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临床试验/CTRI/2016/01/006580
CTRI/2016/01/006580已完成不适用

Evaluation of the role of videogames as active vision therapy in treatment of amblyopia

no sponsor1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2013年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
best corrected visual acuity

研究概览

简要总结

Purpose: To evaluate the role of monocular videogames as active vision therapy in treatment of amblyopia

Materials and methods: Children between the age group of 6-14 years with anisometropic amblyopia (n=68) with BCVA (Best corrected visual acuity) in the amblyopic eye being >6/36 and <6/12 with no manifest squint were recruited. They were randomly allocated into two groups. One group received 6 hours/day of occlusion therapy (group 1) and the other received 1 hour/day of videogame play for initial one month along with 6 hours/day occlusion therapy (group 2) . Patients were evaluated at baseline, 1 month and 3 months with BCVA, stereoacuity and contrast senstivity.

Results: BCVA improved from 0.61+/-0.12 logMAR at baseline to 0.51+/- 0.14 logMAR at 1 month (p-value=0.001) and 0.40+/- 0.15 logMAR at 3 months (p-value=0.001) in group 1 .In group 2 the BCVA improved from a baseline of 0.65+/-0.09 logMAR to 0.60 +/- 0.10 logMAR at 1 month (p-value=0.001) and 0.48+/-0.10 logMAR (p-value=0.001) at 3 months. With in the younger age group (6-<10 years) improvement in visual acuity was better in group 1 at both time points. In older age group improvement in visual acuity was more in group 1 as compared to group 2 at 1 month.

Conclusion: Videogame play along with occlusion therapy has an advantage in visual recovery in amblyopia.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group:6-14 years 2.Anisometropic amblyopia 3.Unilateral cases 4.Visual acuity >6/36 and <6/12 5.No manifest squint
  • Those with access to computers Â.

排除标准

  • 1.Corneal opacities,cataract,ptosis 2.Nystagmus 3.Previous h/o treatment taken for amblyopia 4.Other types of amblyopia 5.Patients with other ocular pathologies(eg.
  • Involving the macula) 6.History of seizure disorder.

结局指标

主要结局

best corrected visual acuity

时间窗: 1 month and 3 months

次要结局

  • stereopsis
  • contrast senstivity(1 month and 3 months)

研究者

发起方
no sponsor
申办方类型
Other [not applicable]

研究点 (1)

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