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

• Status: Active, not recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Line Kessel
• Collaborators: Aarhus University Hospital; Vejle Hospital
• Treatments: Atropine

Criteria

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