Low-dose AtropIne for Myopia control in children (AIM-study)

小剂量阿托品控制儿童近视（AIM 研究）

• 批准号: 416728216
• 负责人: Professor Dr. Wolf A. Lagrèze
• 金额: --
• 依托单位: Klinik für Augenheilkunde
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 财政年份: 2019
• 资助国家: 德国
• 起止时间: 2018-12-31 至 2023-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/416728216?language=en
• 关键词: Low; dose; AtropIne; Myopia; control

Myopia (nearsightedness) is the most common developmental eye disorder in the first decades of life. It is the biggest risk factor for sight threatening degenerative eye diseases later in life, second only to age. Its prevalence is increasing worldwide in pandemic dimensions affecting now > 80% in Asian and > 40% in Caucasian populations. Myopia is one of the five eye diseases identified as immediate priorities by the WHO’s global initiative for the elimination of avoidable blindness. It usually develops during primary school and its onset and progression are related to environmental factors such as near work and lack of day light exposure, to a lesser degree to genetic factors. Therefore, retardation of myopia progression is a major therapeutic goal. Clinical trials from Asia have shown that 0.01% atropine eye drops can attenuate progression of myopia while inducing only little side effects such as light sensitivity and reduced accommodation. However, it is unclear whether this therapy is equally and sufficiently efficacious in a Caucasian population. Due to the increasing prevalence also in Europe and an increasing demand from parents for means to retard myopia progression, we apply for the first European large scale randomized clinical trial investigating the safety and efficacy of 0.01% atropine eye drops in comparison to placebo drops. Such a trial is mandatory to substantiate the increasing offlabel prescriptions of low-dose atropine in children and to develop clinical guidelines.

近视(近视)是生命最初几十年最常见的发育性眼病。它是威胁视力的晚年退行性眼病的最大风险因素，仅次于年龄。它的流行在世界范围内呈大流行趋势，目前影响到亚洲80%和高加索人群40%。近视是世界卫生组织全球消除可避免失明倡议确定的五种眼病之一。它通常发生在小学时期，其发生和发展与环境因素有关，如附近工作和缺乏日光照射，与遗传因素的关系较小。因此，延缓近视进展是治疗的主要目标。来自亚洲的临床试验表明，0.01%的阿托品滴眼液可以延缓近视的进展，同时只会产生很小的副作用，如光敏感和调节能力降低。然而，目前还不清楚这种疗法在高加索人群中是否同样有效和足够有效。由于近视在欧洲的患病率也在不断上升，父母对减缓近视进展的手段的需求也在不断增加，我们申请了欧洲首个大规模随机临床试验，研究0.01%阿托品滴眼液与安慰剂滴眼液的安全性和有效性。这样的试验是强制性的，以证实儿童小剂量阿托品标签外处方的增加，并制定临床指南。