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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: [Redacted] to Eye-yon Medicalv3 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Apr 30, 2029
    • Study completion date: Apr 30, 2030
    • Start date: May 1, 2026
    • Study title shortened, about 2 words
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07344168
Lead Sponsor Eye-yon Medical
Conditions
(from sponsor)		 Corneal Edema
Related terms Corneal Edema
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov