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0.02%和0.01%阿托品对散光的影响:一项为期两年的临床试验。

Effect of 0.02% and 0.01% atropine on astigmatism: a two-year clinical trial.

机构信息

The First Affiliated Hospital of Zhengzhou University, No. 1 Jianshe road, Zhengzhou, 450000, China.

The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China.

出版信息

BMC Ophthalmol. 2022 Apr 7;22(1):161. doi: 10.1186/s12886-022-02385-z.

Abstract

BACKGROUND

To evaluate the effects of 0.02% and 0.01% atropine eye drops on ocular and corneal astigmatism over 2 years.

METHODS

A prospective clinic-controlled trail. The cohort study assessed 400 myopic children and divided them into three groups: 138 and 142 children were randomized to use either 0.02% or 0.01% atropine eye drops, respectively. They wore single-vision (SV) spectacles, with one drop of atropine applied to both eyes once nightly. Control children (n = 120) only wore SV spectacles. Spherical equivalent refractive errors (SER) and corneal curvature were measured every 4 months. The SER and corneal curvature were assessed by cycloplegic autorefraction and IOLMaster. Ocular and corneal astigmatism were calculated by Thibos vector analysis and then split into its power vector components, J0 (with-the-rule astigmatism) and J45 (oblique).

RESULTS

After 2 years, the ocular astigmatism increased by -0.38 ± 0.29 D, -0.47 ± 0.38 D, -0.41 ± 0.35 D in the 0.02%, 0.01% atropine groups and control group, respectively (p = 0.15). The corresponding corneal astigmatism increased by -0.20 ± 0.34 D, -0.28 ± 0.35 D and -0.26 ± 0.26 D (p = 0.18). The ocular astigmatism J0 increased by 0.19 ± 0.28 D, 0.22 ± 0.36 D, 0.18 ± 0.31 D in the 0.02% atropine, 0.01% atropine and control groups, respectively (p = 0.65). The corresponding corneal astigmatism J0 increased by -0.05 ± 0.34 D, -0.11 ± 0.37 D and -0.13 ± 0.30 D (p = 0.23). There was a small but significant increase in ocular astigmatism (including J0) (all P < 0.05), but there were no changes in the ocular astigmatism J45 and corneal astigmatism (including J0 and J45) in the three groups over time (all p > 0.05). However, there were no significant differences in the changes in ocular astigmatism (including J0) among the three groups.

CONCLUSIONS

Treatment with 0.02% and 0.01% atropine had no clinically significant effect on ocular and corneal astigmatism over 2 years.

TRIAL REGISTRATION

The First Affiliated Hospital of Zhengzhou University, ChiCTR-IPD-16008844 . Registered 14/07/2016.

摘要

背景

评估 0.02%和 0.01%阿托品滴眼液对 2 年内眼和角膜散光的影响。

方法

一项前瞻性临床对照试验。该队列研究评估了 400 名近视儿童,并将他们分为三组:138 名和 142 名儿童分别随机使用 0.02%或 0.01%阿托品滴眼液,每晚每只眼滴一滴。对照组儿童(n=120)仅佩戴单视(SV)眼镜。每 4 个月测量一次等效球镜(SER)和角膜曲率。通过睫状肌麻痹自动折射仪和 IOLMaster 评估 SER 和角膜曲率。通过 Thibos 向量分析计算眼散光和角膜散光,并将其分为其功率向量分量 J0(顺规散光)和 J45(斜规散光)。

结果

2 年后,0.02%、0.01%阿托品组和对照组的眼散光分别增加了-0.38±0.29D、-0.47±0.38D、-0.41±0.35D(p=0.15)。相应的角膜散光分别增加了-0.20±0.34D、-0.28±0.35D 和-0.26±0.26D(p=0.18)。0.02%阿托品组、0.01%阿托品组和对照组的眼散光 J0 分别增加了 0.19±0.28D、0.22±0.36D、0.18±0.31D(p=0.65)。相应的角膜散光 J0 分别增加了-0.05±0.34D、-0.11±0.37D 和-0.13±0.30D(p=0.23)。眼散光(包括 J0)有较小但有统计学意义的增加(均 P<0.05),但三组的眼散光 J45 和角膜散光(包括 J0 和 J45)在随访期间无变化(均 P>0.05)。然而,三组之间眼散光(包括 J0)的变化无显著差异。

结论

2 年内,使用 0.02%和 0.01%阿托品滴眼液对眼和角膜散光没有临床显著影响。

试验注册

郑州大学第一附属医院,ChiCTR-IPD-16008844。注册于 2016 年 7 月 14 日。

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