Researchers from the Chinese University of Hong Kong (CUHK) have conducted the world’s first study to show that nightly use of low-concentration (0.05 percent) atropine eye drops may reduce the incidence of myopia in high-risk children.
The randomized, double-masked, placebo-controlled LAMP2 study investigated the efficacy and safety of low-concentration atropine eye drops among high-risk children aged 4–9 years without myopia (cycloplegic spherical equivalent [SE], 0.00 to +1.00 diopter [D]; astigmatism, <-1.00 D; anisometropia, <2.00 D) who had ≥1 parent with myopia (SE, <-3.00 D). [JAMA 2023;329:1-10]
The children were randomly assigned to receive 0.05 percent (n=160) or 0.01 percent (n=159) atropine eye drops, or 0.9 percent sodium chloride as placebo eye drops (n=155) every night for 2 years. The primary outcomes were the 2-year cumulative incidence of myopia (defined as cycloplegic SE <-0.50 D in either eye) and the rate of fast myopic shift (defined as spherical SE >1.00 D) at 2 years.
The 2-year cumulative incidence of myopia was 28.4 percent for 0.05 percent atropine, 45.9 percent for 0.01 percent atropine and 53.0 percent for placebo. The corresponding rates of fast myopic shift at 2 years were 25.0 percent, 45.1 percent and 53.9 percent.
Compared with placebo, 0.05 percent atropine significantly reduced 2-year cumulative myopia incidence (difference, 24.6 percent; 95 percent confidence interval [CI], 12.0–36.4; p<0.001) and fast myopic shift rate at 2 years (difference, 28.9 percent; 95 percent CI, 16.5–40.5; p<0.001). Compared with 0.01 percent atropine, 0.05 percent atropine also significantly reduced both primary endpoints (2-year cumulative myopia incidence: difference, 17.5 percent; 95 percent CI, 5.2–29.2; p<0.005) (fast myopic shift rate at 2 years: difference, 20.1 percent; 95 percent CI, 8.0–31.6; p<0.001). However, no significant differences were observed in the primary endpoints between 0.01 percent atropine and placebo.
“The children tolerated low-concentration atropine well and did not experience significant adverse events [AEs],” said principal investigator, Dr Jason Yam of the Department of Ophthalmology and Visual Sciences, CUHK.
“The most common AE was photophobia, which occurred in 15 [12.9 percent], 23 [18.9 percent] and 14 [12.2 percent] children treated with 0.05 percent atropine, 0.01 percent atropine and placebo, respectively, at year 2,” Yam continued. “No children treated with 0.05 percent atropine required photochromic or progressive lens spectacles. Two children each in the 0.01 percent atropine and placebo groups needed photochromic glasses, and one child treated with 0.01 percent atropine needed progressive glasses.”
Parental myopia is associated with an increased risk of myopia in children, especially if both parents had high myopia (11.9-fold increased risk). [JAAPOS, 2018;22:e73] All levels of myopia are associated with higher risks of complications, such as glaucoma, macular degeneration, retinal detachment and cataracts. [Invest Ophthalmol Vis Sci 2020;61:49] “Wearing glasses or receiving laser refractive surgery cannot reduce myopic complication risks,” said Professor Calvin Pang of the Department of Ophthalmology and Visual Sciences, CUHK.
“Our findings suggest that low-concentration [ie, 0.05 percent] atropine eye drops is an effective strategy for [reducing incidence of] myopia among high-risk children, which might lower their risks of myopic complications,” Yam highlighted.
The researchers will launch the LAMP3 trial to study the efficacy and safety of atropine eye drops in combination with low-intensity red-light therapy for childhood myopia. “Low-intensity red-light therapy is shown to control childhood myopia. In LAMP3, we will examine whether atropine eye drops plus low-intensity red-light therapy will provide synergistic or additional benefits in reducing childhood myopia progression,” Yam added. [Ophthalmology 2022;129:509-519]