Prevention of myopia shift and myopia onset using 0.01% atropine in premyopic children - A Prospective, Randomized, Double-masked, Crossover Trial

Abstract

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, 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 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 0.11mm (0.17 ± 0.11mm vs. 0.28 ± 0.14mm) in period 1, and 0.17D (-0.18 ± 0.24D vs. -0.34 ± 0.31D) and 0.10mm (0.15 ± 0.15mm vs. 0.24 ± 0.11mm) in period 2. GEE model showed that the proportion of myopia onset (p = 0.004) and fast myopic shift (p = 0.009) were 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). 0.01% atropine significantly prevented myopic shift, axial elongation, and myopia onset in premyopic schoolchildren in central Mainland China. Conclusions: 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.

Daily Low-Level Red Light for Spherical Equivalent Error and Axial Length in Children With Myopia

“…The 650-nm LLRL may be a preventive measure for myopia. Previously, few studies [47][48][49] on myopia prevention were conducted because of ethical debates. Two recent studies 47,48 explored the possibility of using atropine for myopia prevention and reported opposite findings.…”

“…Previously, few studies [47][48][49] on myopia prevention were conducted because of ethical debates. Two recent studies 47,48 explored the possibility of using atropine for myopia prevention and reported opposite findings. For 650-nm LLRL, a clinical trial reported a 54.1% reduction in incident myopia among children with premyopia within 12 months.…”

Myopia Control: Are We Ready for an Evidence Based Approach?

“…Similarly, in another recently published systematic review the estimated mean difference (MD) for myopia progression for atropine was found to be 0.29 D (95% CI 0.22-0.36; p = 0.03) [58]. In the present review, the most recent 16 out of initial 41 articles on RCTs were analyzed (Supplementary Table 3): a noticeable difference between these studies can be observed in terms of sample size [107][108][109], study length and design [110][111][112][113][114], the age of the children studied [106,109], location of trial [115][116][117], and the different atropine doses, which varied between 0.0025% and 1%, as well as the application frequency of drops [110,114,118,119], and lastly their aims [109,111,112,120]. Almost half of the selected studies were conducted in East Asia, in predominately Chinese ethnic children [109,110,114,115,[118][119][120].…”

“…In the present review, the most recent 16 out of initial 41 articles on RCTs were analyzed (Supplementary Table 3): a noticeable difference between these studies can be observed in terms of sample size [107][108][109], study length and design [110][111][112][113][114], the age of the children studied [106,109], location of trial [115][116][117], and the different atropine doses, which varied between 0.0025% and 1%, as well as the application frequency of drops [110,114,118,119], and lastly their aims [109,111,112,120]. Almost half of the selected studies were conducted in East Asia, in predominately Chinese ethnic children [109,110,114,115,[118][119][120]. Four studies were conducted in Europe [107,111,112,116], two in India [113,117], one in Iran [108], one in the USA [121], and one in Australia [106].…”

Delaying the Onset of Nearsightedness

“…Three studies have indicated that nightly administration of low-concentration atropine eyedrops can delay the onset of myopia and/or reduce the shift of refractive error in the myopic direction. [14][15][16] The Low-Concentration Atropine for Myopia Prevention (LAMP2) study 17 reported in this issue of JAMA is the first large-scale, 2-year randomized clinical trial to investigate the effects of nightly administration of 0.05% or 0.01% atropine eyedrops vs placebo eyedrops in children without myopia. The objective of the study was to determine whether low-concentration atropine eyedrops could delay the onset of myopia and reduce the percentage of children who experience a 1.00 D myopic shift in refractive error.…”