Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)
ConditionKeratoconus, Unstable
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorKent Wellish MD
About this trial
Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2 (Riboflavin) and the application on UV Light.
Eligibility criteria
Qualifiers
Presence of central or inferior corneal steepening
Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
Fleischer ring
Vogt's striae
Disqualifiers
Eyes classified as either normal or atypical normal on the severity grading scheme
Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution alone will be used or < 300 microns when the hypotonic riboflavin will be used.
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross linking procedure
Trial design
Treatments tested in this trial
- Riboflavin
Treatment groups
600 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Kent Wellish MD
Lead sponsor
Wellish Vision Institute
Sponsor institution
Source ClinicalTrials.gov