Status and phase
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About
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.
Full description
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
8 years of age or older
Having at least one of the following conditions:
Signed written informed consent and/or assent
Likely to complete all study visits
Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,324 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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