Descemet Endothelial Thickness Comparison Trial II
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
In brief
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.
Key facts
- Study ID
- NCT05275972
- Run by
- Stanford University
- People needed
- 60
- Starts
- 2023-01-23
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University — Palo Alto, California, United States (enrolling)
- University of California Davis — Sacramento, California, United States (enrolling)
- University of Miami — Palm Beach Gardens, Florida, United States (enrolling)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
- Legacy Devers Eye Institute — Portland, Oregon, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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