Corneal Collagen Cross-Linking for Ectasia (CXL)

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Inclusion Criteria:

• Diagnosis of ectasia after refractive surgery
• Documented ectasia on Pentacam or topography map
• BSCVA worse than 20/20
• Must complete all study visits

Exclusion Criteria:

• History of delayed wound healing
• History of corneal melt or corneal dystrophy