Conditions: Ectasia
Keywords: ectasia cross-linking crosslinking cornea riboflavin UVA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief 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.

Arms:
arm 1: riboflavin ophthalmic solution and UVA irradiation arm 2: riboflavin opthalmic 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: