Descemet Endothelial Thickness Comparison Trial II
- Conditions
- FuchsFuchs DystrophyFuchs' Endothelial Dystrophy
- Interventions
- Drug: Placebo
- Registration Number
- NCT05275972
- Lead Sponsor
- Stanford University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 assessment
- Other primary endothelial dysfunction such as PPMD
- Visually significant optic nerve or macular pathology
- Hypotony (Intraocular pressure <10mmHg)
- Any prior intraocular surgery other than cataract surgery
- >3 clock hours of ANY anterior or posterior synechiae
- >1 quadrant of stromal corneal vascularization
- Inability to comply with post-operative instructions (i.e. unable to position)
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DMEK plus topical placebo Placebo - DSO plus topical ripasudil 0.4% Ripasudil -
- Primary Outcome Measures
Name Time Method Best spectacle-corrected visual acuity (BSCVA) 12 months Best spectacle-corrected visual acuity (BSCVA)
- Secondary Outcome Measures
Name Time Method Endothelial cell density 3, 6, and 24 months Endothelial cell density
Best spectacle-corrected visual acuity (BSCVA) 3, 6 and 24 months Best spectacle-corrected visual acuity (BSCVA)
Trial Locations
- Locations (7)
Stanford University
🇺🇸Palo Alto, California, United States
University of California Davis
🇺🇸Sacramento, California, United States
University of Miami
🇺🇸Palm Beach Gardens, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States