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Clinical Trials/NCT01214070
NCT01214070
Terminated
Phase 4

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

VA Office of Research and Development1 site in 1 country110 target enrollmentJune 1, 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Brain Injuries
Sponsor
VA Office of Research and Development
Enrollment
110
Locations
1
Primary Endpoint
Dynamic Visual Field
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2012
End Date
November 21, 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Dynamic Visual Field

Time Frame: Baseline

Secondary Outcomes

  • Dynamic Visual Field(After Second Therapy (Average Time is 9 months))
  • Reading Rate and Accuracy(After Second Therapy (average time is 9 months))
  • Reading Rate(After First Therapy / Before Second Therapy (average time is 4.5 months))
  • Visual Search Accuracy and Timing(After Second Therapy (average time is 9 months))

Study Sites (1)

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