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

Not Applicable

Recruiting

• Conditions: Corneal Disease; Corneal Opacity; Corneal Injuries

• Registration Number: NCT05694247
• Lead Sponsor: CorNeat Vision Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-1-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or female aged = 21 and = 80 years on the day of screening<br><br> 2. Candidates must have the ability and willingness to attend all scheduled visits and<br> comply with all study procedures<br><br> 3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case<br> of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the<br> operated eye<br><br> 4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable<br> option or following a verifiable history of prior failed corneal transplantation.<br><br> 5. Indications that fall under poor candidate for keratoplasty include but are not<br> limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial<br> Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency;<br><br> 6. Adequate tear film and lid function<br><br> 7. Perception of light in all quadrants<br><br> 8. Female patients of childbearing age must have negative pregnancy test at screening<br> and agree to use an effective method of contraception throughout the study.<br><br>Exclusion Criteria:<br><br> 1. Reasonable chance of success with traditional keratoplasty<br><br> 2. Current retinal detachment<br><br> 3. Connective tissue diseases or severely scarred conjunctiva in the target eye<br><br> 4. End stage glaucoma or evidence of current uncontrolled glaucoma<br><br> 5. History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis,<br> uveitis, retinitis, scleritis)<br><br> 6. Active inflammation of the conjunctiva in one or both eyes<br><br> 7. History of ocular or periocular malignancy<br><br> 8. History of extensive keloid formation<br><br> 9. Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or<br> component of the device<br><br> 10. Ocular ischemic syndrome<br><br> 11. Signs of current infection, including fever and current treatment with antibiotics<br><br> 12. Severe generalized disease that results in a life expectancy shorter than two years<br><br> 13. Any clinical evidence that the investigator feels would place the subject at<br> increased risk with the placement of the device<br><br> 14. Corneal thickness less than 400 or higher than 1,200 microns in any region of the<br> pachymetry map of the eye intended to be operated<br><br> 15. Currently pregnant or breastfeeding<br><br> 16. Participation in any study involving an investigational drug or device within the<br> past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation<br> in a study with an investigational drug or device<br><br> 17. Intraoperative complication that would preclude implantation of the study device<br><br> 18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes<br> and/or target organ damage associated with diabetes<br><br> 19. Patients requiring anticoagulation treatment, which cannot be interrupted for the<br> surgical procedure<br><br> 20. Vulnerable populations - minors, pregnant women, prisoners, sponsor or study<br> institution employees, military persons, terminally ill, comatose, physically and<br> intellectually challenged individuals, institutionalized patients and refugees<br><br> 21. Subjects with corneal disorders located outside the central 7 mm, such as Mooren<br> ulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (if<br> located outside the central 7 mm of the cornea)<br><br> 22. Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma<br> Surgery (MIGS) device that shunts aqueous from the anterior chamber into the<br> subconjunctival space

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Assessment

Secondary Outcome Measures

Name	Time	Method
Retention rate;Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline