NCT05275972PHASE3Recruiting
Descemet Endothelial Thickness Comparison Trial II
Stanford University
Start Date
1/23/2023
Completion Date
11/30/2028
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 Criteria
Age Range: 18 years to No maximum
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 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
Interventions
DRUG
Ripasudil
DRUG
Placebo
Conditions
FuchsFuchs DystrophyFuchs' Endothelial Dystrophy
Locations
Stanford University
Palo Alto, California 94303
United States
University of California Davis
Sacramento, California 95817
United States
University of Miami
Palm Beach Gardens, Florida 33418
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03766
United States
Legacy Devers Eye Institute
Portland, Oregon 97210
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Wills Eye Hospital
Philadelphia, Pennsylvania 19107
United States