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NOT YET RECRUITING
NCT07344168
NA

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

Sponsor: Eye-yon Medical

View on ClinicalTrials.gov

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.

Official title: A Prospective, Open-label, Single Arm Study to Evaluate the Safety and Effectiveness of the EndoArt® in Subjects With Chronic Corneal Edema in Whom Multiple Prior Keratoplasty (EK/PK) Have Failed, and Who Are Not Reasonable Candidates for Any Form of Corneal Transplant, Including Penetrating Keratoplasty

Key Details

Gender

All

Age Range

35 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2026-05-01

Completion Date

2030-04-30

Last Updated

2026-03-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

The EndoArt® (Corneal Artificial Endothelial layer)

Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSEK/DMEK