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

NCT ID: NCT03911271

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2024-04-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Loading dose

In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime.

In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Group Type: EXPERIMENTAL

0.1% atropine and 0.01% atropine

Intervention Type: DRUG

0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months

Low dose

In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime.

In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Group Type: EXPERIMENTAL

0.01% atropine

Intervention Type: DRUG

0.01% atropine for 24 months

Placebo

In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime.

In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Group Type: PLACEBO_COMPARATOR

0.9% Sodium-chloride

Intervention Type: DRUG

Placebo for 24 months

Interventions

0.1% atropine and 0.01% atropine

0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months

Intervention Type: DRUG

0.01% atropine

0.01% atropine for 24 months

Intervention Type: DRUG

0.9% Sodium-chloride

Placebo for 24 months

Intervention Type: DRUG

Other Intervention Names

Loading dose; Low-dose; Placebo

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: collaborator

Line Kessel

OTHER

Sponsor Role: lead

Responsible Party

Line Kessel

Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Ophthalmology, Aarhus University Hospital

Aarhus, , Denmark

Department of Ophthalmology, Rigshospitalet-Glostrup

Glostrup Municipality, , Denmark

Department of Ophthalmology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

References

Hansen NC, Hvid-Hansen A, Bek T, Moller F, Jacobsen N, Kessel L. The Macular Choroidal Thickness in Danish Children with Myopia After Two-Year Low-Dose Atropine and One-Year Wash-Out: A Placebo-Controlled, Randomized Clinical Trial. Ophthalmol Ther. 2024 Dec;13(12):3111-3122. doi: 10.1007/s40123-024-01051-5. Epub 2024 Oct 18.

Reference Type: DERIVED

PMID: 39422837 (View on PubMed)

Hansen NC, Hvid-Hansen A, Moller F, Bek T, Larsen DA, Jacobsen N, Kessel L. Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety. BMC Ophthalmol. 2023 Oct 30;23(1):438. doi: 10.1186/s12886-023-03177-9.

Reference Type: DERIVED

PMID: 37904082 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Line Kessel, RH-Glostrup

Identifier Type: -

Identifier Source: org_study_id