The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.
The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
510
Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX 365 nm wavelength light source is applied with continued application of riboflavin.
Price Vision Group
Indianapolis, Indiana, United States
Change in Maximum Keratometry From Baseline to 6 Months After Treatment
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
Time frame: 6 months
Pachymetry
Minimum corneal thickness measured by corneal tomography
Time frame: 6 months
Corrected Distance Visual Acuity (CDVA)
Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
Time frame: 6 months
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.
Time frame: 6 months
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