A nightly use of 0.05% atropine eyedrops resulted in a lower incidence of myopia compared with placebo.
Reduced incidence of myopia and myopic shift after 2 years of follow-up was seen in patients who received 0.05% atropine eyedrops nightly compared with patients who received 0.01% atropine eyedrops and placebo, according to a study published in JAMA.
Individuals with myopia have higher risks of sight-threatening complications, as the disease leads to excessive globe elongation, which could lead to poor vision or blindness. Lifestyle modifications can delay onset of myopia, and low-concentration atropine eyedrops have been found to reduce myopia progression. This study aimed to assess how effective low-concentration atropine was in delaying myopia onset in children.
The randomized, placebo-controlled, double-masked trial was conducted at the Chinese University of Hong Kong Eye Centre from July 11, 2017, to June 4, 2022. Children aged 4 to 9 years who did not have diagnosed myopia were recruited. Ocular diseases, history of atropine or pirenzepine use for myopia, use of orthokeratology lenses for myopia, presence of allergies to atropine, or presence of systemic diseases and developmental anomalies meant exclusion from the study.
All participants were randomized into 8 strata defined by age, sex, and mean spherical equivalent in both eyes. All medications were packaged into identical bottles and randomization groups were only revealed 2 years after the preliminary analyses were completed.
The 3 treatments participants received were 0.05% atropine sulfate at 0.05% concentration (n = 116), atropine sulfate at 0.01% concentration (n = 122), and 0.9% sodium chloride placebo (n = 115). All participants received 1 of these treatments nightly in both of their eyes. Participants had follow-ups at 2 weeks and 4, 8, 12, 16, 20, and 24 months after baseline. The primary outcome of the study was the cumulative incidence of myopia and percentage of participants with myopic shift.
Cumulative incidence rates of myopia were 28.4% in the 0.05% atropine group, 45.9% in the 0.01% atropine group, and 53.0% in the placebo group. Fast myopic shift was found in 25.0%, 45.1%, and 53.9%, respectively, at 2 years after baseline.
The 0.05% atropine treatment was able to significantly reduce the cumulative incidence of myopia (difference, 24.6%; 95% CI, 12.0%-36.4%) and the percentage of participants with a fast myopic shift (difference, 28.9%; 95% CI, 16.5%-40.5%) 2 years after baseline vs placebo. The 0.05% atropine treatment was also found to significantly reduce cumulative myopia incidence (difference, 17.5%; 95% CI, 5.2%-29.2%) and percentage of participants with fast myopic shift (difference, 20.1%; 95% CI, 8.0%-31.6%) vs the 0.01% atropine treatment. No significant difference was found between the placebo and the 0.01% atropine treatment.
Myopic shifts after 2 years were found to be –0.46 D (95% CI, –0.58 to –0.33) in the 0.05% atropine group, –0.84 D (95% CI, –0.98 to –0.70) in the 0.01% atropine group, and –1.01 D (95% CI, –1.15 to –0.87) in the placebo group. Mean axial length elongations were 0.48 mm (95% CI, 0.42-0.53), 0.63 mm (95% CI, 0.57-0.70), and 0.70 mm (95% CI, 0.64-0.76), respectively.
There were some limitations to this study. Potential for unmasking participants existed due to the atropine-induced mydriasis and cycloplegia, and treatment masking success was not assessed. The study population was homogeneous in ethnicity, and generalizability may be limited as a result. There was a high dropout rate, which may have led to bias, and the sample size may have lacked statistical power for exploratory and secondary outcomes.
The researchers concluded that the nightly use of 0.05% atropine eyedrops was able to significantly lower the incidence of myopia and myopic shift 2 years after baseline when compared with 0.01% atropine eyedrops and placebo.
Yam JC, Zhang XJ, Zhang Y, et al. Effect of low-concentration atropine eyedrops vs placebo on myopia incidence in children: the LAMP2 randomized clinical trial. JAMA. 2023;329(6):472-481. doi:10.1001/jama.2022.24162