Blindness, AcquiredNCT03344848
Early Feasibility Study of the Orion Visual Cortical Prosthesis System
A study testing Orion Visual Cortical Prosthesis System in people with Blindness, Acquired, run by Second Sight Medical Products at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 74 years
- Conditions the study is for
- Blindness, Acquired
- What is being tested?
- Orion Visual Cortical Prosthesis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2017to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject has uncontrolled chronic pain.
- Subject has significant neurocognitive impairment in memory domain (based on MoCA-BLIND <18 or WAIS-IV <80, described below).
- Subject had moderate or severe depression, as determined by a score of at least 17 on the HAM-D.
- Subject has had a suicide attempt in the last two years, presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview), or a "yes" answer to any one of the ten suicidal ideation and behavior questions on the C-SSRS.
- Subject has a disease or condition that prevents understanding or communication of informed consent, study demands, or testing protocols, including:
- Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
- Psychiatric disease including diagnosed forms of depression
- Does not speak a principal language associated with the region
- Deafness or selective frequency hearing loss that prevents adequate communication with the researchers.
- Subject has a balance disability or frequently participates in contact sports.
- Subject must administer diathermy as part of his/her livelihood.
- Subject is pregnant or is planning on becoming pregnant in the next year.
- Subject has unrealistic expectations of the benefits of the study.
- Subject is enrolled in another therapeutic investigational drug or device trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90025
About this study
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.
Read the detailed description
In this study, 6 subjects with bare light or no light perception in both eyes will be implanted with the Orion Cortical Visual Prosthesis System. 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 be followed for 6 years, with their health monitored throughout. Research sessions, visual function testing, and subject-reported outcomes will be used to evaluate the functioning of the system.
- Conditions
- Blindness, Acquired
- Being tested
- Orion Visual Cortical Prosthesis System
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orion Visual Cortical Prosthesis SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Implanted with the Orion Visual Cortical Prosthesis System Receives: Device: Orion Visual Cortical Prosthesis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device- or Procedure-Related Adverse Events (Safety)
Collection of adverse events
Measured: Through study completion, an average of 6 years
Secondary outcomes (1)
Ability to Create Visual Perception as Measured by Stimulation Thresholds
Measurement of stimulation thresholds on each electrode or groups of electrodes
Measured: 1 month, 6 months, 12 months, 24 months, 60 months, 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start20 Nov 2017
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blindness, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Sight Medical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Uday Patel, PhD, Study director, Second Sight Medical Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344848
- Sponsor's protocol ID
- CP-07
- Other IDs
- 5UH3NS103442
- Status last verified
- Jan 2025
- First submitted
- 9 Nov 2017
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32413298
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Orion Visual Cortical Prosthesis System
- ClinicalTrials.gov ID
- NCT03344848
- Acronym / sponsor ID
- CP-07
- Conditions
- Blindness, Acquired
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Second Sight Medical ProductsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, 6 subjects with bare light or no light perception in both eyes will be implanted with the Orion Cortical Visual Prosthesis System. 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 be followed for 6 years, with their health monitored throughout. Research sessions, visual function testing, and subject-reported outcomes will be used to evaluate the functioning of the system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Orion Visual Cortical Prosthesis SystemImplanted with the Orion Visual Cortical Prosthesis System |
Who may qualify
- Ages
- 22 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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 .
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orion Visual Cortical Prosthesis SystemThe 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. | Device | Single Arm |
Primary outcome
Rate of Device- or Procedure-Related Adverse Events (Safety)
Time frame: Through study completion, an average of 6 years
Collection of adverse events
1 secondary outcome
Ability to Create Visual Perception as Measured by Stimulation Thresholds
Time frame: 1 month, 6 months, 12 months, 24 months, 60 months, 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 32413298Beauchamp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uday Patel, PhD study director
Second Sight Medical Products
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orion Visual Cortical Prosthesis System in people with Blindness, Acquired, run by Second Sight Medical Products at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device- or Procedure-Related Adverse Events (Safety) (time frame: Through study completion, an average of 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.