Title
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
Phase
Phase 3Lead Sponsor
Avedro, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
EctasiaIntervention/Treatment
ribavirin ...Study Participants
130Prospective, 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.
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
riboflavin ophthalmic solution and UVA irradiation
riboflavin opthalmic solution without UVA irradiation
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
| Event Type | Organ System | Event Term | Corneal Collagen Cross-linking (CXL) Treatment Group | Control Group |
|---|
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
