Low-Concentration Atropine (0.01%, 0.025%, 0.05%) for Myopia Progression in Children: A Systematic Review and Meta-Analysis.

Objective

Myopia has reached epidemic proportions globally, with approximately 50% of the world population projected to be affected by 2050. Low-concentration atropine eye drops (0.01%, 0.025%, 0.05%) have emerged as a primary intervention for myopia control. Several meta-analyses on this topic have been published; however, none have included the most recent trials nor separately analyzed premyopia prevention outcomes. This systematic review and meta-analysis evaluates the efficacy and safety of these concentrations for myopia progression control and premyopia prevention.

Methods

We searched PubMed, Web of Science, Embase, and Cochrane CENTRAL from database inception through April 2026. Randomized controlled trials (RCTs) comparing 0.01%, 0.025%, or 0.05% atropine with placebo or no treatment in children were included. Studies were screened using PICOS criteria (Population, Intervention, Comparison, Outcomes, Study design). Meta-analysis was performed using DerSimonian-Laird random-effects models. Subgroup analyses were conducted by concentration, follow-up duration, and population (myopia progression vs. premyopia prevention).

Results

Of 18 full-text articles assessed, 8 RCTs (n = 1756) met all PICOS criteria and were included in the quantitative synthesis. For myopia progression, 0.01% atropine demonstrated significant efficacy at 1 year (pooled MD = +0.291 D, 95% CI: 0.199 to 0.384; p < 0.0001; I2 = 29.1%) and at 2 years (pooled MD = +0.174 D, 95% CI: 0.056 to 0.291; p = 0.0038; I2 = 0%). The 0.05% concentration showed the largest effect (pooled MD = +0.520 D, 95% CI: 0.409 to 0.630; p < 0.0001; I2 = 0%). Clinically, a 0.25 D difference over 1-2 years may translate to approximately 0.50 D cumulative benefit over a typical 5-year treatment course, potentially reducing the risk of high myopia. For premyopia prevention, a narrative synthesis was performed due to extreme heterogeneity between studies (I2 = 99.2%). All concentrations showed an excellent safety profile with no serious adverse events.

Conclusions

Low-concentration atropine is effective for myopia progression control at all three concentrations, with a concentration-dependent gradient (0.05% > 0.025% > 0.01%). The 0.01% concentration offers a reasonable balance of efficacy and tolerability. Further independent validation of the 0.05% concentration is warranted. The premyopia prevention indication requires additional well-designed RCTs.