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临床试验/CTRI/2018/08/015346
CTRI/2018/08/015346已完成3 期

Comparative study of binocular visual stimulation versus monocular occlusion therapy in children with amblyopia

Dr Rajendra Prasad Centre for Ophthalmic Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月4日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
visual outcome in terms of best corrected visual acuity, near vision, contrast sensitivity and stereoacuity after intervention

研究概览

简要总结

Amblyopia is defined as a decrease in visual acuity in one eye caused by abnormal binocular interaction or occurring in one or both eyes as a result of patterned vision deprivation during visual immaturity, for which no cause can be detected during physical examination of the eye and which in appropriate cases is reversible by therapeutic measures. Most common cause of monocular amblyopia is anisometropia, i.e., difference of refractive error between both eyes.

Currently the therapy for amblyopia includes passive monocular approaches like occlusion of the better eye full time or part time (6 hours or 2 hours daily) or pharmacological penalisation using a cyclopagic agent such as atropine, so that the amblyopic eye receives more stimulation and visual acuity improves.

Recently a binocular approach for treatment of amblyopia has been reported. here both the eyes are presented with a different stimulus i.e., dichoptic stimuli. contrast level is kept higher in the amblyopic eye to give it advantage over the good eye and thus to overcome suppression, while encouraging simultaneous use of both the eyes. Multiple ipad, ipod, smartphone and computer video games has been devised based on this principle. One such game is dichoptic version of tetris or falling blocks game which has to be played wearing red green anaglyph glasses. the fallingblocks are seen by one eye and  the landed blocks are seen by the other eye. contrast can be adjusted as per the need.

The main aim of this study is to compare the final visual outcome in the amblyopic eye in terms of best corrected visual acuity between two group of patients having anisometropic amblyopia, one group playing binocular tetris video game for 2 hours daily, 7 days a week for 3 months and the second group using patching over the amblyopic eye for 6 hours a day, 7 days a week for three months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
7.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Age group: 7-15 years Anisometropic amblyopia Unilateral cases Visual acuity 6/12-6/60 in amblyopic eye No manifest squint Ready availability of a computer/tablet/smartphone at home or nearby for daily access Willingness and ability to play the game demonstrated by scoring at least one completed line Children whose parents/guardians give appropriate consent.

排除标准

  • Corneal opacities, cataract, ptosis Nystagmus Manifest squint Previous history of treatment of amblyopia Patients with other ocular pathologies ( e.g., involving the macula) Myopia of >6D History of seizure disorder.

结局指标

主要结局

visual outcome in terms of best corrected visual acuity, near vision, contrast sensitivity and stereoacuity after intervention

时间窗: Day 1, 1 month, 2 and 3 months

次要结局

  • near vision, contrast sensitivity and stereoacuity after intervention(Day 1, 1 month, 2 and 3 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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