Early Feasibility Study of the Orion Visual Cortical Prosthesis System (NCT03344848) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Feasibility Study of the Orion Visual Cortical Prosthesis System
United States6 participantsStarted 2017-11-20
Plain-language 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.
Who can participate
Age range22 Years – 74 Years
SexALL
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Inclusion criteria
✓. 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 .
Exclusion criteria
✕. 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.
What they're measuring
1
Rate of Device- or Procedure-Related Adverse Events (Safety)
Timeframe: Through study completion, an average of 6 years
✕. 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.