NCT03822806已完成不适用
Augmenting Patching Treatment for Amblyopia With Physical Exercise
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
Researches are trying to establish whether moderate exercise enhances the treatment benefit of patching 2 hours a day for residual amblyopia in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5 to < 17 years old
- •Cycloplegic refraction within past year
- •Diagnosis of residual amblyopia, with no evidence of regression of amblyopic eye visual acuity by 1 or more LogMAR from best previous
- •Completed at least 6 months prior patching treatment (minimum 2 hours/day) or atropine treatment.
- •Stable visual acuity as defined by <1 LogMAR change over 2 visits
- •Xbox 360 Kinect, Wii or WiiU gaming system in the home, or a different gaming system with a version of Just Dance® already in the home.
排除标准
- •Known problems with exercise tolerance
- •No gaming system in the home that supports Just Dance® Kids 2014, and no existing version of Just Dance® in the home
- •Current atropine treatment for amblyopia
研究组 & 干预措施
Physical Exercise in addition to Patching
Experimental
Patch for 2 hours a day, and exercise (using the videogame JustDance) for the first 30 minutes of those 2 hours using the video game (continuing to wear the patch for 90 minutes after exercise).
干预措施: Physical Exercise in addition to Patching (Other)
结局指标
主要结局
Visual Acuity
时间窗: 1 month (3 weeks to 8 weeks) after initiating game play
The primary outcome measure will be LogMAR visual acuity measured 1 month (primary analysis window 3 weeks to 8 weeks) after initiating game play.
次要结局
未报告次要终点
研究者
Erick D. Bothun
Principal Investigator
Mayo Clinic
研究点 (1)
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