Efficacy of Over-glasses Patch Treatment for Amblyopia in Children :OPTA Study, A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Changes in visual acuity (logMAR)
研究概览
简要总结
This is a study to investigate efficacy of over-glasses patch treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.
详细描述
In a randomized multi-center controlled clinical trial, children younger than 7 years with moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to receive treatment with either a conventional patch or an over-glasses patch. The patients will be prescribed 2 hours of patching per day for the sound eye. Best-corrected visual acuity (BCVA) and stereopsis will be investigated and ATI questionnaires be collected from parents at 5 weeks and 17 weeks after the initiation of treatment.
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
- Single (Outcomes Assessor)
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
- •moderate amblyopia (logMAR visual acuity in the amblyopic eye 0.3 to 0.7 inclusive)
- •logMAR visual acuity in the sound eye of 0.1 or better
- •intereye acuity difference of larger or equal to 0.3 of logMAR visual acuity
- •the presence of or a history of an amblyogenic factor meeting study-specified criteria for strabismus and/or anisometropia.
排除标准
- •presence of an ocular cause for low vision
- •myopia greater than -6.0 diopters (D) spherical equivalent in either eye
- •prior intraocular or refractive surgery
- •treatment for amblyopia (other than spectacle correction) within the 6 months prior to the enrollment
- •Down syndrome
结局指标
主要结局
Changes in visual acuity (logMAR)
时间窗: 17 weeks
changes in best- corrected visual acuity between before treatment and after 17 weeks. Visual acuity is assessed using the Snellen chart. logMAR visual acuity ranges 0.0 to 3.0. logMAR visual acuity of 0.0 corresponds to 20/20. Lower scores represents better functioning.
次要结局
- amblyopia treatment index(17 weeks)
- the best corrected visual acuity(17 weeks)
- change of binocularity(17 weeks)
研究者
Heeyoung Choi
Professor
Pusan National University Hospital