跳至主要内容
临床试验/CTRI/2024/08/071994
CTRI/2024/08/071994Not Applicable不适用

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

Essilor® India Private Limited10 个研究点 分布在 1 个国家目标入组 395 人开始时间: 2024年8月19日最近更新:

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

发起方
Essilor® India Private Limited
申办方类型
Other [Opthalmic- Essilor® India Private Limited]
责任方
Principal Investigator
主要研究者

Prof Dr Rohit Saxena

AIIMS

研究点 (10)

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