Eye transplant showdown: which surgery saves sight best?
NCT ID NCT05289661
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This study compares two types of corneal transplant surgery (UT-DSAEK and DMEK) in 160 people with Fuchs dystrophy, a condition that clouds the cornea. It also tests whether a drug called rho-kinase inhibitor can reduce loss of important eye cells after surgery. The goal is to find which approach gives better vision and preserves eye health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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160 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata * Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD) * Dysfunctional endothelium from prior graft failure after PKP or EK * Controlled uveitis (defined as quiet for \> 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis * Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP \< 5 mmHg) or no glaucoma * Good candidate for corneal transplantation for either DMEK or UT-DSAEK * Willingness to participate * Age greater than 18 years Exclusion Criteria: * Aphakia, or 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 * Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours * Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Stanford University
Palo Alto, California, 94303, United States
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University of California Davis
Sacramento, California, 95817, United States
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University of Miami
Palm Beach Gardens, Florida, 33418, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
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