Very low-dose atropine of 0.005% and 0.01% each reduce the progression of myopia in children, while doses of 0.0025% do not, according to a study published in the Asia-Pacific Journal of Ophthalmology. The research shows that all of these atropine doses were safe and well tolerated.
In the randomized, double-blind multicenter phase II APPLE study (ClinicalTrials.gov Identifier: NCT03329638), researchers compared the safety and efficacy of very low-dose atropine (0.0025%, 0.005%, and 0.01%) with a placebo in 99 children (age range, 6-11 years; 52 girls, 47 boys; 88 were ethnic Chinese) with mild-to-moderate myopia.
The researchers found that the mean±SD changes in spherical equivalent (SE) from baseline to 1 year in the placebo and atropine 0.0025%, 0.005%, and 0.01% groups were −0.55±0.471, −0.55±0.337, −0.33±0.473, and −0.39±0.519 D, respectively.
They found that the least squares mean differences (atropine−placebo) in the atropine 0.0025%, 0.005%, and 0.01% groups were 0.11 D (P =.246), 0.23 D (P =.009), and 0.25 D (P =.006), respectively.
The mean change in axial length (AL) was significantly higher for atropine 0.005% (−0.09 mm, P =.012) and 0.01% (−0.10 mm, P =.003) compared with placebo.
There were no significant changes in near visual acuity among any of the treatment groups and changes in mean pupil size and amplitude of accommodation were minimal, according to the report.
No serious adverse events (hospitalizations/deaths) were reported. The most frequent adverse events were pruritus and blurred vision, each occurring in 4 (5.5%) children treated with atropine.
Subgroup analysis revealed that younger children experienced greater myopia progression than older children. The report explains that previous research also shows that older children have a better response to atropine compared with younger children.
“The use of atropine eye drops to control myopia requires a balance between efficacy and safety. Ideally, a minimal dose should be administered to achieve the desired effect,” according to the researchers. “The present study found that, although doses ≤ 0.0025% were not effective, atropine doses of 0.005% and 0.01% were effective in slowing myopia, as well as being safe and well tolerated.”
The report is the first to present findings from a randomized study into the efficacy of very low-dose atropine in slowing myopia progression in children. Limitations include the relatively small sample size in each treatment group, the relatively short follow-up period (12 months), failure to investigate outcomes after study drug discontinuation, and failure to consider differences in lifestyle or family history of myopia.
Chia A, Ngo C, Choudry N, Yamakawa Y, Tan D. Atropine ophthalmic solution to reduce myopia progression in pediatric subjects: the randomized, double-blind multicenter phase II APPLE study. Asia Pac J Ophthalmol. Published online May 10, 2023. doi:10.1097/APO.0000000000000609