Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT07185971

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

Led by NeuroAEye LLC · Updated on 2026-04-02

20

Participants Needed

2

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients at least 6 months and up to 10 years after stroke, traumatic brain injury, or brain surgery
  • Diagnosis of homonymous hemianopia, quadrantanopia, or general visual field constriction
  • Age between 21 and 80 years
  • Ability to wear a virtual reality headset for a 30-minute session at least once per week
Not Eligible

You will not qualify if you...

  • Physical, neurological, or mental disabilities interfering with therapy
  • Using another visual therapy currently
  • Using medications affecting training such as amphetamines or dopamine
  • Eye or neurological conditions causing visual impairment or no residual vision
  • Poor ability to fixate visually
  • Use of life-supporting external medical devices like infusion pumps or ventricular assist devices
  • Presence of active implantable medical devices like pacemakers or cochlear implants
  • Known photosensitive epilepsy
  • Chronic active infections on the head or face
  • Immune disorders that could make infections life threatening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Dr. D. M. Fitzgerald & Associates

Cedar Rapids, Iowa, United States, 52404

Actively Recruiting

2

Neuro-Vision Associates of North Texas

Prospect, Kentucky, United States, 40059

Actively Recruiting

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Research Team

M

Michael Lynch, BSME

CONTACT

P

Paige Clinical Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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