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Descemet Endothelial Thickness Comparison Trial II
Recruiting
I'm InterestedTrial ID: NCT05275972
Purpose
Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.
Official Title
Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Stanford Investigator(s)
Jennifer Rose-Nussbaumer
Associate Professor of Ophthalmology
Charles C. Lin, MD
Clinical Associate Professor, Ophthalmology
Eligibility
Inclusion Criteria:
* Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
* Peripheral endothelial cell count \>1500 cells/mm2
* Good surgical candidate for either procedure as determined by the surgeon
* 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:
* Other primary endothelial dysfunction such as PPMD
* Any prior intraocular surgery other than cataract surgery
* Cataract surgery within the last 3 months
* \>3 clock hours of ANY anterior or posterior synechiae
* \>1 quadrant of stromal corneal vascularization
* Visually significant optic nerve or macular pathology
* Fellow eye visual acuity \<20/200
* Pregnancy
* Inability to comply with post-operative instructions (i.e. unable to position)
* Hypotony (Intraocular pressure \<10mmHg)
* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
* Aphakia, 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
Intervention(s):
drug: Ripasudil
drug: Placebo
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nicole Varnado, MPH