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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Shiley Eye Center
La Jolla, California, United States
Gordon -Weiss Vision Institute
San Diego, California, United States
Center for Excellence in Eye Care
Miami, Florida, United States
Mean Change From Baseline in Maximum Keratometry (Kmax)
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Time frame: baseline,12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Price Vision Group
Indianapolis, Indiana, United States
Durrie Vision
Kansas City, Kansas, United States
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States
Minnesota Eye Consultants
Minneapolis, Minnesota, United States
Cornea & Laser Eye Institute; Hersh Vision Group
Teaneck, New Jersey, United States
Edward Harkness Eye Institute at Columbia University Medical Center
New York, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States