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

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

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma Eye; Tissue Breakdown
• Intervention / Treatment: Device: CorNeat EverPatch

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • DaVinci Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female
2. Aged ≥ 18 and ≤ 80 years on screening day
3. Concealment of glaucoma tube shunt or suture tags is indicated
4. Patients with viable and intact conjunctiva
5. Candidates must have the ability and willingness to provide a written informed consent, attend all scheduled visits and comply with study procedures
6. Adequate tear film and lid function as indicated by Tear Film Breakup Time test - more than 5 seconds
7. Visual acuity of light perception or better
8. Female patients of childbearing age must agree to use an acceptable and effective method of contraception throughout the study, including the follow-up period, and have negative pregnancy test at screening.

Exclusion Criteria:

1. Current retinal detachment
2. Active ocular or orbital infection
3. History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation
4. History of ocular or periocular malignancy
5. History of extensive keloid formation
6. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or component of the device, specifically Oxybuprocaine hydrochloride, lidocaine, tropicamide, epinephrine, Iodine solution & aromatic polycarbonate urethane
7. Signs of current infection, including fever and current treatment with antibiotics
8. Severe generalized disease that results in a life expectancy shorter than a year
9. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
10. Pregnant or breastfeeding female subjects
11. Participation in any study involving an investigational drug or device within 30 days of the study or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
12. Any traumatic perforation of the globe OR tissue gaps/weaknesses, resulting either from traumatic, disease- related or iatrogenic damage OR loss of scleral integrity where use of tissue or substitutes is indicated
13. Vulnerable populations
14. Active drug or alcohol abuse or dependence that, in the opinion of the principle investigator, would interfere with adherence to study requirements
15. Subjects with other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study (e.g. active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, uncompensated cirrhosis, active upper GI tract ulceration, active inflammatory disease, malignancy under active treatment)
16. Subjects who receive anti-coagulation treatment which cannot be interfered during the perioperative period
17. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
18. Subjects receiving chronic systemic immunosuppressants (e.g. steroids, cyclosporine etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants	Device: CorNeat EverPatch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: CorNeat Vision Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Actual): September 24, 2023
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: DMS-34948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No