Clinical Trials Directory

Trials / Terminated

TerminatedNCT01214070

Functional Vision in TBI

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
110 (estimated)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
20 Years – 79 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVision Restoration TherapyTherapy that enhances the neuronal plasticity of the visual system
BEHAVIORALNVT Eye Scanning TherapyTherapy that trains eye and head scanning into the blind hemianoptic visual field
BEHAVIORALEccentric Viewing TrainingTherapy 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
BEHAVIORALShamTherapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Timeline

Start date
2012-06-01
Primary completion
2013-11-21
Completion
2013-11-21
First posted
2010-10-04
Last updated
2017-06-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01214070. Inclusion in this directory is not an endorsement.