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

近视是生命最初几十年最常见的发育性眼部疾病。它是在以后的生活中视力威胁退行性眼病的最大风险因素，仅次于年龄。其流行程度在全球范围内呈上升趋势，目前在亚洲人口中占80%，在高加索人口中占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。它通常在小学期间发生，它的发生和发展与环境因素有关，如近距离工作和缺乏日光照射，其次是遗传因素。因此，延缓近视的发展是一个主要的治疗目标。来自亚洲的临床试验表明，0.01%的阿托品滴眼液可以减缓近视的进展，同时只产生轻微的副作用，如对光敏感和调节能力下降。然而，目前尚不清楚这种疗法在高加索人群中是否同样有效。由于近视在欧洲的发病率也在上升，家长对延缓近视进展的需求也在增加，我们申请了欧洲第一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，以证实越来越多的儿童低剂量阿托品的超说明书处方，并制定临床指南。

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.