens (e.g., fenestrations) and / or grooves on the posterior surface to enhance fluid distribution under the lens improves the masking performance of the lens.

[0012] The present invention provides a soft contact lens for correcting refractive errors of the eye, and one aspect of the present invention comprises: a soft continuous lens body having an anterior and posterior surface configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft contact lens being axially symmetric; and the soft continuous lens body having at least a central aspherical portion and a peripheral aspherical portion; the central aspherical portion having a base curve of less than 9 mm at its center and a base curve of less than 8 mm at its edge; and the peripheral aspherical portion having a base curve of greater than 8 mm at its proximal end and a base curve of greater than 8.5 mm at its distal end; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being 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 embodiment, the present invention provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body having an anterior and posterior surface configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft contact lens being axially symmetric; the soft continuous lens body having at least a central aspherical portion and a peripheral aspherical portion; the central aspherical portion having a base curve of less than 9 mm at its center and a base curve of less than 8 mm at its edge; and the peripheral aspherical portion having a base curve of greater than 8 mm at its proximal end and a base curve of greater than 8.5 mm at its distal end; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being 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 embodiment, the present invention provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body having an anterior and posterior surface, configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft lens body having at least a central spherical portion and a peripheral aspherical portion; the central spherical portion having a base curve of less than 9 mm; and the peripheral aspherical portion having a base curve greater than 8 mm at its proximal end and a base curve greater than 8.5 mm at its distal end; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being 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 a further embodiment, the present invention provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body having an anterior and posterior surface configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft lens body having at least a central spherical portion and a peripheral spherical portion; the central spherical portion having a base curve of less than 9 mm; and the peripheral spherical portion having a base curve of greater than 8.5 mm; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being 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 further 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 and having an anterior and posterior surface; and the contact lens having a central thickness of approximately 80 microns to approximately 350 microns; and the soft contact lens being axially symmetric; and the soft continuous lens body having at least a central aspherical portion and a peripheral aspherical portion;

[0017] The central aspherical portion has a base curve of less than 20 mm at its center and a base curve of less than 15 mm at its edge; and the peripheral aspherical portion has a base curve of greater than 20 mm at its proximal end and a base curve of greater than 5 mm at its distal end;

[0018] 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, 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 further provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body having an anterior and posterior surface configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft contact lens being axially symmetric; the soft lens body having at least a central aspherical portion and a peripheral spherical portion; the central aspherical portion having a base curve of less than 20 mm at its center and a base curve of less than 15 mm at its edge; and the peripheral spherical portion having a base curve of greater than 5 mm; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being 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 further provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body having an anterior and posterior surface, configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft lens body having at least a central spherical portion and a peripheral aspherical portion; the central spherical portion having a base curve of less than 0 mm; and the peripheral aspherical portion having a base curve greater than 5 mm at its proximal end and a base curve greater than 5 mm at its distal end; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0021] The present invention further provides a soft contact lens for correcting refractive errors of the eye, comprising: a soft continuous lens body having an anterior and posterior surface, configured to cover the corneal surface of the eye; and the contact lens having a central thickness of about 80 microns to about 350 microns; and the soft lens body having at least a central spherical portion and a peripheral spherical portion; the central spherical portion having a base curve of less than 20 mm; and the peripheral spherical portion having a base curve of greater than 5 mm; and at least a portion of the posterior surface of the soft lens body being configured to be suspended above the corneal surface of the eye when placed thereon, 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 being configured to be filled with tear fluid to form a tear lens on the corneal surface, thereby correcting refractive errors of the eye.

[0022] The present invention further provides a lens for correcting refractive errors; the lens has a lens body having a lens surface and at least one separate discontinuity within such surface; and the at least one separate discontinuity is transitioned on the lens surface having at least one transition radius; and the at least one transition radius has a base curve greater than 1 mm. In some embodiments, the base curve is about 1 mm to 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, 4 mm.

[0023] As used herein, the terms “angular groove” and “smooth transition” are interchangeable. Similarly, the terms “transition radius,” “fillet,” and “curvature-imparting edge” are interchangeable within this specification.

[0024] Features such as individual discontinuities (e.g., grooves and fenestrations) have edges, which are the transitions between the front or back surface of the lens and the individual discontinuities. Such edges have geometries that can affect the function and / or comfort of the lens. To improve the comfort of contact lenses, such edges may be rounded, which softens the transition from the surface of the lens to the geometry of the feature. Without curved edges, these features may have sharp corners (e.g., vertices) that can irritate the eyelid and / or cornea. The curved edges may distribute the pressure of the lens on the eye over a wider area, and allow movement of the lens or movement over the lens while minimizing friction with the cornea and / or eyelid. These curved edges may be uniform across the entire edge of the individual discontinuity, or may have one or more different radii along the edge of the individual discontinuity (e.g., a larger radius in the meridian perpendicular to the movement of the eyelid). These edges may have a progressively variable radius of curvature along the length of the groove. These curved edges may facilitate improved fluid flow through the fenestrations. These curved edges may promote fluid flow along the grooves.

[0025] The angled edges may have a range of 1.0 mm to 4.0 mm or more. In some cases, these curved edges may have a range of 0.5 mm to 8.0 mm or less. In some cases, these curved edges may have a radius of curvature of 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm.

[0026] When fitting a contact lens, it should be considered that the cornea has several base curves. Contact lenses may also have several base curves to fit the cornea, and one numerical value that reflects the combination of base curves is EBC (Equivalent Base Curves).

[0027] 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 fit. This is essential for comfort, visual quality, and ocular health. EBC reflects the equivalent value of all base curves in a single parameter. A lens with several (more than one) base curves and a lens with its equivalent base curve (EBC) have the same total curvature in terms of the same sagittal height from their base to apex. The EBC value of a lens is calculated as follows: EBC=((Rbc*Abc)+(Rpc*Apc)) / (Abc+Apc) Rbc=radius of the central base curve (mm) Abc=area of the central base curve (%) Rpc=radius of the peripheral base curve (mm) Apc=area of the peripheral base curve (%)

[0028] For example, a lens with the following variables has a calculated EBC of 8.57 [EBC=((7.86*0.51)+(9.32*0.49)) / (0.51+0.49)]. [Table 1]

[0029] In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.3 mm to 8.8 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.3 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.8 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.4 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.5 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.6 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.7 mm. In some embodiments, the lens body has an equivalent base curve (EBC), which is approximately 8.8 mm.

