Descemet Endothelial Thickness Comparison Trial I

Recruiting

I'm Interested

Trial ID: NCT05289661

Purpose

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

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

Clinical Associate Professor, Ophthalmology

Eligibility

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 guttata
* 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 assessment
* 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

Intervention(s):

drug: Topical Ripasudil

drug: Topical Placebo

Recruiting

I'm Interested

Contact Information

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