This study is not yet accepting patients

Descemet Endothelial Thickness Comparison Trial I

a study on Fuchs' Dystrophy

Summary

Eligibility
for people ages 18 years and up (full criteria)
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)

Details

Status
not yet accepting 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