Descemet Endothelial Thickness Comparison Trial II

a study on Fuchs' Dystrophy

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Palo Alto, California and other locations
Dates
study started
estimated completion

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 >1500 cells/mm2

  • Good surgical candidate for either procedure as determined by the surgeon
  • Willingness and ability to undergo corneal transplantation
  • Willingness to consistently use study medications (i.e. ROCK-inhibitors)
  • Willingness to participate in follow-up visits
  • Age greater than 18years

You CAN'T join if...

  • Other primary endothelial dysfunction such as PPMD
  • Any prior intraocular surgery other than cataract surgery
  • Cataract surgery within the last 3 months
  • AC IOL or scleral-fixated IOL
  • >3 clock hours of anterior or posterior synechiae
  • >1 quadrant of stromal corneal vascularization
  • Uncontrolled glaucoma (IOP>25)
  • Uncontrolled uveitis
  • Visually significant anterior stromal scarring
  • Visually significant optic nerve or macular pathology
  • Fellow eye visual acuity <20/200
  • Pregnancy
  • Children (18 years and under)

Locations

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

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
Contact us about this trial