Early Feasibility Study of the Orion Visual Cortical Prosthesis System for the Blind

Introduction: The Orion Visual Cortical Prosthesis features a wirelessly powered and controlled pulse generator connected to an array of 60 electrodes designed for implantation on the medical surface of the occipital cortex in blind patients. The externals of the system feature a processing unit that converts a real-time video stream from a camera into the wireless commands for stimulation of the implant. The objectives of this early feasibility study (EFS) are to evaluate the safety and functionality of the Orion system and assess the utility of this neuroprosthetic vision. Here, we present the results of the EFS that completed in March 2025.

Methods: This EFS is a prospective, non-randomized, single-arm trial with subjects who are bilaterally blind with bare light or no light perception due to non-cortical etiology. Safety is evaluated with rates, relatedness, and seriousness of adverse events. Device functionality and stability are tracked via measurement of electrode impedances and psychophysical thresholds. Visual performance measurements include Square Localization, a test of light perception/projection; Direction of Motion, a spatial vision test; Grating Visual Acuity (GVA); and Functional Low-vision Observer Rated Assessment (FLORA).

Results: Six subjects were implanted between January 2018 and January 2019. One serious adverse event due to the device, a seizure, and 16 non-serious adverse events due to the device or procedure have been reported. Three subjects were explanted after their respective 3-year visits and one subject was explanted at the conclusion of the study with no associated adverse events. All devices were functional at time of explant. Cumulatively for the 6 subjects, 355 electrodes were within specification at time of implantation and 342 electrodes remained within specification at the last visits.
Visual performance was evaluated at 6-, 12-, 18-, 24-, and 36-months. Significant improvement with the device on versus off were seen in 23/26 completed Square Localization evaluations and 21/26 Direction of Motion evaluations. 4 subjects scored ≤2.9 logMAR on GVA with the device on in at least one evaluation. All GVA evaluations with the device off were >2.9 logMAR.
FLORA at 12-month demonstrated all 6 subjects had positive or mild positive benefit from the Orion. At 24 months, 2 of 2 had mild positive benefit, and at 36 months, 4 of 4 had positive or mild positive benefit.

Conclusion: The first-in-human EFS of the Orion Visual Cortical Prosthesis system demonstrated the feasibility of safely creating useful artificial vision via subdural stimulation of the visual cortex for over 6 years.