Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.
Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes the front of the eye to bulge out. This results in distorted vision and could eventually result in the need for a cornea transplant. This study proposes to conclude that saturating the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet Light will result in the various layers of corneal tissue linking together. This cross linking results in a stronger cornea which is designed to halt the progression of keratoconus or ectasia. This treatment is already being successfully used in Europe.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Corneal cross linking achieved by combination of Riboflavin and ultraviolet light
Change in Best Corrected Visual Acuity
Use a standard eye chart to determine changes in the subject's best Visual Acuity (with glasses or contact) performed by research staff
Time frame: Baseline and 1 year
Change in Uncorrected Visual Acuity
Use a standard eye chart to determine changes in the subject's best Visual Acuity (without glasses or contact) performed by clinic technician
Time frame: Baseline and 1 year
Occurrence of Adverse Events
Surgeon notes any occurrence of adverse events related to the treatment
Time frame: Through study completion, an average of 1 year
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