Corneal Tissue Inlay for Keratoconus

The objective of this study is to evaluate the outcomes of placing preserved corneal tissue
within the corneal stroma in keratoconus patients as a means of enhancing thickness,
stability, and optical conformation.

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