Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome

Exclusion Criteria

• •1. Normal corneal topography.
• •2. A history of previous corneal transplant in the study eye.
• •3. Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
• •4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:
• •1. History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
• •2. Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking procedure.
• •5. A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
• •6. Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
• •7. If female, pregnant, lactating or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study. \[NOTE: If female and capable of becoming pregnant, must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment. \]
• •7\. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
• •8\. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
• •9\. Inability to return for required postoperative examinations. 10. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.