The cornea is a transparent layer located in front of the iris and the pupil that protects the iris and the lens and helps to focus light on the retina. When the cornea is irreparably damaged in the event of illness or injury, it results in reduced vision or even blindness. Treatment usually consists of cornea transplant from a donor but these grafts are limited compared to the needs of the doctors. As explained by the National Union of Ophthalmologists of France (SNOF), “the controls of the corneas taken lead to the setting aside d‘a number of grafts which are not suitable. In France we need 8,000 corneas to cover the needs “.
Current research in this area consists of create artificial corneasBut again, human tissue is essential to support the connection between the artificial device and parts of the eye. A team of doctors and researchers from CorNeat, an Israeli ophthalmic medical device company, may well have found the solution. Scientists claim have successfully developed and implemented a 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 allowing full integration.
A clinical trial soon planned in France
Researchers make the KPro implant available as a kit including artificial cornea enclosed in a protective box and the tools a surgeon will need to implant it in a patient. The procedure involves removing the epithelium that covers the cornea, the cornea itself, and then placing and suturing the implant. The patient was reportedly able to distinguish the faces of family members and read the numbers on a board the day after the operation. Ultimately, this relatively simple implantation procedure would be possible for patients with deformed or opacified corneas. reachedvisual impairment or blindness.
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 mesh of collagen). 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 gradual 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 conducted at Rabin Medical Center in Israel will include a total of 10 patients including corneal operations previously failed one or more times.
Researchers also want obtain the “CE” marking and clearance from the US Drug Administration (FDA) 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 bring disease, we plan to launch a second study later this year with broader indications for approval. our artificial cornea as a first-line treatment ”, explains Almog Aley-Raz, co-founder of CorNeat Vision