Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Phase 2

Completed

• Conditions: Progressive Keratoconus; Corneal Ectasia

• Registration Number: NCT00567671
• Lead Sponsor: Emory University

Brief Summary

Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Detailed 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 at least 12 months to evaluate the long term effects of corneal collagen cross-linking.

Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Status Verified: 2009-07
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Diagnosis of keratoconus with documented progression over the previous 12 months.
• Diagnosis of corneal ectasia
• Must be able to complete all study visits

Exclusion Criteria

• Prior corneal surgery in the keratoconus group
• Corneal scarring

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in keratometry	3 Months

Secondary Outcome Measures

Name	Time	Method
Best spectacle-corrected visual acuity	3 Months

Trial Locations

Locations (1)

Woolfson Eye Institute; 🇺🇸 Atlanta, Georgia, United States