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Prevention of myopia shift and myopia onset using 0.01% atropine in premyopic children - a prospective, randomized,
Weiqun Wang1, Fengyan Zhang1, Shiao Yu1
1The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450000, China.
Insights
Low-dose 0.01% atropine eye drops effectively prevented myopia onset and progression in premyopic children. This intervention significantly reduced myopia shift and axial elongation over a 13-month period.
Area of Science:
- Ophthalmology
- Pediatric Ophthalmology
- Myopia Control
Background:
- Preventing myopia is a critical target in eye care, yet interventions for pre-myopia remain understudied.
- The International Myopia Institute emphasizes prevention over progression management.
Purpose of the Study:
- To evaluate the efficacy of 0.01% atropine eye drops in preventing myopia onset and progression in premyopic children.
- To assess the impact of atropine on refractive error and axial length changes.
Main Methods:
- A 13-month prospective, randomized, double-masked, placebo-controlled, crossover trial involving 60 premyopic children (aged 6-12).
- Participants received either 0.01% atropine or placebo eye drops nightly.
- Outcomes included changes in spherical equivalent refraction (SER) and axial length (AL), myopia onset, and fast myopic shift.
Main Results:
- 0.01% atropine significantly reduced myopia shift (pSER=0.02) and axial elongation (pAL<0.001) compared to placebo.
- The proportion of myopia onset and fast myopic shift was significantly lower in the atropine group (p=0.004 and p=0.009, respectively).
- Mean SER difference was 0.20D and AL difference was 0.11mm in period 1; 0.17D and 0.10mm in period 2.
Conclusions:
- 0.01% atropine eye drops are effective in preventing myopic shift, axial elongation, and myopia onset in premyopic children.
- The findings support the use of low-dose atropine as a preventive strategy for myopia in children.
- Further research with longer observation periods is warranted.
Abstract:
This study aims to evaluate the efficacy of 0.01% atropine eye drops in preventing myopia shift and myopia onset in premyopic children. A prospective, randomized, double-masked, placebo-controlled, and crossover trial was conducted over 13 months. Sixty premyopic children aged 6-12 years with cycloplegic spherical equivalent refraction (SER) > - 0.75 D and ≤ + 0.50 D in both eyes were assigned in a 1:1 ratio to receive one drop of 0.01% atropine or placebo once nightly for 6 months (period 1), followed by a 1-month recovery period. Then, the 0.01% atropine group was crossed over to the placebo group, and the latter was crossed over to the 0.01% atropine group for another 6 months (period 2). The primary outcomes were changes in SER and axial length (AL), and the secondary outcomes were the proportion of myopia onset (SER ≤ - 0.75D) and fast myopic shift (change in SER ≤ - 0.25D) in the two periods. Generalized estimating equation (GEE) model performed a statistically significant treatment effect of 0.01% atropine compared with placebo (pSER = 0.02, pAL < 0.001), with a mean SER and AL difference of 0.20D (- 0.15 ± 0.26D vs. - 0.34 ± 0.34D) and 0.11 mm (0.17 ± 0.11 mm vs. 0.28 ± 0.14 mm) in period 1, and 0.17D (- 0.18 ± 0.24D vs. - 0.34 ± 0.31D) and 0.10 mm (0.15 ± 0.15 mm vs. 0.24 ± 0.11 mm) in period 2. The GEE model showed that the proportion of myopia onset (p = 0.004) and fast myopic shift (p = 0.009) was significantly lower in the 0.01% atropine group than that in the placebo group. The period effect was not statistically significant (all p > 0.05). A total of 0.01% atropine significantly prevented myopic shift, axial elongation, and myopia onset in premyopic schoolchildren in central Mainland China.
Conclusion:
Within the limits of only two consecutive 6-month observation period, 0.01% atropine eye drops effectively prevented myopic shift, axial elongation, and myopia onset in premyopic children.
Trial Registration:
This trial was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR2000034760). Registered 18 July 2020.
What Is Known:
• Minimal studies on interventions for pre-myopia, despite the International Myopia Institute stating that preventing myopia is an "even more valuable target" for science and practice than reducing progression after onset.
What Is New:
• A total of 0.01% atropine eye drops may safely and effectively reduce the proportion of myopia onset and fast myopic shift in premyopic schoolchildren.
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