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

Launched by CORNEAT VISION LTD. · Jan 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called the CorNeat Keratoprosthesis (KPro) for people with corneal blindness, which is when the clear front part of the eye (the cornea) becomes cloudy or damaged, making it hard to see. The trial aims to evaluate how safe and effective this device is for patients who cannot undergo traditional corneal transplant surgery due to various eye conditions.

To be eligible for this study, participants must be between 21 and 80 years old and legally blind in one or both eyes. They should also be willing to attend all scheduled visits and follow study procedures. Participants can expect to receive the KPro device and will be monitored closely throughout the trial to assess their recovery and vision improvement. It's important to note that certain conditions, like active eye infections or severe eye diseases, may disqualify someone from joining the study. If you're interested in learning more, please talk to your doctor for more details about participation.

Gender

ALL

Eligibility criteria

• 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 and comply with all study procedures
• • 3. Legally 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 eye
• • 4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.
• • 5. 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;
• • 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 screening and 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, 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