Summary

Eligibility
for people ages 18 years and up (full criteria)
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)

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
ID
NCT05275972
Phase
Phase 3 research study
Study Type
Interventional
Last Updated