A team of doctors and researchers at CorNeat, an Israel ophthalmic medical device company, has developed and implanted into a patient a new type of artificial cornea that integrates directly into the eye wall.
Members of the CorNeat team announced on their web page the successful implantation of their device, called the KPro, into a 78-year-old male patient last week.
The cornea is the clear front part of the eye, covering and protecting the iris and pupil. When the cornea is damaged beyond repair due to disease or injury, it results in blindness.
Current treatment generally involves transplanting a healthy cornea from a donor. Unfortunately, there are far fewer donors than people needing new corneas, so medical researchers have been looking to create artificial corneas. To date, such efforts have generally involved the need for human tissue to support the connection between the artificial device and human eye parts.
In this new effort, the researchers have developed a new kind of cornea that does not require the use of any tissue – instead, it has a skirt that is made of a material that allows infiltration by fibroblasts and collagen. The research team claims full integration of the cornea skirt can be achieved within a few weeks of surgery.
The artificial cornea looks very much like a flying saucer from science fiction movies. It has a clear middle section that serves as the cornea; surrounding the clear section is the white skirt – the researchers have not revealed what it is made of for patent reasons.
The procedure for doing so involves removal of the epithelium that covers the cornea, marking where the new cornea should go, removing the old cornea and then suturing the new artificial one in place.
The patient with the new artificial cornea was reportedly able to make out the faces of family members and read numbers on a chart the day after his surgery.
Features, Surgical Kit and Procedure
The CorNeat KPro implantation procedure is relatively short and simple when compared to other KPros and even when compared to keratoplasty. 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 thoroughly trained specialists, the CorNeat KPro snaps into the patient’s trephined cornea and is then sutured to the eye using three non-degradable sutures.
The surgical tools supplied as part of the implantation kit: the marker and the snapper, yield a systematic and accurate implantation process. This procedure is easy to teach and can be learned within a couple of days. The operation minimizes the time the eye’s contents are exposed to the outside world – “open sky” – to less than one minute, significantly reducing associated risks.
The CorNeat KPro implant patented design is the result of an extensive, multidisciplinary (Physics, Chemistry, Biology) research and development process. The device, and its wide aperture PMMA lens, provides unprecedented visual performance and a wide visual field. The KPro lens’ posterior side is designed to easily snap into a trephined cornea and maintain the eye’s integrity and as a result 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 within weeks as it stimulates anchoring cellular growth. Grooves on the circumference of the lens are filled with porous material and as a result are colonized with tissue. This novel integration method of biological stitching further secures the device through its optical member thus ensuring reliable and quick healing, coupled with long-term retention.
Three pairs of suturing holes on the rim of the lens increase safety. These holes enable the ophthalmologist to secure the device quickly and easily to the eye. Suturing the device eases and shortens the implantation procedure and stabilizes both the lens and the skirt post-operation. This physical stability ensures progressive and uninterrupted 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 achieved with four openings or “ports,” located on the rim of the lens, corresponding to the limbal zone. Four corresponding port indicators can be viewed through an ophthalmic microscope directing the surgeon to these port’s locations. This is required as the ports are located and placed subconjunctivally.
Being 100% synthetic, sterile, and composed of inert materials, the device is not expected to bear infectious agents or cause excessive inflammation. This will result in improved quality of life and more effective patient care.