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

Recruiting now · Not applicable

Conditions studied: Homonymous Hemianopsia, Homonymous Quadrantanopia

In brief

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.

Key facts

Study ID

NCT07185971

Run by

NeuroAEye LLC

People needed

20

Starts

2026-03-16

Expected to finish

2026-08-01

Last updated by the study team

2026-04-02

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dr. D. M. Fitzgerald & Associates — Cedar Rapids, Iowa, United States (enrolling)
• Neuro-Vision Associates of North Texas — Prospect, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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