[0030] When referring to "soft contact lenses," it should be understood to include thin lenses that are worn directly on the surface of the eye and are made from flexible polymers such as silicone, silicone hydrogel, and hydrogel. Such flexible polymers typically have a Young's modulus of less than 5 mPa.

[0031] When referring to a "soft continuous lens body configured to cover the surface of the cornea of ​​the eye," it should be understood that the soft contact lens has a shape and form that essentially covers the surface of the cornea of ​​the eye, and has an anterior surface (the lens surface that does not directly contact the surface of the eye) and a posterior surface (the lens surface that directly contacts the surface of the eye, at least partially).

[0032] When referring to the above contact lens having a central thickness of approximately 80 microns to approximately 350 microns, it should be understood that the thickness of the lens may be uniform or non-uniform throughout the portion and zone of the lens of the present invention. In some embodiments, the central thickness is at least approximately 80 microns. In some other embodiments, the central thickness is approximately 350 microns. In other embodiments, the center thickness is approximately 80, 85, 90, 95, 100, 110, 20, 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, and 350 microns.

[0033] When it is mentioned that the soft lens body has at least a central portion and a peripheral portion, it should be understood that this refers to a central portion of the lens that starts from the center of the lens and a peripheral portion that is the outermost portion that surrounds the central portion and ends at the lens margin. In some embodiments, an additional portion may exist 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 zone 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 zone 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.

[0034] When referring to “individual discontinuities,” it should be understood that this refers to a portion of the surface of the lens of the present invention having an isolated, distinct gap or separation section. In some embodiments, the individual discontinuities may be selected from channels, fenestrations, grooves, openings, slits, thin sections, or any combination thereof. In some embodiments, the individual discontinuities are located on the front surface of the lens of the present invention. In other embodiments, the individual discontinuities are located on the rear surface of the lens of the present invention. In further embodiments, the individual discontinuities are located from the front to the rear surface of the lens of the present invention. In other embodiments, the individual discontinuities are located from the rear to the front surface of the lens of the present invention.

[0035] In some embodiments, a contact lens for correcting refractive errors may have a continuous body. In some embodiments, the continuous body does not have a joint (e.g., a living hinge). In some embodiments, the continuous body comprises a substantially uniform material, substantially uniform stiffness, 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.

[0036] In some embodiments, the continuous body refers to a lens that has little or no difference in thickness, modulus of elasticity, and / or stiffness at or near the transition. In some embodiments, the continuous body refers to having a substantially smooth surface along one or more axes or lines from the center to the periphery of the lens.

[0037] In some embodiments, the refractive error of the eye is selected from refractive errors of the eye, corneal irregularities, astigmatism, coma aberration, secondary and higher-order aberrations of the eye, and any combination thereof.

[0038] In some embodiments, the lens is not axially symmetric.

[0039] In some embodiments, the lens may be a unicurve, bicurve, tricurve, or multicurve lens.

[0040] In some embodiments, the soft lens body comprises at least one separate discontinuity selected from channels, fenestrations, grooves, openings, slits, thinned portions, or any combination thereof.

[0041] In some embodiments, the soft contact lens has a Young's modulus of less than 4 MPa.

[0042] In some embodiments, the refractive error is astigmatism. In some embodiments, the refractive error is corneal optical aberration.

[0043] In some embodiments, the lens body has at least one separate discontinuity, which is at least one fenestration traversing between the front and rear surfaces.

[0044] In some embodiments, the soft lens body has an anterior surface, a posterior surface, and at least one fenestration traversing between the anterior and posterior surfaces; in some embodiments, the at least one fenestration is located adjacent to the tear meniscus of the eye.

[0045] In some embodiments, the at least one fenestration is configured to be located adjacent to the tear meniscus, thereby facilitating tear flow from there to the rear surface of the lens body, and into the free volume.

[0046] In some embodiments, the tear meniscus is one or more of the upper or lower tear meniscus of the eye.

[0047] In some embodiments, at least one fenestration is configured to be positioned adjacent to the tear meniscus to facilitate tear flow into the free volume, regardless of the orientation of the lens body relative to the tear meniscus, when the lens body is applied to the corneal surface with the eyelids open.

[0048] In some embodiments, the at least one fenestration is configured to be located adjacent to the tear meniscus to facilitate the flow of tear fluid into the free volume.

[0049] In some embodiments, at least one fenestration is configured to be located adjacent to the tear meniscus at a distance of approximately 0.0 mm to approximately 4.0 mm. In some embodiments, at least one fenestration is configured to be located adjacent to the tear meniscus at distances of approximately 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, 0.34, 3.5, 3.6, 0.37, 3.8, 3.9, and 4.0 mm.

[0050] In some embodiments, the at least one fenestration is located approximately 3 mm to 9 mm from the center of the lens body. In some embodiments, the at least one fenestration is located approximately 3, 3.1, 0.32, 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 from the center of the lens body. It is located at 5.6, 5.7, 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.

[0051] In some embodiments, the soft contact lens and / or lens body comprises multiple fenestrations.

[0052] In some embodiments, multiple fenestrations are evenly distributed around the center of the soft lens body.

[0053] In some embodiments, the multiple fenestrations are unevenly distributed around the center of the soft lens body.

[0054] In some embodiments, multiple fenestrations are distributed in the circumferential direction.

[0055] In some embodiments, the multiple fenestrations are distributed radially.

[0056] In some embodiments, the multiple fenestrations are spaced about 1 mm apart from each other. In some embodiments, the multiple fenestrations are spaced more than 1 mm apart from each other.

[0057] In some embodiments, the multiple fenestrations are distributed along at least one meridian of the soft lens body.

[0058] In some embodiments, the multiple fenestrations are distributed radially within a radius of approximately 3 mm to approximately 9 mm. In some embodiments, the multiple fenestrations are distributed radially within a radius of approximately 0.03, 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.

