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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 : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Tracking Information
First Submitted Date  ICMJE November 9, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE November 20, 2017
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
Rate of Device- or Procedure-Related Adverse Events (Safety) [ Time Frame: Through study completion, an average of 5 years ]
Collection of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03344848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Feasibility Study of the Orion Visual Cortical Prosthesis System
Official Title  ICMJE Early Feasibility Study of the Orion Visual Cortical Prosthesis System
Brief 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.
Detailed Description In this study, 5 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 5 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Blindness, Acquired
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Single Arm
Implanted with the Orion Visual Cortical Prosthesis System
Intervention: Device: Orion Visual Cortical Prosthesis System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2023
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Subject is bilaterally blind due to:

    1. Trauma to the eye, or
    2. Disease or damage of the retina (such as retinopathy, retinal vein occlusion, inherited retinal diseases or retinal detachment), or
    3. Disease or damage of the optic nerve or chiasm (such as glaucoma, methanol intoxication, autoimmune neuropathies, pituitary pathology, and hereditary neuropathies)
  3. Subject's vision cannot be restored with any approved medication or intervention.
  4. Subject has a documented history of useful form vision.
  5. Subject is between the age of 22-74 .
  6. Subject resides within 2 hours (by ground transportation) of the investigational site.
  7. 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.
  8. Subject is able to complete regular office and telephone appointments per the protocol requirements.
  9. Subject is medically fit for neurosurgical intervention.

Exclusion Criteria:

  1. 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.
  2. Subject has history of bleeding or immune compromise.
  3. Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile (either PTT or PT/INR).
  4. Subject has had prior craniotomy or brain surgery that would interfere with placement or function of Orion device.
  5. 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.
  6. Subject has a significant abnormality on preoperative brain MRI.
  7. Subject has a prior history of seizures or epilepsy.
  8. Subject has Parkinson's disease.
  9. Subject has a prior history of serious head injury with loss of consciousness for more than 24 hours.
  10. Subject has a progressive central nervous system disease.
  11. Subject has a history of implant-related infection.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. Subject has uncontrolled chronic pain.
  17. Subject has significant neurocognitive impairment in memory domain (based on MoCA-BLIND <18 or WAIS-IV <80, described below).
  18. Subject had moderate or severe depression, as determined by a score of at least 17 on the HAM-D.
  19. 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.
  20. Subject has a disease or condition that prevents understanding or communication of informed consent, study demands, or testing protocols, including:

    1. Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
    2. Psychiatric disease including diagnosed forms of depression
    3. Does not speak a principal language associated with the region
    4. Deafness or selective frequency hearing loss that prevents adequate communication with the researchers.
  21. Subject has a balance disability or frequently participates in contact sports.
  22. Subject must administer diathermy as part of his/her livelihood.
  23. Subject is pregnant or is planning on becoming pregnant in the next year.
  24. Subject has unrealistic expectations of the benefits of the study.
  25. Subject is enrolled in another therapeutic investigational drug or device trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03344848
Other Study ID Numbers  ICMJE CP-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Sight Medical Products
Study Sponsor  ICMJE Second Sight Medical Products
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jessy D Dorn, PhD Second Sight Medical Products
PRS Account Second Sight Medical Products
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP