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

Status: Recruiting
Location: See location...
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 the clinical outcomes from exposure to the PAVE therapy (test group) are statistically superior to those achieved with a placebo (control group). 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 for the test group when compared with the control group. The participants will visit the investigators office once per week for a minimum of eight weeks and a maximum of twenty four weeks and receive a therapy session. Every four weeks the participants visual field will be measured using kinetic perimetry. Every eight weeks the participant will complete the NEI-VFQ. 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 five (5) 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
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: 2025-09-22
Estimated Completion Date: 2026-08
Participants
Target number of participants: 30
Treatments
Experimental: Test
Weekly treatment using actual PAVE therapy software operating on a virtual reality head mounted display.
Placebo_comparator: Control
Weekly treatment using a placebo that include PAVE software absent the functional component, operating on a virtual reality head mounted display.
Related Therapeutic Areas
Sponsors
Leads: NeuroAEye LLC

This content was sourced from clinicaltrials.gov