Title
Corneal Collagen Cross-linking for Progressive Keratoconus
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
Phase
Phase 3Lead Sponsor
Avedro, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Progressive KeratoconusIntervention/Treatment
ribavirin ...Study Participants
147Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.
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 ophthalmic solution without UVA irradiation.
Inclusion Criteria: Diagnosis of keratoconus Documented progression over previous 24 months Decreased BSCVA Must complete all study visits Exclusion Criteria: Prior corneal surgery or Intacs History of delayed wound healing
| 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.
