Clinical Trials Directory

Trials / Terminated

TerminatedNCT05469867

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
CorNeat Vision Ltd. · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICECorNeat EverPatchThe CorNeat EverPatch will be implanted subconjunctivally over an ocular implant (e.g. glaucoma shunt, exposed suture tags) and fixed to the eye wall. The overlying conjunctiva will be closed over the patch.

Timeline

Start date
2022-08-16
Primary completion
2023-09-24
Completion
2024-06-18
First posted
2022-07-22
Last updated
2024-06-27

Locations

1 site across 1 country: Georgia

Source: ClinicalTrials.gov record NCT05469867. Inclusion in this directory is not an endorsement.