Ectasia Clinical Trial
— CXLOfficial title:
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
NCT number | NCT00674661 |
Other study ID # | UVX-003 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 2007 |
Est. completion date | November 2011 |
Verified date | April 2021 |
Source | Glaukos Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Wilmer Eye Institute at Johns Hopkins University | Baltimore | Maryland |
United States | Price Vision Group | Indianapolis | Indiana |
United States | Durrie Vision | Kansas City | Kansas |
United States | Shiley Eye Center | La Jolla | California |
United States | Center for Excellence in Eye Care | Miami | Florida |
United States | Minnesota Eye Consultants | Minneapolis | Minnesota |
United States | Edward Harkness Eye Institute at Columbia University Medical Center | New York | New York |
United States | Ophthalmic Consultants of Long Island | Rockville Centre | New York |
United States | Gordon -Weiss Vision Institute | San Diego | California |
United States | Cornea & Laser Eye Institute; Hersh Vision Group | Teaneck | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline in Maximum Keratometry (Kmax) | 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. | baseline,12 months |
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