Virtual Reality Game Playing in Amblyopia Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
Background: "Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain".
Purpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children.
Methods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA < 0.6 LogMAR) amblyopia, respectively.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- The best corrected visual acuity worse than 0.3 LogMAR
排除标准
- •Patients with abnormal fixation
- •Patients with neurological problems
- •Patients with any types of ocular pathologies
研究组 & 干预措施
Virtual Reality
Dichoptic playing games with fine stimulation will present to the amblyopic eye.
干预措施: Virtual Reality (Device)
Patching
Non- amblyopic eye will be recommended to patch.
干预措施: Patching (Other)
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: baseline and 6 months after training
Change from baseline BCVA at 6 months
次要结局
未报告次要终点
研究者
Hamideh Sabbaghi
Principal Investigator
Shahid Beheshti University of Medical Sciences