Corneal Tissue Inlay for Keratoconus

Inclusion Criteria: * Be at least 18 years of age, male or female, of any race * Provide written informed 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. Exclusion Criteria: * Contraindications, sensitivity or known allergy to the use of the test article(s) or their components * If female, 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 corneal healing in the eye to be treated * Have used an investigational drug or device within 30 days of the study