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โ† Trials
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PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery

RecruitingNAAges 21 Years - 80 YearsAllNeuroAEye LLC
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In plain words

What the trial is, and whether it could suit you

This is a research study to evaluate the effectiveness of the PAVE (Parallactic Visual-Field Enhancement) System for the treatment of chronic visual field loss due to stroke, traumatic brain injury, or brain surgery. The PAVE regimen involves the use of a virtual reality headset to deliver visual stimulation to subjects diagnosed with visual field loss. The primary objective is to demonstrate that there is an improvement in the visual field after use of the PAVE therapy over a period of eight weeks with three sessions per week. The primary outcome is an increase in visual field area as measured with Goldmann-type kinetic perimetry. The secondary outcome will be demonstration that the subjective assessment of visual function using the National Eye Institute Visual Function Questionnaire (NEI-VFQ) is better after PAVE therapy when compared to before therapy. The participants will visit

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * This study will include patients at least 6 months after the CVA or TBI or brain surgery event and up to ten (10) years after onset * The patients shall have a definitive diagnosis of homonymous hemianopia or quadrantanopia or generalized constriction. Exclusion Criteria: * Presence of any physical, neurological, or mental disability that would interfere with receiving the therapy. * Concurrent use of another visual therapy * Concurrent use of medications judged to affect training (amphetamines, dopamine, etc.) * Presence of ocular or neurological conditions that would interfere with training or cause a visual impairment including no residual vision, disorders of the eye, non-optic nerve heteronymous visual field defects * Insufficient fixation ability * Use of life supporting external medical device such as infusion pumps, ventricular assist devices, etc. * Presence of active implantable medical device including but not limited to cardiac pacemakers, defibrillators, nerve stimulators, cochlear implants, etc. * Subjects with known photosensitive epilepsy. * Subjects with chronic active infections on the head and face should be excluded from the study * Patients with known immune disorders for whom an infection could be life threatening should be excluded from the study.
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What it tests

  • PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display
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Where

2 sites
Dr. D. M. Fitzgerald & Associates
Cedar Rapids, United States
Neuro-Vision Associates of North Texas
Prospect, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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