Atropine Drops for Kids’ Myopia Fail to Boost Long-Term Visual Outcomes

The short-term use of atropine eye drops to treat myopia in children did not affect long-term visual outcomes, the prospective observational ATLAS study of participants from two randomized trials showed.

The mean spherical equivalent (SE) and axial length (AL) in those who received atropine 1.0% in the ATOM1 trial were similar to those who received placebo, with a difference in SE of 0.80 D (95% CI -0.25 to 1.85 D, P=0.13) and a difference in AL of -0.03 mm (95% CI -0.65 to 0.58 mm, P=0.92), reported Marcus Ang, PhD, of Singapore Eye Research Institute at Singapore National Eye Centre, and colleagues.

Among patients from the ATOM2 trial, the mean SE and AL were similar in the 0.01%, 0.1%, and 0.5% atropine groups, at -6.40 D and 26.25 mm, -6.81 D and 26.28 mm, and -7.19 D and 26.31 mm, respectively, they noted in JAMA Ophthalmology.

There were no differences in the 20-year incidence of cataract/lens opacities, myopic macular degeneration, or parapapillary atrophy when comparing the group treated with 1% atropine versus the placebo group. However, rates of myopic macular degeneration were higher in the ATOM2 groups who received higher doses of atropine: 19.6%, 28.7%, and 38.1% in the 0.01%, 0.1%, and 0.5% atropine groups, respectively.

“The ATLAS results remind us that there is uncertainty regarding the long-term value and safety of atropine eye drops for myopia control,” wrote Michael X. Repka, MD, MBA, of Johns Hopkins University School of Medicine in Baltimore, in an accompanying commentary. “These findings highlight the need for randomized clinical studies to define effective and safe myopia control strategies early in myopia development but also include methods to obtain the critical long-term studies of refractive error outcomes.”

Ang told MedPage Today that in recent decades, “several clinical trials have showed that topical administration of atropine eye drops is a safe and effective intervention in slowing the onset of myopia and reducing myopia progression in children in Asia. Atropine eye drops are commonly used in Asia, including in Singapore, where the prevalence of childhood myopia is amongst the highest in the world.”

“There might be potential benefits other than the final refractive errors. We are currently analyzing the ocular imaging data of these participants, to investigate the potential benefits of atropine treatment on the retina, choroid, and optic nerve head, etc.,” he added.

The ATLAS study evaluated two groups of patients: 71 of 400 in the ATOM1 trial (atropine 1% vs placebo, 1999-2003) and 158 of 400 in the ATOM2 trial (atropine 0.01% vs 0.1% vs 0.5%; 2006-2012).

ATOM1 was a single-center, randomized, double-masked, placebo-controlled trial of children ages 6 to 12 with an SE ranging from -1.0 to -6.0 D and an astigmatism of -1.5 D or less. In the primary analysis, kids treated with atropine had higher rates of myopia progression compared with those treated with placebo. However, absolute myopia progression after 3 years was significantly lower in the atropine group compared with the placebo group.

ATOM2 included children ages 6 to 12 with myopia of at least -2.0 D and an astigmatism of -1.50 D or less. Initial results showed that atropine 0.01% had comparable efficacy in controlling myopia progression compared with atropine 0.1% and 0.5%, and had fewer side effects.

Participants in ATLAS were 21 to 34 when they were re-analyzed. In the 63 patients in the ATOM1 follow-up group, mean age was 30.5, and 40.6% were women. For the 148 in the ATOM2 follow-up group, mean age was 24.5, and 42.9% were women.

As for limitations, Ang said “it is possible that the participants with adverse effects were less likely to return for follow-up. Longer-term follow-up of these participants is required, as age is an important risk factor for myopia-related complications.”

For now, he added, “future clinical trials are required to investigate the optimal duration and concentration of atropine treatment needed to produce a sustained effect on myopia progression and reduction of myopia-related complications in adulthood: when treatment can be stopped and whether tapering dosage or continuing treatment into the mid-teens is required.”

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