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NCT Number: NCT05275972

Descemet Endothelial Thickness Comparison Trial 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.

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Key information

Conditions

Fuchs Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs Dystrophy Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

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 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

Treatment and study plan

Ripasudil

Drug

Topical Ripasudil 0.4%

Placebo

Drug

Topical Placebo

Primary outcomes

  1. Best spectacle-corrected visual acuity (BSCVA)

    Time frame: 12 months

    Best spectacle-corrected visual acuity (BSCVA)

Secondary outcomes

  1. Best spectacle-corrected visual acuity (BSCVA)

    Time frame: 3, 6 and 24 months

    Best spectacle-corrected visual acuity (BSCVA)

  2. Endothelial cell density

    Time frame: 3, 6, and 24 months

    Endothelial cell density

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Varnado, MPH

CONTACT

[email protected]

650-725-1688

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Case Western Reserve University
  • Dartmouth-Hitchcock Medical Center
  • Devers Eye Institute
  • 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 II

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 11, 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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