Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
研究概览
简要总结
Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual field defects after brain damage
- •lesion age above 6 months
- •documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging
排除标准
- •hemispatial neglect
- •complete blindness
- •severe psychotic diseases
- •serious drug abuse
- •chronic degenerative diseases (dementia, multiple sclerosis)
- •severe motor impairments
- •noticeable low intelligence influencing proper comprehension of diagnostic and training instructions
- •considerable impaired vision (visual acuity below 0.1 generated by amblyopia, opacity of cornea or lens, maculopathy and other retinal diseases where vision impairment is expected in the next month (e.g. subretinal neovascularisation, retinitis pigmentosa, diabetic retinopathy)
- •inability to fixate due to central scotoma, pathological nystagmus or other forms of fixation disabilities
研究组 & 干预措施
Vision Restoration Training (VRT)
home-based rehabilitation program which applies intense light stimulation via a PC-monitor to areas of residual vision with a duration of 1 hour daily/six days a week, subjects are asked to respond via button press upon appearance of light stimuli without eye movements
干预措施: Vision Restoration Training (VRT) (Behavioral)
Vision Exploration Training (VET)
home-based rehabilitation program to train eye movements upon visual stimuli presented via a PC-monitor with a duration of 1 hour daily/six days a week, subjects are asked to shift their gaze towards targets and respond via button press upon detection of targets
干预措施: Vision Exploration Training (VET) (Behavioral)
结局指标
主要结局
Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
时间窗: 3 months
High Resolution Perimetry - Detectection performance change before vs. after training (%)
时间窗: 3 months
次要结局
未报告次要终点
研究者
Bernhard A. Sabel
Professor, Head of Institute
University of Magdeburg