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NCT Number: NCT05289661

Descemet Endothelial Thickness Comparison Trial I

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fuchs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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 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 criteria

  • 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

Treatment and study plan

Topical Ripasudil

Drug

To determine the effect of rho-kinase inhibitors on endothelial cell loss

Other names: Ripasudil

Topical Placebo

Drug

topical Placebo

Other names: Placebo

Primary outcomes

  1. Best spectacle-corrected visual acuity (BSCVA)

    Time frame: 12 months

    Best spectacle-corrected visual acuity

  2. Endothelial cell loss

    Time frame: 12 months

    Change between endothelial density at baseline versus density at 12 months

Secondary outcomes

  1. Best spectacle-corrected visual acuity (BSCVA)

    Time frame: 3, 6 and 24 months

    Best spectacle-corrected visual acuity

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Case Western Reserve University
  • Dartmouth-Hitchcock Medical Center
  • Oregon Health and Science University
  • University of California, Davis
  • University of California, San Francisco
  • University of Miami
  • University of Pennsylvania
  • Wills Eye Hospital

Registry information

Official study title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Acronym: DETECT I

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 21, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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