Descemet Endothelial Thickness Comparison Trial II
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ripasudil
DrugTopical Ripasudil 0.4%
Placebo
DrugTopical Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: DMEK plus topical placeboPlacebo comparator 1 intervention
Group B: DSO plus topical ripasudil 0.4%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity (BSCVA)
Time frame
12 monthsSecondary outcomes
1
Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity (BSCVA)
Time frame
3, 6 and 24 months2
Endothelial cell density
Endothelial cell density
Time frame
3, 6, and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Oregon Health and Science University
Collaborator
University of California, San Francisco
Collaborator
University of California, Davis
Collaborator
Case Western Reserve University
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
University of Pennsylvania
Collaborator
University of Miami
Collaborator
Wills Eye Hospital
Collaborator
Devers Eye Institute
Collaborator
Source ClinicalTrials.gov