Twice versus once daily application of 0.01% atropine for myopia control in children: a randomised controlled trial.

BACKGROUND

To investigate the efficacy and safety of standard 0.01% atropine at different frequencies (twice daily versus once nightly) for myopia progression.

METHODS

In this randomised controlled trial (ChiCTR2200055532), Participants aged 6-13 years with a spherical equivalent (SE) between -6.00 to -0.75D and a best corrected visual acuity of ≥0.8 were enrolled and randomised 1:1 to receive 0.01% atropine eye drops once nightly (QD group) or twice daily (BID group) for one year. The primary endpoint was the change in axial length (AL) after one year.

RESULTS

Seventy participants were included and assigned to the QD (n = 34) and BID (n = 36) groups, respectively. After one year, the BID group exhibited a significantly smaller increase in mean AL compared with the QD group (0.21 ± 0.18 vs. 0.32 ± 0.14 mm, P = 0.002), corresponding to a 34% reduction in axial elongation. The BID regimen was 53% more effective in slowing SE progression than the QD regimen, with mean SE changes of -0.31 ± 0.50 vs. -0.66 ± 0.37D (P < 0.001). Safety parameters (e.g., amplitude of accommodation, tear film stability, intraocular pressure) remained similar between the two groups (all P > 0.05). Although mesopic pupil diameter (PD) increased more in the BID group (0.65 ± 0.63 vs. 0.27 ± 0.69 mm, P = 0.010), the difference was clinically acceptable and not observed in photopic PD (P = 0.297).

CONCLUSION

Twice-daily administration of 0.01% atropine significantly enhances the management of axial elongation and SE progression compared with once-nightly dosing without increasing the risk of adverse effects.