Comparing two types of corneal transplant surgeries for Fuchs dystrophy
Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
This study is testing which of two corneal transplant surgeries works better for people with Fuchs dystrophy and whether a new eye drop can help protect their vision.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 7 sites (Palo Alto, California and 6 other locations) |
| Trial ID | NCT05289661 on ClinicalTrials.gov |
What this trial studies
The Descemet Endothelial Thickness Comparison Trial I (DETECT I) is a multi-center, outcome assessor-masked, placebo-controlled clinical trial that aims to compare visual outcomes between ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in patients with dysfunctional corneal endothelium due to Fuchs Endothelial Corneal Dystrophy and other conditions. The trial will also evaluate the impact of topical rho-kinase inhibitors on endothelial cell loss. A total of 160 patients will be randomized in a 2x2 factorial design to assess these outcomes. The study is designed to provide insights into the effectiveness of these surgical techniques and the potential benefits of the medication used.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy or other specified conditions.
Not a fit: Patients with aphakia or specific intraocular lens conditions in the study eye may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve visual outcomes for patients undergoing corneal transplant surgeries.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California and 6 other locations
- Stanford University — Palo Alto, California, United States (Recruiting)
- University of California Davis — Sacramento, California, United States (Recruiting)
- University of Miami — Palm Beach Gardens, Florida, United States (Recruiting)
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Rose-Nussbaumer, MD — Stanford University
- Study coordinator: Nicole Varnado, MPH
- Email: nvarnado@stanford.edu
- Phone: 650-725-1688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.