[0059] In some embodiments, the multiple fenestrations are located approximately 3 mm to 9 mm from the center of the soft lens body. In some embodiments, the multiple fenestrations are located 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, and 9.0 mm from the center of the soft lens body.

[0060] In some embodiments, multiple fenestrations are distributed along the length of the soft lens body.

[0061] In some embodiments, the above at least one fenestration is approximately 0.0001 mm 2 ~about 1mm 2 The cross-sectional area is as follows: In some embodiments, the above at least one fenestration has a cross-sectional area of ​​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, and 1.0 mm. 2 It has the following cross-sectional area.

[0062] In some embodiments, the at least one fenestration has a cross-sectional area with a circular shape. In some embodiments, the at least one fenestration has a cross-sectional area with an elliptical shape. In some embodiments, the at least one fenestration has a cross-sectional area in which a portion of its shape is rounded.

[0063] 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, and 9.0 mm.

[0064] 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, and 12.0 mm from the center of the lens.

[0065] In some embodiments, at least one fenestration is located approximately 3 mm to 9.0 mm from the center of the lens body.

[0066] In some embodiments, the at least one fenestration comprises a plurality of fenestrations.

[0067] In some embodiments, multiple fenestrations are distributed in the circumferential direction.

[0068] In some embodiments, multiple fenestrations are distributed radially.

[0069] In some embodiments, multiple fenestrations are distributed along at least one meridian of the soft lens body.

[0070] In some embodiments, multiple fenestrations are distributed along two meridians of the soft lens body, with an angle between them ranging from 45 to 135 degrees.

[0071] This disclosure is generally directed toward ocular vision and treatment to provide improved visual acuity. While it specifically refers to vision-correcting coverings such as soft contact lenses, embodiments of this disclosure may have additional uses and applications, such as the correction of refractive errors of the eye, such as astigmatism.

[0072] In one embodiment, the 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 an anterior surface, a posterior surface, and at least one fenestration. 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, forming a free volume between the posterior 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 a fluid to form a tear lens on the corneal surface to correct refractive errors of the eye.

[0073] In some embodiments, at least a portion of the soft continuous lens body is suspended further 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, and another portion of the soft continuous lens body conforms to the corneal surface.

[0074] At least a portion of the soft continuous lens body may comprise a first portion of the soft continuous lens body suspended above the corneal surface, and a different second portion of the soft continuous lens body suspended above the corneal surface at a greater height, closer proximity, or at the same distance as the first portion of the soft continuous lens body.

[0075] In some embodiments, the soft continuous lens body has a uniform Young's modulus. In some embodiments, the soft continuous lens body has a Young's modulus of about 0.1 megapascals ("MPa") to about 4 MPa.

[0076] In some embodiments, the refractive error of the eye originates from one or more of the following: corneal irregularity, primary aberrations—spherical, secondary aberrations—astigmatism, or higher-order aberrations—e.g., ocular coma and trefoil. In some embodiments, the refractive error of the eye is ocular astigmatism.

[0077] In another embodiment, the disclosure provides a soft contact lens for correcting astigmatism of the eye. In some embodiments, the soft contact lens includes a soft continuous lens body configured to cover the surface of the cornea of ​​the eye.

[0078] In some embodiments, the soft continuous lens body has a front surface, a rear surface, and at least one fenestration.

[0079] In some embodiments, the soft continuous lens body has a uniform Young's modulus of approximately 0.1 MPa to approximately 4 MPa.

[0080] 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 of the eye when placed thereon, forming a free volume between the rear surface of the soft continuous lens body and the corneal surface.

[0081] In some embodiments, at least a portion of the free volume is configured to be filled with a fluid to form a tear lens on the corneal surface to correct astigmatism of the eye.

[0082] In some embodiments, the front surface of the soft continuous lens body is axially symmetric. In some embodiments, the front surface has a front curvature profile. In some embodiments, the front curvature profile is axially symmetric. In some embodiments, the rear surface of the soft continuous lens body is axially symmetric. In some embodiments, the rear surface has a rear curvature profile. In some embodiments, the rear curvature profile is axially symmetric. In some embodiments, the soft continuous lens body further comprises a lens volume. In some embodiments, the lens volume is axially symmetric. In some embodiments, the lens does not provide cylindrical optical power when in a neutral position. In some embodiments, the lens corrects the refractive error or optical aberration of the eye when placed on it, regardless of the orientation of the lens relative to the meridian of the eye. In some embodiments, the lens corrects the refractive error or optical aberration of the eye without rotational fitting to the eye. In some embodiments, the optical aberration of the eye is first-order aberration or spherical aberration. In some embodiments, the optical aberration of the eye is second-order aberration or cylindrical aberration. In some embodiments, the optical aberration is third-order aberration or coma aberration.

[0083] In some embodiments, the lens is made from a single material. In some embodiments, the lens is made from a single material having the same mechanical properties throughout. In some embodiments, the lens is made from a single polymer material. In some embodiments, the lens is made from a hydrogel, silicone hydrogel, or silicone. In some embodiments, the lens is made from a single material selected from diacetone acrylamide, N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, methacrylic acid, methyl methacrylate, N-carboxyvinyl ester, N-vinylpyrrolidone, poly[dimethylsiloxyl]di[silylbutanol]bis[vinylcarbamate], phosphorylcholine, tris-(trimethylsiloxysilyl)propyl vinylcarbamate, tris-(hydroxylmethyl)aminomethane, siloxane, or polyvinylpyrrolidone.

[0084] In some embodiments, the soft continuous lens body has a rigidity range of approximately 1.25E+04 megapascals*micrometers³ ("MPa*μm³") to approximately 5.00E+08 MPa*μm³.

[0085] In some embodiments, the soft continuous lens body comprises 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 of the radius of curvature at the rear surface to the radius of curvature at the front surface. In some embodiments, each of the one or more optical regions independently provides a different optical power 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 either simultaneously present or divided. In some embodiments, the one or more simultaneously present optical regions are either concentric (concentric circles with varying curvature) or aspherical (having a curvature that varies across the surface of the lens rather than a uniform spherical shape).

