Pixium Vision initiates clinical study with IRIS1 retinal implant system for restoring vision in blind people
Pixium Vision (“Pixium”), a developer of innovative retinal implant systems that aim to restore vision in the blind, announces that it has initiated a clinical study to investigate the safety and effectiveness of its first Intelligent Retinal Implant System (IRIS1) in patients who are blind as a result of retinal dystrophy, such as retinitis pigmentosa, choroideremia or cone-rod dystrophy. In these conditions, the photoreceptors – specialized cells in the retina that convert light to a nerve signal that is processed and transmitted to the visual cortex in the brain – are destroyed. The nerves from the retina that collectively form the optic nerve, however, remain intact and functional.
The IRIS1 device is designed to replace the functions of photoreceptors in the healthy retina and stimulate the retinal nerve cells (the ganglion cells) to send a signal via the optic nerve to the brain.
The IRIS1 system includes an intraocular implant (a ‘retinal stimulator’) that is surgically placed into the eye of a patient and attached to the surface of the retina (‘epi-retinal’). The patient wears a pair of spectacles containing an integrated mini-camera and wireless transmitter. The spectacles are connected to a pocket computer worn at the patient’s waist, which processes the image captured by the camera into a signal that is transferred back through the spectacles onto the retinal implant to stimulate the ganglion cells and generate an image. The brain learns to interpret the signals it receives from the implant during a structured rehabilitation program undertaken by patients after healing from the implant surgery.
The study will enrol up to 20 blind patients and is being conducted at three leading eye hospitals in France, Germany and Austria. The primary outcome will be safety and tolerability, with patients undergoing ophthalmological examinations at predefined intervals over an 18-month period after implantation. The effectiveness of the implant for restoring sight in patients will be measured using tests for improved visual acuity, light localization and contrast sensitivity and comparing scores from before and after implantation of the device.
Interim data on the first ten patients is expected in 2014 and will form the basis of an application for a CE Mark, which if successful would allow the device, and potentially any next generation products based on the same format, to be commercialised. Final data is expected in 2015.
Dr Yannick Le Mer, Head of the Vitreo-retinal Unit at Fondation Adolphe de Rothschild Hospital in Paris, said: “If this trial is successful we would expect blind patients to regain some level of visual perception, such as being able to see the outline of shapes and appreciate the main components of an unknown environment. This will be a significant improvement and enable patients to have a greater level of independence than when they were totally blind.”
Dr Bernard Gilly, Chairman and CEO, commented: “In addition to the improvement we hope to see in patient’s vision, success in this study would provide solid proof of concept for the IRIS device. As well as providing the basis for a CE Mark application in 2014, the data generated by the study will be extremely useful for guiding the development of our future generations of retinal implant devices that feature additional breakthrough technologies and are being designed to offer even better visual acuity to patients. A key benefit of IRIS2, for example, is that the retinal implant is based on the same format as the IRIS1 implant, and so patients could upgrade as the technologies advance and get closer to regaining normal sight.”
Bernard Gilly, Chairman and CEO
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Pixium-vision.com [en línea] Paris (FRA): pixium-vision.com, 22 de mayo de 2014 [ref. 24 de abril de 2013] Disponible en Internet: