Comparison of AmblyzTM Glasses and Patching for Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Visual Acuity Change During 12 Weeks
研究概览
简要总结
Electronic eyeglasses, Amblyz™glasses, are a new medical device designed to treat amblyopia, which intermittently become opaque and provide effective occlusion for 50% of the time they are worn. A non-randomized study reported that Amblyz glasses yield an improvement in the amblyopic eye and offer an alternative effective treatment. We are unaware of any randomized clinical trial reports of response to AmblyzTM glasses treatment of amblyopia.
Our hypothesis: Amblyz™glasses can improve visual acuity of the amblyopic eye as effective as traditional patching treatment.
The primary objective is to determine if AmblyzTM equally treats moderate amblyopia as the standard 2-hour patching treatment and AmblyzTM equally treats severe amblyopia as the standard 6-hour patching treatment.
This study is designed to evaluate the effectiveness of a novel amblyopia treatment, AmblyzTM glasses, in treating amblyopia.
Moderate amblyopia: Children ages 3 to <8 years with visual acuity of 20/40 to 20/80 in the amblyopic eye will be enrolled and randomized into two groups: 4-hour AmblyzTM glasses treatment group and standard 2-hour patching control group.
Severe amblyopia: Children ages 3 to <8 years with visual acuity of 20/100 to 20/400 in the amblyopic eye will be enrolled and randomized into two groups: 12-hour AmblyzTM glasses treatment group and standard 6-hour patching control group.
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders and all races are eligible to this study.
- •Age 3 to 8 years
- •Amblyopia associated with strabismus, anisometropia, or both
- •Visual acuity in the amblyopic eye between 20/40 and 20/80 inclusive
- •Visual acuity in the sound eye 20/40 or better and inter-eye acuity difference >3 logarithm of the minimum angle of resolution (logMAR) lines
- •Wearing of optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
排除标准
- •No amblyopia treatment before enrollment.
研究组 & 干预措施
4-hour AmblyZ glasses
4-hour AmblyZ glasses for moderate amblyopia
干预措施: 4-hour AmblyZ glasses (Device)
2-hour eye patching
2-hour eye patching for moderate amblyopia
干预措施: 2-hour patching (Device)
12-hour AmblyZ glasses
12-hour AmblyZ glasses for severe amblyopia
干预措施: 12-hour AmblyZ glasses (Device)
6-hour eye patching
6-hour eye patching for severe amblyopia
干预措施: 6-hour patching (Device)
结局指标
主要结局
Visual Acuity Change During 12 Weeks
时间窗: 12 weeks
Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.
次要结局
未报告次要终点