[0086] In some embodiments, the lens is a bifocal or multifocal lens.

[0087] In some embodiments, the diameter of one or more optical regions is approximately 4 millimeters ("mm") to approximately 15 mm.

[0088] In some embodiments, the radius of curvature on the rear surface of one or more optical regions is about 7 mm to about 9 mm. In some embodiments, the radius of curvature on the front surface of 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 on the rear and front surfaces of one or more optical regions is about 3:5 to about 2:1.

[0089] In some embodiments, the soft continuous lens body has multiple base curves between the central base curve and the peripheral base curve.

[0090] 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 has dimensions 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 portion 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, 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, 1.2, 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, 1 The dimensions are 8.7, 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, and 22.0 mm.

[0091] In some embodiments, the peripheral spherical portion has an inverse base curve of 15.0 mm to 25 mm. In some embodiments, the peripheral spherical portion has a base curve 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, 17 0.2, 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 0.9, 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, 22.5, 22 It has an inverted base curve of 0.6, 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.

[0092] 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 curve of less than 8 mm at its edge. In some embodiments, the dimensions of the central aspherical portion at its center are 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, and 6.8 mm. In some embodiments, the dimensions of the central aspherical portion at its edge are 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, and 6.3 mm. In some embodiments, the central aspherical portion is any combination of the central aspherical portion at its center and the central aspherical portion at its edge.

[0093] 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 0.6, 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, 1.2, 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 The dimensions are 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, and 22.0 mm.

[0094] In some embodiments, the peripheral aspherical portion at its distal 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 0.6, 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, 1.2, 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 The dimensions are 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, and 22.0 mm.

[0095] In some embodiments, the peripheral aspherical portion is any combination of the peripheral aspherical portion at its proximal end and the peripheral aspherical portion at its distal end.

[0096] In some embodiments, the soft continuous lens body has a uniform thickness throughout the optical region. In some embodiments, the soft continuous lens body has a non-uniform thickness throughout the optical region. In some embodiments, the central thickness of the soft continuous lens body in the optical region is about 80 micrometers ("μm") to about 350 μm. In some embodiments, the soft continuous lens body further comprises an axially symmetric lens volume. In some embodiments, the soft continuous lens body further comprises an asymmetric lens volume.

[0097] In some embodiments, the non-optical region begins at a distance from the center of 1.5 mm to about 14 mm. In some embodiments, the optical region has a diameter of about 3 mm to about 12 mm.

[0098] In some embodiments, at least one fenestration is located in the optical region. In some embodiments, at least one fenestration is located in the non-optical region. In some embodiments, at least one fenestration is located in both the optical and non-optical regions. In some embodiments, at least one fenestration is located on the front surface of the lens. In some embodiments, at least one fenestration is located on the rear surface of the lens. In some embodiments, at least one fenestration is located on both the front and rear surfaces. In some embodiments, the lens body further comprises at least one of channels, fenestrations, grooves, openings, slits, thin-walled portions, or any combination thereof. In some embodiments, the lens body further comprises channels. In some embodiments, the lens body further comprises channels further configured to allow fluid to flow into and out of a free volume. In some embodiments, the lens body further comprises grooves. In some embodiments, the lens body further comprises grooves further configured to reduce mechanical strain on the continuous lens body. In some embodiments, the lens body further comprises fenestrations. In some embodiments, the lens body further comprises a fenestration configured to allow fluid to flow into and out of a free volume. In some embodiments, the fenestration is configured to indirectly allow fluid to flow into and out of a free volume by being connected through a channel. In some embodiments, at least a portion of the soft continuous lens body is configured to conform to the corneal surface of the eye while forming deformation of the continuous lens body. In some embodiments, the lens body is further configured to substantially prevent the transmission of deformation to the non-conforming portion of the soft continuous lens body.

[0099] In some embodiments, the lens does not have projections extending from the rear surface.

[0100] In some embodiments, the lens has a diameter of approximately 8 mm to approximately 17 mm.

[0101] 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 approximately 0.001 microliters ("μL") to 10 μL.

[0102] In some embodiments, at least one sector of the soft continuous lens body from the center to the peripheral edge of the soft continuous lens body is configured to be suspended on the corneal surface to form at least a portion of the free volume when the continuous lens body is placed on the corneal surface. In some embodiments, any of the at least one sector of the soft continuous lens body may be suspended on the corneal surface to form at least a portion of the free volume when the continuous lens body is placed on the corneal surface.

[0103] In another embodiment, the Disclosure provides a method for correcting an ocular refractive error using the soft contact lenses of the Disclosure.

[0104] In another embodiment, the Disclosure provides a method for forming a tear lens using the soft contact lenses of the Disclosure. In some embodiments, applying the soft contact lenses of the Disclosure to the eye causes the tear lens to form with an asymmetric volume distribution. In some embodiments, the asymmetric volume distribution corrects one or more of the corneal irregularities, coma aberration, astigmatism, or higher-order aberrations of the eye. In some embodiments, in the asymmetric volume distribution, the volume of a first tear lens sector differs from the volume of a second tear lens sector that is diametrically opposed 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 the coma aberration of the eye.

[0105] The ability of the soft contact lenses described herein to mask astigmatism and coma aberration may offer advantages over many commercially available astigmatism-masking toric contact lenses. Such toric lenses may provide different refractive powers between meridians, but they may not provide different refractive powers within the same meridian. In contrast, the soft contact lenses provided herein may have multiple sectors, the volume of the tear film lens under each sector may differ, and the combination of each sector and the tear film lens portion directly behind each sector may provide different refractive powers. As will be further discussed herein, the soft contact lenses described herein may mask astigmatism and coma aberration independently of the rotational direction, whereas such toric lenses require wearing in a specific rotational direction dependent on masking astigmatism.

[0106] In another embodiment, the Disclosure provides a method for correcting an ocular refractive error, comprising the step of providing optical correction to the subject's eye by the optical area of ​​a soft contact lens and the free volume between the posterior surface of the lens and the corneal surface when placed on the eye. In some embodiments, at least one discontinuity of the soft contact lens allows tear fluid to flow into the free volume, forming a tear lens over the ocular abnormality to correct the ocular refractive error.

