At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 130 enrolled
Drug / intervention
riboflavin ophthalmic solution +1 moredrug
Likely dose
riboflavin ophthalmic solution 1.6 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
In Brief
A Phase 3 clinical trial evaluating riboflavin ophthalmic solution and UVA Irradiation for Ectasia. Completed, enrolled 130 participants across 10 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEctasia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedMay 2008
Primary CompletionNov 2011
TodayJul 2026
First PostedMay 8, 2008
Enrollment StartDec 1, 2007
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.2 years ago
Interventions
riboflavin ophthalmic solutiondrug
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA Irradiationdevice
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes