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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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

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.

Locations (2)

Dr. D. M. Fitzgerald & Associates
Cedar Rapids, Iowa, United States
Neuro-Vision Associates of North Texas
Prospect, Kentucky, United States