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临床试验/CTRI/2016/11/007450
CTRI/2016/11/007450已完成不适用

A randomized controlled trial to evaluate the effect of low dose atropine eyedrop for childhood myopia

Dr Rajendra Prasad Centre for Ophthalmic Science1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
myopia progression

研究概览

简要总结

Myopia has emerged as a worldwide public health issue ans is 1 of the 5 ocular conditions identified as immediate priorities by the World Health Organizations’s Global Initiative for the Elimination of Avoidable Blindness. In addition to the optical impact of myopia on vision and the associated costs of correction, myopia is a major risk factor for ocular disease. Myopia increases the risk of eye diseases including glaucoma, cataract and retinal detachment.The risk of myopia are significant even in low to moderate myopes and comparable to the risks of smoking and hypertension to cardiovascular diseases.Standard of care currently treats only the optical and medical consequences of myopia rather than limiting its progression.There have been various methods in past described for control of progression of myopia.Among these methods Atropine 0.01 % have been shown to control myopia progression with minimal side effects. There have been no studies yet assessing effect of 0.01 % atropine eyedrops in Indian population for controlling myopia progression.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Age 6-12 years Refractive error of spherical equivalent between -2D to -6D in each eye as measured by cycloplegic autorefraction Distance vision correctable to logMAR 0.2 or better in both eyes Normal ocular health other than myopia Informed consent Willing to follow-up.

排除标准

  • Astigmatism more than -1.5 D as measured by cycloplegic autorefraction Amblyopia Strabismus Allergy to atropine or homatropine Previous or concurrent use of contact lenses, bifocals, progressive addition lenses or other forms of treatment (including atropine) for myopia History of cardiac , neurologic or significant respiratory diseases.
  • Unwilling to give consent/ follow-up.

结局指标

主要结局

myopia progression

时间窗: 2 weeks | 2 months | 4 months | 8 months | 1 year

次要结局

  • side effects(2 weeks)

研究者

发起方
Dr Rajendra Prasad Centre for Ophthalmic Science
申办方类型
Research institution and hospital

研究点 (1)

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