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EndoArt® Implantation in Subjects With Chronic Corneal Edema

NCT05139771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-08-28

No results posted yet for this study

Summary

The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity.

The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).

Conditions

  • Corneal Edema

Interventions

DEVICE

THE ENDOART® IMPLANTATION (Artificial Endothelial layer)

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

Sponsors & Collaborators

  • Eye-yon Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • France
  • Georgia
  • Germany
  • India
  • Israel
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05139771 on ClinicalTrials.gov