Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Palo Alto, California and other locations
Dates
study started
completion 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, 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 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

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
  • 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

Locations

  • Stanford University accepting new patients
    Palo Alto California 94303 United States
  • University of California Davis accepting new patients
    Sacramento California 95817 United States
  • Oregon Health & Science University accepting new patients
    Portland Oregon 97239 United States
  • Dartmouth-Hitchcock Medical Center accepting new patients
    Lebanon New Hampshire 03766 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
ID
NCT05289661
Phase
Phase 3 Fuchs' Dystrophy Research Study
Study Type
Interventional
Participants
Expecting 160 study participants
Last Updated