Descemet Endothelial Thickness Comparison Trial II (DETECT II)

Stanford University

Status and phase

Enrolling

Phase 3

Conditions

Fuchs

Fuchs' Endothelial Dystrophy

Fuchs Dystrophy

Treatments

Drug: Ripasudil

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05275972

20220590-II

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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