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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 years
Awards & highlights
Study Summary
This trial is testing a new brain implant that may help people with no vision to see.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Device- or Procedure-Related Adverse Events (Safety)
Secondary outcome measures
Ability to Create Visual Perception as Measured by Stimulation Thresholds
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Implanted with the Orion Visual Cortical Prosthesis System
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,384 Total Patients Enrolled
6 Trials studying Blindness
479 Patients Enrolled for Blindness
Second Sight Medical ProductsLead Sponsor
10 Previous Clinical Trials
181 Total Patients Enrolled
1 Trials studying Blindness
3 Patients Enrolled for Blindness
Jessy D Dorn, PhDStudy DirectorSecond Sight Medical Products
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You use diathermy as part of your job.I am a male, a non-pregnant female using contraception, or a female unable to have children.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.I have had brain surgery that affects the use of the Orion device.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.I have Parkinson's disease.I cannot understand or communicate about the study due to my condition.I have a serious or unstable health condition.I have a history of seizures or epilepsy.I am healthy enough for brain surgery.I have chronic pain that is not managed well.I have significant memory problems.I am between 22 and 74 years old.I have a history of bleeding problems or a weak immune system.My brain or spinal cord disease is getting worse.I often play contact sports or have trouble keeping my balance.You have good vision documented by a doctor.I have a brain condition that cannot be treated with elective surgery.You have a major issue found in a brain MRI before surgery.My vision loss cannot be improved with treatments or medications.You have had a problem with drinking too much alcohol or using illegal drugs in the past 6 months, or your substance use could affect how well the treatment works for you.I have been diagnosed with moderate or severe depression.You have tried to harm yourself in the last two years, have a plan to harm yourself, or have answered "yes" to any of the ten questions about wanting to harm yourself on the C-SSRS.I might need MRIs, diathermy, ECT, or TMS while using the Orion System.I am completely blind in both eyes.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can patients now enroll in this research trial?
"It appears that this medical research has closed recruiting. Originally posted on November 20th 2017, the trial was last updated on December 7th 2021 and is no longer looking for patients to participate. Fortunately, there are 26 other studies actively seeking volunteers at present."
Answered by AI
Are individuals above the age of 30 eligible to join this clinical trial?
"This trial has a narrow age range of 22 to 74 years old. For those younger than 18, 10 studies are available and 23 trials exist for individuals over the age of 65."
Answered by AI
Could I potentially participate in this research project?
"This investigation is recruiting 6 people between the ages of 22 and 74 who have recently become blind. In order to qualify, applicants must meet several conditions including being male or female with a negative pregnancy test who are either unable to bear children or at least two years past menopause; living within 2 hours (by ground transportation) from the trial site; having non-measurable binocular visual acuity or 5° visual field in each eye; not having any vision that can be restored by medication/intervention; demonstrating significantly impaired eyesight due to trauma, retinal diseases, optic nerve damage etc.; possessing the ability to attend regular"
Answered by AI
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