Early Feasibility Study of the Orion Visual Cortical Prosthesis System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03344848|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : January 12, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Blindness, Acquired||Device: Orion Visual Cortical Prosthesis System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Early Feasibility Study of the Orion Visual Cortical Prosthesis System|
|Actual Study Start Date :||November 20, 2017|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||March 1, 2024|
Experimental: Single Arm
Implanted with the Orion Visual Cortical Prosthesis System
Device: Orion Visual Cortical Prosthesis System
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.
- Rate of Device- or Procedure-Related Adverse Events (Safety) [ Time Frame: Through study completion, an average of 5 years ]Collection of adverse events
- Ability to Create Visual Perception as Measured by Stimulation Thresholds [ Time Frame: 1 month, 6 months, 12 months, 24 months, 60 months ]Measurement of stimulation thresholds on each electrode or groups of electrodes
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||22 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344848
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90025|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Study Director:||Uday Patel, PhD||Second Sight Medical Products|
|Responsible Party:||Second Sight Medical Products|
|Other Study ID Numbers:||
5UH3NS103442 ( U.S. NIH Grant/Contract )
|First Posted:||November 17, 2017 Key Record Dates|
|Last Update Posted:||January 12, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Nervous System Diseases