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

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.

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.

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