Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05469867
Other study ID # DMS-34948
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 16, 2022
Est. completion date March 1, 2024

Study information

Verified date February 2023
Source CorNeat Vision Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada EyeCare Miramichi Eye NB Miramichi
Canada Prism Eye Institute Oakville
Canada University Health Network Toronto
France Hôpital Fondation Rothschild Paris
Georgia DaVinci Eye Care Tbilisi

Sponsors (1)

Lead Sponsor Collaborator
CorNeat Vision Ltd.

Countries where clinical trial is conducted

Canada,  France,  Georgia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Assessment The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation will be recorded Up to 12 months
Secondary 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.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05566626 - Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera N/A
Recruiting NCT05685485 - Tied Tube Trial in Glaucoma Surgery
Not yet recruiting NCT03682783 - Artificial Intelligence-assisted Glaucoma Screening (AIAGS)
Recruiting NCT04602923 - Keratometric Change After XEN, Trabeculectomy and Tube Shunts N/A
Recruiting NCT04671550 - The Value of Visual Field Examination in Driving Licence.
Completed NCT03624361 - MINIject Glaucoma Implant in European Patients N/A
Withdrawn NCT04676126 - Augmented Macular Pigment-containing Nutraceutical and Central Visual Function Phase 4
Not yet recruiting NCT05593354 - MicroPulse TLT - UK Study
Not yet recruiting NCT05730478 - Comparison Between Anterior Segment Optical Coherence Tomography and Ultrasound Bio Microscopy Parameters in Glaucoma Assessment
Completed NCT03187418 - Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma N/A
Completed NCT03996200 - MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool N/A
Completed NCT03338101 - Comparative Study Between Tonometers N/A
Completed NCT04052165 - IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient N/A
Completed NCT04648943 - The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties N/A
Completed NCT03138928 - An Innovation in Glaucoma Surgery: XEN45 Gel Stent Implantation N/A
Completed NCT05895617 - Assessment of the Occuity PM1 Pachymeter
Enrolling by invitation NCT04381611 - INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register
Completed NCT05449041 - Bulbicam Validation on Glaucoma- and Cataract Patients
Completed NCT03797846 - Comparison of Fixation Suture Type in Glaucoma Surgery N/A
Terminated NCT04037917 - First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute N/A