The Role of Interactive Binocular Treatment System in Amblyopia Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity, Stereopsis
研究概览
简要总结
Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy.
Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.
详细描述
In this clinical trial study, our case group will receive I-BiTTM in the format of three playing games which have been designed suitable to the age of our cases. The mechanism of I-BiTTM has been designed in three playing games with inducing more foveal stimulation for the amblyopic eye through presentation of movable targets with more detailed. In addition, unmovable targets will presented to the non-amblyopic eyes. Playing games were continued 30 minutes in each session for 5 days in each week within one month.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCVA <= 0.3 LogMAR
排除标准
- •Organic Amblyopia
- •Age less than 4 years
- •Nystagmus
研究组 & 干预措施
Recommendation of Patching
Patients will receive two hours of patching in the case of one line difference of best corrected visual acuity(BCVA) between two eyes during one month.
干预措施: Patching Therapy (Other)
Recommendation of Patching and interactive binocular treatment
Patients will receive interactive binocular treatment addition to patch therapy in the least of 4 to 5 days of a week within 20-30 minutes in each day during one month.
干预措施: Patching Therapy (Other)
Recommendation of Patching and interactive binocular treatment
Patients will receive interactive binocular treatment addition to patch therapy in the least of 4 to 5 days of a week within 20-30 minutes in each day during one month.
干预措施: Interactive Binocular Treatment System (Device)
结局指标
主要结局
Best Corrected Visual Acuity, Stereopsis
时间窗: 30 days
Two arms were under patching and Interactive Binocular Treatment (IBIT)
次要结局
未报告次要终点
研究者
Hamideh Sabbaghi
Shahid Beheshti Medical University
Shahid Beheshti University of Medical Sciences