ow-dose Atropine for the prevention of nearsightedness in Danish Childre
- Conditions
- Childhood myopiaMedDRA version: 20.0Level: LLTClassification code 10036803Term: Progressive high (degenerative) myopiaSystem Organ Class: 100000004853Therapeutic area: Body processes [G] - Biological Phenomena [G16]
- Registration Number
- EUCTR2018-001286-16-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Children aged =6-<9 years: myopia =-1 (spherical equivalent) in at least one eye
Children aged =9-=12 years: myopia =-2 (spherical equivalent) in at least one eye
Cylinder less than 1.5 diopters
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method