Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05275972

Descemet Endothelial Thickness Comparison Trial II

Led by Stanford University · Updated on 2026-05-08

60

Participants Needed

8

Research Sites

305 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

O

Oregon Health and Science University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

CONDITIONS

Official Title

Descemet Endothelial Thickness Comparison Trial II

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
  • Peripheral endothelial cell count >1000 cells/mm2 in at least one quadrant
  • Good surgical candidate for either procedure as determined by the surgeon
  • Willingness to participate
  • Age greater than 18 years
Not Eligible

You will not qualify if you...

  • Aphakia, 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 may impact post-operative stromal clarity assessment
  • Other primary endothelial dysfunction such as PPMD
  • Visually significant optic nerve or macular pathology
  • Hypotony (Intraocular pressure <10mmHg)
  • Any prior intraocular surgery other than cataract surgery
  • More than 3 clock hours of any anterior or posterior synechiae
  • More than 1 quadrant of stromal corneal vascularization
  • Inability to comply with post-operative instructions
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Stanford University

Palo Alto, California, United States, 94303

Actively Recruiting

2

University of California Davis

Sacramento, California, United States, 95817

Actively Recruiting

3

University of Miami

Palm Beach Gardens, Florida, United States, 33418

Actively Recruiting

4

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03766

Actively Recruiting

5

Legacy Devers Eye Institute

Portland, Oregon, United States, 97210

Actively Recruiting

6

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

7

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

8

Wills Eye Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

N

Nicole Varnado, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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