Descemet Endothelial Thickness Comparison Trial I
Trial ID or NCT#
Status
RECRUITING
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)
Eligibility 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
- - 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
Investigator(s)
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Contact
Nicole Varnado, MPH
View on ClinicalTrials.gov
