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

Inclusion Criteria:

1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening

2. Candidates must have the ability and willingness to attend all scheduled visits andcomply with all study procedures

3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In caseof unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in theoperated eye

4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonableoption or following a verifiable history of prior failed corneal transplantation.

5. Indications that fall under poor candidate for keratoplasty include but are notlimited to: herpetic keratitis, vascularized corneal scar, Ocular CicatricialPemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency;

6. Adequate tear film and lid function

7. Perception of light in all quadrants

8. Female patients of childbearing age must have negative pregnancy test at screeningand agree to use an effective method of contraception throughout the study.

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, orcomponent 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 atincreased risk with the placement of the device

14. Corneal thickness less than 400 or higher than 1,200 microns in any region of thepachymetry 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 thepast 30 days or 5 half-lives of the drug (whichever longer) or ongoing participationin 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 diabetesand/or target organ damage associated with diabetes

19. Patients requiring anticoagulation treatment, which cannot be interrupted for thesurgical procedure

20. Vulnerable populations - minors, pregnant women, prisoners, sponsor or studyinstitution employees, military persons, terminally ill, comatose, physically andintellectually challenged individuals, institutionalized patients and refugees

21. Subjects with corneal disorders located outside the central 7 mm, such as Moorenulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (iflocated outside the central 7 mm of the cornea)

22. Patients with a functioning trabeculectomy or existing Microinvasive GlaucomaSurgery (MIGS) device that shunts aqueous from the anterior chamber into thesubconjunctival space