Corneal Onlays and Related Methods

Abstract

Corneal onlays and method of making and using corneal onlays are described. The present corneal onlays may have clinically acceptable lens bodies for use in human eyes. The present corneal onlays may have one or more physical features that contribute to the success of the present onlays in human eyes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of one of the present corneal onlays.

FIG. 2 is a sectional view of the corneal onlay of FIG. 1 along line II-II.

FIG. 3 is a section view of another corneal onlay.

FIG. 4 is a plan view of the anterior surface of another corneal onlay.

FIG. 5 is a section view of a corneal onlay showing the sagittal depth of the corneal onlay.

FIG. 6 is a magnified sectional view of a lens edge region of a corneal onlay.

FIG. 7 is a graph illustrating ramp rate (mm/mm) as a function of optical power (diopters).

Claims

1. A corneal onlay, comprising: a clinically acceptable lens body having an anterior surface and a posterior surface, the lens body being effective in permitting a corneal epithelium to completely heal and cover the anterior surface of the lens body and in retaining an ophthalmically acceptable transparency after implantation of the lens body onto the cornea of an eye of a human patient.

2. The corneal onlay of claim 1, wherein the lens body has an optic zone having an optic zone outer perimeter, an outer peripheral edge located at the junction of the anterior surface and the posterior surface and spaced apart from the optic zone outer perimeter, and a ramp zone located between the outer peripheral edge and the optic zone outer perimeter.

3. The corneal onlay of claim 2, wherein the outer peripheral edge has a thickness less than a maximum dimension of a corneal epithelial cell.

4. The corneal onlay of claim 2, wherein the outer peripheral edge has a thickness less than 7 micrometers.

5. The corneal onlay of claim 2, wherein the outer peripheral edge has a thickness less than about 0.03 mm and the ramp zone has a thickness that increases from the outer peripheral edge toward the optic zone at a rate of at least about 3 micrometers/mm.

6. The corneal onlay of claim 2, wherein the outer peripheral edge has a thickness corresponding to 0-5 micrometers based on the outer peripheral edge thickness of a corneal onlay mold having a lens shaped cavity in the form of the lens body.

7. The corneal onlay of claim 2, wherein the ramping zone has a length from the outer peripheral edge to the optic zone outer perimeter of at least about 0.1 mm.

8. The corneal onlay of claim 2, wherein the ramping zone has a length from the outer peripheral edge to the optic zone outer perimeter from about 0.1 mm to about 3.5 mm

9. The corneal onlay of claim 2, wherein the lens body has a ramp rate defined as the rate of change in thickness of the lens body from the outer peripheral edge to the optic zone outer perimeter, the ramp rate being greater than a rate of change in thickness of the optic zone of the lens body.

10. The corneal onlay of claim 9, wherein the ramp rate is at least about 0.1 mm/mm.

11. The corneal onlay of claim 9, wherein the ramp rate is between about 0.1 mm/mm and about 0.5 mm/mm.

12. The corneal onlay of claim 11, wherein the ramp rate is from about 0.2 mm/mm to about 0.4 mm/mm.

13. The corneal onlay of claim 9, wherein the ramp rate remains substantially constant from the outer peripheral edge to the optic zone outer perimeter.

14. The corneal onlay of claim 1, wherein the lens body has a maximum diameter effective in completely covering the cornea of the eye without adversely interfering with the limbus surrounding the cornea.

15. The corneal onlay of claim 14, wherein the lens body has a maximum diameter of about 8 mm.

16. The corneal onlay of claim 2, wherein the optic zone is larger than the size of the pupil of the eye on which the lens body is placed when the pupil is at its maximum dilation.

17. The corneal onlay of claim 16, wherein the optic zone has a diameter from about 5 mm to about 12 mm.

18. The corneal onlay of claim 16, wherein the optic zone has a diameter of about 7.5 mm.

19. The corneal onlay of claim 9, wherein the lens body has a diameter from about 7 mm to about 8 mm, the optic zone has a diameter from about 6.5 mm to about 7.5 mm, and the ramp rate is at least about 0.1 mm/mm.

