Descemet Endothelial Thickness Comparison Trial I


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Trial ID: NCT05289661


Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.

Official Title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Stanford Investigator(s)

Jennifer Rose-Nussbaumer
Jennifer Rose-Nussbaumer

Associate Professor of Ophthalmology


Inclusion Criteria:

   - Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata
   extending beyond 4.5 mm of the central cornea or severe edema without visualization of

   - Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal
   Endothelial Syndrome (ICE) or other primary endothelial dysfuction such as Posterior
   Polymorphous Corneal Dystrophy (PPMD)

   - Dysfunctional endothelium from prior graft failure after PKP or EK

   - Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or
   without systemic immunosuppression) or no uveitis

   - Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt
   without ongoing hypotony (IOP < 5 mmHg) or no glaucoma

   - Good candidate for corneal transplantation for either DMEK or UT-DSAEK

   - 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:

   - Aphakia, or 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

   - Peripheral anterior synechiae (iris to angle) in the angle greater than a total of
   three clock hours

   - Visually significant optic nerve (ok to have small visual field defects) or macular
   severe pathology

   - Inability to comply with post-operative instructions (i.e. unable to position)

   - Pregnancy

   - Cataract surgery within the last 3 months

   - Fellow eye visual acuity <20/200


drug: Topical Ripasudil

drug: Topical Placebo


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Contact Information

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