Israeli researchers have been working for several years on an artificial cornea called KPro to provide a sustainable medical solution for corneal blindness. The patented implant uses advanced cellular technology to dispense with human-made grafts. A first clinical trial was successfully conducted in a 78-year-old patient, with more to follow soon.

 

The cornea is a transparent layer in front of the iris and pupil that protects the iris and the lens and helps to focus light on the retina. When the cornea is irretrievably damaged by disease or injury, it leads to reduced vision or even blindness. Treatment usually consists of a corneal transplant from a donor, but these grafts are limited compared to the needs of doctors. As explained by the Syndicat national des ophtalmologistes de France (SNOF), "checks on the corneas harvested result in a number of unsuitable grafts being discarded. In France we need 8,000 corneas to cover the needs".

Current research in this area involves the creation of artificial corneas, but again, human tissue is required to support the connection between the artificial device and parts of the eye. A team of doctors and researchers at CorNeat, an Israeli ophthalmic medical device company, may have found the solution. The scientists claim to have successfully developed and implanted an artificial cornea called Kpro, which integrates directly into the eye wall, in a 78-year-old blind patient. This implant does not require the use of any tissue because it has a "skirt" made of a secret material that allows for complete integration.

A clinical trial soon planned in France

The researchers are making the KPro implant available as a kit that includes the artificial cornea enclosed in a protective box and the tools a surgeon will need to implant it in a patient. The procedure involves the removal of the epithelium covering the cornea, the cornea itself, and then the placement and suturing of the implant. The patient would have been able to distinguish the faces of family members and read the numbers on a chart the day after the operation. Ultimately, this relatively simple implantation procedure would be possible for patients with deformed or opaque corneas who are visually impaired or blind.

The material used, 100% synthetic and non-degradable, is placed under the conjunctiva, a vascularized site that heals vigorously, to mimic the structure of connective tissue (a collagen mesh). Once the lens of the device is implanted, offering an optical quality equivalent to that of a perfect cornea, it stimulates cell proliferation for a progressive integration of the implant in the eye without triggering an unfavorable response from the immune system. But this is only the first step since the clinical trial at the Rabin Medical Center in Israel will include a total of 10 patients whose corneal operations have previously failed one or more times. 

Researchers are also seeking CE marking and approval from the FDA (the U.S. Drug Agency) in the United States. They plan to select two sites to continue the clinical trial in Canada and then six other sites at different stages of the approval process in France, the United States and the Netherlands. "Given the exceptional visual performance of our device, the expected healing time and the fact that it cannot cause disease, we plan to launch a second study later this year with broader indications for approval of our artificial cornea as a first-line treatment," explains Almog Aley-Raz, co-founder of CorNeat Vision.