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

A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

Inclusion Criteria:Male or female aged ≥ 21 and ≤ 80 years on the day of screeningCandidates must have the ability and willingness to attend all scheduled visits and comply with all study proceduresLegally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eyeKeratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency;Adequate tear film and lid functionPerception of light in all quadrantsFemale patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study.Exclusion Criteria:Reasonable chance of success with traditional keratoplastyCurrent retinal detachmentConnective tissue diseases or severely scarred conjunctiva in the target eyeEnd stage glaucoma or evidence of current uncontrolled glaucomaHistory or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis)Active inflammation of the conjunctiva in one or both eyesHistory of ocular or periocular malignancyHistory of extensive keloid formationAny known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the deviceOcular ischemic syndromeSigns of current infection, including fever and current treatment with antibioticsSevere generalized disease that results in a life expectancy shorter than two yearsAny clinical evidence that the investigator feels would place the subject at increased risk with the placement of the deviceCorneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operatedCurrently pregnant or breastfeedingParticipation 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 deviceIntraoperative complication that would preclude implantation of the study deviceHemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetesPatients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedureVulnerable populations - minors, pregnant women, prisoners, sponsor or study institution employees, military persons, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized patients and refugeesSubjects 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)Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space