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临床试验/NCT05098236
NCT05098236
已完成
不适用

Effect of Visual Retraining on Visual Loss Following Visual Cortical Damage

University of Rochester1 个研究点 分布在 1 个国家目标入组 280 人2003年9月26日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Vision Loss Partial
发起方
University of Rochester
入组人数
280
试验地点
1
主要终点
Direction Discrimination Threshold
状态
已完成
最后更新
去年

概览

简要总结

This project is intended to collect data using standard clinical tests and psychophysics to quantify the effect of visual cortical damage on the structure of the residual visual system, visual perception, spatial awareness, and brain function. The investigators will also assess the effect of intensive visual retraining on the residual visual system, processing of visual information and the use of such information in real-world situations following damage. This research is intended to improve our understanding of the consequences of permanent visual system damage in humans, of methods that can be used to reverse visual loss, and of brain mechanisms by which visual recovery is achieved.

注册库
clinicaltrials.gov
开始日期
2003年9月26日
结束日期
2024年6月4日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Krystel Huxlin

Professor

University of Rochester

入排标准

入选标准

  • Subjects between the ages of 17 and 75, who have sustained damage to primary visual cortex at age 17 or later, and are rendered blind over a portion of their visual field.
  • Subjects must have some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist.
  • Subjects who demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field.
  • Subjects who are competent and responsible, as determined by the Principal Investigator.
  • Subjects who will receive retinal electrophysiology (mfERG) testing must have a report from their ophthalmologist stating that they are able to receive dilating drops
  • Cortically Blind Subject

排除标准

  • Subjects who do not possess damage of primary visual cortex or its immediate afferents
  • Subjects who are suffering from an active disease process involving their nervous system.
  • Subjects who are unable to fixate visual targets precisely with their eyes
  • Subjects who have unreliable vision fields from prior testing indicated by greater than 20% fixation losses, false positives or false negatives
  • Best corrected visual acuity worse than 20/40 in either eye
  • Impaired foveal sensitivity as indicated by visual field tests
  • Presence of vision loss from ocular disease or disorder
  • Presence of bilateral visual acuity loss from any source
  • Subjects who are suffering from one-sided attentional neglect
  • Subjects who have impaired auditory thresholds that would influence test results and training efficacy (all our testing and training involves sound as a cue for trial/stimulus onset or as feedback)

结局指标

主要结局

Direction Discrimination Threshold

时间窗: Baseline, 4-months, 12-months

For each subject, the investigators will measure the change in ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.

Direction Integration Threshold

时间窗: Baseline to 4-months, 12-months

This will measure the change in ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.

Contrast Sensitivity for Direction

时间窗: Baseline, 4-months, 12-months

Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.

Contrast Sensitivity for Static Orientation

时间窗: Baseline, 4-months, 12-months

Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. This is a change metric as transfer must be compared from pre- to post- each course of training. For each subject, the investigators will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline and at each subsequent visit to the laboratory; minimally from baseline to 4-months, then baseline to 12-months from start of training.

次要结局

  • Goldmann perimetry(Baseline, 4-months, 12-months)
  • MAIA Visual Field Perimetry(Baseline, 4-months, 12-months)
  • Humphrey 10-2 and 24-2 perimetry(Baseline, 4-months, 12-months)

研究点 (1)

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