Descemet Endothelial Thickness Comparison Trial II
Trial ID or NCT#
NCT05275972
Status
RECRUITING
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:
- * 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:
- * 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)
Charles C. Lin, MD
Cornea specialist,
Cataract specialist
Clinical Associate Professor, Ophthalmology
Contact us to find out if this trial is right for you.
Contact
Nicole Varnado, MPH
View on ClinicalTrials.gov
