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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
Device:
UVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Completed NCT03896321 - Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management N/A
Terminated NCT01097447 - Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
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No longer available NCT01384773 - Progressive Keratoconus or Ectasia Treatment Plan