Status:
RECRUITING
Descemet Endothelial Thickness Comparison Trial II
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Oregon Health and Science University
University of California, San Francisco
Conditions:
Fuchs
Fuchs Dystrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 DM...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05275972
Start Date
January 23 2023
End Date
November 30 2028
Last Update
December 18 2025
Active Locations (7)
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1
Stanford University
Palo Alto, California, United States, 94303
2
University of California Davis
Sacramento, California, United States, 95817
3
University of Miami
Palm Beach Gardens, Florida, United States, 33418
4
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766