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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01214070
Other study ID # C6687-R
Secondary ID
Status Terminated
Phase Phase 4
First received September 14, 2010
Last updated June 14, 2017
Start date June 1, 2012
Est. completion date November 21, 2013

Study information

Verified date June 2017
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 110
Est. completion date November 21, 2013
Est. primary completion date November 21, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vision Restoration Therapy
Therapy that enhances the neuronal plasticity of the visual system
Behavioral:
NVT Eye Scanning Therapy
Therapy that trains eye and head scanning into the blind hemianoptic visual field
Eccentric 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
Sham
Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit

Locations

Country Name City State
United States VA Palo Alto Health Care System Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic Visual Field Baseline
Secondary Dynamic Visual Field After First Therapy / Before Second Therapy (Average time is 4.5 months)
Secondary Dynamic Visual Field After Second Therapy (Average Time is 9 months)
Secondary Reading Rate and Accuracy Baseline
Secondary Reading Rate After First Therapy / Before Second Therapy (average time is 4.5 months)
Secondary Reading Rate and Accuracy After Second Therapy (average time is 9 months)
Secondary Visual Search Accuracy and Timing Baseline
Secondary Visual Search Accuracy and Timing After First Therapy / Before Second Therapy (average time is 4.5 months)
Secondary Visual Search Accuracy and Timing After Second Therapy (average time is 9 months)
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