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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
0.01% atropine for 24 months
Placebo for 24 months
Department of Ophthalmology, Aarhus University Hospital
Aarhus, Denmark
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup Municipality, Denmark
Department of Ophthalmology, Vejle Hospital
Vejle, Denmark
Axial Length at 36 Months
Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700
Time frame: 36 months
Spherical Equivalent at 36 Months
Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction
Time frame: 36 months
Adverse Events
Total individual adverse events per interventional arm
Time frame: 36 months
Change in Choroidal Thickness From Baseline to 36 Months
Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)
Time frame: 36 months
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