| Eligibility |
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
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