背景:弱视,儿童时期最常见的视力障碍,是一个公共卫生问题。一些国家的临床指南建议在修补前进行长时间的光学治疗。这项研究的目的是比较强化修补方案,有或没有扩展光学治疗(EOT),在一项随机对照试验中。
方法:EuPatch是一项在英国30家医院进行的随机对照试验,希腊,奥地利,德国,和瑞士。新发现的3-8岁儿童,未经治疗的弱视(定义为眼间差异≥0·30的最小分辨率角度的对数[logMAR]最佳矫正视力[BCVA]),斜视,或者两者都有资格。通过计算机生成的序列将参与者随机分配(1:1)到EOT组(修补前使用眼镜18周)或早期修补组(修补前使用眼镜3周),根据弱视的类型和严重程度进行分层。所有参与者最初都接受了强化修补方案(10小时/天,每周6天),辅以激励材料。修补期长达24周。参与者,父母或监护人,评估人员,而试验统计学家并未掩盖治疗分配.主要结果是成功治疗(即,修补12周后,BCVA的眼间logMAR差异≤0·20)。进行了两项主要分析:主要分析包括所有参与者,包括那些退学的人,但排除了那些在第12周时未提供结局数据并仍在研究中的人;另一项分析估算了这些缺失的数据.对所有符合条件和随机分配的参与者进行不良事件评估。本研究已在国际标准随机对照试验编号注册表(ISRCTN51712593)注册,并且不再招募。
结果:在2013年6月20日至2020年3月12日之间,在排除了经过详细筛查发现不合格的八名参与者之后,我们随机分配了334名参与者(EOT组170名,早期修补组164名),包括188名(56%)男孩,146(44%)女孩,和两名(1%)未记录性别的参与者。对317名参与者(EOT组158名,早期修补组159名)进行了主要结局分析,但未对缺失数据进行填补(EOT组的中位随访时间42周[IQR42]与早期修补组的27周[27])。EOT组170名参与者中的24名(14%)和早期修补组164名参与者中的10名(6%)被排除或退出研究,主要是由于随访失败和撤回同意;EOT组的10例(6%)和早期修补组的3例(2%)错过了12周的访视,但仍在研究中.在修补12周后,早期修补组成功治疗的参与者比例(159人中的107[67%])高于EOT组(158人中的86[54%];差异13%;p=0·019)。未发生与干预措施相关的严重不良事件。
结论:该试验的结果表明,对于大多数弱视儿童,早期修补比EOT更有效。我们的发现还为弱视治疗的个性化提供了数据。
背景:行动医学研究,NIHR临床研究网络,和Ulverscroft基金会.
BACKGROUND: Amblyopia, the most common visual impairment of childhood, is a public health concern. An extended period of optical treatment before patching is recommended by the clinical guidelines of several countries. The aim of this
study was to compare an intensive patching regimen, with and without extended optical treatment (EOT), in a randomised controlled
trial.
METHODS: EuPatch was a randomised controlled
trial conducted in 30 hospitals in the UK, Greece, Austria, Germany, and Switzerland. Children aged 3-8 years with newly detected, untreated amblyopia (defined as an interocular difference ≥0·30 logarithm of the minimum angle of resolution [logMAR] best corrected visual acuity [BCVA]) due to anisometropia, strabismus, or both were eligible. Participants were randomly assigned (1:1) via a computer-generated sequence to either the EOT group (18 weeks of glasses use before patching) or to the early patching group (3 weeks of glasses use before patching), stratified for type and severity of amblyopia. All participants were initially prescribed an intensive patching regimen (10 h/day, 6 days per week), supplemented with motivational materials. The patching period was up to 24 weeks. Participants, parents or guardians, assessors, and the
trial statistician were not masked to treatment allocation. The primary outcome was successful treatment (ie, ≤0·20 logMAR interocular difference in BCVA) after 12 weeks of patching. Two primary analyses were conducted: the main analysis included all participants, including those who dropped out, but excluded those who did not provide outcome data at week 12 and remained on the study; the other analysis imputed this missing data. All eligible and randomly assigned participants were assessed for adverse events. This
study is registered with the International Standard Randomised Controlled
Trial Number registry (ISRCTN51712593) and is no longer recruiting.
RESULTS: Between June 20, 2013, and March 12, 2020, after exclusion of eight participants found ineligible after detailed screening, we randomly assigned 334 participants (170 to the EOT group and 164 to the early patching group), including 188 (56%) boys, 146 (44%) girls, and two (1%) participants whose sex was not recorded. 317 participants (158 in the EOT group and 159 in the early patching group) were analysed for the primary outcome without imputation of missing data (median follow-up time 42 weeks [IQR 42] in the EOT group vs 27 weeks [27] in the early patching group). 24 (14%) of 170 participants in the EOT group and ten (6%) of 164 in the early patching group were excluded or dropped out of the study, mostly due to loss to follow-up and withdrawal of consent; ten (6%) in the EOT group and three (2%) in the early patching group missed the 12 week visit but remained on the study. A higher proportion of participants in the early patching group had successful treatment (107 [67%] of 159) than those in the EOT group (86 [54%] of 158; 13% difference; p=0·019) after 12 weeks of patching. No serious adverse events related to the interventions occurred.
CONCLUSIONS: The results from this trial indicate that early patching is more effective than EOT for the treatment of most children with amblyopia. Our findings also provide data for the personalisation of amblyopia treatments.
BACKGROUND: Action Medical Research, NIHR Clinical Research Network, and Ulverscroft Foundation.