NCT03911271

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Line Kessel · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	0.1% atropine and 0.01% atropine	0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
DRUG	0.01% atropine	0.01% atropine for 24 months
DRUG	0.9% Sodium-chloride	Placebo for 24 months

Timeline

• Start date: 2019-05-30
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2019-04-11
• Last updated: 2025-06-29
• Results posted: 2025-06-18

Locations

3 sites across 1 country: Denmark