Functional Vision in TBI

VA Office of Research and Development

Status and phase: Terminated; Phase 4

Conditions: Brain Injuries; Visually Impaired Persons

Treatments: Other: Vision Restoration Therapy; Behavioral: Eccentric Viewing Training; Behavioral: Sham; Behavioral: NVT Eye Scanning Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01214070

C6687-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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110 participants in 7 patient groups

Arm 1

Active Comparator group

Description:

Group 1 - Combination Treatment

Treatment:

Behavioral: NVT Eye Scanning Therapy

Other: Vision Restoration Therapy

Arm 2

Active Comparator group

Description:

Group 2 - Combination Treatment

Treatment:

Behavioral: Eccentric Viewing Training

Arm 3

Active Comparator group

Description:

Group 3 - Combination Treatment

Treatment:

Behavioral: NVT Eye Scanning Therapy

Other: Vision Restoration Therapy

Arm 4

Active Comparator group

Description:

Group 4 - Combination Treatment

Treatment:

Behavioral: Eccentric Viewing Training

Arm 5

Active Comparator group

Description:

Group 5 - Monotherapy Treatment

Treatment:

Other: Vision Restoration Therapy

Behavioral: Sham

Arm 6

Active Comparator group

Description:

Group 6 - Monotherapy Treatment

Treatment:

Behavioral: Eccentric Viewing Training

Behavioral: Sham

Arm 7

Active Comparator group

Description:

Group 7 - Monotherapy Treatment

Treatment:

Behavioral: NVT Eye Scanning Therapy

Behavioral: Sham