Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

Exclusion Criteria

• •All subjects meeting any of the following criteria will be excluded from this study:
• •1. Eyes classified as either normal or atypical normal on the severity grading scheme.
• •2. Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
• •3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
• •1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
• •2. Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
• •4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
• •5. A known sensitivity to study medications
• •6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• •7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.