The Effect of Varied MP-3 Biofeedback Training on Visual Functions in Central Vision Loss: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reading speed
研究概览
简要总结
The objectives of this investigation are:
- evaluate the results of rehabilitation treatment using photostimulation with a structured stimulus in two different samples of low vision subjects with central vision loss who will be subjected to biofeedback at the MP3 microperimeter with different timing;
- compare the effectiveness of the rehabilitation treatments in the two groups to provide useful indications for proposing standardisation of the rehabilitation pathway focusing on photostimulation in subjects with central vision loss.
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
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
- •Age related macular degeneration
排除标准
- •Cognitive impairment; concomitant eye disease; significant media opacities; ocular surgery within previous 90 days
研究组 & 干预措施
Group A
Training will be performed for two days a week
干预措施: MP-3 microperimeter (Device)
Group B
Training will be performed three days a week
干预措施: MP-3 microperimeter (Device)
结局指标
主要结局
Reading speed
时间窗: 6 months
Achievement of good reading speed: higher than 87 words per minutes was defined as our secondary outcome. Parameters for words per minutes are referred to visually impaired functional reading reported in literature
Fixation stability
时间窗: 6 months
Achievement of a stable fixation, defined according to Fuji classification (Stable: if more than 75% of the fixation points are inside a 2° diameter circle that has as a center the centroid of all fixation points) and the Bivariate Contour Ellipse Area, were selected as primary outcomes.
次要结局
未报告次要终点
研究者
Amore Filippo
Medical Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS