Actively Recruiting
Led by Stanford University · Updated on 2026-05-08
60
Participants Needed
8
Research Sites
52 weeks
Total Duration
S
Stanford University
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
The trial investigates treatments for Fuchs endothelial dystrophy, a condition affecting the cornea's inner layer. It is a Phase 3, multi-center, randomized clinical trial comparing two surgical approaches for this condition. The goal is to better understand how different procedures affect vision and eye health in adults with this disease. The study is led by Stanford University and includes 60 participants who will be randomly assigned to treatment groups with masked outcome assessors to reduce bias. Participants will be randomly assigned to one of two groups: one receiving Descemet Membrane Endothelial Keratoplasty (DMEK) with a topical placebo, and the other undergoing Descemet Stripping Only (DSO) combined with topical Ripasudil 0.4%. The study is triple-masked, meaning patients, surgeons, and outcome assessors are unaware of the treatment assignments. Both treatments are delivered as eye procedures, and the Ripasudil is administered topically to the eye in the DSO group. During the 24-month study period, participants will undergo regular assessments including measuring their best spectacle-corrected visual acuity (BSCVA) at 3, 6, 12, and 24 months. Endothelial cell density will also be measured at 3, 6, and 24 months to monitor the cornea's cell health. Safety and adherence to the protocol will be monitored throughout to ensure accurate evaluation of each treatment's outcomes. Participants will be followed closely to assess the impact of treatments on vision and corneal health over time.
CONDITIONS
Descemet Endothelial Thickness Comparison Trial II
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo one of two surgical procedures combined with topical eye drops as part of the treatment.
Regular visits at 3, 6, 12, and 24 months for assessments
Total: 8 locations
1
Stanford University
Palo Alto, California, United States, 94303
Actively Recruiting
2
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
3
University of Miami
Palm Beach Gardens, Florida, United States, 33418
Actively Recruiting
4
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
5
Legacy Devers Eye Institute
Portland, Oregon, United States, 97210
Actively Recruiting
6
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
N
Nicole Varnado, MPH
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Charles C Lin, Winston Chamberlain, Beth Ann Benetz...
https://pubmed.ncbi.nlm.nih.gov/39353677