Visual Perceptual Learning for the Treatment of Visual Field Defect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Improvement of visual field scores in visual field defect areas
研究概览
简要总结
This study will test the hypothesis whether visual field defect caused by chronic stroke could be improved by visual perceptual learning. The secondary hypothesis is that improvement of visual field defect would be accompanied by connectivity changes in visual networks. In addition, investigators will evaluate whether improvement of visual field defect could achieve improvement of subjective visual function.
详细描述
Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design
Methods:
-
Visual perceptual learning (VPL) group
-
Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
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At baseline and post-VPL evaluations (2 months after): Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
-
Control group
-
At baseline and 2-months later: No VPL, Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
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Visual perceptual learning after 2-month follow-up evaluation (24 times for 2 months, 3 times per week)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has chronic stroke more than 6 months after onset.
- •The patient has visual field defect (Quadrantanopia or Hemianopia).
- •The patient has corrected eyesight 0.7 or above.
排除标准
- •The patient has contraindication to MRI scan.
- •The patient has cognitive impairment (Mini-Mental Status Exam score <24).
- •The patient has ophthalmologic diseases (e.g., glaucoma, cataract).
研究组 & 干预措施
Learning
Visual perceptual learning (VPL) group
干预措施: Visual perceptual learning (Behavioral)
Control
Control group
结局指标
主要结局
Improvement of visual field scores in visual field defect areas
时间窗: At 2 months (plus or minus 7 days) after baseline evaluation
Improvement of mean deviation scores in defected areas by Humphrey 750i Field test
次要结局
- Improvement of visual field score in whole visual field area(At 2 months (plus or minus 7days) after baseline evaluation)
- Change of subjective visual function(At 2 months (plus or minus 7days) after baseline evaluation)
- Performance of visual perceptual learning(At 2 months (plus or minus 7 days) after baseline evaulation)
- Connectivity changes in MRI(Between baseline and 2 months (plus or minus 7 days) after)
- Changes of visual evoked potential(Between baseline and 2 months (plus or minus 7 days) after)
研究者
Dong-Wha Kang
MD, PhD
Asan Medical Center