Summary

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

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
  • Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
  • Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or without systemic immunosuppression)
  • Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP < 5 mmHg)
  • Good candidate for corneal transplantation for either DMEK or UT-DSAEK
  • Prior graft failure after PKP or EK
  • 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...

  • Uncontrolled uveitis
  • Aphakia, or anterior chamber 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
  • Uncontrolled glaucoma (IOP >25 mmHg)
  • Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
  • Participants who are not suitable for the DMEK or UT-DSAEK surgeries
  • Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars)
  • Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL at time of study EK
  • Hypotony (Intraocular pressure <10mmHg)
  • Inability to comply with post-operative instructions (i.e. unable to position)
  • Participants who are decisionally and/or cognitively impaired
  • Pregnancy
  • Fellow eye visual acuity <20/200
  • Children (18 years and under)

Locations

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