Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
study ends around

Description

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.

Official Title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Keywords

Fuchs, K-115, Topical Ripasudil, UT-DSAEK plus topical ripasudil, DMEK plus topical ripasudil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Davis
    Sacramento California 95817 United States
  • Stanford University
    Palo Alto California 94303 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
ID
NCT05289661
Phase
Phase 3 Fuchs' Dystrophy Research Study
Study Type
Interventional
Participants
About 160 people participating
Last Updated