What side effects are associated with this type of intervention?

The Orion Visual Cortical Prosthesis System, which uses electrical stimulation of the visual cortex to induce visual perception, may have side effects similar to other neuromodulation devices. Common side effects of electrical stimulation treatments include sensations such as warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas like the arm, shoulder, or neck. Serious adverse events are rare, but there is a potential for complications such as infection, hemorrhage, or hardware malfunctions, which are generally correctable. It is important to discuss these potential risks with a healthcare provider.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically involving electrical stimulation of the visual cortex to induce visual perception in blind individuals, similar to the Orion Visual Cortical Prosthesis System. However, other FDA-approved treatments for blindness include gene therapies like Luxturna for inherited retinal diseases, and various pharmacological treatments for conditions like diabetic macular edema and retinitis pigmentosa.

What other types of research exist?

Promising alternatives to the Orion Visual Cortical Prosthesis System for blindness treatment include: 1) Stem cell therapies, which aim to regenerate damaged retinal cells; 2) Gene therapies, such as those targeting specific genetic mutations causing blindness; 3) Retinal implants, like the Argus II Retinal Prosthesis System, which stimulate the remaining retinal cells; and 4) Optogenetics, which involves using light to control cells within the retina. These approaches are in various stages of research and clinical trials and hold potential for vision restoration.

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Visual Prosthesis

Orion Visual Prosthesis for Blindness

N/A

Waitlist Available

Research Sponsored by Second Sight Medical Products

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is bilaterally blind due to trauma to the eye, disease or damage of the retina, or disease or damage of the optic nerve or chiasm.

Subject is between the age of 22-74.

Must not have

Subject is at high risk for surgical complications such as active systemic infection, coagulation disorders, or platelet count below 100,000.

Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 6 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include those typically associated with neurosurgery such as infection, bleeding, seizures, and reactions from the implant itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 22 and 74 years old.

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My vision loss cannot be improved with treatments or medications.

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I am completely blind in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had brain surgery that affects the use of the Orion device.

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I have Parkinson's disease.

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I cannot understand or communicate about the study due to my condition.

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I have a history of seizures or epilepsy.

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I have chronic pain that is not managed well.

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I have significant memory problems.

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I have a history of bleeding problems or a weak immune system.

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My brain or spinal cord disease is getting worse.

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I often play contact sports or have trouble keeping my balance.

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I have a brain condition that cannot be treated with elective surgery.

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I have been diagnosed with moderate or severe depression.

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I might need MRIs, diathermy, ECT, or TMS while using the Orion System.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Ability to Create Visual Perception as Measured by Stimulation Thresholds

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Implanted with the Orion Visual Cortical Prosthesis System

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Orion Visual Cortical Prosthesis System works by electrically stimulating the visual cortex to induce visual perception in blind individuals. This approach bypasses damaged or non-functional parts of the eye and optic nerve, directly activating the brain's visual processing areas. Other treatments for blindness, such as retinal implants, also use electrical stimulation to restore vision by targeting different parts of the visual pathway. These treatments are significant for blindness patients as they offer potential restoration of vision, improving quality of life and independence by enabling them to perceive their surroundings more effectively.