Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

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. conjunctivitis, 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
• •10. Ocular ischemic syndrome
• •11. Signs of current infection, including fever and current treatment with antibiotics
• •12. Severe generalized disease that results in a life expectancy shorter than two years
• •13. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
• •14. Corneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operated
• •15. Currently pregnant or breastfeeding
• •16. 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
• •17. Intraoperative complication that would preclude implantation of the study device
• •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. Vulnerable populations - minors, pregnant women, prisoners, sponsor or study institution employees, military persons, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized patients and refugees
• •21. Subjects with corneal disorders located outside the central 7 mm, such as Mooren ulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (if located outside the central 7 mm of the cornea)
• •22. Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space