In Clinical Trial, Atropine, 0.01% Eye Drops Did Not Slow Myopia Progression in School-Aged Children

In a randomized, placebo-controlled, double-masked clinical trial¹ conducted from June 2018 to September 2022, researchers found that atropine, 0.01% eye drops did not slow the progression of myopia nor axial elongation when compared with a placebo among school-aged children with low-to-moderate myopia in the United States.

According to the NIH, the onset of myopia generally occurs between 7 and 16 years of age, when developing eyes can start growing too long from front to back. Recent studies have looked to low-dose atropine eye drops as an option to slow the progression of myopia in children, with positive results found in patients primarily in East Asia.²

A total of 187 children (86 males, 101 females) participated in the study. Eligible participants were randomly assigned 2:1 to nightly administration of one 0.01% atropine eye drop in both eyes (n = 125) or one nightly drop of placebo in both eyes (n = 62). All participants had low-to-moderate bilateral myopia, meaning their refractive error ranged from -1.00 to -6.00 diopters (D) of spherical equivalent refractive error (SER). Children were recruited from 12 different community- and institution-based practices in the United States. Treatment was for 24 months followed by a 6-month observation period.

The primary outcome measure was the change in SER (mean of both eyes) from the baseline to 24 months. Other outcomes included changes in SER from baseline to 30 months (after discontinuing treatment) and changes in axial length at both time points.

At the primary outcome visit at 24 months there was no significant difference in the change in SER between the atropine and placebo groups (adjusted difference = − 0.02 D; [95% CI, − 0.19 to + 0.15 D]; p = 0.83). At 30 months (6 months after discontinuing treatment), the difference remained small and not statistically significant (adjusted difference = − 0.04 D [95% CI, − 0.25 to + 0.17 D]). Researchers found similar results, which were not statistically significant, in axial length differences.

“These results do not support use of atropine, 0.01%, eye drops to slow myopia progression or axial elongation in US children,” the authors concluded.