Low-dose Atropine for the prevention of nearsightedness in Danish Children

Low-dose Atropine for the Prevention of Childhood Myopia Progression in Danish Children (APP-study) - The APP-study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001286-16-DK

Enrollment

150

Registered

2018-05-30

Start date

2018-11-05

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood myopia MedDRA version: 20.0 Level: LLT Classification code 10036803 Term: Progressive high (degenerative) myopia System Organ Class: 100000004853

Interventions

Product Name: Atropine 0.01% Pharmaceutical Form: Ear/eye drops, solution INN or Proposed INN: Atropine 0.01% Other descriptive name: ATROPINE Concentration unit: % percent Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged =6-=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. In order 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. ;Secondary Objective: 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.;Primary end point(s): Axial length elongation at 36 months Change in spherical equivalent at 36 months ;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: 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. In order 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. ;Secondary Objective: 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.;Primary end point(s): Axial length elongation at 36 months Change in spherical equivalent at 36 months ;Timepoint(s) of evaluation of this end point: 36 months

—

Secondary

Measure	Time frame
Secondary end point(s): Patient reported outcome Adverse effects and reactions Change in choroidal thickness Change in ocular biometry (i.e. keratometry, anterior chamber depth, lens thickness, vitreous axial distance) Change in higher-order aberrations ;Timepoint(s) of evaluation of this end point: 12-36 months	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026