Menu
Recruiting NCT05275972

Descemet Endothelial Thickness Comparison Trial II

Phase III Interventional Fuchs Fuchs Dystrophy Fuchs' Endothelial Dystrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ripasudil, Placebo.
Who it may be relevant to
Registry conditions: Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Overview

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.

Interventions

  • Drug Ripasudil
    Topical Ripasudil 0.4%
  • Drug Placebo
    Topical Placebo

Primary outcome measures

  • Best spectacle-corrected visual acuity (BSCVA) [Time frame: 12 months]
Secondary outcome measures (2)
  • Best spectacle-corrected visual acuity (BSCVA) [Time frame: 3, 6 and 24 months]
  • Endothelial cell density [Time frame: 3, 6, and 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Stanford University — Palo Alto
  • University of California Davis — Sacramento
  • University of Miami — Palm Beach Gardens
  • Dartmouth-Hitchcock Medical Center — Lebanon
  • Legacy Devers Eye Institute — Portland
  • Oregon Health & Science University — Portland
  • University of Pennsylvania — Philadelphia
  • Wills Eye Hospital — Philadelphia

Publications

  • Lin CC, Chamberlain W, Benetz BA, Gensheimer W, Li JY, Jeng BH, Clover J, Varnado N, Abdelrahman S, Srinivasan A, Syed ZA, Koo EH, Arnold BF, Lietman TM, Lass J, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) PMID 39353677

Identifiers

NCT: NCT05275972 · 20220590-II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