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Active Not Recruiting
NCT05289661
Descemet Endothelial Thickness Comparison Trial I
Conditions: Fuchs
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 160
Sponsor: Stanford University
Location: Stanford University Palo Alto California
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT05289661). StuddyBuddy aggregates publicly available trial information.