PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss
NeuroAEye LLC
Summary
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 the investigators office at the start of the study to establish a baseline for visual field size and visual field function. The subject will use PAVE in the office or at home three times per week for eight weeks. There will be twenty four therapy sessions in total. At four weeks the subject will visit the office and have perimetry measurements. At eight weeks the subject will visit the office and have perimetry measurements and complete the NEI-VFQ survey. Four weeks after the completion of the therapy sessions a follow up visit will take place where visual field measurement using kinetic perimetry and NEI-VFQ will be administered.
Description
This clinical investigation will focus on patients with chronic visual field loss following a cerebrovascular accident (CVA), a traumatic brain injury (TBI), or surgery of the brain. The CVA and TBI and some surgeries of the brain may affect bilateral visual fields (homonymous hemianopia, quadrantanopia, or general constriction). While perimetric visual field improvements can occur spontaneously in the first few months after brain injury, after six months the condition is considered chronic and permanent . This study will include patients at least 6 months after the brain injury event and up…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DevicePAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display
PAVE (Parallactic Visual-Field Enhancement) treatment is visual stimulation using a virtual reality head mounted display. The treatment is three times per week and entails two 7 minute sessions separated by a minimum 1 minute intermission. The actual therapy is preceded by a visual field assessment and is followed by a second visual field assessment.
Locations (2)
- Dr. D. M. Fitzgerald & AssociatesCedar Rapids, Iowa
- Neuro-Vision Associates of North TexasProspect, Kentucky