Application — Cortical surface
Cortigent Orion visual cortical prosthesis early feasibility study (NCT03344848)
Lab or organization
Cortigent Orion early feasibility study (NCT03344848)
The early feasibility study of the Orion visual cortical prosthesis, which bypasses the eyes and optic nerve to stimulate the visual cortex directly in blind adults. Registry facts are from ClinicalTrials.gov (verified October 28, 2026); interim results are from an ophthalmology-conference report of the sponsor’s presentation, and the phosphene-mapping studies in trial participants are peer reviewed.
Study facts
| Field | Value and source scope |
|---|---|
| Registry | NCT03344848; interventional, single-group, device feasibility, no masking [1] |
| Official title | Early Feasibility Study of the Orion Visual Cortical Prosthesis System [1] |
| Sponsor | Second Sight Medical Products (the Orion program later moved to Cortigent) [1] |
| Sites | University of California, Los Angeles; Baylor College of Medicine, Houston [1] |
| Status | Active, not recruiting [1] |
| Dates | Actual start November 20, 2017; primary completion and study completion estimated March 31, 2025 [1] |
| Enrollment | 6 (estimated) [1] |
| Population | Acquired blindness [1] |
| Intervention | Orion Visual Cortical Prosthesis System: a 60-electrode array on the visual cortex, driven by a camera in the patient’s glasses [1][2] |
| Primary outcome | Rate of device- or procedure-related adverse events, through study completion (average 6 years) [1] |
| Secondary outcome | Ability to create visual perception, measured by stimulation thresholds at 1, 6, 12, 24, 60 and 72 months [1] |
Reported results
| Field | Value and source scope |
|---|---|
| Interim safety (12 months) | Five nonserious adverse events and one serious adverse event (a seizure); four of six patients had no device- or procedure-related adverse event; safety profile described as favorable [2] |
| Phosphene perception | All six subjects perceived phosphenes at 12 months after implantation; the vast majority of the 60 contacts over primary and secondary visual cortices produced a perceived phosphene [2] |
| Functional report | On observer-rated functional low-vision assessments, five patients experienced positive improvements and one patient mild positive improvements at 12 months; the investigator also described Orion performance as at least equivalent to the Argus II retinal implant at 12 months (investigator-reported) [2] |
| Phosphene mapping | In blind Orion participants, multi-electrode stimulation evoked consistent spatial phosphene patterns; bimanual tactile fixation and relative multi-point mapping improved localization consistency [3] |
| Report status | Interim results presented at the American Academy of Ophthalmology 2019 annual meeting and covered in trade press; no peer-reviewed primary outcomes paper identified as of October 28, 2026 [2] |
Primary sources
- ClinicalTrials.gov, NCT03344848. Verified October 28, 2026.
- Healio/OSN, Blind patients implanted with Orion visual cortical prosthesis system reported functional improvements, October 17, 2019. Conference report of Nader Pouratian’s AAO 2019 presentation.
- Oswalt et al., Multi-electrode stimulation evokes consistent spatial patterns of phosphenes and improves phosphene mapping in blind subjects, Brain Stimulation 2021;14(5):1356-1372. Peer reviewed.