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