SCLERAL LENS WITH FENESTRATION AND POCKETS

Abstract

A scleral lens with a fenestration and pockets. One fenestration or a plurality of annularly-distributed fenestrations are provided in an optic zone of the scleral lens; and two or more pockets are provided in a pocket annular zone on a posterior surface of the optic zone. The pockets are configured to trap gas bubbles near the fenestration, where the fenestration is located radially outward from the pocket annular zone and not located in a transition zone of the scleral lens, and the transition zone is configured to be located above the limbus of the eyeball during wearing of the scleral lens. The lens of the present invention will not be adsorbed to the cornea and can be worn comfortably and maintain clear visual acuity for up to 12 hours.

Claims

1. A method of wearing a scleral lens, which comprises: obtaining a scleral lens comprising: i. an optic zone that extends over the cornea of an eyeball of a wearer upon wearing of the scleral lens; ii. a landing zone that is configured to land at a conjunctiva corresponding to a scleral surface of the eyeball upon wearing of the scleral lens; and iii. a transition zone that connects the optic zone and the landing zone and is configured to be located above a limbus when associated with the eyeball upon wearing of the scleral lens, wherein the optic zone comprises: (1) an annular zone in which a plurality of pockets are provided, the annular zone having an inner circumference and an outer circumference and being disposed on a posterior surface of the optic zone; and (2) a fenestration located radially outward from the annular zone and not located in the transition zone, and wherein the pockets are configured to retain gas bubbles near the fenestration, and wherein the number of pockets in the annular zone is at least 2 times more than the number of fenestration(s); and placing the scleral lens over the eyeball, wherein the eyeball has a cornea and wherein the scleral lens is configured to allow delivery of a fluid from the outside of the scleral lens to the cornea while wearing the scleral lens.

2. The method of claim 1, wherein the wearer suffers from an ocular disease or disorder.

3. The method of claim 2, wherein the ocular disease or disorder comprises Stevens-Johnson syndrome, keratoconjunctivitis sicca, graft rejection, ocular cicatricial pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular cornea, spherical cornea, irregular astigmatism, or a combination thereof.

4. The method of claim 1, wherein the wearer has undergone ophthalmic surgery.

5. The method of claim 4, wherein the ophthalmic surgery comprises transplantation, keratoplasty, photorefractive keratectomy (PRK), or laser in situ keratomileusis (LASIK), or a combination thereof.

6. The method of claim 1, wherein the fluid comprises tears or eye drops.

7. The method of claim 1, wherein the scleral lens is further configured to allow metabolites generated on an ocular surface under the scleral lens to be discharged.

8. A method of using a scleral lens, which comprises: obtaining a scleral lens comprising: i. an optic zone that extends over the cornea of an eyeball of a user upon wearing of the scleral lens; ii. a landing zone that is configured to land at a conjunctiva corresponding to a scleral surface of the eyeball upon wearing of the scleral lens; and iii. a transition zone that connects the optic zone and the landing zone and is configured to be located above a limbus when associated with the eyeball upon wearing of the scleral lens, wherein the optic zone comprises: (1) an annular zone in which a plurality of pockets are provided, the annular zone having an inner circumference and an outer circumference and being disposed on a posterior surface of the optic zone; and (2) a fenestration located radially outward from the annular zone and not located in the transition zone, and wherein the pockets are configured to retain gas bubbles near the fenestration, wherein the depth d of at least one pocket is within the range of 0.05 mm to 0.3 mm and the opening of at least one pocket has a maximum dimension t ranging from 0.2 mm to 1 mm, and wherein t≥2d, or the horizontal cross-section of the fenestration has a maximum dimension ranging from 0.2 mm to 1 mm; and treating an ocular disease or disorder by placing the scleral lens over the eyeball, wherein the scleral lens is configured to allow fluid to enter a corneal clearance between the scleral lens and the cornea during wearing of the scleral lens.

9. The method of claim 8, wherein the ocular disease or disorder comprises Stevens-Johnson syndrome, keratoconjunctivitis sicca, graft rejection, ocular cicatricial pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular cornea, spherical cornea, irregular astigmatism, or a combination thereof.

