According to the World Health Organization (WHO), approximately 2 million new cases of corneal blindness are reported each year. Over 30 million people in the world are blind in one or both eyes from corneal injury or disease and degradation of visual acuity impacts many more. A recent JAMA study assessed the shortage of corneas at one available cornea for 70 needed.
The CorNeat KPro is an artificial cornea, Keratoprosthesis (KPro), which provides a long-lasting medical solution for corneal blindness, pathology and injury. The CorNeat KPro implant is a patented synthetic cornea utilizing advanced cell technology to integrate artificial optics within resident ocular tissue. It is produced using nanoscale chemical engineering, which stimulates cellular growth. Unlike the current biological solution (keratoplasty) and previous KPros that are sutured or attempted integration with the native corneal tissue – a tissue that lacks blood vessels and heals very poorly - the CorNeat KPro integrates underneath the conjunctiva, the white part of the eye, a site rich with fibroblasts, which scars aggressively.
The CorNeat KPro is combined with a novel and relatively simple surgical procedure to provide an efficient, healthy and affordable remedy for millions of people with cornea-related visual impairments and is far superior to any available alternatives.
Features, surgical kit and procedure
The CorNeat KPro implantation procedure is relatively short and simple when compared to keratoplasty and other KPros. Unlike current procedures requiring delicate suturing of donor tissue to the patient’s native cornea, a process which can only be performed by very skilled and well-trained specialists, CorNeat KPro snaps into the patient’s trephined cornea and is then sutured to the eye using three non-degradable sutures. The provided surgical marker tool ("Marker") and a dedicated spatula which enables fitting the device into the recipient eye ("Snapper") supplied as part of the kit yield an extremely methodological, accurate, and deterministic implantation process, which can be taught in a couple of days. The process itself minimizes the time the eye is trephined and open (also known as “open sky”) to less than one minute – significantly reducing the risks involved.
The CorNeat KPro implant patented design is a result of extensive multidisciplinary (Physics, Chemistry, Biology) research and development process. The device, which consists of a wide aperture PMMA lens, provides unprecedented visual performance and a wide field of view. The KPro lens posterior side is designed to easily snap into a trephined healthy or edematous cornea and maintain the eye’s normal intraocular pressure post-operation. The lens is surrounded by a non-degradable porous integrating skirt, which is implanted subconjunctivally. The skirt embeds itself into the sclera (eye wall) within weeks as it stimulates anchoring cellular growth. Additional holes on the circumference of the lens are filled with porous material colonized with scar tissue (fibroblasts and collagen). This novel integration method further secures the device by means of biological stitching ensuring quick healing, reliability and retention.
Three pairs of suturing holes on the rim of the lens increase safety. These holes enable the ophthalmologist to quickly and easily secure the device to the eye. The suturing holes also ease and shorten the implantation procedure and stabilize the skirt post-operation. This ensures quick bio-integration.
The CorNeat KPro lens is designed to enable post-operative ophthalmic examinations and subsequent anterior and posterior segment surgeries (i.e. cataract and retinal surgeries). This is enabled by four openings or “ports” located on the rim of the lens, at around the limbus (the edge of the cornea). Four corresponding port indicators can be viewed through an ophthalmic microscope directing the surgeon to the port locations. This is required as the ports are located and placed subconjunctivally.
CorNeat KPro’s Advantages
CorNeat KPro is superior to keratoplasty and current keratoprosthetics in the following aspects:
Wide field of view
Enables cataract surgery post-operation
Healing & retention
Device integrates to the eye wall using nano-fabric
Fast to heal and scar
Short post-operation follow up
Relatively simple, 45-minute operation
No need for tissue
Corneal indications not suitable for keratoplasty such as:
CorNeat Vision has designed, produced and tested several versions of the CorNeat KPro, and has successfully completed the pre-clinical phase which included a groundbreaking 6-months-long study in NZW rabbits, successfully proving its safety.
The CorNeat KPro is planned to start clinical trials during the first half of 2020, toward FDA (510K) clearance (USA), CE mark (Europe) and NMPA approval (China).
Given the limited indications and our aim to provide a solution for blind patients who are not candidates for keratoplasty or have failed one or more transplantations, the study toward CE Mark and FDA (510K) clearance will encompass approximately 30 patients with a follow-up period of 12 months. Given the apparent superiority over donor tissue, we are planning to invest in a broader study, which will enable the expansion of device indications. At present, the device is expected to achieve the initial clearance in 2021.
In China, where there are over 5 million patients waiting for keratoplasty and only a few thousand transplantations a year, we are planning a study which will facilitate turning the CorNeat KPro into a primary solution for corneal blindness. The study is planned to start in early 2020 and will include 60-70 patients.
The plans above are subject to regulatory approvals and requirements.