Overview
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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