Clinical trial NCT05289661: Descemet Endothelial Thickness Comparison Trial I
Official title: Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fuchs
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: 2022-03-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.


Eligibility criteria: Inclusion Criteria:

* Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
* Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
* Dysfunctional endothelium from prior graft failure after PKP or EK
* Controlled uveitis (defined as quiet for \> 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
* Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP \< 5 mmHg) or no glaucoma
* Good candidate for corneal transplantation for either DMEK or UT-DSAEK
* Willingness to participate
* Age greater than 18 years

Exclusion Criteria:

* Aphakia, or 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
* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
* Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
* Pregnancy

Primary outcomes:
measure: Best spectacle-corrected visual acuity (BSCVA)
timeFrame: 12 months
measure: Endothelial cell loss
timeFrame: 12 months
Secondary outcomes:
measure: Best spectacle-corrected visual acuity (BSCVA)
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: