Key points Does the use of low-concentration atropine eye drops affect the incidence of myopia in children? Findings In this randomized clinical trial that included 474 children aged 4 to 9 years without myopia, nocturnal use of atropine 0.05%, atropine 0.01%, and placebo eye drops resulted in a cumulative incidence of myopia at 2 years of 28.4%, 45.9% and 53.0%, respectively. The difference between atropine 0.05% and placebo was statistically significant. Meaning Although atropine 0.05% eye drops resulted in a significantly lower incidence of myopia at 2 years compared to placebo, more research is needed to replicate the findings and understand whether this represents a delay or prevention. of myopia. Importance Early onset of myopia is associated with high myopia later in life, and myopia is irreversible once it develops. |
Myopia is a global public health threat with increasing prevalence in many regions in recent decades, especially in East Asia . People with myopia have excessive elongation of the eyeball and an increased risk of sight-threatening complications that lead to poor vision and even blindness. Myopia is irreversible once it has developed, and the earlier it occurs, the greater the likelihood that high myopia (spherical equivalent indicates more myopia than -6.00 D) will occur later in life. Preventing or delaying the onset of myopia may have the potential to improve long-term visual outcomes.
Lifestyle modifications , such as increasing time spent in outdoor activities, can delay the onset of myopia. A randomized trial in China found that increasing outdoor class time by 40 minutes daily reduced the 3-year cumulative incidence of myopia from 39.5% to 30.4% in first grade children. Although encouraging children to spend more time outdoors is a practical and generalizable approach, additional strategies are warranted, especially for children at high risk of developing myopia.
Low-concentration atropine eye drops are effective in reducing myopia progression, have been widely adopted in Asia, and are being further evaluated in randomized trials in many countries. Low concentration atropine (0.01%-0.05%) may reduce myopia progression, but studies of 0.01% atropine have produced inconsistent results. It should be noted that it is still unknown whether atropine treatment is effective in delaying the onset of myopia. A retrospective study suggested that low concentration atropine should be useful in delaying the onset of myopia. However, randomized trials are needed to provide solid evidence on efficacy and safety. The Low Concentration Atropine for the Prevention of Myopia (LAMP2) trial was conducted to evaluate the effectiveness of low concentration atropine in delaying the onset of myopia in children.
Aim
To evaluate the effectiveness of low concentration atropine eye drops at 0.05% and 0.01% in delaying the onset of myopia.
Design, environment and participants
This randomized, placebo-controlled, double-blind trial conducted at the Eye Center of the Chinese University of Hong Kong enrolled 474 non-myopic children aged 4 to 9 years with cycloplegic spherical equivalent between +1.00 D and 0.00 D and astigmatism less than -1.00 D. The first recruited participant began treatment on July 11, 2017, and the last participant enrolled on June 4, 2020; The date of the last monitoring session was June 4, 2022.
Interventions
Participants were randomly assigned to the 0.05% atropine (n = 160), 0.01% atropine (n = 159), and placebo (n = 155) groups and were given eye drops once. at night in both eyes for 2 years.
Main results and measures
The primary outcomes were the 2-year cumulative incidence rate of myopia (cycloplegic spherical equivalent of at least −0.50 D in either eye) and the percentage of participants with rapid change in myopia (spherical equivalent myopic change of at least −0.50 D in either eye). minus 1.00 D).
Results
Of the 474 randomized patients (mean age, 6.8 years; 50% women), 353 (74.5%) completed the trial. The 2-year cumulative incidence of myopia in the atropine 0.05%, atropine 0.01%, and placebo groups was 28.4% (33/116), 45.9% (56/122), and 53.0% (61/115), respectively, and the percentages of participants with rapid myopic change at 2 years were 25.0%, 45.1%, and 53.9%.
Compared with the placebo group, the 0.05% atropine group had a significantly lower 2-year cumulative myopia incidence (difference, 24.6% [95% CI, 12.0%-36.4 %]) and a percentage of patients with rapid change in myopia (difference, 28.9% [95% CI, 16.5%-40.5%]).
Compared with the 0.01% atropine group, the 0.05% atropine group had a significantly lower 2-year cumulative myopia incidence (difference, 17.5% [95% CI, 5.2 %-29.2%]) and a percentage of patients with rapid change in myopia (difference, 20 1% [95% CI, 8.0%-31.6%]).
The atropine 0.01% and placebo groups were not significantly different in the 2-year cumulative incidence of myopia or the percentage of patients with rapid change in myopia.
Photophobia was the most common adverse event and was reported by 12.9% of participants in the 0.05% atropine group, 18.9% in the 0.01% atropine group, and 12.9% in the 0.01% atropine group . 2% in the placebo group in the second year.
Conclusions Among children aged 4 to 9 years without myopia , randomization to nighttime use of 0.05% atropine eye drops compared to placebo resulted in a significantly lower incidence of myopia and a lower percentage of participants with rapid change in myopia. at 2 years; there was no significant difference between atropine 0.01% and placebo. More research is needed to replicate the findings, to understand whether this represents a delay or prevention of myopia, and to evaluate long-term safety. |
Trial Registry Chinese Clinical Trial Registry: ChiCTR-IPR-15006883
