Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial.

Abstract

Importance:

Early onset of myopia is associated with high myopia later in life, and myopia is irreversible once developed.

Objective:

To evaluate the efficacy of low-concentration atropine eyedrops at 0.05% and 0.01% concentration for delaying the onset of myopia.

Design, Setting, and Participants:

This randomized, placebo-controlled, double-masked trial conducted at the Chinese University of Hong Kong Eye Centre enrolled 474 nonmyopic children aged 4 through 9 years with cycloplegic spherical equivalent between +1.00 D to 0.00 D and astigmatism less than -1.00 D. The first recruited participant started treatment on July 11, 2017, and the last participant was enrolled on June 4, 2020; the date of the final follow-up session was June 4, 2022.

Interventions:

Participants were assigned at random to the 0.05% atropine (n = 160), 0.01% atropine (n = 159), and placebo (n = 155) groups and had eyedrops applied once nightly in both eyes over 2 years.

Main Outcomes 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 fast myopic shift (spherical equivalent myopic shift of at least 1.00 D).

Results:

Of the 474 randomized patients (mean age, 6.8 years; 50% female), 353 (74.5%) completed the trial. The 2-year cumulative incidence of myopia in the 0.05% atropine, 0.01% atropine, and placebo groups were 28.4% (33/116), 45.9% (56/122), and 53.0% (61/115), respectively, and the percentages of participants with fast myopic shift at 2 years were 25.0%, 45.1%, and 53.9%. Compared with the placebo group, the 0.05% atropine group had significantly lower 2-year cumulative myopia incidence (difference, 24.6% [95% CI, 12.0%-36.4%]) and percentage of patients with fast myopic shift (difference, 28.9% [95% CI, 16.5%-40.5%]). Compared with the 0.01% atropine group, the 0.05% atropine group had significantly lower 2-year cumulative myopia incidence (difference, 17.5% [95% CI, 5.2%-29.2%]) and percentage of patients with fast myopic shift (difference, 20.1% [95% CI, 8.0%-31.6%]). The 0.01% atropine and placebo groups were not significantly different in 2-year cumulative myopia incidence or percentage of patients with fast myopic shift. 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 12.2% in the placebo group in the second year.

Conclusions and Relevance:

Among children aged 4 to 9 years without myopia, nightly use of 0.05% atropine eyedrops compared with placebo resulted in a significantly lower incidence of myopia and lower percentage of participants with fast myopic shift at 2 years. There was no significant difference between 0.01% atropine and placebo. Further research is needed to replicate the findings, to understand whether this represents a delay or prevention of myopia, and to assess longer-term safety.

Trial Registration:

Chinese Clinical Trial Registry: ChiCTR-IPR-15006883.

• Authors: Jason C Yam, Xiu Juan Zhang, Yuzhou Zhang, Benjamin H K Yip, Fangyao Tang, Emily S Wong, Christine H T Bui, Ka Wai Kam, Mandy P H Ng, Simon T Ko, Wilson W K Yip, Alvin L Young, Clement C Tham, Li Jia Chen, Chi Pui Pang
• Journal: JAMA (JAMA) Vol. 329 Issue 6 Pg. 472-481 (02 14 2023) ISSN: 1538-3598 [Electronic] United States
• PMID: 36786791 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Atropine
• Mydriatics
• Ophthalmic Solutions

Topics

• Child
• Female
• Humans
• Male
• Atropine (administration & dosage, adverse effects, therapeutic use)
• Disease Progression
• Incidence
• Mydriatics (adverse effects)
• Myopia (diagnosis, prevention & control)
• Ophthalmic Solutions (administration & dosage, adverse effects, therapeutic use)
• Refraction, Ocular
• Age of Onset
• Double-Blind Method
• Child, Preschool