Functional Vision in TBI

Phase 4

Terminated

• Conditions: Visually Impaired Persons; Brain Injuries
• Interventions: Other: Vision Restoration Therapy; Behavioral: Eccentric Viewing Training; Behavioral: NVT Eye Scanning Therapy; Behavioral: Sham

• Registration Number: NCT01214070
• Lead Sponsor: VA Office of Research and Development

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-04
• Study Start: 2012-06-01
• Primary Completion: 2013-11-21
• Study Completion: 2013-11-21
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Vision Restoration Therapy	Group 1 - Combination Treatment
Arm 6	Eccentric Viewing Training	Group 6 - Monotherapy Treatment
Arm 5	Vision Restoration Therapy	Group 5 - Monotherapy Treatment
Arm 1	NVT Eye Scanning Therapy	Group 1 - Combination Treatment
Arm 2	Eccentric Viewing Training	Group 2 - Combination Treatment
Arm 3	Vision Restoration Therapy	Group 3 - Combination Treatment
Arm 5	Sham	Group 5 - Monotherapy Treatment
Arm 6	Sham	Group 6 - Monotherapy Treatment
Arm 7	Sham	Group 7 - Monotherapy Treatment
Arm 4	Eccentric Viewing Training	Group 4 - Combination Treatment
Arm 3	NVT Eye Scanning Therapy	Group 3 - Combination Treatment
Arm 7	NVT Eye Scanning Therapy	Group 7 - Monotherapy Treatment

Primary Outcome Measures

Name	Time	Method
Dynamic Visual Field	Baseline

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States