Title: Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of subjects suffering from corneal edema~Device: EndoArt® (Artificial Endothelial Layer)~Intended Use: The EndoArt® device is intended for use as an endothelial kearatoprosthesis in patients with chronic cornel edema~Study Design: Prospective open-label feasibility clinical study~Study Objectives: To evaluate the safety of the EndoArt® implanted in subjects suffering from corneal edema.~Study Hypothesis: Treatment with the EndoArt® is safe and may result in alleviating symptoms resulting from chronic corneal edema (corneal thickness).~Study population: Men and women suffering from a decrease in vision due to chronic corneal edema that meet the inclusion/exclusion criteria and provide written Informed Consent will enrolled in the study.~Enrollment: A total of up to 30 subjects will be enrolled.~Study Duration: Completion of active enrollment is anticipated to last approximately 18 months. The primary end point will be achieved when the final study subject has completed 6 month follow up. Subject will be followed up to 12 month.~Primary Safety Endpoint: The frequency and severity of all treatment-related adverse events, during and after implantation of the EndoArt® and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.~Secondary Efficacy Endpoints: Corneal thickness, Subjective corneal clarity, Pain as assessed by a Visual Analogue Scale (VAS) Measurement Best Corrected Distance Visual Acuity (BCDVA)~Study Treatment: Subjects will be implanted with the EndoArt®
Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months.