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NCT Number: NCT03911271

Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Ophthalmology, Aarhus University Hospital, Aarhus, Denmark

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About this study

The main hypotheses tested in this study are:

  • 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children.
  • 0.01% atropine one drop nightly is safe and with no significant side effects.
  • A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine.
  • 0.1% atropine one drop nightly is safe and has tolerable side effects.
  • The rebound effect after stopping both atropine regimens is limited.
  • Choroidal thickness is a predictor for the progression of childhood myopia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye
  • Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye
  • Cylinder less than 1.5 diopters

Exclusion criteria

  • Myopia related to retinal dystrophies
  • Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
  • Other ocular pathology (e.g., amblyopia, strabismus)
  • Previous eye surgery
  • Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
  • Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
  • Non-compliance to eye examinations
  • Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays

Treatment and study plan

0.1% atropine and 0.01% atropine

Drug

0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months

Other names: Loading dose

0.01% atropine

Drug

0.01% atropine for 24 months

Other names: Low-dose

0.9% Sodium-chloride

Drug

Placebo for 24 months

Other names: Placebo

Primary outcomes

  1. Axial Length at 36 Months

    Time frame: 36 months

    Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700

  2. Spherical Equivalent at 36 Months

    Time frame: 36 months

    Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction

Secondary outcomes

  1. Adverse Events

    Time frame: 36 months

    Total individual adverse events per interventional arm

  2. Change in Choroidal Thickness From Baseline to 36 Months

    Time frame: 36 months

    Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)

Sponsors and collaborators

Lead sponsor

Line Kessel

Other

Collaborators

  • Aarhus University Hospital
  • Vejle Hospital

Registry information

Official study title

Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo

Acronym: APP

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2019
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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