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PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Iowa
Dr. D. M. Fitzgerald & Associates
RECRUITING
Cedar Rapids
Kentucky
Neuro-Vision Associates of North Texas
RECRUITING
Prospect
Contact Information
Primary
Michael Lynch, BSME
michael.lynch@neuroaeye.com
315-730-9842
Backup
Paige Clinical Study Coordinator
paige.eyecare@gmail.com
319-366-3500
Time Frame
Start Date: 2026-03-16
Estimated Completion Date: 2026-08
Participants
Target number of participants: 20
Treatments
Experimental: Test
Treatment using actual PAVE therapy software operating on a virtual reality head mounted display three times per week for eight weeks.
Related Therapeutic Areas
Sponsors
Leads: NeuroAEye LLC

This content was sourced from clinicaltrials.gov