Phase 3
N=147
Corneal Collagen Cross-linking for Progressive Keratoconus
Progressive Keratoconus
Bottom Line
View on ClinicalTrials.gov: NCT00647699 ↗Enrolled (actual)
147
Serious AEs
2.0%
Results posted
Jul 2016
Primary outcome: Primary: Mean Change From Baseline in Maximum Keratometry (Kmax) — -1.7; 0.6 diopters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- riboflavin ophthalmic solution (Drug); UVA Irradiation (Device)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Glaukos Corporation
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Maximum Keratometry (Kmax) |
-1.7; 0.6 | — |
Summary
Prospective, 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00647699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.