PVEK Corneal Implant For Treatment of Corneal Edema

Inclusion Criteria: age 18/50 years or older Corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and/or pseudophakic bullous keratopathy Pseudophakic study eye Best corrected visual acuity (BCVA) in the study eye between 6/379 (1.8 logMAR) and 6/12 (0.3 logMAR) Central corneal thickness greater than 0.6 mm by OCT Exclusion Criteria: Phakic study eye Study eye is a "single sight eye" (per protocol definition) / fellow eye does not meet protocol vision requirement Malpositioned intraocular lens (dislocation/subluxation) in the study eye Prior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL Axial length below 21 mm or above 26 mm Other significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring/opacities not expected to improve with treatment Active ocular or eyelid infection/inflammation; active/prior herpetic ocular infection; uveitis Glaucoma / history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye) Synechiae; abnormal anterior segment (e.g., aphakia, aniridia) Corneal endothelial cell density above 1000 cells/mm² at screening (or not reliably measurable) Uncontrolled systemic conditions