Les implants d'oeil bionique approuvés par l'UERédigé en anglais par Denise
European regulators have given approval for use and implant of a new bionic eye in the UK which enables blind people to see again.
A trial was undertaken with 30 patients, 10 of which were in Britain, with results showing that the device can restore some of the vision to people that have suffered loss of site through a genetic disease.
The device is actually an artificial retina, called Argus II manufactured by a Californian company called Second Sight. A network of electrodes is implanted on the retina and this receives light signals from a small camera mounted on a pair of dark glasses. The artificial retina then replicates the function of a normal eye in relaying the signals to the optic nerves.
The trial established that participants with no sight at all could see light, colours, motion and distinguish object outlines after receiving the implant. Some could even read large letters on a screen.
The implant has been designed for people suffering with the genetic and incurable disease, retinitis pigmentosa which affects around 1 person in 4000. This disease damages the retina rod and cone cells which leads to poor vision in low light levels, but it can also degenerate into total blindness over time.
Trial results were presented in London at the Euretina (European Society of Retina Specialists) conference during the weekend of 26th May to 29th May 2011. The results show for the first time that implants of this nature can restore sight reliably.
Consultant Ophthalmic Surgeon at Moorfields, the UK's most eminent eye hospital, Dr. Lyndon Da Cruz treated seven of the ten British patients. She said "Patients with retinitis pigmentosa who can afford it can now have an artificial retina. It is proof of principle, always the great unknown with new technology. This demonstrates that plugging in technology to the neural structure of the eye is possible, and that this can integrate stably over a long period. Now we have something that works we can begin to think about how to make it better."
The awarding of a Conformité Européenne, or CE mark to this device means that private patients can now be treated with it at a cost of £53,000 ($86,000). Those receiving the device also need to be trained in how to use it which cost another £11,000.
At the moment approval for use is limited within Europe, but it is expected the American FDA (Food and Drug Administration) will give approval for its use in the United States during 2012. Second Sight said Australia was now one of a series of countries it is looking at for marketing the product. Costs are likely to be in the region of around $100,000 for the equipment and a further $10,000 to $15,000 for the surgery.