June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Safety and efficacy of 0.01% and 0.1% low dose atropine eye drop regimens for reduction of myopia progression in Danish children: one-year interim analysis of a randomized clinical trial
Author Affiliations & Notes
  • Niklas Cyril Hansen
    Department of Ophthalmology, Rigshospitalet Ojenklinikken, Glostrup, Denmark
  • Anders Johan Hvid-Hansen
    Department of Ophthalmology, Rigshospitalet Ojenklinikken, Glostrup, Denmark
  • Flemming Møller
    Department of Ophthalmology, Sygehus Lillebalt Vejle Sygehus, Vejle, Denmark
  • Toke Bek
    Department of Ophthalmology, Aarhus Universitetshospital, Aarhus, Denmark
  • Nina Jacobsen
    Department of Ophthalmology, Rigshospitalet Ojenklinikken, Glostrup, Denmark
  • Line Kessel
    Department of Ophthalmology, Rigshospitalet Ojenklinikken, Glostrup, Denmark
    Department of Clinical Medicine, Kobenhavns Universitet, Kobenhavn, Denmark
  • Footnotes
    Commercial Relationships   Niklas Hansen None; Anders Johan Hvid-Hansen None; Flemming Møller None; Toke Bek None; Nina Jacobsen None; Line Kessel None
  • Footnotes
    Support  Fight for Sight Denmark 2017 The Danish Eye Research Foundation 2018 Fight for Sight Denmark 2018 Synoptik-Fonden 2018 The Danish Eye Research Foundation 2019 Synoptik-Fonden 2019 Danish Regions Fight for Sight Denmark 2019 "Fonden for Faglig Udvikling af Speciallægepraksis" A.P. Møller Fonden (Lægefonden) Synoptik-Fonden 2020 The Danish Eye Research Foundation 2020 Synoptik-Fonden 2020 Fight for Sight Denmark 2020 "Fonden for Faglig Udvikling af Speciallægepraksis" Gangstedfonden 2021 Reimbursement from regional COVID-19 funds Synoptik-Fonden 2021 Aase og Ejnar Danielsens Fond Synoptik-Fonden 2021 Fight for Sight Denmark 2021 "Fonden for Faglig Udvikling af Speciallægepraksis"
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 4961. doi:
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      Niklas Cyril Hansen, Anders Johan Hvid-Hansen, Flemming Møller, Toke Bek, Nina Jacobsen, Line Kessel; Safety and efficacy of 0.01% and 0.1% low dose atropine eye drop regimens for reduction of myopia progression in Danish children: one-year interim analysis of a randomized clinical trial. Invest. Ophthalmol. Vis. Sci. 2023;64(8):4961.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To investigate the efficacy and safety of 0.1% and 0.01% low dose atropine eye drops for reduction of myopia progression (as defined by spherical equivalent refraction and axial length) in Danish children.

Methods : 97 six- to twelve-year old myopic participants were randomized to 0.1% loading dose for six months followed by 0.01% for 6 months (0.1% loading dose group), 0.01% for 12 months (0.01% group) or vehicle for 12 months (placebo). Ocular parameters were measured at three-month intervals, including: axial length by optical biometry (IOLMaster 700, Carl Zeiss AG, Oberkochen, Germany), spherical equivalent refraction by autorefraction (Right group, Retinomax K-plus 3, Tokyo, Japan), pupil diameter by pupillometry (DP-2000 Pupillometer, NeurOptics, CA, USA), accommodation amplitude using a Royal Air Force near point ruler using best-corrected distance spectacles, and adverse events. Data were analyzed according to intention-to-treat method via the Rstudio statistical software.

Results : Mean axial length elongation had progressed 0.10mm (95% CI: 0.17; 0.02, P = 0.02, adjusted-P = 0.06) and 0.07mm (95% CI: 0.15; 0.00, P = 0.06, adjusted-P = 0.16) less in the 0.1% loading dose and 0.01% group at twelve months compared to placebo, respectively. Mean SER was -3.40D (95% CI: -3.86; -2.95) and -3.45D (95% CI: -3.90; -2.99) in the 0.1% loading dose and 0.01% groups at twelve months, compared to -3.64D (95% CI: -4.10; -3.18) in the placebo group (P = 0.02, adjusted-P = 0.06 and P = 0.05, adjusted-P = 0.14, respectively). Few side effects were reported, mainly in the 0.1% loading dose group. Mesopic and photopic pupil diameter was increased in both intervention groups at 12 months compared to placebo (adjusted-P < 0.05).

Conclusions : Low dose atropine eye drops reduced myopia progression by up to 37% after one year of treatment in Danish children. Low dose atropine eye drops appears safe and moderately effective in reducing myopia progression in Danish children.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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