10. The method of claim 8, wherein the user has undergone ophthalmic surgery.

11. The method of claim 10, wherein the ophthalmic surgery comprises transplantation, keratoplasty, photorefractive keratectomy (PRK), or laser in situ keratomileusis (LASIK), or a combination thereof.

12. The method of claim 8, wherein the fluid comprises tears or eye drops.

13. The method of claim 8, wherein the scleral lens is further configured to allow metabolites generated on an ocular surface under the scleral lens to be discharged.

14. A method of treating an ocular disease or disorder in an individual in need thereof, which comprises: providing a scleral lens comprising: i. an optic zone that extends over the cornea of an eyeball of the individual upon wearing of the scleral lens; ii. a landing zone that is configured to land at a conjunctiva corresponding to a scleral surface of the eyeball upon wearing of the scleral lens; and iii. a transition zone that connects the optic zone and the landing zone and is configured to be located above a limbus when associated with the eyeball upon wearing of the scleral lens, wherein the optic zone comprises: (1) an annular zone in which a plurality of pockets are provided, the annular zone having an inner circumference and an outer circumference and being disposed on a posterior surface of the optic zone; and (2) a fenestration located radially outward from the annular zone and not located in the transition zone, and wherein the pockets are configured to retain gas bubbles near the fenestration, and wherein the number of pockets in the annular zone is at least 2 times more than the number of fenestration(s); and administering a fluid to a corneal clearance between the scleral lens and the cornea, wherein the scleral lens is configured to provide a fluid reservoir located on the cornea.

15. The method of claim 14, wherein the ocular disease or disorder comprises Stevens-Johnson syndrome, keratoconjunctivitis sicca, graft rejection, ocular cicatricial pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular cornea, spherical cornea, irregular astigmatism, or a combination thereof.

16. The method of claim 14, wherein the individual has undergone ophthalmic surgery.

17. The method of claim 16, wherein the ophthalmic surgery comprises transplantation, keratoplasty, photorefractive keratectomy (PRK), or laser in situ keratomileusis (LASIK), or a combination thereof.

18. The method of claim 14, wherein the fluid comprises tears or eye drops.

19. The method of claim 14, wherein the scleral lens is further configured to allow metabolites generated on an ocular surface under the scleral lens to be discharged.

20. The method of claim 14, wherein the fluid comprises artificial tears.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0025] For the purpose of illustration and not limitation, the present invention is described below with preferred embodiments of the present invention, particularly with reference to the accompanying drawings, in which:

[0026] FIG. 1 is a schematic cross-sectional view of a conventional scleral lens;

[0027] FIG. 2 is a cross-sectional view of a scleral lens according to an embodiment of the present invention;

[0028] FIG. 3 is a bottom view of a scleral lens according to an embodiment of the present invention;

[0029] FIG. 4 is a bottom view of a scleral lens according to another embodiment of the present invention;

[0030] FIG. 5A to FIG. 5C show exemplary configurations of a pocket applicable to the present invention; and

[0031] FIG. 6 is a photograph of a scleral lens on an eyeball according to an embodiment of the present invention.

DETAILED DESCRIPTION

[0032] The following further describes this application in detail with reference to the accompanying drawings and embodiments. It should be understood that, for simplicity and clarity of the illustration, the elements shown in the drawings are not necessarily drawn to scale, and the features presented in each embodiment can be combined with the features presented in other embodiments. Reference signs are repeated across the accompanying drawings to indicate the same or similar elements. It can be understood that the specific embodiments described herein are only used to explain related content, but not to limit the application.

[0033] The present invention provides a scleral lens with a fenestration and pockets. The scleral lens does not touch the cornea, and therefore is not easy to be adhered to the cornea and is not likely to be absorbed onto the cornea. The scleral lens provides excellent oxygen permeability and moisture retention, and allows delivery of required fluid from the outside of the lens to the eyeball during wearing of the lens, and therefore is especially suitable for patients with keratoconjunctivitis sicca, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, or pellucid marginal corneal degeneration, and patients after ophthalmic surgery (for example, transplantation, keratoplasty, photorefractive keratectomy (PRK), and laser in situ keratomileusis (LASIK)).

[0034] FIG. 1 is a schematic cross-sectional view of a conventional scleral lens. The scleral lens includes an optic zone 1 and a landing zone 2. The posterior surface of the optic zone is configured to be located above cornea 3 of an eyeball, spaced apart from the anterior surface of the cornea of the eyeball, and not in contact with the cornea of the eyeball, thereby forming a corneal clearance 4. The posterior surface of the landing zone is configured to land at conjunctiva 5 corresponding to a scleral surface of the eyeball. The optic zone 1 and the landing zone 2 are connected by a transition zone 6.

[0035] FIG. 2 is a cross-sectional view of a scleral lens according to an embodiment of the present invention. The scleral lens includes an optic zone 1, a transition zone 6, and a landing zone 2. During wearing of the lens, the anterior surface of the optic zone 1 faces away from the eyeball, and the posterior surface of the optic zone 1 faces toward the anterior surface of the cornea of the eyeball; the transition zone 6 is located above the limbus of the eyeball; and the landing zone 2 is in contact with the conjunctiva on the scleral surface. The optic zone 1 is provided with a fenestration 7 penetrating the anterior and posterior surfaces of the optic zone 1 and pockets 8 in the posterior surface of the optic zone 1. The pockets 8 are located in a pocket annular zone 81 (the zone marked gray in the figure), and located inward from the fenestration 7, meaning the pockets 8 are closer to the center of the lens. The distance from the geometric center of the fenestration 7 to the geometric center of the scleral lens is L. The diameter of the inner ring of the pocket annular zone is D, and D is 2 times the closest distance from the opening of a pocket closest to the center of the lens in the posterior surface of the lens to the center of the lens. Similarly, the diameter of the outer ring of the pocket annular zone is 2 times the farthest distance from the opening of a pocket farthest from the center of the lens in the posterior surface of the lens to the center of the lens.

[0036] In embodiments of the present invention, the fenestration and the pockets are not arranged in the transition zone 6, meaning not being arranged in the limbus zone. According to Fadel et al., arranging the fenestration in the limbus zone helps retain gas bubbles produced principally within the limbus zone without affecting vision. However, because the clearance between the lens and the eyeball is small (generally 50 μm to 100 μm) in this zone, which is not conducive to fluid exchange expected from the present invention, the fenestration is arranged in a zone other than the limbus zone in various embodiments of the present invention.

[0037] In various embodiments of the present invention, the distance L from the geometric center of the fenestration to the geometric center of the scleral lens is 4.0 mm to 7.0 mm, for example, 4.5 mm to 6.5 mm, 4.6 mm to 6.0 mm, or 5.0 mm to 5.5 mm, preferably 5.2 mm to 5.3 mm.

[0038] The fenestration in the present invention penetrates the anterior and posterior surfaces of the scleral lens, allowing fluid communication between the inner and outer sides of the scleral lens, allowing tears or eye drops to enter the fluid storage zone (corneal clearance) between the lens and the cornea during wearing, and allowing metabolites generated on the ocular surface under the lens to be discharged in time. Because a small aperture cannot guarantee a smooth flow of fluid due to the action of liquid tension, the fenestration in the present invention preferably has a larger size, for example, a maximum horizontal cross-sectional dimension greater than 0.2 mm, for example, ranging from 0.2 mm to 1.0 mm, from 0.3 mm to 0.9 mm, from 0.4 mm to 0.8 mm, from 0.5 mm to 0.7 mm, or from 0.55 mm to 0.6 mm, for example, being 0.25 mm, 0.35 mm, 0.45 mm, 0.65 mm, 0.75 mm, 0.85 mm, 0.95 mm, or 0.99 mm, and more preferably, being, for example, 0.46 mm, 0.47 mm, 0.48 mm, 0.49 mm, 0.501 mm, 0.51 mm, 0.52 mm, 0.53 mm, or 0.54 mm. In some embodiments, the plurality of fenestrations in the lens have a same size, to be specific, have the same contour and approximately the same maximum horizontal cross-sectional dimension. In still some other embodiments, the plurality of fenestrations in the lens have different sizes.

[0039] In the various embodiments of the present invention, the optic zone is provided with a maximum of 24 fenestrations, preferably an even number of fenestrations, for example, 24, 22, 20, 18, 16, 14, 12, 10, 8, 6, 4, 2 fenestrations. Certainly, an odd number of fenestrations, for example 1 or 3, is also feasible.

[0040] A scleral lens with a large-size fenestration is prone to introduce gas bubbles between the cornea and the lens during wearing of the lens, which affects vision correction. The present invention successfully resolves this problem by providing a pocket annular zone between the fenestration and the center of the lens. Two or more pockets are arranged in the pocket annular zone for trapping gas bubbles near the fenestration, and the pockets are arranged on the posterior surface of the optic zone without penetrating the anterior surface of the optic zone. To achieve this purpose, the present invention requires that the number of pockets in the pocket annular zone be at least 2 times, for example, 3 times, 4 times, 5 times, 6 times, 7 times, or more times, the number of fenestrations. For example, when the scleral lens has one fenestration, at least two pockets are provided in the pocket annular zone. In this case, due to the small number of pockets, preferably the pockets are concentrated near the fenestration (as shown in FIG. 3), so as to effectively trap gas bubbles that may be introduced through the fenestration.

[0041] It should be understood that because objectively speaking, the pockets themselves can reduce paths required for the gas outside the lens to enter the lens, and increase the oxygen permeability of the lens, those skilled in the art can arrange more pockets in the scleral lens of the present invention than required for trapping gas bubbles, so as to gain additional benefits of improving oxygen permeability of the lens. The maximum number of pockets is not limited, provided that the number of pockets and their depth do not damage structural integrity of the scleral lens. It is believed that, the greater the number of the pockets, the better management of the gas bubbles in the fluid storage zone, and the better the fluid retention, and the better the oxygen permeability of the scleral lens. However, for the sake of simplicity in design and manufacture, in a preferred embodiment, the number of pockets does not exceed 100, for example, less than 90, 80, 70, or 60.

[0042] In some other embodiments, the plurality of fenestrations 7 and the plurality of pockets 8 are evenly distributed annularly. Being evenly distributed annularly means being evenly distributed along one or more rings. FIG. 4 shows eight fenestrations 7 evenly distributed annularly, where 48 pockets 8 are located in a pocket annular zone 81 (a gray zone in the figure) and evenly distributed along two rings. In some other embodiments, a different number of pockets is provided in each ring, for example, fewer pockets being provided along an inner ring. Pockets along different rings are spread out in a staggered manner, so as to provide a tightest-possible bubble trapping net for the radially outwardly located fenestration.

[0043] It should be noted that FIG. 3 and FIG. 4 only show exemplary embodiments of the present invention. In the embodiment, the fenestrations 7 are closely adjacent to the outer ring of the pocket annular zone 81. However, in other exemplary embodiments, the fenestrations 7 and the outer ring of the pocket annular zone 81 may be spaced by a specified distance.

[0044] The fenestrations applicable to the present invention may have various horizontal cross-sectional shapes, for example, the shape of a circle, ellipse, oval, rectangle, rhombus, or regular polygon, preferably the shape of a circle, ellipse, or oval. The maximum dimension of the horizontal cross section falls within 0.2 mm to 1.0 mm. The maximum dimension is, for example, the diameter of a circle, the major axis of an ellipse, the largest diagonal of a rhombus, or the like. The maximum dimension of the horizontal cross section gradually becomes larger, gradually smaller, or remains consistent in a direction extending from the anterior surface to the posterior surface of the scleral lens. In conjunction with opening and closing movements of the upper and lower eyelids, this size is sufficient to allow fluid outside the lens (for example, tears and eye drops) to effectively flow into the storage zone between the scleral lens and the eyeball, promoting tear exchange and improving oxygen permeability of the scleral lens.

[0045] Similarly, the pockets applicable to the present invention can form openings of various shapes in the posterior surface of the scleral lens, for example, the shape of a circle, ellipse, oval, rectangle, rhombus, or regular polygon. The opening has a maximum dimension t. In some embodiments, t ranges from 0.2 mm to 1.0 mm, from 0.3 mm to 0.9 mm, from 0.4 mm to 0.8 mm, from 0.5 mm to 0.7 mm, or from 0.55 mm to 0.6 mm, for example, being 0.25 mm, 0.35 mm, 0.45 mm, 0.65 mm, 0.75 mm, 0.85 mm, 0.95 mm, or 0.99 mm, and more preferably, being 0.46 mm, 0.47 mm, 0.48 mm, 0.49 mm, 0.501 mm, 0.51 mm, 0.52 mm, 0.53 mm, or 0.54 mm.

[0046] FIG. 5A to FIG. 5C show exemplary configurations of pockets applicable to the present invention. In the design of the present invention, the pockets are configured to capture and trap gas bubbles that may enter the corneal clearance through the fenestration. Therefore, the maximum dimension t of the opening of a pocket is required to be greater than the depth d of the pocket. In some embodiments, t≥2d. In some embodiments, t≥2.5d. In some embodiments, t≥3d. In some embodiments, d ranges from 0.05 mm to 0.3 mm, from 0.1 mm to 0.25 mm, or from 0.15 mm to 0.2 mm, for example, being 0.08 mm, 0.12 mm, 0.16 mm, 0.24 mm, or 0.28 mm.

[0047] In some embodiments, the two or more pockets configured in the scleral lens of the present invention have the same size, to be specific, having the same contour and approximately the same maximum dimension t and the same depth d. In some other embodiments, the two or more pockets have different sizes. In still some other embodiments, the size of a pocket near the center of the scleral lens is smaller than the size of a pocket near the outside of the scleral lens (as shown in FIG. 3).

[0048] In the scleral lens of the present invention, the pockets are not dedicated to reducing gas bubbles. As is known by those skilled in the art, proper fitting is the key to reducing gas bubbles during wearing of the scleral lens. In the design of the present invention, the pockets are mainly configured for control and management of gas bubbles that may enter the corneal clearance through the fenestration. Therefore, the gas bubbles are controlled to be in the pocket annular zone (as shown in FIG. 6) and cannot enter the pupil zone to affect visual acuity. Based on this, the diameter of the inner ring of the pocket annular zone ranges from 5.0 mm to 13.5 mm, from 6.0 mm to 13.0 mm, from 7.0 mm to 12.0 mm, from 8.0 mm to 11.0 mm, or from 9.0 mm to 10.0 mm. The controlled gas bubbles are not free, so they will not gather to form large gas bubbles and increase the risk of abrasion of the cornea because the air containing the gas bubbles is drier than the fluid in the corneal clearance and may rub the corneal epithelium as if being a solid foreign body.

[0049] The design of the pocket and the fenestration in the scleral lens of the present invention provides the scleral lens of the present invention with additional benefits compared to a conventional scleral lens. Therefore, the scleral lens of the present invention is not only suitable for people who are intolerant to small-diameter corneal gas-permeable lenses (contact lenses), and patients with irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, or irregular astigmatism, and because the scleral lens can deliver tears or therapeutic/wetting eye drops directly through the fenestration, the scleral lens is also particularly suitable for patients after ophthalmic surgery, such as keratoplasty, PRK, and LASIK, and patients with keratoconjunctivitis sicca. Therefore, other aspects of the present invention further relate to use of the scleral lens in the treatment of the above-mentioned diseases or disorders.

[0050] Although specific embodiments have been described herein, many alternatives, modifications, and changes are apparent for those skilled in the art. Those skilled in the art should understand that, depending on design requirements and other factors, various modifications, combinations, sub-combinations, and substitutions can be made. Any modification, equivalent replacement, or improvement made without departing from the spirit and principle of the present invention shall fall within the protection scope of the present invention.