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Recruiting
NCT05275972
Descemet Endothelial Thickness Comparison Trial II
Conditions: Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 60
Sponsor: Stanford University
Location: Stanford University Palo Alto California
Summary
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.
Eligibility Criteria
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 \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
Source: ClinicalTrials.gov (NCT05275972). StuddyBuddy aggregates publicly available trial information.