Method for vision correction

Abstract

Disclosed herein is a soft contact lens for masking astigmatism and other optical aberrations. The soft contact lens has a lens body having a front surface, a rear surface, and at least one aperture penetrating the surfaces. The aperture facilitates or facilitates the flow of tear fluid into the lens volume above the corneal surface of the eye and below the rear surface of the lens body. The tear in the lens volume forms a tear lens to mask astigmatism or other optical aberrations. Further described herein are arrangements, sizes, and geometries of at least one aperture to optimally promote or facilitate tear flow to form a tear lens. The aperture may be configured to optimize tear flow from the eye near a tear meniscus.

Description

[0001] Cross-references

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 429,049, filed November 30, 2022, the contents of which are incorporated herein by reference in their entirety. Background Art

[0003] Astigmatism is a refractive error caused by a rotational asymmetry of the eye's refractive power. The underlying mechanism involves an irregular curvature of the cornea or an abnormality of the eye's lens. People with astigmatic corneas may need contact lenses that correct for different refractive errors in at least two meridians. Additionally, those with this refractive error and who use contact lenses may have many different front surface optical powers. The optical power at each meridian, the angle between meridians, and / or the diameter at which the optical power difference occurs typically vary from individual to individual. Current solutions for treating this corneal irregularity rely on a contact lens that has more than one base curve and has features that allow the lens to be aligned and / or rotated to the wearer's specific astigmatism axis, for example, by relying on structural elements such as prism ballasts, dynamic stabilization components, and other components. Such lenses are generally referred to as toric lenses. However, toric lenses typically require the manufacture of multiple lenses for each power difference and each angle between meridians. It is generally believed that opposite meridians have relatively similar curvatures, and that a deviation of + / - 5 degrees is generally not noticeable, so that for an axis step of 10 degrees, 18 lenses are typically required for each spherical and cylindrical power combination to cover the range of astigmatism a patient may have. Therefore, there is a need for solutions to reduce the number of different contact lenses that need to be manufactured and stored, and to improve treatment options for patients suffering from astigmatism or, generally, other optical aberrations. Summary of the Invention

[0004] Refractive errors in the eye are often poor vision, such as blurred or distorted vision, because the eye cannot focus light on the retina. Common refractive errors include, but are not limited to, myopia (nearsightedness), hyperopia (hyperopia), presbyopia, and astigmatism. Astigmatism is typically caused by an irregularly shaped cornea, where the non-spherical or variable curvature of the cornea causes light to focus at different points on the retina. In some cases, refractive errors include higher-order aberrations (e.g., third order or higher) that are difficult to correct, including, but not limited to, corneal coma, trefoil, and spherical aberration.

[0005] For those with refractive errors in the eye, contact lenses (including toric soft lenses and rigid gas permeable (RGP) contact lenses) can be used to correct the refractive error to help focus light onto the retina. In some cases, specialized and / or personalized contact lenses with a variety of different features can be needed to correct for corneal irregularities. In some cases, various features allow the lens to align and / or rotate to the specific astigmatism axis of the user, for example, by relying on structural elements such as prism ballast, dynamic stabilizing elements, etc. In some cases, to correct for astigmatism, a cylindrical lens (a section cut from a cylinder) can be used, where the cylindrical lens has no refractive power along one axis and is concave or convex along the other axis. Thus, a contact lens that can correct refractive errors with one or fewer designs would be beneficial, as such a contact lens can reduce the number of different types of contact lenses that need to be manufactured and tried on by a subject to find a suitable contact lens.

[0006] Soft contact lenses designed to form a tear lens when worn on the eye have been developed to correct refractive errors. Such lenses can correct vision without the need for prism ballast and / or dynamic stabilizing elements, nor the need to rotate the lens to a desired orientation. Such soft contact lenses with a tear lens can have a domed portion with a space for a lenticular volume between the lens and the cornea that can be filled with tears. The lenticular volume, together with the soft contact lens, forms a lenticular lens that facilitates vision correction. In some cases, the soft contact lens can have at least one fenestration that facilitates filling the lenticular volume. In some cases, the at least one fenestration is proximate to or in continuous contact with the tear meniscus of the eye, which allows tears to continuously flow into and out of the lenticular volume during wear. In some cases, the continuous fluid flow facilitates promoting eye and / or corneal health. In some cases, the continuous fluid flow facilitates delivering at least one of nutrients, oxygen, or eye lubricants, or combinations thereof. In some cases, the at least one or more fenestrations can be disposed on a traditional toric contact lens with a toric element (e.g., prism ballast or dynamic stabilizer). In some cases, the at least one or more fenestrations in a toric contact lens with a toric element can improve user comfort by providing improved fluid flow and improved delivery of at least one of nutrients, oxygen, or eye lubricants. In some cases, the number and location of fenestrations are carefully designed to improve user comfort and ensure continuous contact of the at least one fenestration with the tear meniscus. In some cases, the number and location of fenestrations can be influenced by the lens rotation ability (e.g., free rotation or angle-limited rotation or no rotation).

[0007] The present disclosure relates generally to vision and treatment of the eye to provide improved vision. While specific reference is made to overlays for vision correction, such as soft contact lenses, embodiments of the present disclosure can include other uses and applications, such as correcting optical irregularities or aberrations of the eye, for example, astigmatism.

[0008] In an aspect, the present disclosure provides a soft contact lens for correcting vision of an eye of a subject. In some embodiments, the contact lens masks astigmatism or optical aberrations or irregularities of the eye. In some embodiments, the contact lens includes a soft lens body having an anterior surface, a posterior surface, and at least one fenestration through the anterior and posterior surfaces. The posterior surface of the lens body can be configured to, when applied on a corneal surface of the eye with the eyelids of the eye open, form a fitting portion that substantially conforms to a relatively flat region of the corneal surface and a vaulted portion that forms a lens volume between a relatively steep region of the corneal surface and the posterior surface of the body. The at least one fenestration can be configured to be positioned proximate to a tear meniscus when the soft lens body is applied on the corneal surface with the eyelids of the eye open, for example, to facilitate flow of tear fluid from the tear meniscus to the lens volume, thereby forming a tear lens.

[0009] The lens volume below the lens over the steeper corneal region can be pushed peripherally with each blink and can be pushed out of the lens. Once the lens is fitted to the cornea over the steeper meridian, negative pressure can be created in these regions below the lens. This negative pressure can be utilized to draw fluid back and replenish the tear fluid volume below the lens over the steeper meridian. Thus, this fluid volume below the lens can need to be replenished in order to maintain its function of masking irregularities using the lens fluid volume. This replenishment of tear fluid is done via the fenestration(s). In order to achieve optimal replenishment (e.g., rapid replenishment so that the user does not experience vision different from the optimal vision prior to the blink), the fenestration should preferably have access to a relatively larger pool of tear fluid. While there is tear fluid on the anterior surface of the lens, this tear film is very thin (about 3 microns) and can not enable efficient and rapid movement of fluid into the fenestration and below the lens. However, if this fenestration has access to a larger pool of fluid volume, this replenishment can be done in a more clinically desirable manner. The tear meniscus is a significantly larger pool of fluid relative to the tear film on the anterior surface of the lens, a pool that is about ten times larger or more.

[0010] In some embodiments, the tear lens is configured to at least partially correct astigmatism of the eye. The tear lens can be configured to at least partially correct optical aberrations of the eye.

[0011] In some embodiments, the at least one fenestration has a geometry configured to facilitate flow of tear fluid from a tear meniscus to the lens volume. In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus to facilitate flow of tear fluid from the tear meniscus to the lens volume, from a front surface of the lens body to a back surface of the lens body and to the lens volume.

[0012] In some embodiments, the tear meniscus is one or more of a superior meniscus or an inferior meniscus of the eye of the subject.

[0013] In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus to facilitate flow of tear fluid to the lens volume regardless of an orientation of the lens body relative to the tear meniscus when the lens body is applied on the corneal surface with the eyelids of the eye open.

[0014] In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus to facilitate flow of tear fluid to the lens volume, wherein the contact lens does not include a toric element (e.g., prism ballast, dynamic stabilizer, peripheral ballast, truncation) to rotationally orient the contact lens.

[0015] In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus to facilitate flow of tear fluid to the lens volume, wherein the contact lens includes a toric element (e.g., prism ballast, dynamic stabilizer, peripheral ballast, truncation) to rotationally orient the contact lens. Such toric element can be used to align the at least one fenestration with the tear meniscus. In some embodiments, the toric element does not need to be customized in relation to the orientation of the corneal topography and / or astigmatism.

[0016] In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus at a distance of from about 0.0 mm to about 4 mm away from the tear meniscus when the lens body is applied on the corneal surface with the eyelids of the eye open. At a distance of 0.0 mm, the at least one fenestration proximate to the tear meniscus would overlap and be in direct contact and fluid communication with the tear meniscus. At a distance greater than 0.0 mm, the at least one fenestration proximate to the tear meniscus would be close to the tear meniscus and in substantial fluid communication therewith, i.e., a majority of the tear fluid passing through the at least one fenestration would originate from the tear meniscus. In some embodiments, the at least one fenestration is positioned from about 3 mm to about 9 mm from a center of the lens body. In some embodiments, the at least one fenestration is positioned from about 5 mm to about 8 mm from a center of the lens body.

[0017] In some embodiments, the at least one aperture includes a plurality of apertures. The plurality of apertures may be evenly distributed around the center of the soft lens body. The plurality of apertures may be unevenly distributed around the center of the soft lens body. The plurality of apertures may be circumferentially distributed. The plurality of apertures may be radially distributed. At least one of the plurality of apertures may be spaced approximately 1 mm apart from an adjacent aperture. The plurality of apertures may be distributed along at least one meridian of the soft lens body. The radius defined by the radially distributed plurality of apertures may be approximately 3 mm to approximately 8 mm. The plurality of apertures may be positioned approximately 3 mm to approximately 9 mm from the center of the soft lens body. The plurality of apertures may be distributed along the length of the soft lens body. The length of the soft lens body may be a radius, diameter, or circumference of the lens body. The length of the soft lens body may be approximately 4 mm to approximately 45 mm.

[0018] In some embodiments, the length of the at least one aperture from the front surface to the back surface is about 40 μm to about 600 μm. The at least one aperture may have a length of about 0.0001 mm. 2 to about 1mm 2 The at least one fenestration may have a cross-sectional area that is circular in shape. The at least one fenestration may include 1 to 25 fenestrations.

[0019] In some embodiments, the soft lens body is made of a soft material.

[0020] Some embodiments may include methods of correcting vision. One exemplary method may include applying at least one of the contact lenses described herein to a corneal surface of an eye of a subject with an eyelid open.

[0021] While different corneal base curves for different subjects would appear to necessitate providing a set of lenses with a wide range of base curves to achieve an optimal fit, it has been discovered that little or no adaptation of the lens base curves is required to accommodate a wide range of corneal base curves. Some embodiments herein also include methods for correcting vision in a subject. One exemplary method may include the steps of identifying a subject in need of vision correction comprising masking astigmatism or an optical aberration of the subject's eye; and providing the subject with at least one of the contact lenses described herein, wherein the need to adapt the base curve of at least one contact lens to the base curve of the subject's cornea is minimized, and in some cases, no need to adapt the base curve of at least one contact lens to the base curve of the cornea.

[0022] Some embodiments herein also include methods for correcting vision of a subject. An example method for correcting vision of a subject can include: identifying a subject in need of vision correction, the vision correction including masking astigmatism or optical aberrations of the subject’s eye; and providing the subject with at least one contact lens, which can include (i) measuring astigmatism, optical aberrations, or other refractive errors of the subject’s eye, and (ii) selecting a contact lens from a set of contact lenses that is suitable for correcting vision of the eye, including masking any astigmatism or optical aberrations. The set can have less than 18 contact lenses, i.e., a typical number of standard contact lenses provided in a kit for covering a range of astigmatism that a subject can have, e.g., a kit can provide 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, or 2 lenses or even just 1 lens.

[0023] In another aspect, the disclosure provides methods for correcting vision of an eye of a subject. In some embodiments, the method includes the steps of: applying a contact lens having a soft lens body and at least one fenestration on a corneal surface of an eye of a subject with the eyelids of the eye open, such that a back surface of the lens body forms a conformal portion that substantially conforms to a relatively flat region of the corneal surface and an arch portion that forms a lens volume between a relatively steep region of the corneal surface and the back surface of the lens body. The at least one fenestration can be positioned proximate to a tear meniscus, e.g., to facilitate flow of tear fluid from the tear meniscus to the lens volume, thereby forming a tear lens. The at least one fenestration can be positioned proximate to a tear meniscus to facilitate flow of tear fluid from the tear meniscus to the lens volume, thereby forming a tear lens.

[0024] In some embodiments, the tear lens is configured to at least partially correct astigmatism of the eye. The tear lens can be configured to at least partially correct optical aberrations of the eye.

[0025] In some embodiments, the at least one fenestration is positioned proximate to a tear meniscus to facilitate flow of tear fluid from the tear meniscus to the lens volume, from a front surface of the lens body to a back surface of the lens body, and to the lens volume.

[0026] In some embodiments, the tear meniscus is one or more of a superior meniscus or an inferior meniscus of the eye of the subject.

[0027] In some embodiments, the at least one fenestration is positioned proximate to a tear meniscus to facilitate flow of tear fluid from the tear meniscus to the lens volume, regardless of an orientation of the lens body relative to the tear meniscus when the lens body is applied on the corneal surface with the eyelids of the eye open.

[0028] In some embodiments, the at least one fenestration is positioned proximate to the tear meniscus at a distance of from about 0.0 mm to about 4 mm away when the lens body is applied on the corneal surface with the eyelids of the eye open. At a distance of 0.0 mm, the at least one fenestration proximate to the tear meniscus will overlap and be in direct contact and fluid communication with the tear meniscus. At a distance greater than 0.0 mm, the at least one fenestration proximate to the tear meniscus will be close to and in substantial fluid communication with the tear meniscus, i.e., a majority of the tear fluid passing through the at least one fenestration will originate from the tear meniscus. In some embodiments, the at least one fenestration is positioned from about 3 mm to about 9 mm from the center of the lens body. In some embodiments, the at least one fenestration is positioned from about 5 mm to about 8 mm from the center of the lens body.

