Clinical trial NCT01214070: Functional Vision in TBI
Official title: Functional Vision Consequences of Rehabilitation for TBI Vision Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Brain Injuries
Visually Impaired Persons
Keywords: Visual Perception
Vision, Ocular
Neuronal Plasticity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-10-04
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* TBI (any form)
* Hemianopic Visual Field Loss
* Stable fixation
* 1.0 logMAR or better Reading Acuity
* 20 words per minute or better reading rate

Exclusion Criteria:

* Visual Neglect
* medical conditions that prevent sitting for 30 minutes or following instructions

Primary outcomes:
measure: Dynamic Visual Field
timeFrame: Baseline
Secondary outcomes:
measure: Dynamic Visual Field
timeFrame: After First Therapy / Before Second Therapy (Average time is 4.5 months)
measure: Dynamic Visual Field
timeFrame: After Second Therapy (Average Time is 9 months)
measure: Reading Rate and Accuracy
timeFrame: Baseline
measure: Reading Rate
timeFrame: After First Therapy / Before Second Therapy (average time is 4.5 months)
measure: Reading Rate and Accuracy
timeFrame: After Second Therapy (average time is 9 months)
measure: Visual Search Accuracy and Timing
timeFrame: Baseline
measure: Visual Search Accuracy and Timing
timeFrame: After First Therapy / Before Second Therapy (average time is 4.5 months)
measure: Visual Search Accuracy and Timing
timeFrame: After Second Therapy (average time is 9 months)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Ron Schuchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: