Orion Visual Prosthesis for Blindness

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device designed to help blind individuals regain sight by stimulating the brain's vision center. The study tests the effectiveness and safety of the Orion Visual Cortical Prosthesis System. It targets individuals who are blind in both eyes and cannot restore vision through other treatments. Those who lost vision due to eye trauma or certain diseases might qualify. Participants must live near the study site and attend regular appointments. As an unphased trial, this study allows participants to contribute to groundbreaking research that could transform lives.

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 prior data suggests that the Orion Visual Cortical Prosthesis System is safe for use in blind individuals?

Research shows that the Orion Visual Cortical Prosthesis System is a groundbreaking device designed to help blind individuals see by stimulating the brain's visual area. Although specific safety data for this device is not yet available, similar devices have faced challenges. One challenge involves ensuring the safety of the tiny parts, called electrodes, which send signals to the brain.

Previous studies on similar devices have focused on ensuring that both the device and the implantation surgery are safe and reliable. Results from a one-year study of the Orion System showed it was the first to be tested in humans, indicating it is still in the early stages of development. This means its safety and effectiveness are still being carefully evaluated.

In summary, the Orion device is still being tested to determine its safety and usefulness in restoring vision. Early studies like these are crucial steps in ensuring a new device is safe before it becomes more widely available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Orion Visual Cortical Prosthesis System is unique because it offers a groundbreaking approach to restoring vision for individuals with blindness. Unlike traditional treatments like visual aids or retinal implants that require some functional optic nerves, Orion directly stimulates the visual cortex in the brain to create the perception of sight. This innovative mechanism bypasses damaged eyes and optic nerves entirely, potentially offering sight to those who have been completely blind. Researchers are excited about this treatment because it represents a significant leap forward, potentially transforming the lives of individuals who currently have no other viable options to regain vision.

What evidence suggests that the Orion Visual Cortical Prosthesis System is effective for blindness?

Research has shown that the Orion Visual Cortical Prosthesis System, which participants in this trial will receive, might help restore some vision in people who are completely blind. Studies have found that this device can safely create visual experiences by stimulating the brain's sight-processing area. This method bypasses the eyes entirely, offering a new way to see for those who can't benefit from regular vision aids. Early results suggest that users can perceive helpful visual signals, although the amount of vision varies. While still experimental, early evidence is promising for its potential to aid those with severe vision loss. ^{1 3 6 7 8}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03344848

NCT03344848 | Early Feasibility Study of the Orion Visual ... 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/9403181

Early Feasibility Clinical Trial of a Visual Cortical Prosthesis A cortical prosthesis could help restore visual perception to many more profoundly blind people, including people who have lost their vision due to disease or ...

3. embc.embs.org embc.embs.org/2020/wp-content/uploads/sites/57/2020/02/0012_mini_s.pdf

Recent Advances in Cortical Visual Prostheses Interim results of the Orion EFS study indicate that the System is safely providing some visual perception to a small sample of profoundly blind patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11001790/

Participant perspectives from an early feasibility trial for a ... Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949889925000261

Cortical visual prostheses: a future paradigm shift in ... Cortical visual prostheses aim to restore vision by electrically stimulating neurons in the visual cortex, effectively bypassing the entire ocular system.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9279795/

A narrative review of cortical visual prosthesis systems This review discusses the architecture and physiology of the visual cortex, the neuroplasticity of the blind brain, and the history of CVP development.

7. journalretinavitreous.biomedcentral.com journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-023-00498-1

An update on visual prosthesis The purpose of that study is to evaluate the safety, reliability, and usefulness of the device. Fig. 9. figure 9. The ORION Visual Cortical ...

8. withpower.com withpower.com/trial/phase-blindness-10-2017-62720

Orion Visual Prosthesis for Blindness · Info for Participants While there is no specific safety data mentioned for Orion, the development of cortical visual prostheses involves challenges such as ensuring safe electrode ...