Descemet Endothelial Thickness Comparison Trial I
- Registration Number
- NCT05289661
- Lead Sponsor
- Stanford University
- Brief Summary
Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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 dysfuction 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 and ability to undergo corneal transplantation
- Willingness to consistently use study medications (i.e. ROCK-inhibitors)
- Willingness to participate in follow-up visits
- Age greater than 18 years
- 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
- Inability to comply with post-operative instructions (i.e. unable to position)
- Pregnancy
- Cataract surgery within the last 3 months
- Fellow eye visual acuity <20/200
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description UT-DSAEK plus topical placebo Topical Placebo This arm will receive UT-DSAEK plus topical placebo DMEK plus topical ripasudil Topical Ripasudil This arm will receive DMEK plus topical ripasudil 0.4% DMEK plus topical placebo Topical Placebo This arm will receive DMEK plus topical placebo UT-DSAEK plus topical ripasudil Topical Ripasudil This arm will receive UT-DSAEK plus topical ripasudil 0.4%
- Primary Outcome Measures
Name Time Method Best spectacle-corrected visual acuity (BSCVA) 12 months Best spectacle-corrected visual acuity
Endothelial cell loss 12 months Change between endothelial density at baseline versus density at 12 months
- Secondary Outcome Measures
Name Time Method Best spectacle-corrected visual acuity (BSCVA) 3, 6 and 24 months Best spectacle-corrected visual acuity
Trial Locations
- Locations (7)
University of California Davis
🇺🇸Sacramento, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Miami
🇺🇸Palm Beach Gardens, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Stanford University
🇺🇸Palo Alto, California, United States