Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ACTIVE_NOT_RECRUITING

Descemet Endothelial Thickness Comparison Trial I

Lead Sponsor:

Stanford University

Collaborating Sponsors:

Oregon Health and Science University

University of California, San Francisco

Conditions:

Fuchs

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

July 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2027

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT05289661

Start Date

July 15 2022

End Date

November 30 2027

Last Update

December 17 2025

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Stanford University

Palo Alto, California, United States, 94303

2

University of California Davis

Sacramento, California, United States, 95817

3

University of Miami

Palm Beach Gardens, Florida, United States, 33418

4

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03766