A Multi-Centric, Retrospective, Real World Clinical follow-up study to demonstrate the Efficacy of Essilor® Stellest® Spectacle Lenses in slowing down Myopia progression in children and adolescents in India
试验速览
- 阶段
- 不适用
- 状态
- Not Applicable
- 发起方
- 入组人数
- 395
- 试验地点
- 10
- 主要终点
- To compare with change in SER over 1 year prior to use of Stellest lenses and Change in cycloplegic autorefraction (SER) from baseline upto 12 months
研究概览
简要总结
Considering that, Myopia prevalence in urban India has been projected to spike to 48% by 2050. Myopia currently is widely recognized as a significant public health issue causing significant visual loss and a risk factor for a range of other serious ocular conditions. The prevalence of this condition is increasing on a global basis, for reasons that still are not understood. Although partial reductions in progression rates have been observed from pharmacologic therapies, optical treatments, and behavioural modifications (Interventions for Controlling Myopia Onset and Progression Report), we are a long way from being able to reverse the temporal trends of the last few decades. This makes myopia, and its associated complications, a high research priority. Many prospective studies have been done with Stellest® spectacle in other countries, which shows promising results in control of myopia progression. Therefore, it is imperative to determine whether Stellest® spectacle lenses can effectively reduce the progression of myopia in Indian children. In best of our knowledge, there has been no study done on Stellest® spectacle in Indian children. As the study is retrospective, consenting procedure is waived off.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Year(s) 至 19.00 Year(s)(—)
- 性别
- All
入选标准
- •Inclusion should be progressive myopia based on change in RE in the previous year
- •Information on progression of myopia prior to treatment should be available
- •All participants wearing Essilor® Stellest® Lenses.
排除标准
- •Not Applicable.
结局指标
主要结局
To compare with change in SER over 1 year prior to use of Stellest lenses and Change in cycloplegic autorefraction (SER) from baseline upto 12 months
时间窗: Up to 12 months
次要结局
未报告次要终点
研究者
Prof Dr Rohit Saxena
AIIMS
