Health
Atropine 0.01% is not associated with delayed myopia progression
Atropine 0.01% no longer has a retarding effect myopia progress compared to placebo, according to a new study published in JAMA Ophthalmology. The study focused on children aged 5 to 12 living in the United States.
It is estimated that more than 44 million people in the United States will be myopic by 2050, and the prevalence is increasing worldwide. Atropine eye drops have been used to slow disease progression, but most trials evaluating its efficacy have been conducted outside the United States. This study aimed to report the efficacy of atropine 0.01% compared to placebo over 2 years.
This study was conducted from June 2018 to September 2022. Children were eligible if they had myopia with a spherical equivalent refractive error (SER) of -1.00 diopters (D) to -6.00D, astigmatism of ≤1.50D in both eyes, and anisometropia. Axial length, flat corneal radius, anterior chamber depth, and lens thickness were all measured. Participants were Caucasian (46%), Black (18%), Hispanic or Latino (16%), and East Asian (11%). The mean (SD) age was 10.1 (1.8) years and 54% were female. The mean SER at baseline was –2.83 (1.10) D and the mean axial length was 24.4 (0.8) mm.
All participants completed a 2- to 4-week phase to assess eye drop adherence before receiving test drops. They were randomized in a 2:1 ratio to one dose of atropine 0.01% eye drops (n = 125) or placebo (n = 62). All participants were tasked with once-nightly dosing for 24 months, followed by 6-month follow-up after discontinuing the drops. No other treatment is available during this period. Follow-up visits were performed at 6, 12, 18, 24, and 30 months after randomization. The primary endpoint was to assess the change in cycloplegic SER from baseline to 24 months.
Mean SER at baseline was -2.83 (1.17) D in the atropine group and -2.83 (0.97) D in the placebo group. After 24 months, it changed to -3.64 (1.46) D in the atropine group and -3.54 (1.08) D in the placebo group. The adjusted mean change in axial length from baseline to 24 months was 0.44 (95% CI, 0.39 to 0.50) mm in the atropine group and 0.45 (95% CI, 0.37 to 0.52) mm in the placebo group.
The researchers found that the mean change in SER 30 months after randomization was -0.94 (0.77) D in the atropine group and -0.88 (0.71) D in the placebo group. The corresponding mean changes in axial length were 0.51 (0.35) mm and 0.49 (0.32) mm.
Potential limitations to these findings include the lack of objective measures of eye drop use and the possibility that family-reported use may overestimate adherence. Additionally, due to the COVID-19 pandemic, virtual visits occurred at 6, 12, and 18 months of age.
The researchers concluded that atropine 0.01% was ineffective compared to placebo to slow myopia progression in children aged 5-12 years with mild to moderate myopia.
reference
Repka MX, Weise KK, Chandler DL et al. Low-dose 0.01% atropine eye drops versus placebo for myopia control: a randomized clinical trial. JAMA Ophthalmology. Published online on July 13, 2023. doi:10.1001/jamaophysicalmol.2023.2855
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