Comparison of two procedures for treating Fuchs endothelial dystrophy
Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
This study is testing two different eye surgeries for people with Fuchs endothelial dystrophy to see which one helps improve vision and eye health better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 8 sites (Palo Alto, California and 7 other locations) |
| Trial ID | NCT05275972 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two surgical approaches for patients with Fuchs endothelial dystrophy: Descemet Membrane Endothelial Keratoplasty (DMEK) and Descemet Stripping Only (DSO) with the addition of Ripasudil. The study is a multi-center, outcome assessor-masked, placebo-controlled trial that will randomize 60 patients to evaluate the effectiveness of these interventions. Participants will be monitored for outcomes related to endothelial function and visual clarity post-surgery. The trial aims to determine which procedure offers better results for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years with dysfunctional endothelium from Fuchs endothelial dystrophy and specific endothelial cell counts.
Not a fit: Patients with significant pre-existing ocular conditions or prior intraocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and visual clarity for patients with Fuchs endothelial dystrophy.
How similar studies have performed: Previous studies have shown promise in similar surgical approaches for treating endothelial dystrophies, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Palo Alto, California and 7 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)
- Legacy Devers Eye Institute — Portland, Oregon, 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.