A Phase 4 interventional study of Vision Restoration Therapy and NVT Eye Scanning Therapy in Brain Injuries and Visually Impaired Persons, sponsored by VA Office of Research and Development. Terminated at 1 site in United States. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-06-16.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Treatment
The objective of this study is to test functional vision outcome measures that reflect the loss in everyday life tasks that require vision and that are sensitive to changes after a course of vision rehabilitation in Veterans/participants with TBI.
Traumatic brain injury (TBI) can cause vision loss because of diffuse or focal neuronal injury. Vision can be compromised because of local injury to one or both optic nerves, diffuse brain injury, and/or limitation in eye movements because of dysfunction of cranial nerves. These typical injuries may compromise any of the neural pathways that subserve afferent or efferent visual function. Self-reports of vision loss include diplopia, visual field loss, light sensitivity, reading problems and contrast sensitivity (color and luminance) loss. This project will pursue the following aims: 1) Identify the relationship between functional vision loss in everyday vision tasks (reading, visual search, way finding) and the characteristics of potential visual impairment (visual acuity, contrast sensitivity, visual fields, stereoacuity, eye movement disorders) associated with TBI; and 2) Determine the ability of the vision rehabilitation interventions (both monotherapy and combination therapy) to improve functional vision outcome measures that reflect everyday visual tasks. The vision rehabilitation interventions incorporated into this study will be Vision Restoration Therapy, NVT Eye Scanning Therapy, and standard Eccentric Viewing Training. These therapies are rehabilitative interventions prescribed for Veterans in Polytrauma Rehabilitation Centers, Blind Rehabilitation Centers, and advocated for VA Medical Center TBI clinics.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 110 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1 - Combination Treatment
Other: Vision Restoration Therapy · Behavioral: NVT Eye Scanning Therapy
Group 2 - Combination Treatment
Behavioral: Eccentric Viewing Training
Group 3 - Combination Treatment
Other: Vision Restoration Therapy · Behavioral: NVT Eye Scanning Therapy
Group 4 - Combination Treatment
Behavioral: Eccentric Viewing Training
Group 5 - Monotherapy Treatment
Other: Vision Restoration Therapy · Behavioral: Sham
Group 6 - Monotherapy Treatment
Behavioral: Eccentric Viewing Training · Behavioral: Sham
Group 7 - Monotherapy Treatment
Behavioral: NVT Eye Scanning Therapy · Behavioral: Sham
Therapy that enhances the neuronal plasticity of the visual system
Therapy that trains eye and head scanning into the blind hemianoptic visual field
Therapy that trains the person to compensate for visual field loss by learning to move the visual field loss to the position that is least likely to impact the current visual task
Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit
Dynamic Visual Field
Time frame: Baseline
Dynamic Visual Field
Time frame: After First Therapy / Before Second Therapy (Average time is 4.5 months)
Dynamic Visual Field
Time frame: After Second Therapy (Average Time is 9 months)
Reading Rate and Accuracy
Time frame: Baseline
Reading Rate
Time frame: After First Therapy / Before Second Therapy (average time is 4.5 months)
Reading Rate and Accuracy
Time frame: After Second Therapy (average time is 9 months)
Visual Search Accuracy and Timing
Time frame: Baseline
Visual Search Accuracy and Timing
Time frame: After First Therapy / Before Second Therapy (average time is 4.5 months)
Visual Search Accuracy and Timing
Time frame: After Second Therapy (average time is 9 months)
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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VA Office of Research and Development