Low-dose Atropine for the Prevention of Myopia Progression in Danish Children (APP)
Myopia
About this trial
This is an interventional treatment trial for Myopia
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
Sites / Locations
- Department of Ophthalmology, Aarhus University Hospital
- Department of Ophthalmology, Rigshospitalet-Glostrup
- Department of Ophthalmology, Vejle Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Loading dose
Low dose
Placebo
In phase 1 (treatment phase), the participants (n=50) 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.
In phase 1 (treatment phase), the participants (n=50) 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.
In phase 1 (treatment phase), the participants (n=50) 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.