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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

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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