[0107] In another embodiment, the Disclosure provides a method for forming a tear lens, comprising the step of applying a soft contact lens having a continuous body to the eye such that a free volume is formed between the posterior surface of the continuous body 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, thereby forming a tear lens over an abnormality in the eye to correct a refractive error of the eye.

[0108] In some embodiments, the soft contact lens is applied to the eye in any orientation so that the lens corrects the refractive error of the eye, regardless of the orientation of the lens relative to the meridian of the eye.

[0109] In some embodiments, the soft contact lens has a stiffness range of approximately 1.25E+04mPa*μm3 to approximately 5.00E+08mPa*μm3.

[0110] In some embodiments, the refractive error of the eye originates from one or more of the following: corneal irregularities, coma aberration, astigmatism, or higher-order aberrations of the eye.

[0111] In some embodiments, the refractive error is astigmatism of the eye.

[0112] In some embodiments, one or both of the front and rear surfaces of the lens are axially symmetric.

[0113] In some embodiments, the optical area of ​​the lens has a uniform thickness.

[0114] In some embodiments, the optical region of the lens has a non-uniform thickness.

[0115] In some embodiments, soft contact lenses are made from a single material.

[0116] Additional aspects and advantages of the Disclosure will be readily apparent to those skilled in the art from the following detailed description, but only exemplary embodiments of the Disclosure are shown and described. As will be recognized, other and different embodiments of the Disclosure are possible, and several of its details can be modified in various obvious ways without departing from the Disclosure. Accordingly, the drawings and description should be considered as exemplary in nature and not as limiting.

[0117] The subject matter considered to be the invention is specifically pointed out and explicitly claimed in the concluding section of the specification. The present invention, however, with respect to both its configuration and method of operation, as well as its object, features, and advantages, can be best understood by referring to the following detailed description when read together with the accompanying drawings. [Brief explanation of the drawing]

[0118] [Figure 1] The cylindrical correction of the two lenses compared in Example 5 is shown (cylindrical masking, paired, N=6). [Figure 2] The comfort scores of the two lenses compared in Example 5 are shown (comfort, paired, N=6). [Figure 3A-B] The lens design of the present invention is shown, with an aspherical (3A) versus spherical (3B) lens. [Figure 4A-B] This document demonstrates the performance and comfort of the aspherical (4A) versus spherical (4B) lens of the present invention. [Figure 5] Table 2 of Example 8 shows the comfort level of each lens. [Figure 6] Table 2 of Example 8 shows the cylindrical reduction for each lens. [Figure 7] This invention demonstrates the effect of EBC on the comfort and stability of the lens.

[0119] For the sake of simplification and clarity, it should be understood that the elements shown in the figures are not necessarily drawn to scale. For example, the dimensions of some elements may be exaggerated relative to others for clarity. Furthermore, where deemed appropriate, reference numerals may be repeated between figures to indicate corresponding or similar elements. [Modes for carrying out the invention]

[0120] In the following detailed description, numerous specific details are provided to give a full understanding of the invention. However, it will be understood by those skilled in the art that the invention can be carried out without these specific details. In other cases, well-known methods, procedures, and components are not described in detail so as not to obscure the invention.

[0121] In the following detailed description, the accompanying drawings, which form part of this specification, are referenced. In the drawings, unless the context otherwise indicates, similar symbols typically identify similar components. The detailed description, drawings, and exemplary embodiments described in the claims are not intended to be limiting. Other embodiments may be used and other modifications may be made without departing from the scope of the subject matter presented herein. It will be readily apparent that the aspects of this disclosure generally described herein and shown in the drawings may be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are expressly assumed herein.

[0122] While specific embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as their modifications and equivalents. Therefore, the scope of the claims appended herein is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to a specific disclosed order. Various operations may be described sequentially as a number of separate operations in a manner that may be helpful in understanding a particular embodiment, but the order of description should not be construed as suggesting that these operations are order-dependent. Furthermore, the structures, systems, and / or devices described herein may be embodied as integrated components or as individual components.

[0123] For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by a particular embodiment. Therefore, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0124] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by those with ordinary art in the art to which this disclosure belongs. Where used herein, the singular forms “a,” “an,” and “the” include plural references unless the context otherwise clearly indicates. Any reference to “or” herein is intended to include “and / or” unless otherwise stated. Where used herein, the terms “comprises” and / or “comprising” identify the presence of the described 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. Where used herein, the terms “and / or” include any and all combinations of one or more of the related list items, and may be abbreviated as “ / ”.

[0125] Spatial relative terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein to facilitate explanation and to describe the relationship between one element or feature and another, as shown in the figures. It will be understood that spatial relative terms are intended to encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in a figure is inverted, an element described as being “under” or “beneath” another element or feature will subsequently be oriented “above” that other element or feature. Thus, the exemplary term “under” may encompass both over and under orientations. A device may be oriented separately (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein may be interpreted accordingly. Similarly, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein for illustrative purposes only, unless otherwise specifically indicated.

[0126] The terms “first” and “second” may be used herein to describe various features / elements (including processes), but these features / elements should not be limited by these terms unless otherwise indicated by the context. 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.

[0127] Throughout this specification and the following claims, unless the context otherwise requires, the word “comprise,” and variations such as “comprises” and “comprising,” mean that various components may be used together in a method and product (e.g., a composition and apparatus including a device and a method). For example, the term “comprising” would be understood to suggest the inclusion of any element or step described, but not the exclusion of any other element or step.

[0128] Whenever the terms “at least,” “greater than,” or “greater than or equal to” precede the first number in a sequence of two or more numbers, the terms “at least,” “greater than,” or “greater than or equal to” apply to each number in that sequence. For example, “greater than 1, 2, or 3 or equal to 1, 2, or 3” is equivalent to “greater than 1 or equal to 1,” “greater than 2 or equal to 2,” or “greater than 3 or equal to 3.”

