PAVE Parallactic Visual-Field Enhancement for chronic visual field loss after stroke, brain injury, or brain surgery
PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss
This study will test whether using the PAVE virtual-reality headset can expand the visual field in adults with chronic vision loss following stroke, traumatic brain injury, or brain surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | NeuroAEye LLC Industry-sponsored |
| Locations | 2 sites (Cedar Rapids, Iowa and 1 other locations) |
| Trial ID | NCT07185971 on ClinicalTrials.gov |
What this trial studies
This single-arm interventional study enrolls adults aged 21–80 with chronic homonymous hemianopia, quadrantanopia, or generalized constriction occurring 6 months to 10 years after stroke, TBI, or brain surgery. Participants will use the PAVE software delivered through a virtual-reality head-mounted display for an eight-week training course with three sessions per week, with a minimum planned sample of 15 subjects. The primary outcome is change in visual field area measured by semiautomated Goldmann-type kinetic perimetry (SKP), and the secondary outcome is change on the NEI Visual Function Questionnaire (NEI-VFQ). Baseline and post-therapy measurements will be compared to see if the VR regimen produces measurable field enlargement and improved self-reported visual function.
Who should consider this trial
Good fit: Ideal candidates are adults 21–80 who are at least six months and no more than ten years post-stroke, traumatic brain injury, or brain surgery with a confirmed homonymous hemianopia or quadrantanopia and who can wear a VR headset and attend regular clinic sessions.
Not a fit: Patients with no residual vision, active ocular disorders or non-optic nerve field defects, insufficient fixation, interfering neurological or psychiatric conditions, recent injury under six months, use of conflicting visual therapies or certain medications, or implanted active medical devices are unlikely to benefit.
Why it matters
Potential benefit: If successful, PAVE could enlarge patients' usable visual field and improve everyday visual tasks such as navigation and reading.
How similar studies have performed: Prior visual-restoration and perceptual-learning programs have produced modest field or functional gains in some patients, but the PAVE parallactic VR approach is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cedar Rapids, Iowa and 1 other locations
- Dr. D. M. Fitzgerald & Associates — Cedar Rapids, Iowa, United States (Recruiting)
- Neuro-Vision Associates of North Texas — Prospect, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: DeAnn Fitzgerald, Doctor of Optometry — Dr. D. M. Fitzgerald & Associates
- Study coordinator: Michael Lynch, BSME
- Email: michael.lynch@neuroaeye.com
- Phone: 315-730-9842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.