A Phase 2 interventional study of Theralight crosslinking and Riboflavin in Keratoconus, sponsored by Cxlusa. Terminated at 6 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2018-10-12.
Sponsored by Cxlusa · Phase 2, Interventional, and Treatment
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.
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 1,324 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Cxlusa is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Having at least one of the following conditions:
Exclusion Criteria:
ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin
Other: Theralight crosslinking and Riboflavin
Corneal Collagen cross linking with UV light and riboflavin
Change in Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6-9 months
Change in Uncorrected Visual Acuity (UCVA)
Time frame: 6-9 months
Change in Corneal topography
Time frame: 6-9 months
Change in Manifest Refraction
Time frame: 6-9 months
Change in Keratometry on topography and Pentacam
Time frame: 6-9 months
Change in Wavefront Refraction and aberrations
Time frame: 6-9 months
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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