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

Anders Hvid-Hansen*, Nina Jacobsen, Flemming Møller, Toke Bek, Brice Ozenne, Line Kessel


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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.

TidsskriftJournal of Personalized Medicine
Udgave nummer2
Antal sider13
StatusUdgivet - feb. 2023

Bibliografisk note

Funding Information:
This research was funded by Bagenkop Nielsens Øjen-Fond, Fight for Sight Denmark, Fonden for Faglig Udvikling i Speciallægepraksis, The Danish Research Foundation, Synoptik-Fonden, Danish Regions, Gangstedfonden, Reimbursement from Regional COVID-19 funds, Aase og Ejnar Danielsens Fond, and A.P. Møller Fonden (Lægefonden). Publication costs were included in fund applications, and fund support was used to pay the APC.


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