NCT03344848

Early Feasibility Study of the Orion Visual Cortical Prosthesis System

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Second Sight Medical Products · Industry
• Sex: All
• Age: 22 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is an early feasibility study of a new device, the Orion Visual Cortical Prosthesis System. The device is intended to stimulate the surface of the visual cortex to induce visual perception in blind individuals.

Detailed description

In this study, 6 subjects with bare light or no light perception in both eyes will be implanted with the Orion Cortical Visual Prosthesis System. The study will evaluate the safety of the device and surgery, as well as reliability of the system and the usefulness of any restored vision. Each subject will be followed for 6 years, with their health monitored throughout. Research sessions, visual function testing, and subject-reported outcomes will be used to evaluate the functioning of the system.

Conditions

• Blindness, Acquired

Interventions

Type	Name	Description
DEVICE	Orion Visual Cortical Prosthesis System	The Orion Visual Cortical Prosthesis System is intended to stimulate the medial surface of the occipital lobe in the visual cortex to induce visual perception in blind individuals.

Timeline

• Start date: 2017-11-20
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2017-11-17
• Last updated: 2025-01-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study