0.01% Atropine Eye Drops Fail to Slow Myopia Progression in US Children

Low-dose 0.01% atropine eye drops may not slow myopia progression or axial elongation in US children despite their proven efficacy for slowing myopia progression in children in East Asia, according to a study published in JAMA Ophthalmology. 

Researchers randomly assigned 187 children (mean age, 10.1 years; 54% girls) to treatment with 0.01% atropine (n=125) or placebo (n=62) in a randomized, placebo-controlled, double-masked, clinical trial (ClinicalTrials.gov Identifier: NCT03334253) conducted between June 2018 and September 2022. 

Study participants had low to moderate bilateral myopia (−1.00 diopters [D] to −6.00 D spherical equivalent refractive error [SER]) and received treatment for 24 months, followed by 6 months of observation. 

At 24 months, 119 of 125 children (95%) in the 0.01% atropine eye drop group and 58 of 62 children (94%) in the placebo group completed 24 months of follow up. At 30 months, 118 of 125 children (94%) in the 0.01% atropine eye drop group and 57 of 62 children (92%) in the placebo group completed follow up.

At the 24-month follow-up visit, the adjusted mean change in SER from baseline was −0.82 (95% CI, −0.96 to −0.68) D and −0.80 (95% CI, −0.98 to −0.62) D in the 0.01% atropine eye drop and placebo groups, respectively (adjusted difference = −0.02 D; 95% CI, −0.19 -0.15 D; P =.83). 

At a 30-month follow-up visit performed 6 months after treatment ended, the adjusted difference in mean SER change from baseline was −0.04 D (95% CI, −0.25 to +0.17 D) between the atropine and placebo groups.  

The adjusted mean changes in axial length from baseline to 24 months were 0.44 (95% CI, 0.39-0.50) mm and 0.45 (95% CI, 0.37-0.52) mm in the 0.01% atropine eye drop and placebo groups, respectively (adjusted difference, −0.002 mm; 95% CI, −0.106-0.102 mm), and the adjusted difference in mean axial elongation from baseline to 30 months was +0.009 mm (95% CI, −0.115-0.134 mm).

The study authors suggest that race may play a role in the efficacy of 0.01% atropine treatment.

“[T]he study populations differed in race and ethnicity, and there may be racial differences in response to atropine eye drops,” the researchers explain. “We enrolled fewer Asian children, whose myopia progresses more quickly, and we included Black children, whose myopia progresses less quickly, compared with other races. It is possible that a different atropine concentration is needed for US children to experience a benefit.”

Study limitations include a lack of an objective measure of 0.01% atropine eye drop usage. 

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.