Corneal Blindness Corneal scarring
Conditions
Interventions
The CorNeat KPro will be implanted into the subject*s eye with the optic
component snapping into the patient*s trephined cornea then sutured to the eye
wall using 3 non-degradable sutures and the sk
Sponsors
Corneat Vision Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged >= 18 and
Exclusion criteria
Exclusion criteria: 1. Reasonable chance of success with traditional keratoplasty 2. Current retinal detachment 3. Connective tissue diseases or severely scarred conjunctiva in the target eye 4. End stage glaucoma or evidence of current uncontrolled glaucoma 5. History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) 6. Active inflammation of the conjunctiva in one or both eyes 7. History of ocular or periocular malignancy 8. History of extensive keloid formation 9. Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device, specifically acrylate 10. Signs of current infection, including fever and current treatment with antibiotics 11. Severe generalized disease that results in a life expectancy shorter than a year 12. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device 13. Currently pregnant or breastfeeding 14. Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device 15. Intraoperative complication that would preclude implantation of the study device. 16. Vulnerable populations. 17. Active orbital, scleral or corneal inflammation 18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes 19. Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure 20. Ocular ischemic syndrome 21. Severely scarred conjunctiva
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint is the frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 24 months. The frequency should be less than SOC (as detailed in the Investigator*s Brochure). | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness Endpoints: (i) Primary Endpoint: Retention of implant; (ii) Secondary Endpoint: Improved visual acuity | — |
Countries
Netherlands
Outcome results
None listed