[0029] In one aspect, the present disclosure provides a contact lens for correcting vision of an eye of a subject, the contact lens comprising: a soft lens body having an anterior surface, a posterior surface, and at least one fenestration through between the anterior surface and the posterior surface; wherein the posterior surface of the lens body is configured to, when applied on a corneal surface of the eye with eyelids of the eye open, form a fitting portion that substantially conforms to a relatively flat region of the corneal surface and an arch portion that forms a lens volume between a relatively steep region of the corneal surface and the posterior surface of the lens body; wherein the at least one fenestration is configured to be positioned proximate to a tear meniscus when the lens body is applied on the corneal surface with the eyelids of the eye open.

[0030] In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus when the lens body is applied on the corneal surface with the eyelids of the eye open to facilitate flow of tear fluid from the tear meniscus to the lens volume, thereby forming a tear lens.

[0031] In some embodiments, the tear lens is configured to at least partially correct astigmatism of the eye.

[0032] In some embodiments, the tear lens is configured to at least partially correct optical aberrations of the eye.

[0033] In some embodiments, the at least one fenestration has a geometry configured to facilitate flow of tear fluid from the tear meniscus to the lens volume.

[0034] In some embodiments, the at least one fenestration is configured to be positioned proximate to a tear meniscus to facilitate flow of tear fluid from the tear meniscus to the lens volume, from the anterior surface of the lens body to the posterior surface of the lens body and to the lens volume.

[0035] In some embodiments, the tear meniscus is one or more of an upper meniscus or a lower meniscus of the eye of the subject.

[0036] In some embodiments, the at least one fenestration is configured to be positioned proximate to the tear meniscus to facilitate tear flow to the lens volume when the lens body is applied on the corneal surface with the eyelids of the eye open, regardless of the orientation of the lens body relative to the tear meniscus.

[0037] In some embodiments, the at least one fenestration is configured to be positioned proximate to the tear meniscus to facilitate tear flow to the lens volume.

[0038] In some embodiments, the contact lens does not include a rotational orientation feature.

[0039] In some embodiments, the rotational orientation feature includes a prism ballast or a stabilizing dynamic element.

[0040] In some embodiments, the at least one fenestration is configured such that one of the at least one fenestrations is always proximate to the tear meniscus during wear.

[0041] In some embodiments, the contact lens includes a rotational orientation feature.

[0042] In some embodiments, the rotational orientation feature includes a prism ballast or a stabilizing dynamic element.

[0043] In some embodiments, the rotational orientation feature is not customized to the corneal topography or astigmatism.

[0044] In some embodiments, the at least one fenestration is configured to be positioned proximate to the tear meniscus at a distance of from about 0.0 mm to about 4 mm away when the lens body is applied on the corneal surface with the eyelids of the eye open.

[0045] In some embodiments, the at least one fenestration is positioned from about 3 mm to about 9 mm from the center of the lens body.

[0046] In some embodiments, the at least one fenestration is positioned from about 5 mm to about 8 mm from the center of the lens body.

[0047] In some embodiments, the at least one fenestration includes a plurality of fenestrations.

[0048] In some embodiments, the plurality of fenestrations is evenly distributed around the center of the soft lens body.

[0049] In some embodiments, the plurality of fenestrations is unevenly distributed around the center of the soft lens body.

[0050] In some embodiments, the plurality of fenestrations is distributed circumferentially.

[0051] In some embodiments, the plurality of fenestrations is distributed radially.

[0052] In some embodiments, adjacent fenestrations are separated from each other by a distance of about 1 mm.

[0053] In some embodiments, the plurality of fenestrations are distributed along at least one meridian of the soft lens body.

[0054] In some embodiments, the radius defined by the radially distributed plurality of fenestrations is about 3 mm to about 8 mm.

[0055] In some embodiments, the plurality of fenestrations are positioned about 3 mm to about 9 mm from the center of the soft lens body.

[0056] In some embodiments, the plurality of fenestrations are distributed along the length of the soft lens body.

[0057] In some embodiments, at least one fenestration of the plurality of fenestrations is positioned proximate to the constant tear meniscus.

[0058] In some embodiments, the length of the soft lens body is the radius, diameter, or circumference of the lens body.

[0059] In some embodiments, the length of the soft lens body is about 4 mm to about 45 mm.

[0060] The length of the at least one fenestration from the anterior surface to the posterior surface is about 40 pm to about 600 pm.

[0061] In some embodiments, the at least one fenestration has a cross-sectional area of about 0.0001 mm 2 to about 1 mm 2 .

[0062] In some embodiments, the at least one fenestration has a cross-sectional area that is shaped as a circle.

[0063] In some embodiments, the at least one fenestration comprises 1 to 25 fenestrations.

[0064] In some embodiments, the soft lens body is made of a soft material.

[0065] In another aspect, the present disclosure provides a method of correcting vision of an eye of a subject, the method comprising: applying the contact lens of the present disclosure on a corneal surface of the eye of the subject with the eyelid of the eye open.

[0066] In another aspect, the present disclosure provides a method for correcting vision of an eye of a subject, the method comprising: identifying a subject in need of vision correction, the vision correction comprising masking an optical aberration or astigmatism of the eye of the subject; and providing the contact lens of the present disclosure to the subject, wherein the need to adapt the base curve of the contact lens to the base curve of the cornea of the eye of the subject is minimized.

[0067] In some embodiments, a contact lens is provided to a subject without fitting the base curve of the contact lens to the subject's eye.

[0068] In another aspect, the present disclosure provides a method for correcting vision in an eye of a subject, the method comprising applying a contact lens having a soft lens body and at least one window onto a corneal surface of the eye of the subject with an eyelid of the eye open, such that the posterior surface of the lens body forms a conforming portion that substantially conforms to a relatively flat area of ​​the corneal surface and an arched portion that forms a lens volume between a relatively steep area of ​​the corneal surface and the posterior surface of the lens body, wherein the at least one window is positioned adjacent to the tear meniscus.

[0069] In some embodiments, at least one fenestration is positioned adjacent the tear meniscus to facilitate flow of tear liquid from the tear meniscus to the lens volume, thereby forming a tear lens.

[0070] In some embodiments, the tear lens is configured to at least partially correct astigmatism of the eye.

[0071] In some embodiments, the tear lens is configured to at least partially correct optical aberrations of the eye.

[0072] In some embodiments, at least one fenestration has a geometry configured to facilitate tear fluid flow from the tear meniscus to the lens volume.

[0073] In some embodiments, at least one fenestration is positioned adjacent the tear meniscus to facilitate tear flow from the tear meniscus to the lens volume, from adjacent the anterior surface of the lens body to the posterior surface of the lens body and to the lens volume.

[0074] In some embodiments, the tear meniscus is one or more of the superior meniscus or inferior meniscus of the subject's eye.

[0075] In some embodiments, at least one fenestration is positioned adjacent to the tear meniscus to facilitate tear flow from the tear meniscus to the lens 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 eyelid open.

[0076] In some embodiments, the at least one fenestration is configured to be positioned adjacent to the tear meniscus at a distance of about 0.0 mm to about 4 mm when the lens body is applied to the corneal surface with the eyelid open.

[0077] In some embodiments, the at least one aperture is positioned from about 3 mm to about 9 mm from the center of the lens body.

[0078] In some embodiments, the at least one window is positioned from about 5 mm to about 8 mm from the center of the lens body.

[0079] In some embodiments, the at least one window comprises a plurality of windows.

[0080] Additional aspects and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description, which is only illustrative of specific embodiments of the disclosure. It will be appreciated that the disclosure is capable of variations and modifications other than those specifically set forth herein, and that its multiple details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0081] Incorporation by Reference

[0082] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent there is a conflict between the disclosure of this specification and the disclosure of a publication, patent, or patent application incorporated herein by reference, the disclosure of this specification shall control. BRIEF DESCRIPTION OF DRAWINGS

[0083] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which:

[0084] Figure 1 is an illustration depicting the anatomical structure of an eye.

[0085] Figure 2A is an illustration depicting a side view of a soft contact lens having a circumferentially distributed window in accordance with some embodiments of the present disclosure.

[0086] Figure 2B is an illustration depicting a front view of a soft contact lens having a circumferentially distributed window in accordance with some embodiments of the present disclosure.

[0087] Figure 2C is an illustration depicting Figure 2A and Figure 2B a soft contact lens having a circumferentially distributed window positioned proximate to the upper and lower tear menisci.

[0088] Figure 2D is an illustration depicting a corneal surface, Figures 2A to 2C a soft contact lens having a circumferentially distributed window is disposed on the corneal surface.

[0089] Figure 3A is a side view of a soft contact lens having radially distributed window holes according to some embodiments of the present disclosure.

[0090] Figure 3B is a front view of a soft contact lens having radially distributed window holes according to some embodiments of the present disclosure.

[0091] Figure 3C is a depiction of a soft contact lens having circumferentially distributed window holes positioned near the upper and lower tear menisci. Figure 3A and Figure 3B is a depiction of a soft contact lens having circumferentially distributed window holes positioned near the upper and lower tear menisci.

[0092] Figure 3D shows a corneal surface, Figures 3A to 3B a soft contact lens having circumferentially distributed window holes is disposed on the corneal surface. DETAILED DESCRIPTION

[0093] In the following detailed description, references are made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments. The drawings are for purposes of illustration only and the embodiments described herein can have other embodiments, and be practiced or carried out in various ways. One skilled in the art will readily recognize from the following description that alternative embodiments of the present disclosure can be employed without departing from the scope of the concept disclosed herein.

[0094] While certain embodiments and examples are disclosed herein, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses of the invention and obvious modifications and equivalents thereof. It is therefore not intended that the scope of the appended claims be limited to the specifically recited embodiments herein. For instance, in any method or process disclosed herein, the acts or operations can be performed in any suitable order and are not necessarily limited to any particular

[0095] For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all of these aspects or advantages are achieved in any particular embodiment. Thus, for example, various embodiments can be performed that achieve or optimize one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as can also be taught or suggested herein.

[0096] Definitions

[0097] Unless otherwise defined, all technical terms as used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. As used herein, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Any reference to “or” as used herein means “and / or” unless otherwise indicated to indicate a sole alternative (i.e., the phrase “A / B” means “A or B” but not both). It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude 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 can be abbreviated as “ / ”.

[0098] Spatially relative terms, such as “beneath,” “below,” “lower,” “above,” “upper” and the like, can be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the exemplary term “below” can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly,” “downwardly,” “vertical,” “horizontal,” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0099] While the terms “first” and “second” can be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms. These terms can be used to distinguish one feature / element from another feature or element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present disclosure.

[0100] Throughout this specification and the following claims, unless the context otherwise requires, the word "comprise," and variations such as "comprises" and "comprising," will be understood to mean various components can be co-used in the methods and articles (e.g., compositions and devices comprising devices and methods). For example, the term "comprising" will be understood as implying inclusion of any recited elements or steps, but not precluding any other elements or steps.

[0101] Whenever the term "at least," "greater than," or "greater than or equal to" precedes the first numerical value in a series of two or more numerical values, the term "at least," "greater than," or "greater than or equal to" applies to each of the numerical values in that series of numerical values. 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.

[0102] Whenever the term "no more than," "less than," "less than or equal to," or "at most" precedes the first numerical value in a series of two or more numerical values, the term "no more than," "less than," "less than or equal to," or "at most" applies to each of the numerical values in that series of numerical values. 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.

[0103] In the case where values are described as ranges, it is understood that the disclosure includes disclosure of all possible subranges of such ranges, whether or not a particular numerical value or a particular sub-range is expressly stated, whether the range is absolute or relative.

[0104] As used herein in the specification and claims, including in the examples, all numbers are to be interpreted as approximations rather than exact measurements, unless expressly indicated otherwise. When describing amplitude and / or location, the phrases "about" or "approximate" can be used to indicate that the described value and / or location allows for a reasonable range of variability as is expected by one of ordinary skill in the art in making the described measurement or determination. For example, a numerical value has a value that can be the stated value (or range of values) + / -0.1%, the stated value (or range of values) + / -1%, the stated value (or range of values) + / -2%, the stated value (or range of values) + / -5%, the stated value (or range of values) + / -10% and so on. Unless otherwise indicated, any numerical values given herein are to be understood as being approximate or about. For example, if a value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, although not always explicitly stated (unless otherwise indicated herein). For example, if a value "X" is disclosed then "less than or equal to X" as well as "greater than or equal to X" (for example, where X is a number) is also disclosed. It is further understood that the endpoints of all ranges recited herein are not limiting. For example, if a range of "1 to 10" is disclosed, then it is understood that values such as 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 are also disclosed. It is also understood that the specific data values given herein are not to be construed as limiting. For example, if a numerical value is given as "10", then it is understood that values such as "about 10" are also disclosed. Further, it is understood that the data recited herein is to be interpreted in the context of the specification as a whole. For example, if a specific data point "10" is disclosed, then it is understood that "less than or equal to 10" and "greater than or equal to 10" are also disclosed. Further, it is understood that the data recited herein is to be interpreted in the context of the specification as a whole. For example, if a specific data point "10" is disclosed, then it is understood that "less than or equal to 10" and "greater than or equal to 10" are also disclosed. Further, it is understood that the data recited herein is to be interpreted in the context of the specification as a whole. For example, if a specific data point "10" is disclosed, then it is understood that "less than or equal to 10" and "greater than or equal to 10" are also disclosed.