[0129] Whenever the terms “no more than,” “less than,” “less than or equal to,” or “at most” precede the first number in a series of two or more numbers, those terms apply to each number in that series. For example, less than 3, 2, or 1 or equal to 3, 2, or 1 is equivalent to less than 3 or equal to 3, less than 2 or equal to 2, or less than 1 or equal to 1.

[0130] When values ​​are stated as a range, it will be understood that such disclosure includes the specific numerical values ​​that fall within such range, whether or not specific numerical values ​​or specific subranges are explicitly stated, as well as the disclosure of all possible subranges within such range.

[0131] Where used in the specification and claims of this specification, including where used in the examples, and unless otherwise expressly specified, all numerical values ​​may be read as if preceded by the words “about” or “approximately,” even if such terms do not explicitly appear. The phrase “about” or “approximately” may be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonably expected range of the value and / or location. For example, a numerical value may have values ​​such as + / -0.1% of the stated value (or range of value), + / -1% of the stated value (or range of value), + / -2% of the stated value (or range of value), + / -5% of the stated value (or range of value), and + / -10% of the stated value (or range of value). Any numerical value given herein should also be understood to include an approximate or approximate value of that value unless the context otherwise indicates. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any numerical range enumerated herein is intended to include all subranges contained therein. Where a value is disclosed, it is understood that, as can be appropriately understood by a skilled technician, the values ​​"less than or equal to" that value, "greater than or equal to" that value, and the possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "greater than or equal to X" (e.g., if X is a number) is also disclosed, as is "less than or equal to X". Throughout the application, data is provided in many different forms, and this data is also understood to represent endpoints and starting points, as well as ranges, for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that values ​​greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are disclosed, as is the case between 10 and 15. It is also understood that each unit between two particular units is also disclosed.For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0132] Many of the features of this disclosure are described in relation to the anatomical structure of the subject's eye. The eye contains several tissues that enable the subject to see. The subject may be an animal. The subject may be a human, such as a patient. The cornea of ​​the eye is the anterior region of the eye, which is transparent in a healthy eye and refracts light to form an image on the retina. The retina is the posterior region of the eye, which senses the light from the image formed on it and transmits signals from the image to the brain. The cornea includes the Bowman's membrane, the interstitium, and the outer layer of tissue, i.e., the epithelium, which protects the underlying tissues of the cornea, such as nerve fibers extending into the interstitium and Bowman's membrane. A healthy eye includes a tear film, which is arranged on the epithelium. The tear film may smooth out small irregularities in the epithelium to provide an optically smooth surface. The tear film is substantially shaped by the shape of the underlying epithelium, interstitium, and Bowman's membrane, if present. The tear film contains a fluid, which is mainly water but also contains additional components such as mucoids and lipids. Many nerve fibers in the cornea provide sensation, which facilitates blinking by allowing the cornea to be covered with a tear film. These nerve fibers also sense pain, which typically helps individuals avoid corneal trauma and direct contact of objects with the cornea.

[0133] Embodiments described herein may be used to treat the eye in many ways using one or more coverings. The covering may comprise a contact lens. The covering may be a soft contact lens. The covering and / or contact lens may mask astigmatism and may be used to treat the same. Such a contact lens may comprise one or more astigmatism-masking contact lenses. The contact lens may be available in various versions. The covering may comprise one or more soft lenses that can normally fit. In some cases, the contact lens may be used for long-term vision correction by long-term wear. The contact lens may be used to treat astigmatism. In other examples, the covering and / or contact lens may be used in combination with or after surgery for improved results and / or restoration.

[0134] Unlike toric soft contact lenses, which require stabilization to position the corrective cylinder on the correct axis, the lenses of this disclosure generally do not require stabilization. Therefore, the lenses of this disclosure may not have a mechanism for stabilizing the rotation of the lens to a particular cylinder of the eye. Furthermore, the lenses of this disclosure may not have orientation features or indicators for stabilizing the rotation of the lens to a particular cylinder of the eye (e.g., discoloration markings on or within the contact lens body, one or more cuts on the peripheral edge of the contact lens body, asymmetric shape of the contact lens body, etc.). For example, the lenses of this disclosure may not have prism ballast (a difference in thickness across the entire lens profile that determines the direction of lens rotation) or peripheral ballast (i.e., val flange). Furthermore, the lenses of this disclosure may not have non-prism ballast features such as thin zone, double slab off, or dynamic stabilization.

[0135] In some embodiments, soft contact lenses may correct or mask refractive errors of the eye. Refractive errors of the eye may include one or more of corneal irregularities, coma aberration, astigmatism, or higher-order aberrations of the eye.

[0136] In some embodiments, soft contact lenses can correct (i.e., mask) refractive errors or aberrations 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 primary aberration or spherical aberration. In some embodiments, the optical aberration of the eye is a secondary aberration or cylindrical aberration. In some embodiments, the optical aberration is a tertiary aberration or coma aberration.

[0137] In some embodiments, 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, a soft contact lens may mask astigmatism of up to 1D. In some examples, a soft contact lens may also mask astigmatism of up to 2D. In other examples, a soft contact lens may also mask astigmatism of up to 3D. A soft contact lens may mask astigmatism by an amount within the range defined by any two of the aforementioned values.

[0138] In some cases, correcting an ocular refractive error or aberration involves masking a diameter of 1 millimeter (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, masking an ocular refractive error or aberration involves masking 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. An ocular refractive error or aberration may have an area within the range defined by any two of the aforementioned values. For example, an ocular refractive error or aberration may have an area of ​​approximately 9 mm to approximately 8 mm in the central diameter of the cornea.

[0139] In some cases, correcting astigmatism involves masking 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, masking astigmatism involves masking 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 may be within the range defined by any two of the aforementioned values. For example, the astigmatic area may be approximately 9 mm to approximately 8 mm of the central diameter of the cornea.

[0140] In some cases, soft contact lenses may reduce inventory unit (SKU) requirements by at least approximately 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 99%, or more compared to soft toric contact lenses or other conventional contact lenses. In some cases, soft contact lenses may reduce SKU requirements by up to approximately 99%, 95%, 90%, 80%, 70%, 60%, 50%, or less compared to soft toric contact lenses or other conventional contact lenses. For example, the soft contact lenses provided herein may reduce SKU requirements by up to approximately 95%. Contact lenses may reduce SKU requirements by an amount within the range defined by any two of the aforementioned values.

