Trial Search Results

Descemet Endothelial Thickness Comparison Trial II

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Oregon Health and Science University

Stanford Investigator(s):

Intervention(s):

  • Drug: Ripasudil
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm

   - Peripheral endothelial cell count >1500 cells/mm^2

   - 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

Exclusion Criteria:

   - 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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicole Varnado, MPH
4802981310
Not Recruiting