[0105] Many features of the present disclosure are described in relation to the anatomy of the eye of a subject. The eye includes several tissues that enable a subject or individual to see. The subject can be an animal. The subject can be a human, such as a human patient. The subject can need vision treatment, such as treatment of one or more refractive errors of the eye, including myopia, hyperopia, astigmatism, coma, or coma aberration, or other optical aberrations. The cornea of the eye is the front region of the eye that is transparent in a healthy eye and that, in combination with the natural lens of the eye, refracts light to focus the light on the retina. The retina is the back region of the eye that senses light focused thereon and that transmits signals indicative of the focused light to the brain, which forms an image based on the sensed and focused light. The cornea includes an outer layer of tissue, namely, 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 disposed on the epithelium. The tear film can smooth out small irregularities of the epithelium to provide an optically smooth surface. The shape of the tear film is substantially determined by the shape of the underlying epithelium, stroma, and Bowman’s membrane, if present. The tear film includes a liquid that is primarily water but also includes additional components, such as mucin and lipids. Many of the nerve fibers of the cornea provide sensation to promote blinking, which can coat the cornea with tear film. The nerve fibers can also sense pain, such that the subject will generally avoid injury to the cornea and also avoid direct contact of objects to the cornea.

[0106] Figure 1is a diagram depicting the anatomy of the eye. The eye includes a horizontal palpebral fissure ("HEF") defined by the distance between the nasal and temporal canthi; a medial canthus to temporal canthus ("NC-TC") defined by the vertical distance between the medial canthus and the temporal canthus, e.g., when the NC-TC value is greater than 0, the medial canthus is superior to (i.e., above) the temporal canthus; a pupil center to temporal canthus ("PC-TC") defined by the horizontal distance from the center of the pupil to the temporal canthus; a pupil center to upper eyelid ("PC-UL") defined by the vertical distance from the center of the pupil to the upper eyelid; a pupil center to lower eyelid ("PC-LL") defined by the vertical distance from the center of the pupil to the lower eyelid; a palpebral aperture ("PA") defined by the vertical distance between the upper and lower eyelids measured at the center of the pupil (i.e., the sum of PC-UL and PC-LL); and a vertical distance from the medial canthus to the lower eyelid. the inferior nasal aperture ("INA") defined by the angle between the temporal canthus and the medial canthus, e.g., when the θHEF value is greater than 0, the medial canthus is higher than (i.e., above) the temporal canthus; the θ-upper lid (θ-UL) defined by the angle between a line connecting two points where the upper eyelid intersects the limbus and a horizontal line, e.g., when the θ-UL value is greater than 0, the nasal portion of the central upper eyelid is higher than (i.e., above) the temporal portion of the central upper eyelid; and the θ-lower lid (θ-LL) defined by the angle between a line connecting two points where the lower eyelid intersects the limbus and a horizontal line, e.g., when the θ-LL value is greater than 0, the nasal portion of the central lower eyelid is higher than (i.e., above) the temporal portion of the central lower eyelid.

[0107] Contact lenses with improved fluid flow are described herein for forming a tear lens on the corneal surface of an eye with astigmatism or optical aberrations. Figure 2A 、 Figure 2B 、 Figure 2C 、 Figure 2D 、 Figure 3A 、 Figure 3B 、 Figure 3C and Figure 3Dare illustrations depicting various perspectives of contact lenses of the present disclosure, according to some embodiments. The contact lenses of the present disclosure can include a soft lens body. In some embodiments, the soft lens body has an anterior surface, a posterior surface, and at least one fenestration through the anterior surface and the posterior surface. The posterior surface of the lens body can be configured to, when applied on a corneal surface of an eye with the eyelids of the eye open, form a fitting portion that substantially conforms to a relatively flat region of the corneal surface and an arching portion that forms a lens volume between a relatively steep region of the corneal surface and the posterior surface of the lens body. The arching portion can be supported by the fitting portion on the relatively steep region of the corneal surface. A

[0108] A standard soft contact lens typically conforms to the corneal surface due to the adhesive force between the posterior surface of the lens and the corneal surface and the downward pressure caused by the eyelids during blinking. In irregular or astigmatic corneas, a standard soft contact lens generally assumes the shape of the irregularity or astigmatism of the cornea when conforming to the corneal surface. Thus, the anterior surface of a standard soft contact lens will generally assume the shape of the anterior surface of the cornea (and not form a lens volume or a tear lens as described above). For example, upon blinking, the downward pressure from the eyelids will cause a standard soft contact lens to immediately assume the shape of the anterior surface of the cornea. The conformance of the contact lens to the corneal surface causes fluid to be displaced between the contact lens and the corneal surface.

[0109] If fluid (such as tear fluid or artificial tear fluid) does not flow or does not flow fast enough (i.e., the fluid has low delivery capacity) to enter the space between the back surface of the contact lens and the corneal surface, the lens can not fully correct for astigmatism, particularly for contact lenses that rely on forming a tear lens to correct for astigmatism or other optical aberrations. Thus, a subject wearing a soft contact lens with limited flow can experience a decrease in vision over time. In order for such a contact lens to function without or with minimal visual disturbance, the lens body itself should be able to mask about 0.25 D or more so that the wearer is rarely or not aware that the lens assumes an irregular shape during blinking.

[0110] In standard soft contact lenses, windows and / or holes are typically used to facilitate increased oxygen supply to the cornea compared to contact lenses without windows and / or holes. However, while these types of windows connect the front surface of the lens to the back surface of the lens, they do not allow fluid from the tear film residing on the front surface of the contact lens to be transported through the perforations to the lens volume between the back surface of the lens and the steep region of the corneal surface.

[0111] The contact lenses of the present disclosure include at least one window configured to facilitate the flow of fluid (such as tear fluid or artificial tear fluid) between the back surface of the contact lens and the corneal surface of the eye. In some embodiments, the fitting portion of the lens that overlies the relatively flat region of the corneal surface supports the non-fitting, vaulted, or arcuate portion of the lens, allowing the fluid to fill the lens volume formed between the arcuate portion of the lens and the steep region of the cornea. By filling the lens volume between the back surface of the lens and the steep region of the cornea, the lens can assume a shape closer to its as-manufactured shape. In some embodiments, the vaulting of the contact lens facilitates filling of the lens volume with fluid. In some embodiments, the at least one window allows for increased oxygen transport through the lens to the cornea compared to a contact lens having only holes. In some embodiments, the at least one window allows for increased oxygen transport through the lens to the cornea compared to a contact lens without holes and / or without windows.

[0112] Factors that determine the flow of fluid through a contact lens include fluid availability, flow resistance, lens material properties such as chemical properties (e.g., hydrophilicity or hydrophobicity), mechanical properties (e.g., modulus and elasticity), geometry of the lens, or a combination thereof.

[0113] Fluid availability

[0114] To provide sufficient fluid flow to the lens volume, the contact lens should have access to a fluid source with sufficient volume. Typically, the total amount of accessible tear fluid is between about 1.5 pL to about 7 pL, with 75% to 90% of the tear fluid being held in the tear meniscus. Generally, the remaining amount of tear fluid is held on the surface of the eye and / or between the eyelids. The height of the lower tear meniscus ("LTM") is between about 0.1 mm and about 0.3 mm (e.g., about 0.2 mm to about 0.3 mm). For example, if the at least one fenestration of the contact lens is positioned such that it only has access to the tear film (approximately 310 microns ("pm") thick) that overlies the front surface of the lens, the contact lens can not work as intended due to insufficient amount of accessible tear fluid. Thus, merely placing a fenestration in an arbitrary location can not provide sufficient fluid availability or fluid flow characteristics to allow the fluid to fill the lens volume.

[0115] Figure 2C and Figure 3C is a depiction of a contact lens of the present disclosure disposed on the corneal surface of an eye, the contact lens having a fenestration adjacent to a tear meniscus.

[0116] In some embodiments, for example, the at least one fenestration (fenestrations 201 and / or 301) is positioned adjacent to the tear meniscus (i.e., the volume of tear fluid located at the junction of the bulbar conjunctiva and the lower lid margin) that holds about 75% to 90% of the total amount of tear fluid that exposes the ocular surface. In some embodiments, the tear fluid is produced by the main lacrimal gland (230 or 330) and / or the accessory lacrimal gland (240 or 340), as shown in Figure 2C and Figure 3C In some embodiments, the tear meniscus can be one or more of the superior meniscus (210 or 320) or the inferior meniscus (220 or 320), as shown in Figure 2C and Figure 3C In some embodiments, the tear fluid drains from the superior or inferior meniscus into the canaliculi (250 or 350), into the lacrimal sac (260 or 360), and through the nasolacrimal duct (270 or 370), as shown in Figure 2C and Figure 3C

[0117] ​In some embodiments, at least one window 201 and / or 301 being adjacent to the tear meniscus means that the at least one window is at least about 0 mm, at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, at least 0.9 mm, at least 1 mm, at least 1.1 mm, at least 1.2 mm, at least 1.3 mm, at least 1.4 mm, at least 1.5 mm, at least 1.6 mm, at least 1.7 mm, at least 1.8 mm, at least 1.9 mm, at least 2 mm, at least 2.1 mm, at least 2.2 mm, at least 2.3 mm, at least 2.4 mm, at least 2.5 mm, at least 2.6 mm, at least 2.7 mm, at least 2.8 mm, at least 2.9 mm, at least 3.0 mm, at least 3.1 mm, at least 3.2 mm, at least 3.3 mm, at least 3.4 mm, at least 3.5 mm, at least 3.6 mm, at least 3.7 mm, at least 3.8 mm, at least 3.9 mm, at least 4.0 mm, or any value therebetween (e.g., when measured from the boundary of the tear meniscus or when measured from the center of the tear meniscus) from the nearest tear meniscus. In some embodiments, at least one window 201 and / or 301 being adjacent to the tear meniscus means that the at least one window is at most about 4.0 mm, at most 3.9 mm, at most 3.8 mm, at most 3.7 mm, at most 3.6 mm, at most 3.5 mm, at most 3.4 mm, at most 3.3 mm, at most 3.2 mm, at most 3.1 mm, at most 3.0 mm, at most 2.9 mm, at most 2.8 mm, at most 2.7 mm, at most 2.6 mm, at most 2.5 mm, at most 2.4 mm, at most 2.3 mm, at most 2.2 mm, at most 2.1 mm, at most 2.0 mm, at most 1.9 mm, at most 1.8 mm, at most 1.7 mm, at most 1.6 mm, at most 1.5 mm, at most 1.4 mm, at most 1.3 mm, at most 1.2 mm, at most 1.1 mm, at most 1.0 mm, at most 0.9 mm, at most 0.8 mm, at most 0.7 mm, at most 0.6 mm, at most 0.5 mm, at most 0.4 mm, at most 0.3 mm, at most 0.2 mm, at most 0.1 mm, at most or 0.1 mm, or any value therebetween (e.g., when measured from the boundary of the tear meniscus or when measured from the center of the tear meniscus) from the nearest tear meniscus. The distance between the at least one window 201 and / or 301 and the tear meniscus can be within a range defined by any two of the foregoing values. For example, the distance between the at least one window 201 and / or 301 and the tear meniscus can be about 0 mm to about 4 mm, e.g., about 0.1 mm to about 4 mm or 0.1 mm to about 1.0 mm. In some embodiments, the position of the window relative to the tear meniscus changes depending on whether the eye is holding a first gaze or gazing downward.In some embodiments, the position of the fenestrations relative to the tear meniscus changes as the eye changes between the first gaze and the downward gaze. In some embodiments, at least one fenestration is adjacent to the tear meniscus at a distance of about 0 mm or greater, regardless of the gaze (e.g., the first gaze or the downward gaze). In some embodiments, at least one fenestration is in contact with the tear meniscus even when the eye gaze position changes. In some embodiments, at least one fenestration covers a portion of the tear meniscus. In some embodiments, at least one fenestration covers a portion of the tear meniscus even when the eye gaze position changes. At a distance of 0 mm, fenestrations 201 and / or 301 that are adjacent to the tear meniscus can overlap and be in direct contact and fluid communication with the tear meniscus. At a distance greater than 0 mm, fenestrations 201 and / or 301 that are adjacent to the tear meniscus can be close to the tear meniscus and in substantial fluid communication therewith, i.e., most of the tear fluid passing through the at least one fenestration would originate from the tear meniscus.

[0118] In some embodiments, at least one fenestration 201 and / or 301 is located proximal (e.g., adjacent) to the tear meniscus regardless of the rotational position of the lens (i.e., the angle of the lens relative to the meridian of the eye).

[0119] The tear meniscus can have an excess of fluid volume relative to the volume of fluid required to fill the lens volume that resides between the back surface of the lens and the corneal surface. In some embodiments, at least one fenestration is positioned adjacent to the tear meniscus of the eye.

[0120] In some embodiments, at least one fenestration is a plurality of fenestrations distributed over a length (i.e., radius, diameter, circumference, or a combination thereof) of the contact lens, as shown in Figure 2B and Figure 3B The length over which the fenestrations are distributed covers the interpalpebral fissure (“IPF”) (i.e., the elliptical space between the medial and lateral canthi of the two eyelids) during far, intermediate, and near gaze. The IPF for far (i.e., the first gaze) is about 9.5 ± 1.0 mm; for intermediate (i.e., a 20 degree gaze), about 8.0 ± 1.0 mm; and for near (i.e., a 40 degree gaze), about 6.5 ± 1.0 mm. In some embodiments, the orientation of the fenestrations does not affect the ability of the lens to provide vision correction. In some embodiments, the orientation of the fenestrations does not affect the ability of the lens to form a lens volume filled with fluid. In some embodiments, the orientation of the fenestrations does not affect the ability of the lens to form a lens volume with tears due to the at least one fenestration being in contact with the tear meniscus during wear by the subject.

[0121] The at least one window 201 and / or 301 can be a plurality of windows distributed over a length (i.e., radius 305, diameter 205, circumference, or a combination thereof) that can be located on a radius (distance from the center) of the contact lens of at least about 2 mm, at least 2.2 mm, at least 2.4 mm, at least 2.6 mm, at least 2.8 mm, at least 3 mm, at least 3.1 mm, at least 3.2 mm, at least 3.3 mm, at least 3.4 mm, at least 3.5 mm, at least 3.6 mm, at least 3.7 mm, at least 3.8 mm, at least 3.9 mm, at least 4 mm, at least 4.1 mm, at least 4.2 mm, at least 4.3 mm, at least 4.4 mm, at least 4.5 mm, at least 4.6 mm, at least 4.7 mm, at least 4.8 mm, at least 4.9 mm, at least 5 mm, at least 5.1 mm, at least 5.2 mm, at least 5.3 mm, at least 5.4 mm, at least 5.5 mm, at least 5.6 mm, at least 5.7 mm, at least 5.8 mm, at least 5.9 mm, at least 6.0 mm, at least 6.1 mm, at least 6.2 mm, at least 6.3 mm, at least 6.4 mm, at least 6.5 mm, at least 6.6 mm, at least 6.7 mm, at least 6.8 mm, at least 6.9 mm, at least 7 mm, at least 7.1 mm, at least 7.2 mm, at least 7.3 mm, at least 7.4 mm, at least 7.5 7.6 mm, at least 7.7 mm, at least 7.8 mm, at least 7.9 mm, at least 8 mm, at least 8.1 mm, at least 8.2 mm, at least 8.3 mm, at least 8.4 mm, at least 8.5 mm, at least 8.6 mm, at least 8.7 mm, at least 8.8 mm, at least 8.9 mm, at least 9 mm, at least 9.5 mm, at least 10 mm, at least 10.5 mm, at least 11 mm, at least 11.5 mm, at least 12 mm, at least 13 mm, at least 14 mm, at least 15 mm, at least 16 mm, at least 17 mm, at least 18 mm, at least 19 mm, at least 20 mm, at least 25 mm, at least 30 mm, at least 35 mm, at least 40 mm, at least 45 mm, or any value therebetween.In some embodiments, the window holes can be distributed over a length of the contact lens of at most about 45 mm, at most 40 mm, at most 35 mm, at most 30 mm, at most 25 mm, at most 20 mm, at most 19 mm, at most 18 mm, at most 17 mm, at most 16 mm, at most 15 mm, at most 14 mm, at most 13 mm, at most 12 mm, at most 11.5 mm, at most 11 mm, at most 10.5 mm, at most 10 mm, at most 9.5 mm, at most 9 mm, at most 8.9 mm, at most 8.8 mm, at most 8.7 mm, at most 8.6 mm, at most 8.5 mm, at most 8.4 mm, at most 8.3 mm, at most 8.2 mm, at most 8.1 mm, at most 8 mm, at most 7.9 mm, at most 7.8 mm, at most 7.7 mm, at most 7.6 mm, at most 7.5 mm, at most 7.4 mm, at most 7.3 mm, at most 7.2 mm, at most 7.1 mm, at most 7 mm, at most 6.9 mm, at most 6.8 mm, at most 6.7 mm, at most 6.6 mm, at most 6.5 mm, at most 6.4 mm, at most 6.3 mm, at most 6.2 mm, at most 6.1 mm, at most 6 mm, at most 5.9 mm, at most 5.8 mm, at most 5.7 mm, at most 5.6 mm, at most 5.5 mm, at most 5.4 mm, at most 5.3 mm, at most 5.2 mm, at most 5.1 mm, at most 5 mm, at most 4.9 mm, at most 4.8 mm, at most 4.7 mm, at most 4.6 mm, at most 4.5 mm, at most 4.4 mm, at most 4.3 mm, at most 4.2 mm, at most 4.1 mm, at most 4 mm, at most 3.9 mm, at most 3.8 mm, at most 3.7 mm, at most 3.6 mm, at most 3.5 mm, at most 3.4 mm, at most 3.2 mm, at most 3.1 mm, at most 3 mm, at most 2.8 mm, at most 2.6 mm, at most 2.4 mm, at most 2.2 mm, at most 2 mm, or any value therebetween. The window holes can be distributed over a length of the contact lens that can be within a range defined by any two of the foregoing values. For example, the window holes can be distributed over a length of about 2 mm to about 7 mm of the radius of the contact lens. In an example, the window holes can be distributed over a length of about 3 mm to about 6 mm of the radius.

[0122] In some embodiments, the plurality of window holes are distributed equally (i.e., uniformly) about the center of the lens body. In some embodiments, the plurality of window holes are distributed unequally (i.e., non-uniformly) about the center of the lens body.

[0123] In some embodiments, the window holes are distributed circumferentially about the contact lens. Figure 2A and Figure 2Bis an illustration depicting a side view and a top view of a contact lens 200 having circumferential window holes 201. In some embodiments, the number of circumferential window holes 201 is proportional to the circumference of the circle formed by the circumferential window holes 201. The number of circumferential window holes 201 can be approximated by the formula π*radius or ½*π*diameter. For example, when the circle formed by the circumferential window holes 201 has a 6 mm diameter, the number of window holes is about 9 or about half the circumference of the circle formed by the circumferential window holes 201. In another example, when the circle formed by the circumferential window holes 201 has a 14 mm diameter, the number of window holes is about 21 or about half the circumference of the circle formed by the circumferential window holes 201. In some embodiments, the number of window holes is at least about 1, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, at least 15, at least 16, at least 17, at least 18, at least 19, at least 20, at least 21, at least 22, at least 23, at least 24, at least 25, at least 26, at least 27, at least 28, at least 29, at least 30, at least 31, at least 32, at least 33, at least 34, at least 35, at least 36, at least 37, at least 38, at least 39, at least, or 40. In some embodiments, the number of window holes is at most about 40, at most 39, at most 38, at most 37, at most 36, at most 35, at most 34, at most 33, at most 32, at most 31, at most 30, at most 29, at most 28, at most 27, at most 26, at most 25, at most 24, at most 23, at most 22, at most 21, at most 20, at most 19, at most 18, at most 17, at most 16, at most 15, at most 14, at most 13, at most 12, at most 11, at most 10, at most 9, at most 8, at most 7, at most 6, at most 5, at most 4, at most 3, at most 2, at most, or 1. In some embodiments, the window holes are evenly distributed around the circumference. In some embodiments, the window holes are unevenly distributed around the circumference.

[0124] In some embodiments, the window holes are radially distributed. Figure 3A and Figure 3B is an illustration depicting a side view and a top view of a contact lens 300 having radial window holes 301. In some embodiments, the radial window holes 301 are distributed along at least one axis of the lens body, such as an axis defining a meridian of the lens body. In some embodiments, the radii formed by the radial window holes 301 form one or more sectors of the contact lens. The one or more sectors can be defined by an angle 305 between any two adjacent radially distributed window holes.

[0125] In some embodiments, the angle 305 of the one or more sectors can be at least about 1 degree, at least 2 degrees, at least 3 degrees, at least 4 degrees, at least 5 degrees, at least 6 degrees, at least 7 degrees, at least 8 degrees, at least 9 degrees, at least 10 degrees, at least 20 degrees, at least 30 degrees, at least 40 degrees, at least 50 degrees, at least 60 degrees, at least 70 degrees, at least 80 degrees, at least 90 degrees, at least 100 degrees, at least 120 degrees, at least 140 degrees, at least 160 degrees, at least 180 degrees, or any value therebetween. In some embodiments, the angle 305 of the one or more sectors can be at most about 180 degrees, at most 160 degrees, at most 140 degrees, at most 120 degrees, at most 100 degrees, at most 90 degrees, at most 80 degrees, at most 70 degrees, at most 60 degrees, at most 50 degrees, at most 40 degrees, at most 30 degrees, at most 20 degrees, at most 10 degrees, at most 9 degrees, at most 8 degrees, at most 7 degrees, at most 6 degrees, at most 5 degrees, at most 4 degrees, at most 3 degrees, at most 2 degrees, at most 1 degree, or any value therebetween. The one or more sectors can have an angle 305 that can be within a range defined by any two of the foregoing values. For example, the one or more sectors can have an angle 305 of about 1 degree to about 180 degrees. In an example, the one or more sectors have an angle 305 of about 70 degrees to about 90 degrees.

[0126] In some embodiments, the lenses described herein include one or more windows radially distributed from a center of the lens. In some embodiments, the radially distributed windows include one or more windows that extend in a straight line from the center of the lens toward the edge of the lens. In some embodiments, the lens includes one or more radial window lines. In some embodiments, the lens includes one radial window line. In some embodiments, the lens includes two radial window lines. In some embodiments, the lens includes three radial window lines. In some embodiments, the lens includes four radial window lines.

[0127] In some embodiments, the radial window line includes one or more windows. In some embodiments, the radial window line includes one window. In some embodiments, the radial window line includes two windows. In some embodiments, the radial window line includes three windows. In some embodiments, the radial window line includes four windows. In some embodiments, the radial window line includes five windows. In some embodiments, the radial window line includes at most five windows. In some embodiments, the radial window line includes at most four windows. In some embodiments, the radial window line includes at most three windows. In some embodiments, the radial window line includes at most two windows. In some embodiments, the radial window line includes at most one window.

[0128] In some embodiments, a lens having two or more radial window lines is configured such that the angle between two window lines is about 0 degrees to 180 degrees. In some embodiments, two radial window lines are configured to form an angle of about 90 degrees. In some embodiments, two radial window lines are configured to form an angle of about 180 degrees. In some embodiments, a lens comprising two or more radial window lines does not include toric elements. For example, a lens without toric elements comprising two radial window lines distributed about 90 degrees apart can provide sufficient access to the tear meniscus (e.g., the superior or inferior tear meniscus) by at least one window regardless of the orientation of the lens on the eye.

[0129] In some embodiments, a lens comprises one radial window line. In some embodiments, a lens comprises two radial window lines. In some embodiments, a lens comprises three radial window lines. In some embodiments, a lens comprises four radial window lines.

[0130] In some embodiments, a lens comprising one radial window line has a toric element. In some embodiments, the toric element positions the lens such that at least one window in the radial window line is adjacent to the superior or inferior tear meniscus when disposed on the eye. In some embodiments, the toric element positions the lens such that the toric element is in a downward orientation (e.g., 6 o’clock) when the lens is worn on the eye. In some embodiments, the toric element positions the lens such that the toric element is in an upward orientation (e.g., 12 o’clock) when the lens is worn on the eye.

[0131] In some embodiments, at least one window on the lens is adjacent to the tear meniscus. In some embodiments, at least one window of one or more windows on the lens is continuously accessing tear from the tear meniscus (e.g., superior or inferior meniscus) during wear. In some embodiments, at least two windows of one or more windows on the lens are accessing tear from the tear meniscus (e.g., superior or inferior meniscus) during wear. In some embodiments, continuous access to the tear meniscus means being adjacent to or in contact with the tear meniscus for at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of the time the user wears the contact lens. In some embodiments, continuous access is also referred to herein as continuous contact, continuous access, or continuous proximity.

[0132] In some embodiments, a lens with fewer windows can be advantageous because the lens is more comfortable for the wearer compared to a lens with more windows. In some embodiments, minimizing the total number of windows on a lens while simultaneously increasing the interaction between one or more windows and the tear meniscus provides more comfort to the wearer of the lens compared to an otherwise similar lens with a greater number of windows. In some embodiments, the number of windows is selected so as to provide comfort to the user by having fewer surface interruptions (e.g., windows) while simultaneously providing sufficient tear and oxygen exchange.

[0133] Depending on the design of the lens, only 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 windows can be sufficient to achieve various functions, including enabling at least one window to consistently access the tear meniscus. In some embodiments, for lenses with toric elements that allow for a fixed orientation (e.g., no rotation), no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 windows can be sufficient to enable at least one window to consistently access the tear meniscus. In some embodiments, for lenses with toric elements that allow for a fixed orientation (e.g., no rotation), 2 windows can be sufficient to enable at least one window to consistently access the tear meniscus. In some embodiments, for lenses with toric elements that allow for a 180-degree orientation (e.g., 180-degree free rotation), no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 windows can be sufficient to enable at least one window to consistently access the tear meniscus. In some embodiments, for lenses with toric elements that allow for a 180-degree orientation (e.g., 180-degree free rotation), 4 windows can be sufficient to enable at least one window to consistently access the tear meniscus. In some embodiments, for lenses without toric elements (e.g., free rotation), no more than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 windows can be sufficient to enable at least one window to consistently access the tear meniscus. In some embodiments, for lenses without toric elements (e.g., free rotation), 4 windows can be sufficient to enable at least one window to consistently access the tear meniscus.

[0134] In some embodiments, at least 10% or more of the windows on the lens are proximate to the tear meniscus (e.g., the superior or inferior tear meniscus). In some embodiments, at least 20% or more of the windows on the lens are proximate to the tear meniscus (e.g., the superior or inferior tear meniscus). In some embodiments, at least 30% or more of the windows on the lens are proximate to the tear meniscus (e.g., the superior or inferior tear meniscus). In some embodiments, at least 40% or more of the windows on the lens are proximate to the tear meniscus (e.g., the superior or inferior tear meniscus). In some embodiments, at least 50% or more of the windows on the lens are proximate to the tear meniscus (e.g., the superior or inferior tear meniscus). For example, a lens including 4 windows can have 25% (e.g., ¼) of the windows proximate to the tear meniscus. For example, a lens including 4 windows distributed on one radial line can have 25% (e.g., ¼) of the windows proximate to the tear meniscus. For example, a lens including 8 windows can have about 12% (e.g., 1 / 8) of the windows proximate to the tear meniscus. For example, a lens including 8 windows distributed on two radial lines can have about 12% (e.g., 1 / 8) of the windows proximate to the tear meniscus, each line including 4 windows and each line separated by 90 degrees.

[0135] In some embodiments, a lens including a toric element (e.g., a dynamic stabilizer or a weight) includes at least one window positioned proximate to the inferior or superior tear meniscus. In some embodiments, a lens including a toric element (e.g., a dynamic stabilizer or a weight) includes at least two windows, one window positioned proximate to the inferior tear meniscus and another window positioned proximate to the superior tear meniscus. In some embodiments, a lens including a toric element (e.g., a dynamic stabilizer or a weight) includes at least two windows, one window positioned proximate to the inferior tear meniscus and positioned about 3 mm to about 7 mm (e.g., about 5 mm) from the center of the lens, and another window positioned proximate to the superior tear meniscus and positioned about 2 mm to about 4 mm (e.g., about 3.5 mm) from the center of the lens. In some embodiments, when two or more windows are located on a radial line, one window is closer to the center of the lens than the other window.

