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Descemet Endothelial Thickness Comparison Trial I
Recruiting
I'm InterestedTrial 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
Associate Professor of 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 InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nicole Varnado, MPH