Phase 3 N=130 Randomized Treatment

Corneal Collagen Cross-Linking for Ectasia (CXL)

Ectasia

Bottom Line

View on ClinicalTrials.gov: NCT00674661 ↗

Enrolled (actual)

130

Serious AEs

0.8%

Results posted

Jan 2017

Primary outcome: Primary: Mean Change From Baseline in Maximum Keratometry (Kmax) — -0.5; 0.5 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: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Maximum Keratometry (Kmax)	-0.5; 0.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00674661). 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.