[0136] In some embodiments, the lens includes a toric element (e.g., a dynamic stabilizer or a weight) and is free to rotate about 180 degrees when disposed on an eye. In some embodiments, the lens including a toric element includes at least two windows, where at least one window is positioned inferiorly (e.g., proximate to the inferior tear meniscus) and at least one window is positioned superiorly (e.g., proximate to the superior tear meniscus). In some embodiments, the lens including a toric element (e.g., a dynamic stabilizer or a weight) includes at least two windows, where at least one window is positioned proximate to the inferior tear meniscus and is positioned from about 3 mm to about 7 mm (e.g., about 5 mm) from the center of the lens, and at least one window is positioned proximate to the superior tear meniscus and is positioned from about 2 mm to about 7 mm (e.g., about 3.5 mm) from the center of the lens. In some embodiments, when two or more windows are located on a radial line, one window is closer to the center of the lens than the other window.

[0137] In some embodiments, the lens includes a toric element (e.g., a dynamic stabilizer or a weight) and is free to rotate about 180 degrees when disposed on an eye. In some embodiments, the lens including a toric element includes at least four windows, where at least two windows are positioned inferiorly (e.g., proximate to the inferior tear meniscus) and at least two windows are positioned superiorly (e.g., proximate to the superior tear meniscus). In some embodiments, the at least two windows positioned toward the inferior tear meniscus are positioned from about 2 mm to about 7 mm (e.g., about 3.5 mm and about 5 mm) from the center of the lens. In some embodiments, the at least two windows positioned toward the superior tear meniscus are positioned from about 2 mm to about 7 mm (e.g., about 3.5 mm and about 5 mm) from the center of the lens. In some embodiments, at least one window is proximate to the inferior tear meniscus or the superior tear meniscus. In some embodiments, when two or more windows are located on a radial line, one window is closer to the center of the lens than the other window.

[0138] In some embodiments, the lens has no toric element and the lens can freely rotate (e.g., the angle of rotation is not limited) when disposed on the eye. In some embodiments, the lens without a toric element includes at least two windows, where the at least two windows are distributed about 90 degrees apart such that at least one window is adjacent to the inferior or superior tear meniscus when the lens is disposed on the eye. In some embodiments, the lens without a toric element includes at least two windows, where the at least two windows are distributed about 90 degrees apart and each window is positioned from about 2 mm to about 7 mm (e.g., about 3.5 mm or about 5 mm) from the center of the lens and positioned such that at least one window is adjacent to the inferior or superior tear meniscus when the lens is disposed on the eye. In some embodiments, when two or more windows are located on a radial line, one window is closer to the center of the lens than the other window.

[0139] In some embodiments, the lens has no toric element and the lens can freely rotate when disposed on the eye. In some embodiments, the lens without a toric element includes at least four windows, where at least two windows are distributed about 90 degrees apart such that at least one window is adjacent to the inferior or superior tear meniscus when the lens is disposed on the eye. In some embodiments, the lens without a toric element includes at least four windows, where at least two windows are distributed about 90 degrees apart and the windows are positioned from about 2 mm to about 7 mm (e.g., about 3.5 mm and about 5 mm) from the center of the lens and positioned such that at least one window is adjacent to the inferior or superior tear meniscus when the lens is disposed on the eye.

[0140] In some embodiments, the distance 302 between each of the radially distributed windows is from about 0.5 mm to about 2 mm. In some embodiments, the distance between each of the radially distributed windows is about 0.5 mm. In some embodiments, the distance between each of the radially distributed windows is about 1 mm. In some embodiments, the distance between each of the radially distributed windows is about 1.5 mm. In some embodiments, the distance between each of the radially distributed windows is about 2 mm.

[0141] In some embodiments, the number of radially distributed windows is proportional to the radius formed by the radially distributed windows. For example, if the radius of the radially distributed windows is about 8 mm and the distance between each of the radially distributed windows is about 1 mm, then the number of windows distributed along any given radius is about 4.

[0142] In some embodiments, the number of fenestrations is at least about 1, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, at least 15, at least 16, at least 17, at least 18, at least 19, at least 20, at least 21, at least 22, at least 23, at least 24, at least 25, at least 26, at least 27, at least 28, at least 29, at least 30, at least 31, at least 32, at least 33, at least 34, at least 35, at least 36, at least 37, at least 38, at least 39, at least, or 40. In some embodiments, the number of fenestrations is at most about 40, at most 39, at most 38, at most 37, at most 36, at most 35, at most 34, at most 33, at most 32, at most 31, at most 30, at most 29, at most 28, at most 27, at most 26, at most 25, at most 24, at most 23, at most 22, at most 21, at most 20, at most 19, at most 18, at most 17, at most 16, at most 15, at most 14, at most 13, at most 12, at most 11, at most 10, at most 9, at most 8, at most 7, at most 6, at most 5, at most 4, at most 3, at most 2, at most, or 1.

[0143] In some embodiments, the at least one fenestration is connected to the at least one window when gazing at a distance, at an intermediate distance, and at a near distance. The at least one fenestration can be disposed radially or circumferentially on the contact lens. The at least one fenestration can be located on a back surface of the contact lens. The at least one fenestration can be in fluid communication with the at least one window. For example, in at least some cases, the at least one fenestration can extend radially from the at least one window to an outer edge of the contact lens so as to facilitate the flow of tear fluid from about the outer edge of the contact lens. Alternatively or in combination, the at least one fenestration can extend from the at least one window to a relatively more interior portion of the contact lens so as to facilitate the flow of tear fluid to the formed lens volume. The contact lens can have a plurality of fenestrations.

[0144] The at least one groove can be distributed over a length (i.e., radius, diameter, or circumference) of the contact lens of at least about 4 mm, at least 4.1 mm, at least 4.2 mm, at least 4.3 mm, at least 4.4 mm, at least 4.5 mm, at least 4.6 mm, at least 4.7 mm, at least 4.8 mm, at least 4.9 mm, at least 5 mm, at least 5.1 mm, at least 5.2 mm, at least 5.3 mm, at least 5.4 mm, at least 5.5 mm, at least 5.6 mm, at least 5.7 mm, at least 5.8 mm, at least 5.9 mm, at least 6.0 mm, at least 6.1 mm, at least 6.2 mm, at least 6.3 mm, at least 6.4 mm, at least 6.5 mm, at least 6.6 mm, at least 6.7 mm, at least 6.8 mm, at least 6.9 mm, at least 7 mm, at least 7.1 mm, at least 7.2 mm, at least 7.3 mm, at least 7.4 mm, at least 7.5 7.6 mm, at least 7.7 mm, at least 7.8 mm, at least 7.9 mm, at least 8 mm, at least 8.1 mm, at least 8.2 mm, at least 8.3 mm, at least 8.4 mm, at least 8.5 mm, at least 8.6 mm, at least 8.7 mm, at least 8.8 mm, at least 8.9 mm, at least 9 mm, at least 9.5 mm, at least 10 mm, at least 10.5 mm, at least 11 mm, or any value therebetween. In some embodiments, the at least one groove can be at most about 11 mm, at most 10.5 mm, at most 10 mm, at most 9.5 mm, at most 9 mm, at most 8.9 mm, at most 8.8 mm, at most 8.7 mm, at most 8.6 mm, at most 8.5 mm, at most 8.4 mm, at most 8.3 mm, at most 8.2 mm, at most 8.1 mm, at most 8 mm, at most 7.9 mm, at most 7.8 mm, at most 7.7 mm, at most 7.6 mm, at most 7.5 mm, at most 7.4 mm, at most 7.3 mm, at most 7.2 mm, at most 7.1 mm, at most 7 mm, at most 6.9 mm, at most 6.8 mm, at most 6.7 mm, at most 6.6 mm, at most 6.5 mm, at most 6.4 mm, at most 6.3 mm, at most 6.2 mm, at most 6.1 mm, at most 6 mm, at most 5.9 mm, at most 5.8 mm, at most 5.7 mm, at most 5.6 mm, at most 5.5 mm, at most 5.4 mm, at most 5.3 mm, at most 5.2 mm, at most 5.1 mm, at most 5 mm, at most 4.9 mm, at most 4.8 mm, at most 4.7 mm, at most 4.6 mm, at most 4.5 mm, at most 4.4 mm, at most 4.3 mm, at most 4.2 mm, at most 4.1 mm, at most 4 mm, or any value therebetween. The at least one groove can be distributed over a length of the contact lens that can be within a range bounded by any two of the foregoing values.For example, the at least one groove can be distributed over a length of about 4 mm to about 11 mm of the contact lens. In an example, the at least one groove can be distributed over a length of about 5.5 mm to about 10.5 mm.

[0145] Flow resistance

[0146] In another aspect, the contact lenses described herein feature windows with improved flow resistance. The flow resistance of a window depends on at least two factors: the cross-sectional area of the window and the length of the window (i.e., the thickness of the contact lens) from the anterior surface of the contact lens (i.e., from the source of fluid) to the posterior surface of the contact lens (i.e., to the volume of the lens). In some embodiments, a window with a larger cross-sectional area has a smaller flow resistance relative to an otherwise similar window with a smaller cross-sectional area. In some embodiments, a window with a shorter length has a smaller flow resistance relative to an otherwise similar window with a longer length. In some embodiments, a smaller flow resistance is that the fluid easily flows through the window. In some embodiments, a window providing a smaller flow resistance is able to transport fluid from one surface to the opposite surface relatively more easily than a window that does not provide a smaller flow resistance.

[0147] In some embodiments, the thickness of the contact lens varies in position. For example, in some embodiments, the central portion of the contact lens is thicker than the peripheral portion of the contact lens. In some embodiments, a window positioned in the center has a longer length between the anterior surface and the posterior surface to reduce flow resistance. In some embodiments, a window positioned toward the periphery has a shorter length between the anterior surface and the posterior surface to reduce flow resistance. In some embodiments, the volume of fluid disposed on the central portion of the contact lens is less than the volume of fluid disposed on the peripheral portion of the contact lens. Thus, a balance between window length and fluid volume should be struck by positioning the windows a minimum distance away from the center of the contact lens.

[0148] The window can be positioned on any portion of the contact lens. The window can be at least about 3 millimeters (mm), at least 3.1 mm, at least 3.2 mm, at least 3.3 mm, at least 3.4 mm, at least 3.5 mm, at least 3.6 mm, at least 3.6 mm, at least 3.7 mm, at least 3.8 mm, at least 3.9 mm, at least 4 mm, at least 4.1 mm, at least 4.2 mm, at least 4.3 mm, at least 4.4 mm, at least 4.5 mm, at least 4.6 mm, at least 4.7 mm, at least 4.8 mm, at least 4.9 mm, at least 5 mm, at least 5.1 mm, at least 5.2 mm, at least 5.3 mm, at least 5.4 mm, at least 5.5 mm, at least 5.6 mm, at least 5.7 mm, at least 5.8 mm, at least 5.9 mm, at least 6.0 mm, at least 6.1 mm, at least 6.2 mm, at least 6.3 mm, at least 6.4 mm, at least 6.5 mm, at least 6.6 mm, at least 6.7 mm, at least 6.8 mm, at least 6.9 mm, at least 7 mm, at least 7.1 mm, at least 7.2 mm, at least 7.3 mm, at least 7.4 mm, at least 7.5 mm 7.6 mm, at least 7.7 mm, at least 7.8 mm, at least 7.9 mm, at least 8 mm, at least 8.1 mm, at least 8.2 mm, at least 8.3 mm, at least 8.4 mm, at least 8.5 mm, at least 8.6 mm, at least 8.7 mm, at least 8.8 mm, at least 8.9 mm, at least 9 mm or more away from the center of the contact lens.In some embodiments, the window hole can be located at a distance of at most about 9 mm, at most 8.9 mm, at most 8.8 mm, at most 8.7 mm, at most 8.6 mm, at most 8.5 mm, at most 8.4 mm, at most 8.3 mm, at most 8.2 mm, at most 8.1 mm, at most 8 mm, at most 7.9 mm, at most 7.8 mm, at most 7.7 mm, at most 7.6 mm, at most 7.5 mm, at most 7.4 mm, at most 7.3 mm, at most 7.2 mm, at most 7.1 mm, at most 7 mm, at most 6.9 mm, at most 6.8 mm, at most 6.7 mm, at most 6.6 mm, at most 6.5 mm, at most 6.4 mm, at most 6.3 mm, at most 6.2 mm, at most 6.1 mm, at most 6 mm, at most 5.9 mm, at most 5.8 mm, at most 5.7 mm, at most 5.6 mm, at most 5.5 mm, at most 5.4 mm, at most 5.3 mm, at most 5.2 mm, at most 5.1 mm, at most 5 mm, at most 4.9 mm, at most 4.8 mm, at most 4.7 mm, at most 4.6 mm, at most 4.5 mm, at most 4.4 mm, at most 4.3 mm, at most 4.2 mm, at most 4.1 mm, at most 4 mm, at most 3.9 mm, at most 3.8 mm 3.7 mm, at most 3.6 mm, at most 3.5 mm, at most 3.4 mm, at most 3.3 mm, at most 3.2 mm, at most 3.1 mm, at most 3 mm, or less from the center of the contact lens. The window hole can be located at a distance from the center of the contact lens that can be within a range defined by any two of the foregoing values. For example, the window hole can be located about 3 mm to about 9 mm from the center of the contact lens. In an example, the window hole can be located about 5 mm to about 8 mm from the center of the contact lens.

[0149] In some embodiments, the window hole is located about 4 mm to about 6 mm from the center of the lens. Because the IPF is typically about 10 mm during distance vision, it can be preferable to locate the window hole 5 mm + / - 1 mm from the center of the lens (e.g., the diameter of the window hole is about 8 mm to about 12 mm).

[0150] In some embodiments, the length 203 of the circumferential window hole 201 or the length 303 of the radial window hole 303 depends on the thickness of the contact lens at a given location. For example, the contact lens can be thicker towards the center relative to the peripheral region, and thus, the window hole will have a longer length when located towards the center as compared to a window hole located towards the periphery.

