Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study

Hieda, Osamu; Hiraoka, Takahiro; Fujikado, Takashi; Ishiko, Satoshi; Hasebe, Shinji; Torii, Hidemasa; Takahashi, Hiroshi; Nakamura, Yo; Sotozono, Chie; Oshika, Tetsuro; Morimoto, Takeshi; Nishida, Kohji; Nishikawa, Noriko; Song, Youngseok; Tokutake, Tomoki; Nishi, Yutaro; Shigeno, Yuta; Kurihara, Toshihide; Negishi, Kazuno; Tsubota, Kazuo; Ono, Masafumi; Nakai, Takaaki; Tan, Donald; Tanaka, Shiro; Kinoshita, Shigeru

doi:10.1007/s10384-021-00822-y

Cited by 72 publications

(104 citation statements)

References 17 publications

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“…The treatment group demonstrated a 50% reduction in power progression over a year compared to progression before treatment and to a control group which was statistically significant. Another study, multicenter randomized, double-masked placebo control, confirmed the efficacy and safety of atropine 0.01% in a two-year study [27]. This Japanese study also demonstrated a statistically significant reduction of AL and SE myopic progression with atropine 0.01%.…”

Section: Plos Onementioning

confidence: 60%

Use baseline axial length measurements in myopic patients to predict the control of myopia with and without atropine 0.01%

2021

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Purpose Identifying axial length growth rate as an indicator of fast progression before initiating atropine 0.01% for myopia progression in children. Method From baseline, axial length growth over six months was measured prospectively. Subjects were then initiated on atropine 0.01% if axial length growth was greater than 0.1mm per 6 months (fast progressors), axial length and spherical equivalent change measurements recorded every six months. The rate of change was compared to the baseline pre-treatment rate. If axial length change was below the threshold, subjects received monitoring only. Results 73 subjects were identified as fast progressors and commenced atropine 0.01%, (mean baseline refraction of OD -2.9±1.6, OS -2.9±1.8 and a mean baseline axial length OD 24.62 ± 1.00 mm, OS 24.53 ± 0.99 mm). At six months, the mean paired difference of axial length growth rate was significantly reduced by 50% of baseline (all 73 subjects, p<0.05). 53 subjects followed to 12 months, and 12 to 24 months maintained a reduced growth rate. Change in mean spherical equivalent was significantly reduced compared to pre-treatment refractive error (mean paired difference p<0.05) and at each subsequent visit. 91 children were slow progressors and remained untreated. Their axial length growth rate did not change significantly out to 24 months. Spherical equivalent changed less than -0.5D annually in this group. Conclusion Identifying fast progressors before treatment initiation demonstrated a strong treatment effect with atropine 0.01% reducing their individual rate of myopia progression by 50%. Another large group of myopic children, slow progressors, continued without medical intervention. A baseline axial length growth rate is proposed as a guideline to identify fast progressors who are more likely to benefit from atropine 0.01%.

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Section: Plos Onementioning

confidence: 60%

Use baseline axial length measurements in myopic patients to predict the control of myopia with and without atropine 0.01%

2021

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“…A total of 1178 participants (0.01% atropine group, 600; control group, 578) were included. All RCTs [14,19,20,27,28] were conducted in Asian countries (Hong Kong, India, Japan, and China), while the retrospective studies [35][36][37] enrolled European or multi-ethnic participants and were performed in Italy [36] or the United States [35,37]. Among the included studies, one RCT [28] and one retrospective study [35] had follow-up data for 2 years, while the others provided 1-year follow-up data.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Although these were short-term and minimal in 0.01% atropine [14,19], it is also worthy of being investigated and compared with other concentrations of atropine in long-term use. Furthermore, the relevant evidence regarding the efficacy of 0.01% atropine compared to placebo continues to accumulate in recent years [19,20,27,28]. Thus, we conducted a rigorous quantitative and systematic summary of the evidence to increase the statistical power and elucidate the conflicting results of 0.01% atropine in childhood myopia.…”

