NCT00674661

Corneal Collagen Cross-Linking for Ectasia (CXL)

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

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 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Conditions

• Ectasia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-05-08
• Last updated: 2021-04-26
• Results posted: 2017-01-27

Locations

10 sites across 1 country: United States