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

NCT03911271 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-06-29

Study results available
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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.

Conditions

  • Myopia

Interventions

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Line Kessel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2024-04-23
Completion
2024-04-23

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911271 on ClinicalTrials.gov