Atropine 0.01% did not prevent the onset of myopia in young children with premyopia and low myopia.In the ATOM*3 trial, atropine 0.01% did not prevent the onset of myopia in young children with premyopia (SE** +1.00 to −0.49 dioptres [D]) and low myopia (SE −0.50 to −1.50 D), but there was a trend towards less progression with atropine.
“Although there were no significant differences in myopia progression between the atropine and placebo groups, there were trends towards less myopic shift in atropine-treated premyopic eyes that remained emmetropic, and in low-myopic eyes,” said the investigators, led by Dr Audrey Chia from the Singapore National Eye Centre.
Children with premyopia (n=156; mean age 6.8 years, mean baseline SE +0.5 D) or low myopia (n=52; mean age 7.6 years, mean baseline SE –1.00 D), with at least one parent with myopia of >3 D in one eye, were randomized 1:1 to placebo or atropine 0.01% eyedrops for 2 years. Approximately 90 percent of participants were Chinese. All study processes were conducted at the Singapore Eye Research Institute. [Br J Ophthalmol 2026;110:356-362]
In the premyopia group, there were trends towards less progression with atropine than with placebo at all timepoints (6, 12, 18, and 24 months), but these were not significant except for the change in SE at 6 months (–0.19 vs –0.06 D; p=0.021).
In the low myopia group, there were significant changes in SE at 6 (−0.63 vs −0.35 D; p=0.011), 12 (−1.01 vs −0.60 D; p=0.008), and 18 months (−1.38 vs −0.99 D; p=0.037), and in axial length (AL) at 12 months (0.53 vs 0.39 mm; p=0.015) with atropine vs placebo. Sensitivity analyses showed significant differences in SE (−1.83 vs −1.40 D; p=0.012) and AL (0.92 vs 0.75 mm; p=0.005) between the atropine and placebo groups at 24 months.
Incident myopia
At 24 months, the atropine and placebo groups had similar rates of incident myopia (44.8 percent and 43.6 percent; p=0.896). The overall rate of incident myopia was 48.8 percent in children aged 5–6 years and 38.4 percent in children aged 7–9 years.
In premyopic children who remained emmetropic, progression was smaller with atropine vs placebo at 24 months (SE: −0.29 vs 0.41 D; p=0.007; AL: 0.41 vs 0.49 mm; p=0.209). A similar pattern was seen in the incident myopia subgroup (SE: −1.63 vs −1.78 D; p=0.121; AL: 0.96 vs 1.08 mm; p=0.010).
Adverse effects
There was no reduction in distance or near visual acuity in either group. Pupil size was larger (0.5–0.7 mm), but there was no loss of accommodation. Approximately 3 percent of children reported photophobia. Six percent of children had an allergy, but most were mild and did not require study withdrawal. Of the 15 children who required hospitalization, nine did so for viral/bacterial infections and two for limb fractures, but none were associated with the study drugs.
High myopia rates in SG
Children with early-onset myopia are at greater risk of developing high myopia later in life. [Ophthalmic Physiol Opt 2016;36:388-394] In Singapore, the rates of myopia have jumped from 30 percent among those born in the 1930–40s to 80 percent among those born after the 1980s. [Ann Acad Med Singap 2017;46:229-236]
Atropine eyedrops, myopia-control glasses, and contact lenses are effective interventions to slow myopia progression, but it remains unclear whether they can be used for myopia prevention. [Invest Ophthalmol Vis Sci 2019;60:M106-M131; Invest Ophthalmol Vis Sci 2021;62:6]
“[If] the purpose of intervention is to prevent myopia, it is important to balance the risks of unnecessary treatment, early-onset myopia, and eventual high myopia, treatment duration, and treatment side effects,” they explained.
“[In] the treatment of myopic children with progressive myopia, it may be necessary to assess myopia risk, monitor cycloplegic SE and AL, choose a dose to start depending on risk profile, and individually tailor dose and duration of treatment to achieve the most effective and safe outcome over time,” they added.