Descemet Endothelial Thickness Comparison Trial II

Recruiting

I'm Interested

Trial ID: NCT05275972

Purpose

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.

Official Title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Stanford Investigator(s)

Jennifer Rose-Nussbaumer
Jennifer Rose-Nussbaumer

Associate Professor of Ophthalmology

Charles C. Lin, MD
Charles C. Lin, MD

Clinical Associate Professor, Ophthalmology

Eligibility

Inclusion Criteria:

* Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
* Peripheral endothelial cell count \>1500 cells/mm2
* 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 18 years

Exclusion Criteria:

* Other primary endothelial dysfunction such as PPMD
* Any prior intraocular surgery other than cataract surgery
* Cataract surgery within the last 3 months
* \>3 clock hours of ANY anterior or posterior synechiae
* \>1 quadrant of stromal corneal vascularization
* Visually significant optic nerve or macular pathology
* Fellow eye visual acuity \<20/200
* Pregnancy
* Inability to comply with post-operative instructions (i.e. unable to position)
* Hypotony (Intraocular pressure \<10mmHg)
* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
* 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

Intervention(s):

drug: Ripasudil

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Varnado, MPH