NCT00567671

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Keratoconus
• Corneal Ectasia

Interventions

Type	Name	Description
PROCEDURE	Corneal collagen	Corneal collagen cross-linking with riboflavin/UVA light
PROCEDURE	Sham comparator	Sham treatment

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-12-05
• Last updated: 2010-09-02

Locations

1 site across 1 country: United States