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

NCT07185971 | Recruiting FDA Device

• 1 other identifier: CLN001 Version 2.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Homonymous Hemianopsia; Homonymous Quadrantanopia

Keywords

PAVE; Parallactic Visual-Field Enhancement; NeuroAEye; chronic visual field loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Visual field area will be assessed at the baseline, week 4, week 8, and follow up at week 12.

Secondary Outcomes (1)

• Proportion of subjects showing improvement.

  The proportion of the subjects showing improvement will be assessed at week 4, week 8, and at the follow up at week 12.

Other Outcomes (1)

• Change in Subjective Visual Function

  NEI-VFQ will be administered at baseline, at week 8, again at the 4 week post-treatment follow up which is week 12.

Study Arms (1)

Test

EXPERIMENTAL

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

Interventions

PAVE (Parallactic Visual-Field Enhancement) treatment using a virtual reality head mounted display DEVICE

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.

Test

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NeuroAEye LLC: lead

Study Sites (2)

Dr. D. M. Fitzgerald & Associates

Cedar Rapids, Iowa, 52404, United States

RECRUITING

Neuro-Vision Associates of North Texas

Prospect, Kentucky, 40059, United States

RECRUITING

Related Publications (28)

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  BACKGROUND

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MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• DeAnn Fitzgerald, Doctor of Optometry

  Dr. D. M. Fitzgerald & Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lynch, BSME

CONTACT

315-730-9842; michael.lynch@neuroaeye.com

Paige Clinical Study Coordinator

CONTACT

319-366-3500; paige.eyecare@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm study - all subjects receive treatment.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 22, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (2)