Clinical Trial

EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study

Not Yet Recruiting
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Summary
The EndoArt® device is intended to treat patients with chronic corneal edema due to endothelial dysfunction, in whom prior multiple keratoplasty (EK/PK) have failed, and who are not reasonable candidates for any form of corneal transplant, including penetrating keratoplasty. The EndoArt® (Corneal Artificial Endothelial layer) is a permanent synthetic implant. It is made of a clear, transparent, foldable, biologically compatible hydrophilic copolymer. The device serves as an inert physical barrier, blocking the ingress of fluid from the Anterior Chamber (AC) into the cornea.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-14; most recent amendment 2026-03-11.
Status change: Withheld → Not Yet Recruiting 2026-03-11
Trial Details
NCT Number NCT07344168
Lead Sponsor Eye-yon Medical
Conditions Corneal Edema
Enrollment 123 participants
Start Date 2026-05-01
Primary Completion 2029-04-30 (estimated)
Study Completion 2030-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-13