Ophthalmology may be one step closer to the hope of providing artificial vision for individuals affected by virtually all forms of blindness.
Second Sight Medical Products, manufacturer of the only retinal prosthesis approved by the FDA (Argus II Retinal Prosthesis System), has begun the clinical testing phase of its program to develop a visual cortical prosthesis.
Named Orion I, the system uses an electrode array implanted on the surface of the brain over the visual cortex.
The first patient in a study investigating the safety and feasibility of the approach was operated on in October 2016.
The procedure involved implantation of an off-the-shelf, 8-electrode neurostimulator in a 30-year-old woman with blindness secondary to a rare autoimmune disease.
The surgery was performed safely and successfully by neurosurgeon Nader Pouratian, MD, assistant professor of neurosurgery, University of California, Los Angeles. Postoperatively, the patient is doing well, has had no adverse effects, and reports seeing spots of light in response to electrode stimulation.
“There is a history in neurosurgery of using brain stimulators to treat various neurological diseases, such as Parkinson’s disease,” Dr. Pouratian said. “Accordingly, there has been a lot of interest in using brain stimulation to treat other disorders, including depression and chronic pain. This effort to try to restore vision through brain stimulation is a relatively unique focus.
“Although the initial procedure did not involve implantation of the Orion I, it is the first modern era demonstration of eliciting phosphenes after placing a fully implantable device onto the surface of the brain,” Dr. Pouratian added. “The outcomes provide us with a reasonable expectation of achieving success with the Orion I.”
“The positive experience in this first patient confirmed that we are on the right track for developing a visual cortical prosthesis,” said Robert Greenberg, MD, PhD, president and chief executive officer of Second Sight. “Now, we will continue to follow this patient while working to refine the technology and software as we look forward to beginning evaluation of the Orion I platform in a clinical trial.”