[0151] The length 203, 303 of the circumferential window hole 201 or the radial window hole 301 can be at least about 40 pm, at least 50 pm, at least 60 pm, at least 70 pm, at least 80 pm, at least 90 pm, at least 100 microns, 150 pm, at least 200 pm, at least 250 pm, at least 300 pm, at least 350 pm, at least 400 pm, at least 450 pm, at least 500 pm, at least 550 pm, at least 600 pm, or any value therebetween. In some embodiments, the length 203, 303 of the circumferential window hole 201 or the radial window hole 301 can be at most about 600 pm, at most 550 pm, at most 500 pm, at most 450 pm, at most 400 pm, at most 350 pm, at most 300 pm, at most 250 pm, at most 200 pm, at most 150 pm, at most 100 pm, at most 90 pm, at most 80 pm, at most 70 pm, at most 60 pm, at most 50 pm, at most 40 pm, or any value therebetween. The circumferential window hole 201 or the radial window hole 301 can have a length 203, 303 that can be within a range defined by any two of the foregoing values. For example, the circumferential window hole 201 or the radial window hole 301 can have a length 203, 303 of about 40 pm to about 600 pm. In an example, the window hole 201, 301 can have a length 203, 303 from about 300 pm to about 600 pm.

[0152] The window hole can have any cross-sectional geometry, including square, rectangular, circular, semi-circular, curved, triangular, or any other geometry. In some embodiments, the window hole has a square cross-sectional geometry. In some embodiments, the window hole has a rectangular cross-sectional geometry. In some embodiments, the window hole has a circular cross-sectional geometry. In some embodiments, the window hole has a semi-circular cross-sectional geometry. In some embodiments, the window hole has a curved cross-sectional geometry. In some embodiments, the window hole has a triangular cross-sectional geometry.

[0153] The cross-sectional area of ​​the window can be at least about 0.0001 square millimeters ("mm2"), at least 0.0003 mm2, at least 0.0006 mm2, at least 0.0009 mm2, at least 0.001 mm2, at least 0.002 mm2, at least 0.004 mm2, at least 0.006 mm2, at least 0.008 mm2, at least 0.01 mm2, at least 0.02 mm2, at least 0.04 mm2, at least 0.06 mm2, at least 0.08 mm2, at least 0.1 mm2, at least 0.2 mm2, at least 0.3 mm2, at least 0.4 mm2, at least 0.5 mm2, at least 0.6 mm2, at least 0.7 mm2, at least 0.8 mm2, at least 0.9 mm2, at least 1 mm2, or any value therebetween. In some embodiments, the cross-sectional area of ​​the window aperture may be at most about 1 mm2, at most 0.9 mm2, at most 0.8 mm2, at most 0.7 mm2, at most 0.6 mm2, at most 0.5 mm2, at most 0.4 mm2, at most 0.3 mm2, at most 0.2 mm2, at most 0.1 mm2, at most 0.08 mm2, at most 0.06 mm2, at most 0.04 mm2, at most 0.02 mm2, at most 0.01 mm2, at most 0.008 mm2, at most 0.006 mm2, at most 0.004 mm2, at most 0.002 mm2, at most 0.001 mm2, at most 0.0009 mm2, at most 0.0006 mm2, at most 0.0003 mm2, at most 0.0001 mm2 or any value therebetween. The aperture may have a cross-sectional area within a range defined by any two of the aforementioned values. For example, the aperture may have a cross-sectional area of ​​about 0.0001 mm2 to about 1 mm2. In an example, the aperture may have a cross-sectional area of ​​about 0.0025 mm2 to about 0.25 mm2.

[0154] In some embodiments, the fenestration can have a circular cross-section (i.e., the fenestration is cylindrical). In these embodiments, the cross-sectional area of ​​the fenestration can be approximately the diameter 204 of the circumferential fenestration 201 or the diameter 304 of the radial fenestration 301. Generally, fenestrations with larger diameters offer less resistance to fluid flow.

[0155] In some embodiments, the volume flow rate of a given aperture can be approximated by the formula Q=vA, where Q is the volume flow rate (mm 3 / s), v is the flow velocity (mm / s) and A is the cross-sectional area of ​​the fenestration (mm 2 For example, the volume required to mask 0.25D of astigmatism with a diameter of 2 mm is approximately 2.0 x 10 -4 For example, the volume required to mask 2.5D of astigmatism on a 4mm diameter is approximately 5.0x10 -2microliters. For example, to fill a volume of 5.0 x 10 -2 microliters, the aperture can be able to achieve a volumetric flow rate (Q) of 2.0 x 10 -1 mm 3 / s assuming a single aperture and a linear flow rate of 10 mm / s, the diameter should be 0.16 mm or greater.

[0156] The diameter of the aperture can be at least about 0.01 mm, at least 0.02 mm, at least 0.03 mm, at least 0.04 mm, at least 0.05 mm, at least 0.06 mm, at least 0.07 mm, at least 0.08 mm, at least 0.09 mm, at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, at least 0.9 mm, at least 1 mm, or any value therebetween. In at least some embodiments, the diameter of the aperture can be at most about 1 mm, at most 0.9 mm, at most 0.8 mm, at most 0.7 mm, at most 0.6 mm, at most 0.5 mm, at most 0.4 mm, at most 0.3 mm, at most 0.2 mm, at most 0.1 mm, at most 0.09 mm, at most 0.08 mm, at most 0.07 mm, at most 0.06 mm, at most 0.5 mm, at most 0.04 mm, at most 0.03 mm, at most 0.02 mm, at most 0.01 mm, or any value therebetween. The aperture can have a diameter that can be within a range defined by any two of the foregoing values. For example, the aperture can have a diameter of about 0.05 mm to about 1 mm. In an example, the aperture can have a diameter of about 0.05 mm to about 0.5 mm.

[0157] The contact lens of the present disclosure can have at least one aperture. The contact lens can have at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or more apertures. In some embodiments, the contact lens can have at most about 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 aperture.

[0158] Lens Material Properties

[0159] Chemical Properties

[0160] In some embodiments, the adhesion between the contact lens and a fluid (e.g., tear fluid or artificial tear fluid) and the adhesion between the contact lens and the corneal surface determine how easily fluid migrates from the front surface to the back surface of the lens. For example, weaker adhesion between the contact lens and a fluid and / or weaker adhesion between the contact lens and the corneal surface allows liquid to migrate more easily through the fenestrations on the contact lens. In some embodiments, the adhesion can be controlled by modifying or specifically selecting the chemical properties of the surface of the contact lens. For example, selecting a lens with a more hydrophilic surface or modifying the surface of the lens to be more hydrophilic will increase the adhesion. In some embodiments, selecting a lens with a less hydrophilic surface or modifying the surface of the lens to be less hydrophilic will decrease the adhesion.

[0161] In some embodiments, the adhesion causes the lens to adhere to the surface of the cornea while providing about 0.1 mm to about 0.5 mm of contact lens movement (e.g., in any direction along the surface of the cornea) after a blink. In preferred embodiments, the lens should adhere to the surface of the cornea while providing some lens movement after a blink, as is generally expected in the art.

[0162] In some embodiments, the soft contact lens is made of a polymer or hydrogel whose chemical properties are defined by its chemical composition. In some embodiments, the contact lens is made of a single material. In some embodiments, the contact lens is made of a soft material. In some embodiments, the contact lens is made of a single material that has substantially uniform mechanical properties throughout. In some embodiments, the contact lens is made of a single polymeric material. In some embodiments, the contact lens comprises a hydrogel, a silicone hydrogel, or a silicone. In some embodiments, the contact lens is made of a single material comprising: diacetone acrylamide, N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, methacrylic acid, methyl methacrylate, N-carboxyvinyl ester, N-vinylpyrrolidone, poly[dimethylsiloxy]di[methylsilylbutanol]bis[vinyl carbamate], phosphorylcholine, tris(trimethylsiloxy)silylpropyl vinyl carbamate, tris(hydroxymethyl)aminomethane, silicone, or polyvinylpyrrolidone. In some embodiments, the contact lens comprises a hydrogel. In some embodiments, the contact lens comprises a silicone hydrogel.

[0163] In some embodiments, the chemical properties of the surface of the lens are modified by applying a coating or other suitable means known in the art. In some embodiments, the surface of the lens can be modified by at least one of chemical treatment, chemical vapor deposition, chemical etching, gas plasma, or laser treatment.

[0164] Mechanical properties

[0165] In some embodiments, the soft contact lens is made of an elastomeric or partially elastomeric material. This elasticity means that any deformation from the neutral configuration (i.e., the “as manufactured” shape) is caused by external stresses such as blinking. Such external stresses are stored in the deformed lens in the form of potential energy and cause the lens to shift towards the neutral configuration when the external stresses are reduced or eliminated. In some embodiments, for a soft spherical contact lens on a keratoconic cornea, the act of the contact lens conforming to the aspherical (i.e., non-axially symmetric) surface of the (cornea) results in a small amount of potential energy stored in the lens. In some embodiments, the act of blinking causes the contact lens to fully conform to the aspherical cornea. In some embodiments, the fully conformed contact lens remains in the deformed shape (i.e., deformed from the neutral configuration) due to the adhesive energy between the surface of the lens and the surface of the cornea (e.g., if the adhesive energy is greater than the potential energy stored in the fully conformed contact lens). In some embodiments, the stored energy causes the contact lens to partially vault off the cornea in the process of returning the contact lens to a configuration closer to its minimum energy configuration (i.e., the neutral configuration or “as manufactured” shape). In some embodiments, as the contact lens partially vaults, fluid flows into the space formed between the surface of the cornea and the back surface of the lens that structurally supports the contact lens. In some embodiments, the greater the potential energy stored in the lens body, the more easily the lens body deviates from the deformed configuration (i.e., returns to the neutral configuration) and the more easily fluid flows between the back surface of the lens and the surface of the cornea.

[0166] In some embodiments, the contact lens of the present disclosure further includes at least one groove to facilitate fluid flow. In some embodiments, the lens includes at least one fenestration and at least one groove that function as a fluid pathway between a source of fluid and the lens volume formed between the back surface of the lens and the surface of the cornea of the eye. For example, the at least one groove can function as a fluid pathway from the tear meniscus to the fenestration or the lens volume. In some embodiments, the at least one groove also reduces the flow resistance of the fluid, allowing the fluid to flow more quickly into the lens volume. In some embodiments, the at least one groove is a plurality of grooves. In some embodiments, the grooves are distributed radially, circumferentially, or a combination thereof.

[0167] In some embodiments, the elastic modulus of the lens, the thickness of the lens, and / or the degree of deformation when the lens is conformed to the surface of the cornea affects how much energy is stored in the lens. For example, a relatively thicker lens can store more energy when conformed to the surface of the cornea. In some embodiments, the degree of deformation is determined by measuring the difference in volume between the neutral configuration (i.e., the “as manufactured” shape) and the deformed configuration of the lens.

[0168] In some embodiments, the contact lens can have an elastic modulus of at least about 0.1 megaPascal (MPa), at least 0.2 MPa, at least 0.3 MPa, at least 0.4 MPa, at least 0.5 MPa, at least 0.6 MPa, at least 0.7 MPa, at least 0.8 MPa, at least 0.9 MPa, at least 1 MPa, at least 1.1 MPa, at least 1.2 MPa, at least 1.3 MPa, at least 1.4 MPa, at least 1.5 MPa, at least 1.6 MPa, at least 1.7 MPa, at least 1.8 MPa, at least 1.9 MPa, at least 2 MPa, at least 2.1 MPa, at least 2.2 MPa, at least 2.3 MPa, at least 2.4 MPa, at least 2.5 MPa, at least 2.6 MPa, at least 2.7 MPa, at least 2.8 MPa, at least 2.9 MPa, at least 3 MPa, at least 4 MPa, at least 5 MPa, at least 6 MPa, at least 7 MPa, at least 8 MPa, at least 9 MPa, at least 10 MPa, or more. In some embodiments, the contact lens can have an elastic modulus of at most about 10 MPa, at most 9 MPa, at most 8 MPa, at most 7 MPa, at most 6 MPa, at most 5 MPa, at most 4 MPa, at most 3 MPa, at most 2.9 MPa, at most 2.8 MPa, at most 2.7 MPa, at most 2.6 MPa, at most 2.5 MPa, at most 2.4 MPa, at most 2.3 MPa, at most 2.2 MPa, at most 2.1 MPa, at most 2 MPa, at most 1.9 MPa, at most 1.8 MPa, at most 1.7 MPa, at most 1.6 MPa, at most 1.5 MPa, at most 1.4 MPa, at most 1.3 MPa, at most 1.2 MPa, at most 1.1 MPa, at most 1 MPa, at most 0.9 MPa, at most 0.8 MPa, at most 0.7 MPa, at most 0.6 MPa, at most 0.5 MPa, at most 0.4 MPa, at most 0.3 MPa, at most 0.2 MPa, at most 0.1 MPa, or less. The elastic modulus of the contact lens can be within a range bounded by any two of the foregoing values. For example, the elastic modulus of the contact lens can be about 0.1 MPa to about 10 MPa. For example, the elastic modulus of the contact lens can be about 0.1 MPa to about 4 MPa.

[0169] In some embodiments, the contact lens comprises a material having a stiffness ranging from about 1.25E+04 MPa*pm 3 to about 5.00E+08 MPa*pm 3 .

[0170] In some embodiments, the mechanical properties of any feature of the lenses described herein depend on the geometry of the feature and the material of the feature (including the properties of the material). A mechanical model of a simply supported circular plate is used to describe various aspects of the mechanical properties of the lens body. In this model, the deflection ("D") of the simply supported plate is proportional to the cube of the Young's modulus ("E") and the thickness ("t") multiplied by t, or D = Et3 / (12*(1-v2). When comparing various modulus and thickness configurations, other parameters of the model (such as plate radius, uniform load, and Poisson's ratio ("v")) can be treated as constants. When comparing the lenses of the present disclosure, the current description utilizes the units customary to contact lens designers, with Young's modulus in megapascals ("MPa") and thickness in micrometers ("um").

