open access publication

Article, 2024

Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial

Journal of Personalized Medicine, ISSN 2075-4426, Volume 14, 2, 10.3390/jpm14020175

Contributors

Hansen N.C. (Corresponding author) [1] Hvid-Hansen A. 0000-0002-7325-0217 [1] Moller F. 0000-0001-9678-2171 [2] Bek T. 0000-0002-0409-2534 [3] Larsen D.A. [3] Jacobsen N. [1] Kessel L. 0000-0002-9375-1510 [1] [4]

Affiliations

  1. [1] Copenhagen University Hospital
  2. [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
  3. [2] Vejle Hospital
  4. [NORA names: Region of Southern Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
  5. [3] Aarhus University Hospital
  6. [NORA names: Central Denmark Region; Hospital; Denmark; Europe, EU; Nordic; OECD];
  7. [4] University of Copenhagen
  8. [NORA names: KU University of Copenhagen; University; Denmark; Europe, EU; Nordic; OECD]

Abstract

We investigated the two-year safety and efficacy of 0.1% loading dose and 0.01% low-dose atropine eye drops in Danish children for reduction in myopia progression in an investigator-initiated, placebo-controlled, double-masked, randomized clinical trial. Ninety-seven six- to twelve-year old myopic participants were randomized to 0.1% loading dose for six months and then 0.01% for eighteen months (loading dose group, N = 33), 0.01% for two years (0.01% group, N = 32) or placebo for two years (placebo, N = 32). Axial length (AL) and spherical equivalent refraction (SER) were primary outcomes. Secondary outcomes included adverse events and reactions, choroidal thickness, and other ocular biometrical measures. Outcomes were measured from baseline and at six-month intervals. Individual eyes nested by participant ID were analyzed with linear-mixed model analysis. Data were analyzed with intention-to-treat. Mean AL was 0.08 mm less (95% confidence interval (CI): −0.01; 0.17, p-value = 0.08) in the 0.1% loading dose and 0.10 mm less (95% CI: 0.01; 0.19, p-value = 0.02) in the 0.01% group after two years of treatment compared to placebo. Mean SER progression was 0.12 D (95% CI: −0.10; 0.33) less in the loading dose and 0.26 D (95% CI: 0.04; 0.48) less in the 0.01% groups after two years of treatment compared to placebo (p-value = 0.30 and 0.02, respectively). In total, 17 adverse events were reported in the second-year follow-up, and all were rated as mild. Adjusting for iris color did not affect treatment effect estimates. Intra-ocular pressure increased over two years comparably between all groups but remained within normal limits. Two-year treatment with 0.01% low-dose atropine eye drops is a safe and moderately efficacious intervention in Danish children for reducing myopia progression.

Keywords

axial length, low-dose atropine, myopia, myopia control, spherical equivalent

Funders

  • Fonden for Faglig Udvikling af Speciallægepraksis
  • Bagenkop-Nielsens Øjen-Fond
  • A.P. Møller Fonden (Lægefonden)
  • Aase og Ejnar Danielsens Fond
  • Synoptik-Fonden
  • Danmarks Grundforskningsfond
  • Fight for Sight Denmark

Data Provider: Elsevier