20. The corneal onlay of claim 1, wherein the lens body has a sagittal depth of at least 0.5 mm.

21. The corneal onlay of claim 1, wherein the lens body has a sagittal depth less than about 6 mm.

22. The corneal onlay of claim 1, wherein the lens body has a sagittal depth from about 0.5 mm to about 1.5 mm.

23. The corneal onlay of claim 1, wherein the lens body has a sagittal depth from 1.005 mm to 1.316 mm.

24. The corneal onlay of claim 1, wherein the lens body has a maximum diameter of about 7.5 mm, an optic zone diameter of about 7.0 mm, and a sagittal depth of about 1.300 mm.

25. The corneal onlay of claim 1, wherein the lens body has a base curve from about 4 mm to about 9 mm.

26. The corneal onlay of claim 25, wherein the lens body has a maximum diameter from about 6 mm to about 12 mm.

27. The corneal onlay of claim 1, wherein the lens body has a water content of at least about 75% (w/w).

28. The corneal onlay of claim 27, wherein the lens body has a water content from about 85% (w/w) to about 95% (w/w).

29. The corneal onlay of claim 1, wherein the lens body has a refractive index from about 1.300 to about 1.400.

30. The corneal onlay of claim 29, wherein the lens body has a refractive index from about 1.340 to about 1.350.

31. The corneal onlay of claim 1, wherein the lens body is dimensioned to move no more than 0.25 mm relative to the corneal epithelium of the eye.

32. The corneal onlay of claim 2, wherein the lens body has a center thickness less than about 0.35 mm.

33. The corneal onlay of claim 32, wherein the lens body has a center thickness from about 0.03 mm to about 0.06 mm.

34. The corneal onlay of claim 32, wherein the lens body has a center thickness and a thickness at the optic zone outer perimeter that is not equal to the center thickness.

35. The corneal onlay of claim 34, wherein the optic zone outer perimeter thickness is less than the center thickness.

36. The corneal onlay of claim 34, wherein the optic zone outer perimeter thickness is greater than the center thickness.

37. The corneal onlay of claim 34, wherein the center thickness is from about 0.04 mm to about 0.05 mm, and the optic zone perimeter thickness is less than 0.27 mm.

38. The corneal onlay of claim 34, wherein the optic zone outer perimeter thickness is at least 0.03 mm and the center thickness is greater than 0.03 mm and less than about 0.35 mm.

39. The corneal onlay of claim 1, wherein the lens body comprises non-donor corneal tissue.

40. The corneal onlay of claim 1, wherein the lens body is substantially free of a synthetic polymeric component.

41. The corneal onlay of claim 1, wherein the lens body is free of a fluoropolymer component.

42. The corneal onlay of claim 1, wherein the lens body consists essentially of cross-linked collagen polymers.

43. The corneal onlay of claim 1, wherein the lens body comprises recombinant collagen.

44. The corneal onlay of claim 1, wherein the lens body includes at least one marking effective in facilitating positioning of the lens body on the cornea of the eye.

45. The corneal onlay of claim 1, wherein the lens body has an optical power that in combination with the corneal epithelium located over the anterior surface of the lens body provides a desired vision correcting power to the patient.

46. The corneal onlay of claim 1, wherein the lens body comprises cross-linked collagen polymers comprising collagen fibrils spaced apart so as to not occupy a space greater than half the wavelength of visible light.

47. The corneal onlay of claim 1, wherein the lens body is substantially free of microscopic defects.

48. The corneal onlay of claim 47, wherein the lens body is substantially free of microscopic defects as determined by a knife edge optical system used to inspect the corneal onlay.

49. A method of making a corneal onlay, comprising: placing a polymerizable corneal onlay precursor composition in a cavity of a first corneal onlay mold member;placing a second corneal onlay mold member in contact with the first corneal onlay mold member to form a corneal onlay shaped cavity containing the polymerizable corneal onlay precursor composition, the second corneal onlay mold member being placed in contact with the first corneal onlay mold member within an amount of time effective in avoiding formation of surface features indicative of premature polymerization of the polymerizable corneal onlay precursor composition; andpolymerizing the polymerizable corneal onlay precursor composition to form a polymerized corneal onlay.

50. The method of claim 49, wherein the second corneal onlay mold member is placed in contact with the first corneal onlay mold member within about sixty seconds after placing the polymerizable corneal onlay precursor composition in the cavity of the first mold member.

