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RecruitingPhase 3NCT05275972

Descemet Endothelial Thickness Comparison Trial II

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Sponsor

Stanford University

Enrollment

60 participants

Start Date

Jan 23, 2023

Study Type

INTERVENTIONAL

Conditions

Fuchs' Endothelial DystrophyFuchs DystrophyFuchs

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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
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Interventions

DRUGRipasudil

Topical Ripasudil 0.4%

DRUGPlacebo

Topical Placebo

Locations(7)

Stanford University

Palo Alto, California, United States

University of California Davis

Sacramento, California, United States

University of Miami

Palm Beach Gardens, Florida, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

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NCT05275972

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