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

Study Overview
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Brief Summary
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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

Detailed Description
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This clinical trial will assess the clinical safety and performance of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal blindness in subjects who are not candidates for traditional corneal transplant. 40 subjects who are willing to take part in the study will undergo screening examinations to verify their eligibility. The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures will be performed at 1 day, 1 week, 2 weeks, 1, 2, 3, 4, 5, 6,8, 10,12,15,18,21 and 24 months post-surgery and will include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be assessed and recorded throughout the 24 months follow up period.

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

Conditions
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Corneal Disease, Corneal Opacity, Corneal Injuries

Intervention / Treatment
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* Device: CorNeat KPro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥ 21 and ≤ 80 years on the day of screening Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures 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 Keratoprosthesis 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 function Perception of light in all quadrants 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: Reasonable chance of success with traditional keratoplasty Current retinal detachment Connective tissue diseases or severely scarred conjunctiva in the target eye End stage glaucoma or evidence of current uncontrolled glaucoma History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis) Active inflammation of the conjunctiva in one or both eyes History of ocular or periocular malignancy History of extensive keloid formation Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device Ocular ischemic syndrome Signs of current infection, including fever and current treatment with antibiotics Severe generalized disease that results in a life expectancy shorter than two years Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device 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 Currently pregnant or breastfeeding 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 Intraoperative complication that would preclude implantation of the study device Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure 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 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) Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CorNeat KPro<br>Intraocular implantation of the CorNeat KPro | Device: CorNeat KPro<br>* The optical component of the CorNeat KPro will be implanted into a circular disc of the cornea (as performed in standard penetrating keratoplasty surgery) and the skirt component will be embedded under a 360º conjunctival flap.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation | Throughout 24 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate | The number of retained devices at the end of 24- months follow up period will be calculated | 24 months post-op | 
| Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline | Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after | Throughout 24 months post-op |