51. The method of claim 49, wherein the amount of the polymerizable corneal onlay precursor composition placed in the cavity of the first corneal onlay mold member is from about 2 microliters to about 40 microliters.

52. The method of claim 51, wherein the amount of the polymerizable corneal onlay precursor composition placed in the cavity of the first corneal onlay mold member is about 5 microliters.

53. The method of claim 49, wherein the placing steps are performed at a temperature less than the denaturing temperature of the polymerizable corneal onlay precursor composition and greater than the freezing temperature of the polymerizable corneal onlay precursor composition.

54. The method of claim 53, wherein the placing steps are performed at a temperature from about 0 degrees C. to about 5 degrees C.

55. The method of claim 49, wherein the polymerizing comprises maintaining the polymerizable corneal onlay precursor composition at a temperature greater than the temperature of the composition when the composition was placed in the cavity of the first mold member.

56. The method of claim 55, wherein the polymerizing comprises maintaining the polymerizable corneal onlay precursor composition at a temperature from about 20 degrees C. to about 40 degrees C. for a time period of at least 1.5 minutes.

57. The method of claim 55, wherein the polymerizing comprises maintaining the polymerizable corneal onlay precursor composition at a temperature from about 20 degrees C. to about 40 degrees C. for a time period of at least 10 minutes.

58. The method of claim 55, wherein the polymerizing comprises maintaining the polymerizable corneal onlay precursor composition at a temperature from about 20 degrees C. to about 40 degrees C. for a time period from about 18 hours to about 24 hours.

59. The method of claim 49, further comprising hydrating the polymerized corneal onlay.

60. The method of claim 49, further comprising separating the first corneal onlay mold member and the second corneal onlay mold member.

61. The method of claim 49, further comprising sterilizing the polymerized corneal onlay.

62. The method of claim 49, wherein at least one of the steps is semi-automated.

63. The method of claim 49, wherein at least one of the steps is automated.

64. The method of claim 49, wherein the polymerizable corneal onlay precursor composition comprises a collagen component and a collagen cross-linker component.

65. The method of claim 64, wherein the collagen component comprises recombinant collagen.

66. The method of claim 49, wherein the polymerized corneal onlay is substantially free of microscopic and macroscopic defects.

67. The method of claim 49, wherein the polymerized corneal onlay is substantially free from a defect selected from the group consisting of surface irregularities, bubbles, particles, tears, edge defects, blemishes, opacities, flash ring, flash ring portions, and combinations thereof.

68. The method of claim 49, wherein the polymerized corneal onlay has a substantially smooth anterior surface and posterior surface.

69. The method of claim 49 which is effective at producing clinically acceptable polymerized corneal onlays for placement in a cornea of a human patient at a rate of at least about 5%.

70. A method of improving vision of a patient, comprising placing a corneal onlay on Bowman's membrane of the cornea of an eye of a patient, wherein the corneal onlay comprises a clinically acceptable lens body having an anterior surface and a posterior surface, the lens body being effective in permitting a corneal epithelium to completely heal and cover the anterior surface of the lens body and in retaining an ophthalmically acceptable transparency after implantation of the lens body onto the cornea of an eye of a human patient.

71. The method of claim 70, further comprising abrading corneal epithelium of the eye of the patient before placing the corneal onlay on Bowman's membrane.

72. The method of claim 70, further comprising separating a living layer of corneal epithelium from Bowman's membrane before placing the corneal onlay on Bowman's membrane.

73. The method of claim 70, further comprising forming an epithelial pocket of the cornea before placing the corneal onlay on Bowman's membrane.

74. The method of claim 70, further comprising cooling the eye of the patient.

75. The method of claim 70, wherein the corneal onlay remains optically transparent while placed on Bowman's membrane.

76. The method of claim 70, further comprising applying a healing agent to the eye of the patient to promote epithelial healing.

77. The method of claim 70, wherein the corneal onlay remains centered on the cornea of the eye for at least one day after placement thereon.

78. A method for identifying a clinically acceptable corneal onlay for use in a human patient, comprising: placing a potentially acceptable corneal onlay on a layer of epithelial cells on a cornea of an eye at a first position;identifying a clinically acceptable corneal onlay from a plurality of potentially acceptable corneal onlays, each located on a layer of epithelial cells on a cornea of an eye, if the onlay moves less than 0.25 mm from the first position.