Myopia Control with Low-Dose Atropine in European Children: Six-Month Results from a Randomized, Double-Masked, Placebo-Controlled, Multicenter Study

Abstract

The effect and safety of low-dose atropine in myopia control have not been studied in randomized, placebo-controlled trials outside Asia. We investigated the efficacy and safety of 0.1% atropine loading dose and 0.01% atropine compared with a placebo in a European population. Investigator-initiated, randomized, double-masked, placebo-controlled, equal-allocation, multicenter study comparing 0.1% atropine loading dose (six months) followed by 0.01% atropine (18 months), 0.01% atropine (24 months), and placebo (24 months). Participants were monitored for a 12-months washout period. Outcome measures were axial length (AL), cycloplegic spherical equivalent (SE), photopic and mesopic pupil size, accommodation amplitude, visual acuity, intraocular pressure (IOP), and adverse reactions and events. We randomized 97 participants (mean [standard deviation] age, 9.4 [1.7] years; 55 girls (57%) and 42 boys (43%)). After six months, AL was 0.13 mm shorter (95% confidence interval [CI], -0.18 to -0.07 [adjusted p < 0.001]) with 0.1% atropine loading dose and 0.06 mm shorter (95% CI, -0.11 to -0.01 [adjusted p = 0.06]) with 0.01% atropine than in the placebo group. We observed similar dose-dependent changes in SE, pupil size, accommodation amplitude, and adverse reactions. No significant differences in visual acuity or IOP were found between groups, and no serious adverse reactions were reported. We found a dose-dependent effect of low-dose atropine in European children without adverse reactions requiring photochromatic or progressive spectacles. Our results are comparable to those observed in East Asia, indicating that results on myopia control with low-dose atropine are generalizable across populations with different racial backgrounds.

Keywords: axial length; low-dose atropine; myopia; myopia control; spherical equivalent.

Figure 1

CONSORT diagram for the flow of participants. Notes: The run-in phase consisted of at-home administration of lubricant eye drops to access and maximize future treatment adherence. Abbreviations: CONSORT = consolidated standards of reporting trials; N = number of participants.

Figure 2

Change in AL from baseline. Notes: Mean change in axial length from baseline to six-month visit with placebo (blue), 0.01% atropine (red), and 0.1% atropine loading dose (green). Error bars denote the 95% CIs of the mean changes. Means and CIs are derived from the constrained linear mixed model with inherent baseline adjustment. P and adj-P values are presented in Table 2. Abbreviations: adj-P = adjusted P; CI = confidence interval.