Stochastic Resonance Applied to Amblyopia Training and the Plasticity of Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Visual acuity (VA)
研究概览
简要总结
The prevalence of Taiwan's population with amblyopia is 2-5%. Amblyopia affects the daily life and learning ability. The human visual system can be developed normally with exposure of clear images on the retina, which often drive the development and projection of optic nerves progressively. In general, the visual acuity progresses gradually with age. A normal vision is relatively mature until 8 years old. Several types of amblyopia (strabismic amblyopia, refractive amblyopia, and deprivation amblyopia) are identified. The refractive amblyopia and deprivation amblyopia must be corrected by wearing glasses or surgeries. Otherwise, amblyopia is often corrected by occlusion of the dominant eye or amblyopia training. The Cambridge Stimulator (CAM) with rotating grating is commonly used in clinic in Taiwan. The principle of the CAM allows subjects to draw pictures on the plate in coincidence with occlusion of the dominant eye. The parents have to go with their children to a hospital weekly. The CAM training is a stereotyped visuomotor behavior, which usually causes fatigue and uninteresting results for children.
Recently, some computer games have been incorporated with CAM training. However, their clinical impact on amblyopia is largely unknown. Moreover, most of studies don't have long-term tracking, and they only use limited assessments. In this project, a home-based training would be built for children with amblyopia. A CAM training with a hierarchical structure with story-based organization would be implemented in the tablet. It will save time for children and parents for traffic between the home and hospital. The CAM training with organized structure would increase acceptability and create subjects' motivation for long-term training. In addition, a stochastic resonance theory would be incorporated with the CAM training to potentiate the learning curve of a visuomotor skill in young children. Five systematic assessments, including visual acuity, grating acuity, contrast sensitivity, and 2 measurements of visual evoked potentials (VEPs), would be used. The investigators hypothesized that the rotating grating stimulation and stochastic resonance stimulation groups showed significant enhancement of the visual functions compared with the control group and performance of the VEPs toward better eye through the home-based training apparatus.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants were 4-8 years old.
- •Participant had binocular or monocular best-corrected visual acuity (BCVA) of ≤0.8, or they exhibited binocular BCVA difference of ≥0.
- •Participant had the wearing of optimal spectacle correction.
排除标准
- •Children with deprivation amblyopia were excluded.
- •Children with ptosis were excluded.
研究组 & 干预措施
Control group
This group received eye-hand practice for drawing pictures.
干预措施: Portable tablet (Device)
Grating group
This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies.
干预措施: Portable tablet (Device)
Random dot group
This group received eye-hand practice for drawing pictures with rotating grating stimuli of various spatial frequencies constructed by random dots of stochastic resonance.
干预措施: Portable tablet (Device)
结局指标
主要结局
Visual acuity (VA)
时间窗: Change from Baseline VA at 1, 2, 3 and 6 months
Landolt C chart was used.
Grating acuity (GA)
时间窗: Change from Baseline GA at 1, 2, 3 and 6 months
Horizontal or vertical square-wave grating stimuli were used.
Contrast sensitivity (CS)
时间窗: Change from Baseline CS at 1, 2, 3 and 6 months
Circular-shape horizontal square-wave grating stimuli were used.
Visual evoked potential (VEP)
时间窗: Change from Baseline VEP at 1, 2, 3 and 6 months
Transient VEP and Steady state VEP of the Cortical EEG were recorded.
次要结局
- Total practice duration(Throughout 6 months)
