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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2024
  • participants needed
    150
  • sponsor
    Line Kessel
Updated on 2 May 2021
Investigator
Anders Hvid-Hansen, MD
Primary Contact
Department of Ophthalmology, Aarhus University Hospital (0.0 mi away) Contact
+2 other location
ophthalmic solution
atropine
retinal detachment

Summary

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.

Description

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.

Details
Condition Myopia, myopic, near vision
Treatment 0.9% Sodium-chloride, 0.1% atropine and 0.01% atropine, 0.01% atropine
Clinical Study IdentifierNCT03911271
SponsorLine Kessel
Last Modified on2 May 2021

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