Section: Introductionmentioning

confidence: 99%

Is 0.01% Atropine an Effective and Safe Treatment for Myopic Children? A Systemic Review and Meta-Analysis

Tsai

Chen

Wang

et al. 2021

JCM

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Several conflicting results regarding the efficacy of 0.01% atropine in slowing axial elongation remain in doubt. To solve this issue and evaluate the safety of 0.01% atropine, we conducted a systematic review and meta-analysis with the latest evidence. The review included a total of 1178 participants (myopic children). The efficacy outcomes were the mean annual progression in standardized equivalent refraction (SER) and axial length (AL). The safety outcomes included mean annual change in accommodative amplitude, photopic and mesopic pupil diameter. The results demonstrated that 0.01% atropine significantly retarded SER progression compared with the controls (weighted mean difference [WMD], 0.28 diopter (D) per year; 95% confidence interval (CI) = 0.17, 0.38; p < 0.01), and axial elongation (WMD, −0.06 mm; 95% CI = −0.09, −0.03; p < 0.01) during the 1-year period. Patients receiving 0.01% atropine showed no significant changes in accommodative amplitude (WMD, −0.45 D; 95% CI = −1.80, 0.90; p = 0.51) but showed dilated photopic pupil diameter (WMD, 0.35 mm; 95% CI = 0.02, 0.68; p = 0.04) and mesopic pupil diameter (WMD, 0.20 mm; 95% CI = 0.08, 0.32; p < 0.01). In the subgroup analysis of SER progression, myopic children with lower baseline refraction (>−3 D) and older age (>10-year-old) obtained better responses with 0.01% atropine treatment. Furthermore, the European and multi-ethnicity groups showed greater effect than the Asian groups. In conclusion, 0.01% atropine had favorable efficacy and adequate safety for childhood myopia over a 1-year period.

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“…Atropine therapy has been shown to be effective in many studies, specifically 0.01% had been acknowledged in the literature at the commencement of this study to be the preferred concentration and most potent monotherapy to decrease myopia progression [2,[6][7][8][9][10]. Additionally, it has been shown to have an advantage of exhibiting relatively low rebound effect after cessation of therapy [11].…”

Section: Discussionmentioning

confidence: 98%

Myopia Control with Combination Low-Dose Atropine and Peripheral Defocus Soft Contact Lenses: A Case Series

Erdinest

London

Levinger

et al. 2021

Case Rep Ophthalmol

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The goal of this retrospective case series is to demonstrate the effectivity of combination low-dose atropine therapy with peripheral defocus, double concentric circle design with a center distance soft contact lenses at controlling myopia progression over 1 year of treatment. Included in this series are 3 female children aged 8–10 years with progressing myopia averaging −4.37 ± 0.88 D at the beginning of treatment. Their average annual myopic progression during the 3 years prior to therapy was 1.12 ± 0.75 D. They had not attempted any myopia control treatments prior to this therapy. The children were treated with a combination of 0.01% atropine therapy with spherical peripheral defocus daily replacement soft lenses MiSight<sup>®</sup> 1 day (Cooper Vision, Phoenix, AZ, USA). They underwent cycloplegic refraction, and a slit-lamp evaluation every 6 months which confirmed no adverse reactions or staining was present. Each of the 3 children exhibited an average of 0.25 ± 0.25 D of myopia progression at the end of 1 year of treatment. To the best of the authors’ knowledge, this is the first published study exhibiting that combining low-dose atropine and peripheral defocus soft contact lenses is effective at controlling children’s moderate to severe myopia progression during 1 year of therapy.

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Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study

Cited by 72 publications

References 17 publications

Use baseline axial length measurements in myopic patients to predict the control of myopia with and without atropine 0.01%

Use baseline axial length measurements in myopic patients to predict the control of myopia with and without atropine 0.01%

Is 0.01% Atropine an Effective and Safe Treatment for Myopic Children? A Systemic Review and Meta-Analysis

Myopia Control with Combination Low-Dose Atropine and Peripheral Defocus Soft Contact Lenses: A Case Series

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