Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM.
In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.
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 (Participant)
入排标准
- 年龄范围
- 3 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye
- •A difference of two BCVA lines of Snellen between the two eyes
排除标准
- •A history of penalization one month prior to the study
- •Bilateral amblyopia
- •BCVA less than 20/200
- •Eccentric fixation
- •Nystagmus
- •Ocular deviation more than 10 prism diopter (pd)
- •Organic amblyopia
- •Uncooperative children those with
- •Mental and physical disability
- •Systemic diseases
研究组 & 干预措施
I-BiT group
Amblyopic patients will play I-BiT games without patching.
干预措施: Interactive Binocular Treatment (Device)
Placebo group
Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games.
干预措施: Patching Therapy (Procedure)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: 6 months
次要结局
未报告次要终点
研究者
Hamideh Sabbaghi
PhD student, Teacher Assistant
Shahid Beheshti University of Medical Sciences