[0171] In some embodiments, the thickness of the contact lens can be at least about 40 μm, at least 50 μm, at least 60 μm, at least 70 μm, at least 80 μm, at least 90 μm, at least 100 microns, 150 μm, at least 200 μm, at least 250 μm, at least 300 μm, at least 350 μm, at least 400 μm, at least 450 μm, at least 500 μm, at least 550 μm, at least 600 μm, at least 650 μm, at least 700 μm, at least 750 μm, or any value therebetween. In some embodiments, the thickness of the contact lens can be at most about 800 μm, at most 750 μm, at most 700 μm, at most 650 μm, at most 600 μm, at most 550 μm, at most 500 μm, at most 450 μm, at most 400 μm, at most 350 μm, at most 300 μm, at most 250 μm, at most 200 μm, at most 150 μm, at most 100 μm, at most 90 μm, at most 80 μm, at most 70 μm, at most 60 μm, at most 50 μm, at most 40 μm, or any value therebetween. The thickness of the contact lens can be within a range defined by any two of the aforementioned values. For example, the thickness of the contact lens can be from about 40 μm to about 600 μm. For example, the thickness of the contact lens can be from about 300 μm to about 600 μm. In some embodiments, the thickness of the aperture at a location on the contact lens is the thickness of the contact lens at the same location.

[0172] lens geometry

[0173] In some embodiments, the greater the difference between the "as manufactured" contact lens curvature and the curvature of the cornea (i.e., the curvature of the corneal surface), the greater the amount of energy stored in the lens during a blink when the lens is fitted to the corneal surface. In some embodiments, the higher the potential energy stored in the lens when deformed, the greater the ability of the lens to return to a neutral (i.e., "as manufactured") shape. In some embodiments, the closer the lens is to its as manufactured shape when disposed on the corneal surface, the greater the ability of the lens to facilitate fluid flow to the volume of the lens. In some embodiments, the greater the difference between the "as manufactured" curvature and the curvature of the cornea, the more energy the contact lens has to draw liquid from the tear meniscus to provide corrective power.

[0174] In some embodiments, the "as manufactured" contact lens has at least some portions that are flatter than the steep regions of the cornea (i.e., the curvature of the portions of the lens is less than the curvature of the cornea) to enable fluid movement. In some embodiments, the "as manufactured" contact lens has at least some portions that substantially fit the flat regions of the cornea (i.e., the curvature of the portions of the lens is equal to the curvature of the cornea) to stabilize the contact lens and determine the average curvature of the lens. In some embodiments, the average curvature of the contact lens is less than the curvature of the cornea (i.e., flatter than the curvature of the cornea).

[0175] In some embodiments, the average curvature of the contact lens is at least about 5 mm, at least 5.5 mm, at least 6 mm, at least 6.5 mm, at least 7 mm, at least 7.5 mm, at least 8 mm, at least 8.5 mm, at least 9 mm, at least 9.5 mm, at least 10 mm, at least 10.5 mm, at least 11 mm, at least 11.5 mm, at least 12 mm, at least 12.5 mm, or any value therebetween. In at least some embodiments, the average curvature of the contact lens is at most about 12.5 mm, at most 12 mm, at most 11.5 mm, at most 11 mm, at most 10.5 mm, at most 10 mm, at most 9.5 mm, at most 9 mm, at most 8.5 mm, at most 8 mm, at most 7.5 mm, at most 7 mm, at most 6.5 mm, at most 6 mm, at most 5.5 mm, at most 5 mm, or any value therebetween. The contact lens can have an average curvature that can be within a range defined by any two of the foregoing values. For example, the contact lens can have an average curvature of about 5 mm to about 12.5 mm. In an example, the contact lens can have an average curvature of about 6.5 mm to about 9.5 mm.

[0176] In some embodiments, the contact lens is axially symmetric (i.e., axisymmetric). In some embodiments, the front surface of the contact lens is axisymmetric.

[0177] In some embodiments, the contact lens includes at least one fenestration positioned proximate to the tear meniscus to facilitate tear flow to the lens volume. In some embodiments, the contact lens does not have a toric element (e.g., prism ballast, dynamic stabilizer, peripheral ballast, truncation) to rotationally orient the contact lens. In some embodiments, the contact lens includes a toric element (e.g., prism ballast, dynamic stabilizer, peripheral ballast, truncation) to rotationally orient the contact lens. In some embodiments, the toric element is used to align the at least one fenestration with the tear meniscus. In some embodiments, the toric element does not need to be customized to the orientation of the corneal topography and / or astigmatism.

[0178] Methods

[0179] Methods for forming a tear lens that masks or corrects optical aberrations of an eye are described herein. In some embodiments, the method includes the steps of positioning a contact lens having a soft lens body and at least one fenestration on a corneal surface of an eye such that a portion of a back surface of the soft lens body of the contact lens (i.e., a conforming portion) substantially conforms to a relatively flat region of the corneal surface to support another portion of the back surface (i.e., a vaulted portion) that vaults over a relatively steep region of the corneal surface. In some embodiments, the vaulted portion forms a lens volume between the relatively steep region of the cornea and the back surface of the soft lens body of the contact lens. In some embodiments, the at least one fenestration facilitates or facilitates flow of tears to fill the lens volume with tears, thereby forming a tear lens.

[0180] In some embodiments, the tear lens is configured to at least partially correct an optical aberration of the eye. In some embodiments, the tear lens is configured to at least partially correct an astigmatism of the eye.

[0181] In some embodiments, the lens is applied on a corneal surface of an eye such that the at least one fenestration is positioned proximate to one or more of an upper, lower, or lateral tear meniscus of the eye to enhance tear flow from the one or more tear menisci through the at least one fenestration into the lens volume. In some embodiments, the at least one fenestration is positioned on the contact lens such that the at least one fenestration is disposed proximate to the one or more tear menisci regardless of a rotational orientation of the contact lens applied on the corneal surface of the eye.

[0182] In some embodiments, the tear lens is configured to mask astigmatism of the subject’s eye. In some embodiments, the tear lens can be configured to mask astigmatism up to about 2.5 diopters (D). In some embodiments, the tear lens is configured to mask astigmatism up to about 5 D, up to 4.75 D, up to 4.5 D, up to 4.25 D, up to 4 D, up to 3.75 D, up to 3.5 D, up to 3.25 D, up to 3 D, up to 2.75 D, up to 2.5 D, up to 2.25 D, up to 2.0 D, up to 1.75 D, up to 1.5 D, up to 1 D, up to +0.7 D, up to 0.5 D, or less. In some embodiments, the tear lens is configured to mask astigmatism of at least about 0.5 D, at least 0.7 D, at least 1 D, at least 1.5 D, at least 1.75 D, at least 2.0 D, at least 2.25 D, at least 2.5 D, at least 2.75 D, at least 3 D, at least 3.25 D, at least 3.5 D, at least 3.75 D, at least 4 D, at least 4.25 D, at least 4.5 D, at least 4.75 D, at least 5 D, or more. In some embodiments, the tear lens is configured to mask astigmatism in a range defined by any two of the foregoing values. In some embodiments, the astigmatism is in a range of about 2.25 D to about 2.5 D. In some embodiments, the tear lens is configured to mask astigmatism in increments of 0.01 D due to the sensitivity of the tear lens, and is not limited to the 0.25 D increments as is customary in standard toric lenses. In some cases, the tear lens can be configured to mask astigmatism up to about 5 D, up to 4.9 D, up to 4.8 D, up to 4.7 D, up to 4.6 D, up to 4.5 D, up to 4.4 D, up to 4.3 D, up to 4.2 D, up to 4.1 D, up to 4 D, up to 3.9 D, up to 3.8 D, up to 3.7 D, up to 3.6 D, up to 3.5 D, up to 3.4 D, up to 3.3 D, up to 3.2 D, up to 3.1 D, up to 3 D, up to 2.9 D, up to 2.8 D, up to 2.7 D, up to 2.6 D, up to 2.5 D, up to 2.4 D, up to 2.3 D, up to 2.2 D, up to 2.1 D, up to 2.0, up to 1.9 D, up to 1.8 D, up to 1.7 D, up to 1.6 D, up to 1.5 D, up to 1.4 D, up to 1.3 D, up to 1.2 D, up to 1 D, up to 0.9 D, up to 0.8 D, up to 0.7 D, up to 0.6 D, up to 0.5 D, up to 0.4 D, up to 0.3 D, up to 0.2 D, up to 0.1 D, or less.In some embodiments, the tear lens is configured to mask at least about 0.1 D, at least 0.2 D, at least 0.3 D, at least 0.4 D, at least 0.5 D, at least 0.6 D, at least 0.7 D, at least 0.8 D, at least 0.9 D, at least 1 D, at least 1.1 D, at least 1.2 D, at least 1.3 D, at least 1.4 D, at least 1.5 D, at least 1.6 D, at least 1.7 D, at least 1.8 D, at least 1.9 D, at least 2 D, at least 2.1 D, at least 2.2 D, at least 2.3 D, at least 2.4 D, at least 2.5 D, at least 2.6 D, at least 2.7 D, at least 2.8 D, at least 2.9 D, at least 3 D, at least 3.1 D, at least 3.2 D, at least 3.3 D, at least 3.4 D, at least 3.5 D, at least 3.6 D, at least 3.7 D, at least 3.8 D, at least 3.9 D, at least 4 D, at least 4.1 D, at least 4.2 D 4.3 D, at least 4.4 D, at least 4.5 D, at least 4.6 D, at least 4.7 D, at least 4.8, at least 4.9 D, at least 5 D, or more of astigmatism.

[0183] In some embodiments, the contact lens is configured such that only the spherical power of the lens is needed to correct the vision of a subject in need to its best-corrected visual acuity. In some embodiments, the contact lens is configured to mask astigmatism such that only the spherical power of the lens is needed to correct the vision of a subject in need to a certain visual acuity.

[0184] In some embodiments, the tear lens is configured to correct meridian angles of about 10 degrees to about 1 degree. In some embodiments, the tear lens is configured to correct meridian angles of up to about 10 degrees, up to 9 degrees, up to 8 degrees, up to 7 degrees, up to 6 degrees, up to 5 degrees, up to 4 degrees, up to 3 degrees, up to 2 degrees, up to 1 degree, or less. In some cases, the cover 120 can be configured to correct meridian angles of at least about 1 degree, at least 2 degrees, at least 3 degrees, at least 4 degrees, at least 5 degrees, at least 6 degrees, at least 7 degrees, at least 8 degrees, at least 9 degrees, at least 10 degrees, or more. The tear lens can be configured to correct meridian angles in a range defined by any two of the foregoing values. In some embodiments, the meridian angle can be in a range of about 3 degrees to about 4 degrees.

[0185] In some embodiments, the tear lens is configured to correct a corneal power difference between meridians of about 3D to about 0D. In some embodiments, the tear lens is configured to correct a corneal power difference of up to about 3D, up to 2.9D, up to 2.8D, up to 2.7D, up to 2.6D, up to 2.5D, up to 2.4D, up to 2.3D, up to 2.2D, up to 2.1D, up to 2D, up to 1.9D, up to 1.8D, up to 1.7D, up to 1.6D, up to 1.5D, up to 1.4D, up to 1.3D, up to 1.2D, up to 1D, up to 0.9D, up to 0.8D, up to 0.7D, up to 0.6D, up to 0.5D, up to 0.4D, up to 0.3D, up to 0.2D, up to 0.1D, or less. In some embodiments, the tear lens is configured to correct a corneal power difference of at least about 0.1D, at least 0.2D, at least 0.3D, at least 0.4D, at least 0.5D, at least 0.6D, at least 0.7D, at least 0.8D, at least 0.9D, at least 1D, at least 1.1D, at least 1.2D, at least 1.3D, at least 1.4D, at least 1.5D, at least 1.6D, at least 1.7D, at least 1.8D, at least 1.9D, at least 2D, at least 2.1D, at least 2.2D, at least 2.3D, at least 2.4D 2.5D, at least 2.6D, at least 2.7D, at least 2.8D, at least 2.9D, at least 3D, or more. The tear lens can be configured to correct a corneal power difference in a range bounded by any two of the foregoing values. In some embodiments, the corneal power difference is in a range of about 0.5D to about 2.5D.

[0186] Examples

[0187] Embodiments of the present disclosure will now be generally described, and will be more readily understood, by reference to the following examples, which are included merely for purposes of illustration of certain aspects and embodiments of the present disclosure and are not intended to limit the scope of the present disclosure in any way.

[0188] Example 1: Pupil to Lid Measurement

[0189] In many of the embodiments described herein, the fenestrations, grooves, and / or other tear fluid channels can be optimally positioned to facilitate or ease the flow of tear fluid to the lens volume formed when a soft, tear fluid forming contact lens described herein is applied to the eye with the eyelids open. To optimally position such features on a contact lens, the lens manufacturer should have a good understanding of the anatomy of the eye. While the anatomy and relative dimensions of the eye are well known in the scientific and medical literature, the inventors have also conducted experiments to verify this knowledge. Table 1 shows experimental pupil to eyelid measurements made by the present inventors. Table 2 shows pupil to eyelid measurements extrapolated from Bosch et al., 1999 (Topographic anatomic of the eyelids and the effects of gender and age; W A van den Bosch, I. Leenders, P Mulder; Br J Opthalmol. 1999 Mar; 83(3): 347-52; doi: 10.1136 / bjo.83.3.347). In both of these studies, the pupil-lower eyelid distance (PLD) measurements and the intra palpebral distance (IPD) measurements were not significantly different and can be considered to be in agreement with each other. Thus, according to the embodiments described herein, the eye anatomical measurements from the scientific and medical literature and independent studies can be relied upon as conditions for lens design.

[0190] Table 1.

[0191]

[0192] Table 2.

[0193]

[0194]

[0195] Example 2: Lens Fitting

[0196] The inventors have also tested contact lenses to assess the degree of fitting that is required for particular subjects. Subjects with a wide range of corneal curvatures at 3 mm from the center of the cornea in the range of 7.2 mm to 8 mm and varying degrees of astigmatism in the range of about 0.75 D to about 3.5 D were tested. These subjects were provided with a contact lens with a non-optimized base curve of 7.86 mm. Surprisingly, the contact lens with a non-optimized base curve of 7.86 mm was able to reduce astigmatism by 0.75 D to 1.5 D in all of the subjects. Thus, it can be possible to provide a suitable fitting lens for most people who can require a contact lens that masks astigmatism and other optical aberrations with minimal, if any, fitting.

