Corneal Collagen Cross-linking for Progressive Keratoconus

Progressive Keratoconus Clinical Trial

— CXL  

Official title:

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647699
• Other study ID #: UVX-002
• Status: Completed
• Phase: Phase 3
• Start date: December 2007
• Est. completion date: April 2011

Study information

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

Clinical Trial 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.

Description:

This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus
• Progressive Keratoconus

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