Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in visual ability
研究概览
简要总结
This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.
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
- None (Participant)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with ultra low vision (visual acuity ≤20/1600)
排除标准
- •<12 years of age
- •dependent on sighted guide
- •cognitive impairment
结局指标
主要结局
Change in visual ability
时间窗: Baseline, 1 month, 3 months, 6 months
Change in visual ability as measured by the Ultra Low Vision Visual Function Questionnaire. The scale measures both visual ability (Person Measure) and difficulty (Item Measure) in people with ultra low vision. 150 items on a likert scale ranging from 1 impossible, to 4 not difficult. Using a Rasch-Andrich rating model, Person Measures range from -6 to +2.8 logits, Item Measures range from -3.3 to +3.0 logits. Higher scores indicating better outcome.
次要结局
- Change in hearing ability(Baseline, 1 month, 3 months, 6 months)
- Change in hand-eye coordination(Baseline, 1 month, 3 months, 6 months)