The study is a single arm six subject study at UCLA and Baylor College of Medicine. The study was paused due to the COVID-19 pandemic, but is now resumed at both centers. All subjects are still enrolled in the study and recent visual function and functional vision results continue to demonstrate that a majority of participants benefit from Orion. Five out of five of those tested at the two-year mark are able to locate a white square on a dark computer screen significantly better with the Orion System on than with it off. Four out of five of those tested at the two-year mark are able to better identify the direction of motion of a bar moving across a computer screen with the Orion System on. The Functional Low-Vision Observer Rated Assessment (FLORA) has only been performed with two subjects due to COVID-19 travel restrictions, but both were rated as receiving mild positive or positive benefit from the Orion in real-world settings. The remaining 24-month visits are currently being scheduled. There has been only one serious adverse event early in the study. The event was completely resolved without hospitalization.
“We are excited to resume the study and see such promising results, especially after all visits were paused for several months due to COVID-19,” said Jessy Dorn, vice president of Clinical and Scientific Research at Second Sight.
Nader Pouratian, a principal investigator on the Orion clinical trial and professor and chair of Neurological Surgery at UT Southwestern Medical Center, added, “We have learned about the therapeutic potential of Orion from the results of this early feasibility study and feel they support progress toward a larger study.”
Leveraging Second Sight’s 20 years of experience in neuromodulation for vision, the Orion Visual Cortical Prosthesis System (Orion) is an implanted cortical stimulation device intended to provide useful artificial vision to individuals who are blind due to a wide range of causes, including glaucoma, diabetic retinopathy, optic nerve injury or disease, and eye injury. Orion is intended to convert images captured by a miniature video camera mounted on glasses into a series of small electrical pulses. The device is designed to bypass diseased or injured eye anatomy and to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the brain’s visual cortex, where it is intended to provide the perception of patterns of light. A six-subject early feasibility study of the Orion is currently underway at the Ronald Reagan UCLA Medical Center in Los Angeles and the Baylor College of Medicine in Houston. No peer-reviewed data is available yet for the Orion system.