Conditions: Progressive Keratoconus
Keywords: keratoconus cross-linking riboflavin UVA light cornea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 147
Healthy volunteers: no

Brief 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.

Arms:
arm 1: riboflavin ophthalmic solution and UVA irradiation arm 2: riboflavin ophthalmic solution without UVA irradiation.

Interventions: intervention 1: riboflavin ophthalmic solution intervention 2: UVA Irradiation
Intervention descriptions: intervention 1: riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) intervention 2: UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes

Protocol document: