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Efficacy and Safety of 0.03% Atropine Eye Drops in Controlling Myopia Progression: A One-Year Prospective Clinical
Dovile Simonaviciute1, Andrzej Grzybowski2,3, Arvydas Gelzinis1
1Department of Ophthalmology, Medical Academy, Lithuanian University of Health Sciences, 44037 Kaunas, Lithuania.
Insights
Low-dose atropine eye drops (0.03%) effectively slowed myopia progression in children aged 6-12 years over one year. While some side effects occurred, the treatment demonstrated significant efficacy in reducing refractive error and axial length changes.
Area of Science:
- Ophthalmology
- Pediatric Optometry
- Pharmacology
Background:
- Myopia progression is a growing concern in children.
- Effective interventions are needed to slow myopia development.
- Low-dose atropine has shown promise in previous studies.
Purpose of the Study:
- To evaluate the one-year efficacy and safety of 0.03% atropine eye drops in slowing myopia progression in children aged 6-12 years.
- To compare changes in axial length and refractive error between atropine and control groups.
- To assess safety and tolerability of 0.03% atropine eye drops.
Main Methods:
- A one-year randomized controlled trial involving healthy Caucasian children aged 6-12 years with myopia.
- Participants received either 0.03% atropine eye drops or a placebo.
- Measurements included spherical equivalent (SE), axial length (AL), intraocular pressure (IOP), central corneal thickness (CCT), anterior chamber depth (ACD), and lens thickness (LT).
Main Results:
- The 0.03% atropine group showed significantly less myopic progression in SE (-0.34 D/year vs. -0.60 D/year) and AL (0.19 mm vs. 0.31 mm) compared to the control group (p=0.024 and p=0.015, respectively).
- A higher proportion of children in the atropine group (64.5%) had progression <0.5 D/year versus the control group (39.0%) (p=0.032).
- No significant differences in IOP, CCT, or LT changes were observed; however, ACD increased significantly more in the atropine group. Adverse events were mostly mild, with 16% discontinuing treatment.
Conclusions:
- One-year treatment with 0.03% atropine eye drops is effective in slowing myopia progression in children.
- The treatment leads to significant reductions in axial elongation and refractive error changes.
- While mild adverse events can occur, 0.03% atropine presents a viable option for myopia control in pediatric populations.
Abstract:
Objective: To investigate the efficacy and safety of one-year treatment with 0.03% atropine eye drops for slowing myopia progression among children aged 6-12 years. Methods: Healthy Caucasian children aged 6-12 years with cycloplegic spherical equivalent (SE) from -1.0 D to -5.0 D and astigmatism and anisometropia ≤1.5 D were included. Changes in mean axial length (AL) and objective SE as well as changes in intraocular pressure (IOP), central corneal thickness (CCT), anterior chamber depth (ACD) and lens thickness (LT) were assessed in the 0.03% atropine eye drops group and the control group from baseline through the 1-year follow-up. The proportion of participants showing myopia progression of <0.5 D from baseline in each group and any potential side effects in 0.03% atropine group were evaluated. Results: The study involved 31 patients in the 0.03% atropine eye drops group and 41 in the control group. Administration of 0.03% atropine for 1 year resulted in a mean change in SE of -0.34 (0.44) D/year, significantly lower than the -0.60 (0.50) D/year observed in the control group (p = 0.024). The change in AL was 0.19 (0.17) mm in the 0.03% atropine group, compared to 0.31 (0.20) mm in the control group (p = 0.015). There were no significant differences in changes of IOP, CCT and LT between the groups (all p ≥ 0.05). The 0.03% atropine group had a significantly greater increase in ACD compared to the control group (p = 0.015). In total, 64.5% of patients in the 0.03% atropine group showed progression <0.5 D/year, in contrast to 39.0% in the control group (p = 0.032). Adverse events were reported in 13 (35.0%) out of 37 patients in the treatment group, leading to discontinuation of the eye drops in six (16.0%) cases. None of the adverse events were severe. Conclusions: Despite a higher incidence of adverse events, 0.03% atropine eye drops effectively slowed the progression of myopia over 1-year.
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