Descemet Endothelial Thickness Comparison Trial II

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Case Western Reserve University; Kaiser Permanente; Oregon Health and Science University; University of California, Davis; University of California, San Francisco; University of Maryland, Baltimore

Criteria

Inclusion Criteria:

• Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm

• Peripheral endothelial cell count >1500 cells/mm^2

• Good surgical candidate for either procedure as determined by the surgeon

• Willingness and ability to undergo corneal transplantation

• Willingness to consistently use study medications (i.e. ROCK-inhibitors)

• Willingness to participate in follow-up visits

• Age greater than 18years

Exclusion Criteria:

• Other primary endothelial dysfunction such as PPMD

• Any prior intraocular surgery other than cataract surgery

• Cataract surgery within the last 3 months

• AC IOL or scleral-fixated IOL

• >3 clock hours of anterior or posterior synechiae

• >1 quadrant of stromal corneal vascularization

• Uncontrolled glaucoma (IOP>25)

• Uncontrolled uveitis

• Visually significant anterior stromal scarring

• Visually significant optic nerve or macular pathology

• Fellow eye visual acuity <20/200

• Pregnancy

• Children (18 years and under)