Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Riboflavin drops + NXL System to Total Energy Level 1
Riboflavin drops + NXL System to Total Energy Level 2
Riboflavin drops + NXL System to Total Energy Level 3
Glaukos Investigative Site
Dothan, Alabama, United States
RECRUITINGGlaukos Investigative Site
Teaneck, New Jersey, United States
RECRUITINGGlaukos Investigative Site
Westerville, Ohio, United States
RECRUITINGTopography
Change in Kmax topography value from baseline
Time frame: 12 Months
Distance Uncorrected Visual Acuity (UCVA)
Change in Distance UCVA
Time frame: 12 Months
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Sham Drops and No exposure to NXL system