Role of atropine 0.01% drops for controlling progression of myopia in children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study role of Atropine 0.01% drops for controlling progression of Myopia in children
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
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •patient diagnosed with progressive myopia Normal ocular health other than myopia Informed consent Willing to follow-up.
排除标准
- •1.allergy to atropine.
- •2.previous eye surgery or trauma.
- •3.previous use of contact lenses , bifocals or other form of treatment for myopia.
- •4.any cause for visual impairment other than myopia( glaucoma, cataract,Amblyopia,Strabismus ) 5.Previous or concurrent use of contact lenses, bifocals, progressive addition lenses or other forms of treatment (including atropine) for myopia 6.History of cardiac , neurologic or significant respiratory diseases.
- •Unwilling to give consent/ follow-up.
结局指标
主要结局
To study role of Atropine 0.01% drops for controlling progression of Myopia in children
时间窗: 2 weeks | 3 months | 6 months | 9 months | 1 year
次要结局
- To study side effects of lose dose 0.01% Atropine in children with progressive Myopia(2 weeks)