EndoArt® Implantation in Subjects With Chronic Corneal Edema - US Study
NCT07344168 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123
Last updated 2026-03-13
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.
Conditions
- Corneal Edema
Interventions
- DEVICE
-
The EndoArt® (Corneal Artificial Endothelial layer)
Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK
Sponsors & Collaborators
-
Eye-yon Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2029-04-30
- Completion
- 2030-04-30
- FDA Device
- Yes
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