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临床试验/NCT01214070
NCT01214070终止4 期

Functional Vision Consequences of Rehabilitation for TBI Vision Loss

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
110
试验地点
2
主要终点
Dynamic Visual Field

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • TBI (any form)
  • Hemianopic Visual Field Loss
  • Stable fixation
  • 1.0 logMAR or better Reading Acuity
  • 20 words per minute or better reading rate

排除标准

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

结局指标

主要结局

Dynamic Visual Field

时间窗: Baseline

次要结局

  • 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))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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Functional Vision in TBI | 临床试验