A Randomized Controlled Trial of Gradual (Slow Versus Very Slow) Versus Sudden Cessation of Atropine Therapy and Monitored Lifestyle Changes in the Incidence and Magnitude of Rebound Myopia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Myopia in diopter (sphere)
研究概览
简要总结
Atropine eye drop therapy has emerged as a globally accepted and effective intervention for slowing down myopia progression. Numerous studies highlight the efficacy of atropine therapy in mitigating myopia progression, often complemented by increased outdoor daylight activities and reduced screen time. However, the recent ATOM2 study(phase 2- washout period) revealed a concerning phenomenon known as rebound myopia, characterized by a worsening of myopia (progression of >0.5D) after the cessation of atropine therapy.
Remarkably, despite the growing significance of atropine therapy in myopia management, there is a notable lack of published guidance on strategically ceasing atropine treatment to minimize the incidence and magnitude of rebound myopia. Additionally, the role of monitored lifestyle changes, such as outdoor activities and screen time reduction, in addressing rebound myopia remains largely unexplored.
This study aims to fill this critical gap by assessing the efficacy of two atropine cessation regimes- gradual (slow vs very slow) versus sudden cessation of atropine therapy. Simultaneously, the research seeks to delineate the impact of monitored lifestyle changes on the incidence and magnitude of rebound myopia.
Methods;
The study will involve the randomization of patients into two groups, namely Group A and Group B. the group of children, the higher myopic eye will undergo a gradual tapering of atropine eye drops over 7 months, while the low myopic eye will undergo sudden cessation of atropine therapy. Lifestyle modification advice will be provided in this group. in group B children, the high myopic eye will undergo gradual tapering of atropine eye drop therapy over 3 months and the lower myopic eye will undergo sudden cessation of atropine eye drop. lifestyle modification including over 45 minutes of daily outdoor daylight activity and less than 1 hour of screen time, will be monitored using monitoring charts.
Patients will be followed up every three months, during which refractive power and axial length will be measured. The recruitment period for this comprehensive study is expected to span 13 months, aiming to provide insight into the evolving landscape of rebound myopia management strategies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Magnitude of myopia at least -1D in each eye.
- •Astigmatism less than 4.5D in each eye.
- •Documented nonprogressive myopia i.e. 0D and axial length progression less than 0.2mm per year.
- •Children who are on atropine eye drop therapy at any frequency and various concentration.
排除标准
- •Allergic to atropine.
- •Any comorbidities systemic as well as ocular Children who have pathological myopia BCVA less than 20 by 40 and 6 by 24 Axial length more than 26.5mm OCT macula abnormal.
结局指标
主要结局
Myopia in diopter (sphere)
时间窗: 13 months
次要结局
- Axial length in mm(13 months)
研究者
Sneha Jain
Jupiter Hospital
