Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
Conditions
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.
Interventions
DRUGRipasudil
Topical Ripasudil 0.4%
DRUGPlacebo
Topical Placebo
Sponsors
University of Pennsylvania
University of Miami
Wills Eye Hospital
Devers Eye Institute
Dartmouth-Hitchcock Medical Center
Stanford University
Oregon Health and Science University
University of California, San Francisco
University of California, Davis
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best spectacle-corrected visual acuity (BSCVA) | 12 months | Best spectacle-corrected visual acuity (BSCVA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best spectacle-corrected visual acuity (BSCVA) | 3, 6 and 24 months | Best spectacle-corrected visual acuity (BSCVA) |
| Endothelial cell density | 3, 6, and 24 months | Endothelial cell density |
Countries
United States
Contacts
CONTACTNicole Varnado, MPH
PRINCIPAL_INVESTIGATORJennifer Rose-Nussbaumer, MD
Stanford University
Outcome results
None listed