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Functional Vision in TBI

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01214070
Enrollment
110
Registered
2010-10-04
Start date
2012-06-01
Completion date
2013-11-21
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Visually Impaired Persons

Keywords

Visual Perception, Vision, Ocular, Neuronal Plasticity

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.

Interventions

OTHERVision Restoration Therapy

Therapy that enhances the neuronal plasticity of the visual system

BEHAVIORALNVT Eye Scanning Therapy

Therapy that trains eye and head scanning into the blind hemianoptic visual field

BEHAVIORALEccentric Viewing Training

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

BEHAVIORALSham

Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dynamic Visual FieldBaseline

Secondary

MeasureTime frame
Dynamic Visual FieldAfter First Therapy / Before Second Therapy (Average time is 4.5 months)
Reading Rate and AccuracyBaseline
Reading RateAfter First Therapy / Before Second Therapy (average time is 4.5 months)
Visual Search Accuracy and TimingBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026