Clinical trial NCT05275972: Descemet Endothelial Thickness Comparison Trial II
Official title: Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fuchs
Fuchs Dystrophy
Fuchs' Endothelial Dystrophy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: University of California, San Francisco
name: University of California, Davis
name: Case Western Reserve University
name: Dartmouth-Hitchcock Medical Center
name: University of Pennsylvania
name: University of Miami
name: Wills Eye Hospital
First posted: 2022-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \<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

Primary outcomes:
measure: Best spectacle-corrected visual acuity (BSCVA)
timeFrame: 12 months
Secondary outcomes:
measure: Best spectacle-corrected visual acuity (BSCVA)
timeFrame: 3, 6 and 24 months
measure: Endothelial cell density
timeFrame: 3, 6, and 24 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Palm Beach Gardens
country: United States
facility: University of Miami
state: Florida
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Jennifer Rose-Nussbaumer, MD
role: PRINCIPAL_INVESTIGATOR
References: