Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00674661 | Corneal Collagen Cross-Linking for Ectasia (CXL) | PHASE3 | COMPLETED | 130 | — | — | Dec 1, 2007 | Nov 1, 2011 | Apr 26, 2021 | 10 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group | ACTIVE_COMPARATOR | riboflavin ophthalmic solution and UVA irradiation |
| Control Group | SHAM_COMPARATOR | riboflavin opthalmic solution without UVA irradiation |
| Name | Type | Description |
|---|---|---|
| riboflavin ophthalmic solution | DRUG | riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) |
| UVA Irradiation | DEVICE | UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes |
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