NCT00647699

Corneal Collagen Cross-linking for Progressive Keratoconus

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (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 cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Detailed 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.

Conditions

• Progressive Keratoconus

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: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-04-01
• Last updated: 2021-04-26
• Results posted: 2016-07-07

Locations

10 sites across 1 country: United States