Introduction: The purpose of this study was to investigate the efficacy and safety of consecutive use of 1% and 0.01% atropine compared with 0.01% atropine alone over 1 year.
Methods: A total of 207 participants aged 6-12 years with myopia of - 0.50 to - 6.00 D in both eyes were enrolled in this randomized, controlled, non-masked trial and randomly assigned (1:1) to groups A and B. Group A received 1% atropine weekly and were tapered to 0.01% atropine daily at the 6-month visit, and group B received 0.01% atropine daily for 1 year.
Results: Of the 207 participants, 109 were female (52.7%) and the mean (± standard deviation) age was 8.92 ± 1.61 years. Ninety-one participants (87.5%) in group A and 80 participants (77.7%) in group B completed the 1-year treatment. Group A exhibited less refraction progression (- 0.53 ± 0.49 D vs. - 0.74 ± 0.52 D; P = 0.01) and axial elongation (0.26 ± 0.17 mm vs. 0.36 ± 0.21 mm; P < 0.001) over 1 year compared with group B. The changes in refraction (- 0.82 ± 0.45 D vs. - 0.46 ± 0.35 D; P < 0.001) and axial length (0.29 ± 0.12 mm vs. 0.17 ± 0.11 mm; P < 0.001) during the second 6 months in group A were greater than those in group B, with 72.5% of participants presenting refraction rebound. No serious adverse events were reported.
Conclusions: The 1-year results preliminarily suggest that consecutive use of 1% and 0.01% atropine confers an overall better effect in slowing myopia progression than 0.01% atropine alone, despite myopia rebound after the concentration switch. Both regimens were well tolerated. The long-term efficacy and rebound after the concentration switch and regimen optimization warrant future studies to determine.
Trial registration number: Clinical Trials.gov PRS (Registration No. NCT03949101).
Keywords: Atropine; Consecutive use; Myopia control; Myopia rebound.
© 2022. The Author(s).