At a glance
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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
In Brief
A Phase 2 clinical trial evaluating 0.1% atropine and 0.01% atropine, 0.01% atropine, and 1 other intervention for Myopia. Completed, enrolled 97 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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