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Sponsor decided to stop the trial due to a shift in strategic business priorities.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CorNeat EverPatch | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation will be recorded | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Assessment | Tube or suture exposure will be detected by slit-lamp Biomicroscopy throughout the entire follow up period and incidence will be calculated. Prevention of tube or suture exposure associated with conjunctival erosion and graft melting should be demonstrated in at least 90% of the patients. | 6 & 12 months post-op. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVinci Eye Care | Tbilisi | Georgia |
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