An interventional study of PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display in Homonymous Hemianopsia and Homonymous Quadrantanopia, sponsored by NeuroAEye LLC. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by NeuroAEye LLC · Not applicable, Interventional, and Treatment
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 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 to ten years after onset. If available for the study, patients suffering field loss as a result of brain surgery may also be enrolled. All patients shall have a definitive diagnosis of homonymous hemianopia, quadrantanopia, or general constriction. The patients shall have the ability to wear the virtual reality head mounted display HMD for a 30-minute session performed in the clinic at least once per week. Patients will be between 21 and 80 years of age. The clinical study shall be comprised of a single arm with all subjects receiving therapy with the PAVE software on the HMD. The initial sample size will be a minimum of fifteen. Performance will be evaluated using a semiautomated kinetic perimeter (SKP) measurement derived from the Goldmann method.
The goal will be to determine the amount of statistically significant improvement of the visual field for the subjects. Additional endpoints will include the percentage of subjects showing improvement and subjective assessment of the subject's visual performance using the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ).
63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.
This study's planned enrollment of 20 is below the median of 32 across 53 interventional studies indexed under Hemianopsia.
Browse Hemianopsia studies →This is the only study on the registry with NeuroAEye LLC as lead sponsor.
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Exclusion Criteria:
Treatment using actual PAVE therapy software operating on a virtual reality head mounted display three times per week for eight weeks.
Device: PAVE (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.
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.
Time frame: Visual field area will be assessed at the baseline, week 4, week 8, and follow up at week 12.
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.
Time frame: The proportion of the subjects showing improvement will be assessed at week 4, week 8, and at the follow up at week 12.
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.
Time frame: NEI-VFQ will be administered at baseline, at week 8, again at the 4 week post-treatment follow up which is week 12.
Plan to share: Undecided
Started Mar 2026 (actual). Primary completion is estimated for Jul 2026, 4 months after the start.
Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's planned 4 months is below that.
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