Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Stanford University
Summary
Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm * Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant * Good surgical candidate for either procedure as determined by the surgeon * Willingness to participate * Age greater than 18 years Exclusion Criteria: * Aphakia, anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK * Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity ass…
Interventions
- DrugRipasudil
Topical Ripasudil 0.4%
- DrugPlacebo
Topical Placebo
Locations (8)
- Stanford UniversityPalo Alto, California
- University of California DavisSacramento, California
- University of MiamiPalm Beach Gardens, Florida
- Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire
- Legacy Devers Eye InstitutePortland, Oregon
- Oregon Health & Science UniversityPortland, Oregon