Orion Visual Prosthesis for Blindness

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Second Sight Medical Products

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Seizures, Parkinson's, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new device that helps blind people see by sending signals directly to their brain. It targets those who can't see even with other treatments. The device works by stimulating the part of the brain responsible for vision.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on chronic anticoagulants or antiplatelet agents, you may not be eligible to participate.

What safety data exists for the Orion Visual Prosthesis for Blindness?

The Orion Visual Prosthesis, also known as the Orion Visual Cortical Prosthesis System, is still in clinical testing and has not yet been approved for general use. While there is no specific safety data mentioned for Orion, the development of cortical visual prostheses involves challenges such as ensuring safe electrode insertion and managing immune responses to the implant. ^{1 2 3 4 5}

How does the Orion Visual Cortical Prosthesis System treatment differ from other treatments for blindness?

The Orion Visual Cortical Prosthesis System is unique because it directly stimulates the visual cortex (the part of the brain responsible for processing visual information) using an array of electrodes, bypassing damaged parts of the eye. This approach is different from other treatments that focus on stimulating the retina or optic nerve, making it suitable for patients with severe eye damage or diseases affecting the entire eye. ^{1 6 7 8 9}

What data supports the effectiveness of the Orion Visual Cortical Prosthesis System treatment for blindness?

Research shows that electrical stimulation of the visual cortex can create visual sensations in blind individuals, allowing them to recognize simple patterns. This suggests that the Orion Visual Cortical Prosthesis System could potentially help restore some level of vision in people with acquired blindness. ^{1 7 9 10 11}

Who Is on the Research Team?

Uday Patel, PhD

Principal Investigator

Second Sight Medical Products

Are You a Good Fit for This Trial?

This trial is for blind individuals aged 22-74 who live close to the study site and are medically fit for brain surgery. They must have been able to see before, can't be pregnant or at risk of pregnancy without contraception, and should not have any conditions that would complicate surgery or affect their ability to participate.

Inclusion Criteria

I am a male, a non-pregnant female using contraception, or a female unable to have children.

I am blind in both eyes due to injury or disease affecting my retina or optic nerve.

I can attend all required office and phone appointments.

Exclusion Criteria

You use diathermy as part of your job.

I am at high risk for surgery complications due to an infection, bleeding disorders, or low platelet count.

I am on long-term blood thinners or have abnormal blood clotting tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Testing

Participants are implanted with the Orion Visual Cortical Prosthesis System and undergo initial testing

1 month

Follow-up

Participants are monitored for safety and effectiveness after implantation

6 years

What Are the Treatments Tested in This Trial?

Interventions

• Orion Visual Cortical Prosthesis System

Trial Overview The Orion Visual Cortical Prosthesis System is being tested. It's a device designed to stimulate the visual cortex in an attempt to restore some form of vision for people who are completely blind due to eye trauma, retina damage, or optic nerve issues.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Implanted with the Orion Visual Cortical Prosthesis System

Who Is Running the Clinical Trial?

Second Sight Medical Products

Lead Sponsor

Trials

11

Recruited

190+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Contemporary approaches to visual prostheses. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Artifical vision for the blind: electrical stimulation of visual cortex offers hope for a functional prosthesis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sequence of visual cortex stimulation affects phosphene brightness in blind subjects. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Advances in implantable bionic devices for blindness: a review. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Visual percepts evoked with an intracortical 96-channel microelectrode array inserted in human occipital cortex. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Argus II retinal prosthesis system: An update. [2017]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Modern concepts of bionic vision]. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Restoration of vision in blind individuals using bionic devices: a review with a focus on cortical visual prostheses. [2014]

9. England pubmed.ncbi.nlm.nih.gov

The functional performance of the Argus II retinal prosthesis. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Visual prostheses]. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Retinal prosthesis for the blind. [2022]