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Descemet Endothelial Thickness Comparison Trial II

RecruitingPhase 3

Sponsor: Stanford University

Conditions: Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy

Interventions: Ripasudil, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<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

Locations (8)

Palo Alto, California, United States
Sacramento, California, United States
Palm Beach Gardens, Florida, United States
Lebanon, New Hampshire, United States
Portland, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States