Early Feasibility Study of the Orion Visual Cortical Prosthesis System

NCT03344848 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: CP-075UH3NS103442
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Blindness, Acquired

Outcome Measures

Primary Outcomes (1)

• Rate of Device- or Procedure-Related Adverse Events (Safety)

  Collection of adverse events

  Through study completion, an average of 6 years

Secondary Outcomes (1)

• Ability to Create Visual Perception as Measured by Stimulation Thresholds

  1 month, 6 months, 12 months, 24 months, 60 months, 72 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Implanted with the Orion Visual Cortical Prosthesis System

Device: Orion Visual Cortical Prosthesis System

Interventions

Orion Visual Cortical Prosthesis System DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 22 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is bilaterally blind with bare or no light perception. This is defined as non-measurable binocular visual acuity or 5° or less visual field in each eye.
• Subject is bilaterally blind due to:
• Trauma to the eye, or
• Disease or damage of the retina (such as retinopathy, retinal vein occlusion, inherited retinal diseases or retinal detachment), or
• Disease or damage of the optic nerve or chiasm (such as glaucoma, methanol intoxication, autoimmune neuropathies, pituitary pathology, and hereditary neuropathies)
• Subject's vision cannot be restored with any approved medication or intervention.
• Subject has a documented history of useful form vision.
• Subject is between the age of 22-74 .
• Subject resides within 2 hours (by ground transportation) of the investigational site.
• Subject is (a) male or (b) a female of childbearing potential with a negative pregnancy test who is using a reliable method of contraception or (c) a female who is at least two years post-menopause or otherwise unable to bear children.
• Subject is able to complete regular office and telephone appointments per the protocol requirements.
• Subject is medically fit for neurosurgical intervention.

You may not qualify if:

• Subject is at high risk for surgical complications such as active systemic infection, coagulation disorders (such as the use of anti-thrombotic therapies) or platelet count below 100,000.
• Subject has history of bleeding or immune compromise.
• Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile (either PTT or PT/INR).
• Subject has had prior craniotomy or brain surgery that would interfere with placement or function of Orion device.
• Subject has evidence of active intracranial disease that would preclude elective neurosurgical intervention, such as unruptured intracranial aneurysm or brain tumor, or aberrant visual cortex anatomy, such as prior stroke or arteriovenous malformation.
• Subject has a significant abnormality on preoperative brain MRI.
• Subject has a prior history of seizures or epilepsy.
• Subject has Parkinson's disease.
• Subject has a prior history of serious head injury with loss of consciousness for more than 24 hours.
• Subject has a progressive central nervous system disease.
• Subject has a history of implant-related infection.
• Subject requires or is likely to require any of the following medical procedures while implanted with the Orion System: MR imaging, diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS). These medical procedures are contraindicated for subjects implanted with an Orion System. Energy from these procedures can be sent through the implanted brain stimulation system and cause permanent brain damage which may cause severe injury, coma, or death.
• Subject is implanted with any neurostimulation or neuromodulation device in the head including, but not limited to cochlear implant, deep brain stimulator, or auditory brain implant.
• Subject has a clinically significant or unstable medical condition including uncontrolled systemic hypertension with values above 170/100; cardiac or pulmonary disease; uncorrected coagulation abnormalities; diabetes; or any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
• Subject has had an alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.

Sponsors & Collaborators

• Second Sight Medical Products: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90025, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Beauchamp MS, Oswalt D, Sun P, Foster BL, Magnotti JF, Niketeghad S, Pouratian N, Bosking WH, Yoshor D. Dynamic Stimulation of Visual Cortex Produces Form Vision in Sighted and Blind Humans. Cell. 2020 May 14;181(4):774-783.e5. doi: 10.1016/j.cell.2020.04.033.

  PMID: 32413298 DERIVED

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Uday Patel, PhD

  Second Sight Medical Products

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: November 20, 2017
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)