Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around
Principal Investigator
by Jennifer Li, MD (ucdavis)

Description

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.

Official Title

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Keywords

Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Ripasudil, DSO plus topical ripasudil 0.4%

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Davis accepting new patients
    Sacramento California 95817 United States
  • Stanford University accepting new patients
    Palo Alto California 94303 United States

Lead Scientist at University of California Health

  • Jennifer Li, MD (ucdavis)
    Professor, MED: Eye Center, School of Medicine. Authored (or co-authored) 115 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
ID
NCT05275972
Phase
Phase 3 Fuchs' Dystrophy Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated