Descemet Endothelial Thickness Comparison Trial II (DETECT II)

May 6, 2026 updated by: Jennifer Rose-Nussbaumer, Stanford University

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Jennifer Rose-Nussbaumer, MD
        • Sub-Investigator:
          • Charles Lin, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
        • Principal Investigator:
          • Mathew Margolis, MD
    • Florida
      • Palm Beach Gardens, Florida, United States, 33418
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Ellen Koo, MD
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Principal Investigator:
          • William Gensheimer, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Sub-Investigator:
          • Afshan Nanji, MD
        • Sub-Investigator:
          • Richard Stutzman, MD
        • Principal Investigator:
          • Roma Pegany, MD
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Devers Eye Institute
        • Principal Investigator:
          • Michael Straiko, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Wills Eye Hospital
        • Principal Investigator:
          • Zeba Syed, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 the investigator believes is visually significant and could 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
  • >3 clock hours of ANY anterior or posterior synechiae
  • >1 quadrant of stromal corneal vascularization
  • Inability to comply with post-operative instructions (i.e. unable to position)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: DMEK plus topical placebo
Drug: Placebo
Topical Placebo
Experimental: DSO plus topical ripasudil 0.4%
Drug: Ripasudil
Topical Ripasudil 0.4%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best spectacle-corrected visual acuity (BSCVA)
Time Frame: 12 months
Best spectacle-corrected visual acuity (BSCVA)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best spectacle-corrected visual acuity (BSCVA)
Time Frame: 3, 6 and 24 months
Best spectacle-corrected visual acuity (BSCVA)
3, 6 and 24 months
Endothelial cell density
Time Frame: 3, 6, and 24 months
Endothelial cell density
3, 6, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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

Investigators

  • Principal Investigator: Jennifer Rose-Nussbaumer, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220590-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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