Abstract
Purpose: To evaluate the efficacy and safety of atropine for slowing myopia progression and to investigate whether the treatment effect remains constant with continuing treatment.Method: Studies were retrieved from MEDLINE, EMBASE, and the Cochrane Library from their inception to May 2021, and the language was limited to English. Randomized controlled trials (RCTs) and cohort studies involving atropine in at least one intervention and placebo/non-atropine treatment in another as the control were included and subgroup analysis based on low dose (0.01%), moderate dose (0.01%–<0.5%), and high dose (0.5–1.0%) were conducted. The Cochrane Collaboration and Newcastle-Ottawa Scale were used to evaluate the quality of RCTs and cohort studies, respectively.Results: Twelve RCTs and fifteen cohort studies involving 5,069 children aged 5 to 15 years were included. The weighted mean differences in myopia progression between the atropine and control groups were 0.73 diopters (D), 0.67 D, and 0.35 D per year for high-dose, moderate-dose, and low-dose atropine, respectively (χ2 = 13.76; P = 0.001, I2 = 85.5%). After removing studies that provided extreme findings, atropine demonstrated a significant dose-dependent effect on both refractive change and axial elongation, with higher dosages of atropine resulting in less myopia progression (r = 0.85; P = 0.004) and less axial elongation (r = −0.94; P = 0.005). Low-dose atropine showed less myopia progression (−0.23 D; P = 0.005) and less axial elongation (0.09 mm, P < 0.001) in the second year than in the first year, whereas in high-dose atropine more axial elongation (−0.15 mm, P = 0.003) was observed. The higher dose of atropine was associated with a higher incidence of adverse effects, such as photophobia with an odds ratio (OR) of 163.57, compared with an OR of 6.04 for low-dose atropine and 8.63 for moderate-dose atropine (P = 0.03).Conclusion: Both the efficacy and adverse effects of atropine are dose-dependent in slowing myopia progression in children. The efficacy of high-dose atropine was reduced after the first year of treatment, whereas low-dose atropine had better efficacy in a longer follow-up period.
Highlights
Myopia has emerged as a serious public health issue with a rapidly increasing prevalence worldwide [1, 2], especially in some Asian areas [3–6]
The total sample size of participants included in our study was 5,069, among which 3,024 were received atropine treatment and 2,045 participants were received placebo or non-atropine treatment, with a follow-up period from 12 to 144 months
All randomized clinical trials (RCTs) were conducted in Asia, among which Wei et al [16] provided the first placebo-controlled RCT data for low-dose atropine in mainland China
Summary
Myopia has emerged as a serious public health issue with a rapidly increasing prevalence worldwide [1, 2], especially in some Asian areas [3–6]. The treatment with different doses of topical atropine has been recognized as currently one of the most effective treatments for myopia [11], and has been applied to more than 60% of children with myopia in Taiwan [12]. It is still pending approval by the FDA and has remained an off-label treatment in mainland China and most of the western countries since high doses (0.5–1%) of atropine have inevitable ocular side effects, such as cycloplegia, photophobia, allergic reaction, blurred near vision, and accelerated progression on cessation (rebound effect) [13, 14]. Moderate doses (0.01–0.5%) and low doses of atropine (0.01%) have been widely applied in clinical treatment for children with myopia in recent years
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