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Pivotal Trial for a Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants — EverPatch  

Glaucoma Eye Clinical Trial

Official title:
A Single Arm, Pivotal, Open Label, Multi-centre Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat EverPatch, A Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants

Clinical Trial Summary

This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants.

Clinical Trial Description

A single arm, pivotal, open label, multi-centre clinical investigation to evaluate the clinical safety and performance of the CorNeat EverPatch, a synthetic tissue substitute for concealment of artificial ocular implants. Subjects will sign a consent form and will be assessed for eligibility based on clinical examinations and medical history. Upon eligibility verification, subjects will be implanted with the investigational device as part of an ophthalmic surgery in which a concealment of an artificial implant is required. Clinical examinations at follow up will include slit lamp biomicroscopy, assessment of visual acuity and intra ocular pressure, and recording of concomitant medications and any safety issues. Follow up visits will be performed at 1 week, 1-, 2-, 3-, 6-, 9- and 12-months post-op. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05469867
Study type Interventional
Source CorNeat Vision Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date August 16, 2022
Completion date March 1, 2024
View Details
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