[0141] In some embodiments, soft contact lenses can also reduce the fitting time or chair time required by an ophthalmic medical professional, or the number of visits required until the final lens fit is determined.

[0142] Example 1: Comparison of BC at 8.06 and BC at 7.86 A J1 lens with a central BC of 7.86 mm was compared to a J1 lens with a central BC of 8.06 mm (with a central thickness of 300 μm, transitioning to peripheral BC at R=5.2 mm, and peripheral BC=9.32).

[0143] The comparison focused on comfort, function, and visual acuity (VA). Lenses with a central curve of 7.86 mm were found to have superior correction and superior comfort (with a central thickness of 300 μm, peripheral thickness). [Table 2]

[0144] Example 2: An aspheric lens made of silicone hydrogel, having a central aspheric design (central BC of 9.05->8.0, central thickness = 300μ and 250μ) and a relatively steep aspheric periphery (BC of 8.1-8.5mm). The lens was tested on 10 subjects for 250u and N=8 for 300u. The mean cylindrical correction amount in both groups was less than 0.25 diopters, and the mean comfort level was 7.8 (on a scale of 1-10) - thus this geometric shape was found to be ineffective and uncomfortable.

[0145] Example 3: Aspheric lens with an aspheric peripheral of 8.1-8.5 (relatively steep) and a flat-to-steep aspheric center (8.55->7.35, average 7.85, similar to corneal curvature) - cylinder not corrected.

[0146] Example 4: Featureless hydrogel lens with flat periphery - Functions and demonstrates that the flat periphery allows fluid access. A hydrogel lens with a central thickness of 200u, a spherical central curve of 8.6mm, and a peripheral inverse base curve of 19.8mm was tested in 5 subjects and showed an average cylindrical correction of 0.62 diopters and a comfort score of 9.7 (on a 1-10 scale) - the flat periphery allows fluid access.

[0147] Example 5: Two designs were compared in 6 subjects (Figures 1 and 2): 1. An aspheric lens with an aspheric central design (central curve of 9.05->8.0 mm, central thickness = 300u) and a relatively steep aspheric periphery of 8.1->8.5 mm. 2. An aspheric lens with an aspheric central design (central curve of 9.05->8.0 mm, central thickness = 300u) and a flatter aspheric periphery of 8.8->9.2 mm. Lens 2 performed well, masked astigmatism better, and was more comfortable. The average cylindrical correction was -0.87 diopters, and the comfort score was 9.3 (on a 1-10 scale). The flatter periphery of 8.8->9.2 mm allowed for fluid access, performed well, and was comfortable. [Table 3]

[0148] Example 6: Effect of Sphericity on Performance. Two designs with the same material, same manufacturing process, same features, and same EBC (Equivalent Base Sphere) were compared in five subjects (designs are shown in Figures 3A and 3B): Lens 1. An aspherical lens with an aspherical central design (central curve of 9.05->8.0 mm, central thickness = 300u) and an aspherical peripheral of 8.5->8.0 mm. Lens 2. An aspherical lens with a spherical central design (central curve of 8.05 mm, central thickness = 300u) and a spherical peripheral of 9.32 mm. The average cylindrical correction was -0.6 diopters for the aspherical design and -0.96 for the spherical design, and the comfort score was 8.9 (on a scale of 1-10) for both designs - comfort was the same, but the spherical design performed better than the aspherical design (Figures 4A and 4B).

[0149] Example 7: Effect of circumferential fillet at the transition zone (transition to peripheral curve) at a radius of 5.2 mm. 74 subjects wearing astigmatism-correcting lenses with a minimum fillet at the transition zone (0.2 mm base curve in the opposite direction of the lens curve) were compared with 32 subjects wearing lenses of the same design but with a smoother transition zone (30 mm base curve in the opposite direction of the lens curve). The average comfort score for the 0.2 mm fillet was 8 (on a comfort scale of 1 to 10), while the average comfort score for the 30.0 mm fillet was 9.2. In a paired retrospective comparison (only 22 subjects who wore both 0.2 mm and 30 mm fillets participated), the average comfort score for the 0.2 mm fillet was 8.2 (on a comfort scale of 1 to 10), while the average comfort score for the 30.0 mm fillet was 9.1.

[0150] Example 8: Five subjects were tested to evaluate the comfort and efficiency of astigmatism-correcting contact lenses of different designs. The lenses tested were as follows: a control lens with radial angular grooves to evaluate the radial vs. circumferential effect, a control lens with circumferential annular grooves to evaluate the radial vs. circumferential effect and to function as a circumferential control with a curvature-imparting transition, and three lenses with different levels of curvature-imparting transitions: narrow, intermediate, and wide. The results are summarized in Table 2 below. Figures 5 and 6 show comfort (Figure 5) and cylinder reduction (Figure 6) for each lens listed in Table 2 below. [Table 4]

[0151] Conclusion: Circumferential contact lenses with a curvature-imparting transition are more acceptable. Curvature-imparting transitions exceeding 3.5 mm do not appear to add further comfort due to saturation of the effect. The optimal point between comfort and function is around 3.5 mm.

[0152] Example 9: Instability Experiment. Nineteen eyes of 19 subjects with astigmatism (ranging from -0.75D to -1.75D) were tested for the effect of EBC (mean curvature of the lens) on cylindrical correction performance, comfort, and stability (stability is defined as visual acuity not improving or worsening immediately after blinking), and silicone hydrogel contact lenses were manufactured. All manufactured lenses had a central thickness of 300u and a diameter of 14.5mm. The lenses had different curvatures, and the base curve of the EBC ranged from 7.98 to 8.85mm. The EBC was modified by shifting the transition point between the central and peripheral curvature (central curvature is steeper than peripheral curvature).

[0153] Instability exceeding 20% ​​was defined as unstable. The cylindrical correction amount ranged from -0.75D to -0.92D, with no significant difference between EBCs, and comfort was above 8 (1-10) for all EBCs. Figure 7 shows the effect of EBC on comfort and instability of the lens of the present invention.

[0154] Conclusion: The results suggest that when the EBC shifts from a geometric match between the lens and the cornea to either a "flat mismatch" or a "steep mismatch," a mismatch volume is formed, making the lens more susceptible to blinking. The best EBC range found was 8.41 mm to 8.7 mm.

[0155] While certain features of the present invention are illustrated and described herein, many modifications, substitutions, alterations, and equivalents will arise for those of ordinary art in the art. It should therefore be understood that the appended claims are intended to encompass all such modifications and alterations that fall within the true spirit of the invention.

Claims

1. These are soft contact lenses for correcting refractive errors of the eye. A soft continuous lens body having a front and a rear surface, configured to cover the corneal surface of the eye. Equipped with, The aforementioned contact lens has a central thickness of approximately 80 microns to approximately 350 microns, and The aforementioned soft contact lens is axially symmetric, The soft continuous lens body has at least a central aspherical portion and a peripheral aspherical portion, 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, The peripheral aspherical portion has a base curve at its proximal end that is greater than 8 mm and a base curve at its distal end that is greater than 8.5 mm. At least a portion of the rear surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, forming a free volume between the rear 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 the refractive error of the eye. Soft contact lenses.

2. These are soft contact lenses for correcting refractive errors of the eye. A soft continuous lens body having a front and a rear surface, configured to cover the corneal surface of the eye. Equipped with, The aforementioned contact lens has a central thickness of approximately 80 microns to approximately 350 microns, and The aforementioned soft contact lens is axially symmetric, The soft lens body has at least a central aspherical portion and a peripheral spherical portion, 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, The peripheral spherical portion has a base curve greater than 8.5 mm. At least a portion of the rear surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, forming a free volume between the rear 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 the refractive error of the eye. Soft contact lenses.

3. These are soft contact lenses for correcting refractive errors of the eye. A soft continuous lens body having a front and a rear surface, configured to cover the corneal surface of the eye. Equipped with, The aforementioned contact lens has a central thickness of approximately 80 microns to approximately 350 microns, and The aforementioned soft contact lens is axially symmetric, The soft lens body has at least a central spherical portion and a peripheral aspherical portion, The central spherical portion has a base curve of less than 9 mm, 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. At least a portion of the rear surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, forming a free volume between the rear 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 the refractive error of the eye. Soft contact lenses.

4. These are soft contact lenses for correcting refractive errors of the eye. A soft continuous lens body having a front and a rear surface, configured to cover the corneal surface of the eye. Equipped with, The aforementioned contact lens has a central thickness of approximately 80 microns to approximately 350 microns, and The aforementioned soft contact lens is axially symmetric, The soft lens body has at least a central spherical portion and a peripheral spherical portion, The central spherical portion has a base curve of less than 9 mm, The peripheral spherical portion has a base curve greater than 9 mm, At least a portion of the rear surface of the soft lens body is configured to be suspended above the corneal surface of the eye when placed thereon, forming a free volume between the rear 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 the refractive error of the eye. Soft contact lenses.

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

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

7. A soft contact lens according to any one of claims 1 to 6, having a Young's modulus of less than 4 MPa.

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

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

10. The soft contact lens according to claim 6, wherein the individual discontinuities are at least one fenestration traversing between the front and rear surfaces.

11. The soft contact lens according to any one of claims 1 to 10, wherein the soft lens body has a front surface, a rear surface, and at least one fenestration traversing between the front surface and the rear surface, and the at least one fenestration is located adjacent to the tear meniscus of the eye.

12. The soft contact lens according to claim 11, wherein the at least one fenestration is configured to be located adjacent to the tear meniscus of the eye to facilitate the flow of tear fluid from there toward the rear surface of the lens body and toward the free volume.

13. The soft contact lens according to claim 12, wherein the tear meniscus is one or more of the upper or lower tear meniscus of the eye.

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

15. The soft contact lens according to claim 12, wherein the at least one fenestration is configured to be located adjacent to the tear meniscus to facilitate the flow of tear fluid into the free volume.

16. The soft contact lens according to claim 12, wherein the at least one fenestration is configured to be located adjacent to the tear film 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 fenestration is located approximately 3 mm to approximately 9 mm from the center of the lens body.

18. A soft contact lens according to claim 10, comprising multiple fenestrations.

19. The soft contact lens according to claim 18, wherein the plurality of fenestrations are evenly distributed around the center of the soft lens body.

20. The soft contact lens according to claim 18, wherein the plurality of fenestrations are unevenly distributed around the center of the soft lens body.

21. The soft contact lens according to claim 18, wherein the plurality of fenestrations are distributed in the circumferential direction.

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

23. The soft contact lens according to claim 18, wherein the plurality of fenestrations are separated from each other by a distance of approximately 1 mm.

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

25. The soft contact lens according to claim 18, wherein the plurality of fenestrations are distributed radially with a radius of approximately 3 mm to approximately 8 mm.

26. The soft contact lens according to claim 18, wherein the plurality of fenestrations are located approximately 3 mm to approximately 9 mm from the center of the soft lens body.

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

28. The soft contact lens according to claim 10, wherein at least one of the fenestrations has a length of about 40 μm to about 600 μm.

29. The soft contact lens according to claim 10, wherein at least one fenestration has a cross-sectional area of ​​about 0.0001 mm² to about 1 mm². .

30. The soft contact lens according to claim 10, wherein the at least one fenestration has a cross-sectional area that is circular in shape.

31. The soft contact lens according to 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 according to claim 1, wherein the peripheral portion begins and extends from the center of the lens with a radius of approximately 3 mm to 8 mm.

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

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

35. The soft contact lens according to claim 18, wherein the plurality of fenestrations are distributed in the circumferential direction.

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

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

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

39. A lens for correcting refractive errors, The lens body has a lens surface and at least one separate discontinuity within the lens surface, and The at least one individual discontinuity is transitioned on the lens surface with at least one transition radius. Furthermore, the at least one transition radius has a base curve greater than 1 mm, lens.

40. The lens according to claim 39, wherein the lens body has an equivalent base curve (EBC), and the EBC is approximately 8.3 mm to 8.8 mm.

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