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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
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