Low-Dose Atropine for Myopia in China

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In the first year of a two-year study, a once-nightly dose of atropine 0.01% eyedrops slowed the progres­sion of myopia and axial elongation in Chinese children with low and moder­ate myopia.¹ However, given a relatively high rate of loss to follow-up (nearly 30%), additional research is necessary, the researchers cautioned.

PREVALENCE. In China, the prevalence of myopia reaches 5.25% of children by age 6 and exceeds 80% among university students.

First in China. This is the first ran­domized, double-masked, placebo-controlled trial of low-dose atropine in mainland China.

Researchers at Beijing Tongren Hos­pital enrolled 220 children (age range, 6-12 years) with myopia of –1.00 D to –6.00 D in both eyes. The children were randomized in a 1:1 ratio to receive ei­ther 0.01% atropine eyedrops or place­bo once each night in both eyes for one year. Refraction and axial length were measured at baseline and at six and 12 months. At the beginning of the second year, the groups were crossed over.

At baseline, mean refractive error was –2.58 D and axial length was 24.59 mm. At one year, myopia progression in the atropine group had declined by a mean of 0.26 D (34.2% reduction) and axial elongation declined by 0.09 mm (22.0%) compared with placebo. No serious adverse events occurred.

Respectable but weak. Ningli Wang, MD, PhD, and his coauthors noted that a 34.2% difference in myopia between atropine and placebo groups was smaller than that observed in a European study.²

In an accompanying commentary, Michael X. Repka, MD, MBA, called the 34% reduction “respectable,” but he noted that the results were less than the 50% reduction hoped for.³ “The best concentration of low-dose atropine eyedrops remains to be determined, but this study suggests to me that a stronger formulation should be considered for a more substantial effect,” said Dr. Repka, at Wilmer Eye Institute in Baltimore.

Dr. Wang agreed. “A reasonable strategy may be to treat initially with atropine 0.01%, then change to a high­er concentration if myopia progression continues.”

Dr. Repka also questioned the study’s crossover design, which eliminates the ability to detect multiyear evidence of effectiveness in treating a progressive condition. Dr. Wang, who designed the study, hoped the crossover data might reveal a rebound of myopia after cessa­tion of eyedrops.

Going forward. Trial results from Europe and North America are not ex­pected for at least two years, Dr. Repka said. For now, he advises families inter­ested in atropine treatment to expect to treat for at least two years, with three or four years more likely to achieve a meaningful reduction in myopia progression. He also noted that, in the United States, low-dose atropine is pre­scribed off-label, requires compounding by a pharmacy, and is not covered by insurance.

—Miriam Karmel

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1 Wei S et al. JAMA Ophthalmol. Published online Oct. 1, 2020.

2 Sacchi M et al. Acta Ophthalmol. 2019;97(8):e1136-e1140.

3 Repka MX. JAMA Ophthalmol. Published online Oct. 1, 2020.

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Relevant financial disclosures—Dr. Repka: NEI: S; Dr. Wang: None.

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