Descemet Endothelial Thickness Comparison Trial II

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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

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