Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in visual acuity of the amblyopic eye
研究概览
简要总结
- To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children
- To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)
详细描述
Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
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
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 to 7 years old
- •Amblyopic eye visual acuity 20/32-20/125
- •Fellow eye visual acuity 20/16-25
- •Interocular visual acuity difference of at least 2 lines
- •Anisometropia or corrected strabsimus (<5pd)
- •in glasses at least 8 weeks or no change in visual acuity over two visits
- •no prior binocular treatment
- •must be able to see full video screen
排除标准
- •prematurity of 8 weeks or more
- •coexisting ocular or systemic disease
- •developmental delay
- •poor ocular alignment (>=5 pd)
结局指标
主要结局
Change in visual acuity of the amblyopic eye
时间窗: Baseline vs 2 weeks
HOTV (preferred) or picture chart
次要结局
- Change in Contrast Balance Index(Baseline vs 2, 4, 6, 8 weeks)
- Change in visual acuity of the amblyopic eye(Baseline vs 4 weeks, 6 weeks, and 8 weeks)
- Change in Stereoacuity(Baseline vs 2, 4, 6, 8 weeks)
研究者
Eileen Birch
Senior Research Scientist
Retina Foundation of the Southwest