Descemet Endothelial Thickness Comparison Trial I

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Fuchs

In brief

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.

Key facts

Study ID

NCT05289661

Run by

Stanford University

People needed

160

Starts

2022-07-15

Expected to finish

2027-11-30

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 dysfunction 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 to participate
• Age greater than 18 years

You may not qualify if…

• 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
• Pregnancy

Where it is running

• Stanford University — Palo Alto, California, United States
• University of California Davis — Sacramento, California, United States
• University of Miami — Palm Beach Gardens, Florida, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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