Descemet Endothelial Thickness Comparison Trial II

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I'm Interested

Trial 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
Jennifer Rose-Nussbaumer

Professor of Ophthalmology

Charles C. Lin, MD
Charles C. Lin, MD

Clinical Professor, Ophthalmology

Eligibility

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

Intervention(s):

drug: Ripasudil

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Varnado, MPH