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0.01%阿托品联合角膜塑形术用于儿童近视控制(AOK)研究:一项为期2年的随机临床试验。

Combined 0.01% atropine with orthokeratology in childhood myopia control (AOK) study: A 2-year randomized clinical trial.

作者信息

Tan Qi, Ng Alex Lk, Cheng George Pm, Woo Victor Cp, Cho Pauline

机构信息

School of Optometry, The Hong Kong Polytechnic University, Hong Kong, China.

Department of Ophthalmology, The University of Hong Kong, Hong Kong, China; Hong Kong Ophthalmic Associates, Hong Kong, China.

出版信息

Cont Lens Anterior Eye. 2023 Feb;46(1):101723. doi: 10.1016/j.clae.2022.101723. Epub 2022 May 31.

DOI:10.1016/j.clae.2022.101723
PMID:35654683
Abstract

BACKGROUND

To investigate whether combining 0.01% atropine with orthokeratology (AOK) has a better effect in retarding axial elongation, compared with orthokeratology alone (OK) over two years.

METHODS

A total of 96 Chinese children aged six to < 11 years with myopia (1.00 - 4.00 D, inclusive) were randomized into either the AOK or OK group in a 1:1 ratio. Axial length (the primary outcome), and secondary outcomes (e.g. pupil size and choroidal thickness) were measured at 1-month and at 6-monthly intervals after commencement of treatment.

RESULTS

Both intention-to-treat and per-protocol analyses showed significantly slower axial elongation in the AOK group than OK group over two years (P = 0.008, P < 0.001, respectively). AOK subjects had statistically slower axial elongation (adjusted mean [standard error], 0.17 [0.03] mm vs 0.34 [0.03] mm, P < 0.001), larger increase in mesopic (0.70 [0.09] mm vs 0.31 [0.09] mm, P = 0.003) and photopic pupil size (0.78 [0.07] mm vs 0.23 [0.07] mm, P < 0.001), and greater thickening of the choroid (22.6 [3.5] µm vs -9.0 [3.5] µm, P < 0.001) than OK subjects over two years. Except for a higher incidence of photophobia in the AOK group (P = 0.006), there were no differences in the incidence of any other symptom or adverse events between the two groups. Slower axial elongation was associated with a larger increase in the photopic pupil size and a greater thickening in the choroid in the AOK group.

CONCLUSIONS

Slower axial elongation following 2-year AOK treatment may result from increased pupil dilation and a thickening in the choroid observed in the AOK group.

摘要

背景

为研究与单独使用角膜塑形术(OK)相比,联合使用0.01%阿托品与角膜塑形术(AOK)在延缓两年轴向伸长方面是否具有更好的效果。

方法

总共96名6至<11岁近视(1.00 - 4.00 D,含)的中国儿童按1:1比例随机分为AOK组或OK组。在治疗开始后的1个月和每6个月测量轴向长度(主要结局)以及次要结局(如瞳孔大小和脉络膜厚度)。

结果

意向性分析和符合方案分析均显示,在两年期间,AOK组的轴向伸长明显慢于OK组(分别为P = 0.008,P < 0.001)。AOK组受试者的轴向伸长在统计学上更慢(调整后均值[标准误差],0.17[0.03]mm对0.34[0.03]mm,P < 0.001),中视(0.70[0.09]mm对0.31[0.09]mm,P = 0.003)和明视瞳孔大小增加更大(0.78[0.07]mm对0.23[0.07]mm,P < 0.001),并且在两年期间脉络膜增厚程度大于OK组受试者(22.6[3.5]µm对 - 9.0[3.5]µm,P < 0.001)。除了AOK组畏光发生率较高(P = 0.006)外,两组之间任何其他症状或不良事件的发生率没有差异。在AOK组中,较慢的轴向伸长与明视瞳孔大小的更大增加和脉络膜的更大增厚有关。

结论

AOK治疗两年后轴向伸长较慢可能是由于AOK组观察到的瞳孔扩张增加和脉络膜增厚所致。

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