Descemet Endothelial Thickness Comparison Trial II

Trial ID or NCT#

NCT05275972

Status

recruiting iconRECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Jennifer Rose-Nussbaumer
Jennifer Rose-Nussbaumer
Ophthalmologist
Associate Professor of Ophthalmology

Contact us to find out if this trial is right for you.

Contact

Nicole Varnado, MPH