[0197] Example 3: Testing of Fenestration Positioning

[0198] The inventors also conducted experiments to apply contact lenses manufactured according to embodiments described herein to test subjects with astigmatism. Seven subjects with astigmatism ranging from 0.75D to 2.5D were tested, and each subject was tested with two versions of a contact lens. The two versions of the contact lens had the same material and geometry, i.e., made of Unisil silicone hydrogel available from Contamac US of Grand Junction, Colorado, with a base curve of 7.87 mm, a diameter of 14.5 mm, with 8 radial grooves, and with 8 windows each with a radius of 300 pm. The only difference between the two versions of the contact lens was that the window location was either 3.0 mm from the center of the lens or 6.6 mm from the center of the lens, which would be closer to the subject’s eye’s tear meniscus. Both versions of the contact lens were able to reduce astigmatism, but it was found that the contact lens with the window location closer to the tear meniscus was more effective. In particular, the lens with the center window location 3.0 mm reduced astigmatism by an average of 0.67D, while the lens with the center window location 6.6 mm reduced astigmatism by an average of 1.04D. Thus, this experiment supports the inventors’ theory that positioning a contact lens window closer to the tear meniscus can improve astigmatism reduction.

[0199] Example 4: Configuration of windows on lenses with fixed orientation

[0200] Provided herein are exemplary contact lenses having toric elements and windows. Generally, toric elements on a lens are used to position the lens in a particular orientation when disposed on an eye. When making lenses with windows, the ability to utilize the toric elements to orient the lens to a particular position can be utilized such that at least one window is in constant contact with the tear meniscus (e.g., the superior or inferior tear meniscus). In some cases, the windows can be designed to be radially distributed such that at least one window is in constant contact with the tear meniscus.

[0201] Provided herein are contact lenses having toric elements (e.g., stabilizers or weights) where the lens is oriented such that the toric elements are oriented downward (e.g., a 6 o'clock orientation and / or toward the lower tear meniscus when worn on the eye), where the lens is in a fixed orientation in the downward orientation (e.g., the lens does not rotate). The contact lens includes two windows, a first window positioned downward and a second window positioned 180 degrees apart from the first window (e.g., a 12 o'clock orientation) and positioned at a distance from the center of the lens that is approximately closer than the first window. In some cases, the contact lens includes two windows, a first window positioned about 5 mm downward from the center of the lens and a second window positioned 180 degrees apart from the first window (e.g., a 12 o'clock orientation) and positioned about 3.5 mm from the center of the lens. When worn on the eye by a user, at least one of the windows is adjacent to the tear meniscus (e.g., the upper tear meniscus or the lower tear meniscus). In some cases, the distance of the windows is selected by taking into account the fixed orientation of the lens when worn on the eye and / or the possible position of the tear meniscus on the eye such that at least one window is in continuous contact with the tear meniscus.

[0202] Example 5: Configuration of windows on a lens with 180 degrees of free orientation

[0203] Provided herein are exemplary contact lenses having toric elements (e.g., stabilizers or weights) that can be positioned downward (e.g., a 6 o'clock orientation and / or toward the lower tear meniscus when worn on the eye) or upward (e.g., a 12 o'clock orientation and / or toward the upper tear meniscus). Such lenses can be free to rotate in 180 degrees of orientation such that the toric elements are in a downward or upward orientation. In some cases, the lens is oriented such that the toric elements are toward the upper tear meniscus or the lower tear meniscus. The contact lens includes four windows, where two windows are positioned downward and the other two windows are positioned upward. The two upward pointing windows are on a line from the center of the lens, one window closer to the center of the lens than the other. The two downward pointing windows are on a line from the center of the lens, one window closer to the center of the lens than the other. In some cases, the windows form a line where two windows are symmetrically apart from the center by a first distance and two windows are symmetrically apart from the center by a second distance that is further from the center than the first distance. In some cases, a first window is positioned about 3.5 mm from the center of the lens and a second window is positioned about 5 mm from the center of the lens in the downward or upward orientation. In some cases, the distance of the windows is selected by taking into account the ability of the lens to rotate freely in 180 degrees when worn on the eye and / or the possible position of the tear meniscus on the eye such that at least one window is in continuous contact with the tear meniscus.

[0204] Example 6: Configuration of windows on a lens with free orientation

[0205] Provided herein are exemplary contact lenses having windows without toric elements (e.g., stabilizers or weights) such that the lenses are able to freely rotate (e.g., free spin) when worn on an eye. The contact lenses include four windows, two of which are positioned in a first radial line and the other two of which are positioned in a second radial line that is about 90 degrees from the first radial line. In some cases, the first radial line is oriented upward (e.g., 12 o’clock direction). In some cases, the second line is oriented in a 3 o’clock orientation. In some cases, the second line is oriented in a 9 o’clock orientation. The two windows in the first radial line are on a line from the center of the lens, one window closer to the center of the lens than the other. The two windows in the second radial line are on a line from the center of the lens, one window closer to the center of the lens than the other. In some cases, one window in the first and second radial lines is at a first distance from the center and the second window in the first and second radial lines is at a second distance further from the center than the first distance. In some cases, the windows are positioned about 3.5 mm from the center of the lens and the second window is positioned about 5 mm from the center of the lens. In some cases, the distances of the windows are selected by considering the ability of the lens to rotate when worn on an eye by a user and / or the possible locations of the tear meniscus on the eye such that at least one window is in continuous contact with the tear meniscus.

[0206] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example. The present disclosure is not intended to be limited by the specific examples provided in the specification. While the present disclosure has been described with reference to the above explanation to the foregoing description, the description and explanation of the embodiments herein are not to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. Furthermore, it should be understood that all aspects of the disclosure are not limited to the specific depictions, configurations or relative proportions set forth herein which depend on a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the disclosure described herein can be employed in practicing the disclosure. Accordingly, the disclosure is intended to encompass all such alternatives, modifications and variations falling within the scope of the present disclosure. The appended claims are intended to cover all methods and structures falling within the scope of the claims and their equivalents.

Claims

1. A contact lens for correcting vision in an eye of a subject, the contact lens comprising: a soft lens body having a front surface, a back surface, and at least one window extending between the front surface and the back surface; wherein the posterior surface of the lens body is configured to, when applied to the corneal surface of the eye with the eyelid of the eye open, form a conforming portion that substantially conforms to a relatively flat area of ​​the corneal surface and a vaulted portion that forms a lens volume between a relatively steep area of ​​the corneal surface and the posterior surface of the lens body; wherein the at least one fenestration is configured to be positioned adjacent to the tear meniscus when the lens body is applied to the corneal surface with the eyelid of the eye open.

2. The contact lens according to claim 1, wherein The at least one fenestration is configured to be positioned adjacent the tear meniscus when the lens body is applied to the corneal surface with the eyelid of the eye open to promote tear flow from the tear meniscus to the lens volume, thereby forming a tear lens.

3. The contact lens according to claim 2, wherein The tear lens is configured to at least partially correct astigmatism of the eye.

4. The contact lens according to claim 2 or 3, wherein The tear lens is configured to at least partially correct optical aberrations of the eye.

5. The contact lens according to any one of claims 1 to 4, wherein The at least one fenestration has a geometry configured to facilitate flow of the tear fluid from the tear meniscus to the lens volume.

6. The contact lens according to any one of claims 1 to 5, wherein The at least one fenestration is configured to be positioned adjacent the tear meniscus to facilitate tear flow from the tear meniscus to the lens volume, from adjacent the anterior surface of the lens body to the posterior surface of the lens body and to the lens volume.

7. The contact lens according to any one of claims 1 to 6, wherein The tear meniscus is one or more of the superior meniscus or inferior meniscus of the eye of the subject.

8. The contact lens according to any one of claims 1 to 7, wherein The at least one fenestration is configured to be positioned adjacent the tear meniscus to facilitate tear flow to the lens 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 eyelid of the eye open.

9. The contact lens according to any one of claims 1 to 8, wherein The at least one fenestration is configured to be positioned adjacent the tear meniscus to facilitate tear flow to the lens volume.

10. The contact lens according to any one of claims 1 to 9, wherein The contact lens does not include rotational orientation features.

11. The contact lens of claim 10, wherein: The rotational orientation features include prismatic weights or stabilizing dynamic elements.

12. The contact lens according to any one of claims 1 to 11, wherein The at least one fenestration is configured such that one of the at least one fenestration is always adjacent to the tear meniscus during wear.

13. The contact lens according to any one of claims 1 to 12, wherein The contact lens includes a rotational orientation feature.

14. The contact lens of claim 13, wherein: The rotational orientation features include prismatic weights or stabilizing dynamic elements.

15. The contact lens according to claim 13 or 14, wherein The rotational orientation features are not customized for corneal topography or astigmatism.

16. The contact lens according to any one of claims 1 to 15, wherein The at least one fenestration is configured to be positioned adjacent the tear meniscus at a distance of about 0.0 mm to about 4 mm when the lens body is applied to the corneal surface with the eyelid of the eye open.

17. The contact lens according to any one of claims 1 to 16, wherein The at least one aperture is positioned about 3 mm to about 9 mm from the center of the lens body.

18. The contact lens of claim 17, wherein: The at least one aperture is positioned about 5 mm to about 8 mm from the center of the lens body.

19. The contact lens according to any one of claims 1 to 18, wherein The at least one aperture includes a plurality of apertures.

20. The contact lens of claim 19, wherein The plurality of apertures are evenly distributed around the center of the soft lens body.

21. The contact lens of claim 19, wherein: The plurality of apertures are non-uniformly distributed around the center of the soft lens body.

22. The contact lens according to any one of claims 19 to 21, wherein The plurality of windows are distributed circumferentially.

23. The contact lens according to any one of claims 19 to 21, wherein The plurality of window holes are distributed radially.

24. The contact lens of claim 23, wherein: Adjacent windows are separated from each other by a distance of about 1 mm.

25. The contact lens of claim 23 or 24, wherein The plurality of apertures are distributed along at least one meridian of the soft lens body.

26. The contact lens according to any one of claims 23 to 24, wherein The radius defined by the radially distributed plurality of window apertures is about 3 mm to about 8 mm.

27. The contact lens according to any one of claims 19 to 26, wherein The plurality of fenestrations are positioned about 3 mm to about 9 mm from the center of the soft lens body.

28. The contact lens according to any one of claims 19 to 27, wherein The plurality of windows are distributed along the length of the soft lens body.

29. The contact lens according to any one of claims 1 to 28, wherein The at least one fenestration of the plurality of fenestrations is always positioned adjacent to the tear meniscus.

30. The contact lens according to any one of claims 19 to 28, wherein The length of the soft lens body is the radius, diameter or circumference of the lens body.

31. The contact lens of claim 30, wherein: The length of the soft lens body is about 4 mm to about 45 mm.

32. The contact lens according to any one of claims 1 to 31, wherein The at least one aperture has a length from the front surface to the rear surface of about 40 μm to about 600 μm.

33. The contact lens according to any one of claims 1 to 32, wherein The at least one window has a width of about 0.0001 mm. 2 to about 1mm 2 cross-sectional area.

34. The contact lens according to any one of claims 1 to 33, wherein The at least one window has a cross-sectional area that is circular in shape.

35. The contact lens according to any one of claims 1 to 34, wherein The at least one fenestration includes 1 to 25 fenestrations.

36. The contact lens according to any one of claims 1 to 35, wherein The soft lens body is made of soft material.

37. A method of correcting vision in an eye of a subject, the method comprising: A contact lens according to any one of claims 1 to 36 is applied on the corneal surface of the eye of the subject with the eyelid of the eye open.

38. A method for correcting vision in an eye of a subject, the method comprising: identifying a subject in need of vision correction comprising masking astigmatism or optical aberrations of the subject's eye; as well as The subject is provided with a contact lens according to any one of claims 1 to 34, wherein the need to adapt a base curve of the contact lens to a base curve of a cornea of ​​the eye of the subject is minimized.

39. The method according to claim 38, wherein The contact lens is provided to the subject without fitting the base curve of the contact lens to the eye of the subject.

40. A method for correcting vision in an eye of a subject, the method comprising: A contact lens having a soft lens body and at least one window is applied to the corneal surface of the eye of the subject with the eyelid of the eye open, such that the posterior surface of the lens body forms a fitting portion that substantially fits a relatively flat area of ​​the corneal surface and a vaulted portion that forms a lens volume between a relatively steep area of ​​the corneal surface and the posterior surface of the lens body, wherein the at least one window is positioned adjacent to the tear meniscus.

41. The method according to claim 40, wherein The at least one fenestration is positioned adjacent the tear meniscus to facilitate flow of tear liquid from the tear meniscus to the lens volume, thereby forming a tear lens.

42. The method according to claim 41, wherein The tear lens is configured to at least partially correct astigmatism of the eye.

43. The method according to claim 41 or 42, wherein The tear lens is configured to at least partially correct optical aberrations of the eye.

44. The method according to any one of claims 40 to 43, wherein The at least one fenestration has a geometry configured to facilitate flow of the tear fluid from the tear meniscus to the lens volume.

45. The method according to any one of claims 40 to 44, wherein The at least one fenestration is positioned adjacent the tear meniscus to promote tear flow from the tear meniscus to the lens volume, from adjacent the anterior surface of the lens body to the posterior surface of the lens body and to the lens volume.

46. ​​The method according to any one of claims 40 to 45, wherein The tear meniscus is one or more of the superior meniscus or inferior meniscus of the eye of the subject.

47. The method according to any one of claims 40 to 46, wherein The at least one fenestration is positioned adjacent the tear meniscus to facilitate tear flow to the lens 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 eyelid of the eye open.

48. The method according to any one of claims 40 to 47, wherein The at least one fenestration is configured to be positioned adjacent the tear meniscus at a distance of about 0.0 mm to about 4 mm when the lens body is applied to the corneal surface with the eyelid of the eye open.

49. The method according to any one of claims 40 to 48, wherein The at least one aperture is positioned about 3 mm to about 9 mm from the center of the lens body.

50. The method of claim 49, wherein The at least one aperture is positioned about 5 mm to about 8 mm from the center of the lens body.

51. The method according to any one of claims 40 to 50, wherein The at least one aperture includes a plurality of apertures.

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