Clinical trial NCT03911271: Low-dose Atropine for the Prevention of Myopia Progression in Danish Children
Official title: Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myopia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Vejle Hospital
First posted: 2019-04-11
Enrollment: 97
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Axial Length at 36 Months
timeFrame: 36 months
measure: Spherical Equivalent at 36 Months
timeFrame: 36 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 36 months
measure: Change in Choroidal Thickness From Baseline to 36 Months
timeFrame: 36 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology, Aarhus University Hospital
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet-Glostrup
city: Vejle
country: Denmark
facility: Department of Ophthalmology, Vejle Hospital
Study officials:
References: