Descemet Endothelial Thickness Comparison Trial I

Description

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.

Conditions

Fuchs

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Study Overview

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Study Details

Study overview

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.

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Descemet Endothelial Thickness Comparison Trial I

Condition
Fuchs
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94303

Sacramento

University of California Davis, Sacramento, California, United States, 95817

Palm Beach Gardens

University of Miami, Palm Beach Gardens, Florida, United States, 33418

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03766

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Wills Eye Hospital, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Jennifer Rose-Nussbaumer, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2027-03-31