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.
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.
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
Single group
PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display
DevicePAVE (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.
Population Mean Change in Visual Field Area
The visual field area is derived from the isopter plot output of semiautomated kinetic perimetry. A baseline visual field area will be taken and subsequent measurements will be compared to the baseline.
Proportion of subjects showing improvement.
The percentage of the subjects that demonstrates improvement when compared to the mean change in field of view area for the control group.
Change in Subjective Visual Function
Use of NEI-VFQ to survey subjects at baseline and intermediate endpoints with regard to their assessment of visual function. Compare baseline and final assessments.
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