Low-dose atropine drops, 0.01%, ineffective in stopping myopia progression in children

The study's authors also recommended optical and environmental approaches to reduce myopia progression. Image credit: InsideCreativeHouse – stock.adobe.com

The use of low-dose atropine 0.01% to slow the progression of myopia in children is not supported by a recent randomised clinical trial study (ClinicalTrials.gov Identifier: NCT03334253).¹

This finding is in contrast to the results of a trial conducted in East Asia that reported atropine’s effectiveness in children,² according to Michael X. Repka, MD, MBA, lead study author from the Wilmer Eye Institute, Baltimore.

While high-dose atropine, 1%, seemed to slow progression of myopia, there were too many substantial side effects, such as persistent ocular dilation, light sensitivity and inability to see at near, to support its use.

He and his colleagues conducted a 2-year randomised placebo-controlled, double-masked, clinical trial from June 2018 to September 2022. The study included 5- to 12-year-old children recruited from 12 community- and institution-based practices in the US. All children had low to moderate myopia in both eyes, ie, −1.00 diopters [D] to −6.00 D spherical equivalent refractive (SER) error.

The children were randomised 2:1 to receive 1 eye drop of atropine, 0.01%, nightly or 1 drop of placebo. Treatment continued for 24 months followed by 6 months of observation. The primary outcome was the change in SER, ie, the mean of both eyes, from baseline to 24 months in treated children. Other outcomes included the change in the SER from baseline to 30 months in children not treated and the change in the axial length at both time points.

Myopia results

The study included 187 children (mean age, 10.1 years; range, 5.1-12.9 years) from diverse ethnic groups; 54% were female.

Two-thirds of participants (125 children) received atropine 0.01%, and 62 children (33%) received placebo; 95% of the actively treated children (n=119) completed follow-up at 24 months and 94% of the placebo group (n=62 children) did so. At 30 months, the completed follow-up data were similar: 118 of 125 children (94%) in the atropine group and 57 of 62 children (92%) in the placebo group.

The authors reported that at the 24-month primary outcome visit, the respective adjusted mean (95% confidence interval [CI]) changes from baseline in the SER from baseline were −0.82 D (−0.96 to −0.68) and −0.80 D (−0.98 to −0.62) D in the atropine and placebo groups, for a nonsignificant adjusted difference of −0.02 D (95% CI, −0.19 to +0.15 D; P =0 .83). At 30 months when the patients had not been treated for 6 months, the adjusted difference in the mean SER change from baseline was −0.04 D (95% CI, −0.25 to +0.17 D).

The adjusted mean (95% CI) changes in the axial length from baseline to 24 months were 0.44 mm (0.39-0.50) and 0.45 mm (0.37-0.52) mm in the atropine and placebo groups, respectively, for an adjusted difference of −0.002 mm (95% CI, −0.106 to 0.102 mm). The adjusted difference in the mean axial elongation from baseline to 30 months was +0.009 mm (95% CI, −0.115 to 0.134 mm).

The authors concluded that these results did not support use of low-dose atropine, 0.01%, eye drops to slow myopia progression or axial elongation in US children and suggested that future studies of myopia control should test stronger concentrations of atropine or optical and environmental approaches to reduce myopia progression, which may reduce the risk of adult myopic macular degeneration and retinal detachment.

References

1. Repka MX, Weise KK, Chandler DL, et al. for the Pediatric Eye Disease Investigator Group. Low-dose 0.01% atropine eye drops vs placebo for myopia control: a randomised clinical trial. JAMA Ophthalmol. Published online July 13, 2023; doi:10.1001/jamaophthalmol.2023.2855

2. Chia A, Lu QS, Tan D. Five-year clinical trial on atropine for the treatment of myopia 2: myopia control with atropine 0.01% eyedrops. Ophthalmology. 2016;123:391-399. doi:10.1016/j.ophtha.2015.07.004