January 26th2018, Paris
The Department run by Prof. José-Alain Sahel and the Clinical Investigation Center of the A. de Rothschild Foundation achieve success with the 1st retinal implant using the PRIMA device.
Within the scope of the clinical study conducted by the Adolphe de RothschildFoundation'sClinical Investigation Center, Dr. Yannick Le Mer, a Deputy Department Manager with the Foundation and retina specialist surgeon, performed the first successful implant of a PRIMA electronic device developed by the company Pixium Vision.
This breakthrough PRIMA implant was carried out as part of the French feasibility assessment performed by teams under Prof. Sahel at the Adolphe de Rothschild Foundation andthe Quinze-Vingts Ophthalmological Hospital in Paris, spearheaded by the Clinical Investigation Center operating at both sites.
This procedure enabled restoring the perception of light signals for a patient afflicted with a dry atrophic form of Age-Related Macular Degeneration (ARMD). This female patient will be following up with a therapy phase, in accordance with the clinical protocol over a 6-month evaluation period.
This clinical study is intended to determine the tolerance ofthe PRIMA implant anddemonstrate the restoration of visual perception among patients who have lost their central vision as a result of the dry atrophic form of ARMD. Up to 5 patients will be included in the study and tested over a period lasting at least 6 months and capable of being extended to at most 36 months.
"This initial successful implant step lies within the continuum of a robust development effort targeting PRIMA. The relative simplicity of the surgical procedure speeds patients' recovery. The activation process, as stipulated in the study protocol, was undertaken one month following the implant procedure." Dr. Yannick Le Mer adds: "The activation step enabled the patient to perceive a light signal in the zone of total vision loss andinitiated a reeducation step to learn how to interpret such perceived signals. This step is critical to establishing an overall assessment of the efficiency of a PRIMA bionic visionsystem."
This success is the outcome of a fruitful collaboration between project institutions andpartners (Stanford University, the Vision Institute /Sorbonne University /INSERM/CNRS), plus the involvement of the full panoply of medical expertise in coordinating this innovative clinical study.
ABOUT PRIMA
PRIMA is a next-generation,miniature implant completely wireless and not requiring any connection. Featuring a photovoltaic microchip 2 millimeters longby 30 microns thick, PRIMA is composed of 378 electrodes. Implanted below the retina by a relatively non-invasive surgical procedure, this PRIMA device converts the infrared signal, received from an external visual interface fitted with a mini-camera, into an electrical signal transmitted to the brain via the optic nerve. PRIMA is intended to treat retinal dystrophies. Thanks to its size, designed to preserve patients' residual vision, this device is particularly well adapted to treating dry age-related macular degeneration, which is the most common form of this pathology. PRIMA can also be developed to treat retinitis pigmentosa.
Adolphe de Rothschild Foundation
Founded in 1905, the Adolphe de Rothschild Foundation has developed a full array of competences in the treatment of pathologies between the eye and the brain. Its activities span many fields of study, including 6 Foundation departments treating all ophthalmological disciplines, from screening to surgery on the most complex cases: cataract, refractive surgery, glaucoma, corneal diseases or conjunctivitis, retinal diseases, eyelid disorders, tear ducts and the orbit, neuro-ophthalmology, strabismus, neonatal / pediatric ophthalmology, ocular inflammation and infections.
In 2016, more than 254,000 tests andtechnical procedures were performed at the Foundation; in addition, 39,000 emergency room visits dedicated exclusively to ophthalmological pathologies were recorded. Also in 2016, over 1,800 hospitalstays in ophthalmology specifically involved retinal pathologies.
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