Descemet Endothelial Thickness Comparison Trial II

Descemet Endothelial Thickness Comparison Trials (DETECT I & 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.

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