PAVE System for Visual Field Loss from Stroke or Injury
PAVE (Parallactic Visual-Field Enhancement) System for Treatment of Chronic Visual Field Loss Due to Stroke, Traumatic Brain Injury, or Brain Surgery
Recruiting
N/AInterventional Study
Homonymous HemianopsiaHomonymous Quadrantanopia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
NeuroAEye LLC · Industry
Who this trial is looking for
This trial is looking for people who have lost part of their vision due to a stroke, brain injury, or brain surgery. Participants will use a virtual reality device at home or in the office for eight weeks, attending three sessions each week to see if their vision improves.
Are You a Good Fit for This Trial?
Rules you outChronic active infections on the head and faceImmune disorders
You may be able to join if
I am at least 6 months and less than 10 years after my stroke, brain injury, or brain surgery.
I have been diagnosed with homonymous hemianopia or quadrantanopia.
You may not be able to join if
I have any physical, neurological, or mental disability that would interfere with therapy.
I am currently using another visual therapy.
I take medications that could affect training, like amphetamines or dopamine.
I have other eye or brain conditions that could interfere with training.
I have insufficient ability to fixate my vision.
I use life-supporting medical devices.
I have an active implantable medical device like a pacemaker or defibrillator.
I have photosensitive epilepsy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 tha…
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.
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Eligibility 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:
* …
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.
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