Gamma-Irradiated Corneal Inlay for Keratoconus

Inclusion Criteria: * At least 18 years of age, male or female, of any race * Provide written consent and sign a HIPAA form * Willingness and ability to follow all instructions and comply with schedule for follow-up visits * For females: must not be pregnant * Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus defined as the following: * Moderate Keratoconus: Axial topography consistent with keratoconus, Maximum keratometry on Pentacam greater than or equal to 51.01 D * Severe Keratoconus: Axial topography consistent with keratoconus with marked areas of steepening, Maximum keratometry on Pentacam greater than or equal to 56.01 D * Presence of central or inferior steepening on the Pentacam map * BSCVA less than or equal to 20/25 * Contact lens wearers only: remove contact lenses one week prior to the screening refraction Exclusion Criteria: * Contraindications, sensitivity or known allergy to the use of the test article(s) or their components * If female, be pregnant * Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme * Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: a) History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.) * A history of delayed epithelial healing in the eye to be treated * Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study