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Descemet Endothelial Thickness Comparison Trial II

RecruitingPhase 3Ages 18 Years - anyAllStanford University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm * Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant * Good surgical candidate for either procedure as determined by the surgeon * Willingness to participate * Age greater than 18 years Exclusion Criteria: * 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 * Other primary endothelial dysfunction such as PPMD * Visually significant optic nerve or macular pathology * Hypotony (Intraocular pressure \<10mmHg) * Any prior intraocular surgery other than cataract surgery * \>3 clock hours of ANY anterior or posterior synechiae * \>1 quadrant of stromal corneal vascularization * Inability to comply with post-operative instructions (i.e. unable to position) * Pregnancy
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What it tests

  • Ripasudil
  • Placebo
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Where

8 sites
Stanford University
Palo Alto, United States
University of California Davis
Sacramento, United States
University of Miami
Palm Beach Gardens, United States
Dartmouth-Hitchcock Medical Center
Lebanon, United States
Legacy Devers Eye Institute
Portland, United States
Oregon Health & Science University
Portland, United States
University of Pennsylvania
Philadelphia, United States
Wills Eye Hospital
Philadelphia, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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