ow-dose AtropIne for Myopia control in childre

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

1.Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
2.Myopia of -1 D to -6 D with reported or documented annual progression = 0.5 D of myopia
3.Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
4.Ability to understand the nature of the trial and the trial related procedures and to comply with them

Are the trial subjects under 18? yes
Number of subjects for this age range: 300
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

Exclusion Criteria

1.Asian or African origin
2.Abnormal binocularity
3.Strabismus
4.Astigmatism >1.5 D
5.Anisometropia >1.5 D
6.History of amblyopia
7.Corrected visual acuity in any eye <0.63
8.Any acquired or developmental organic eye disease
9.Premature birth
10.Any known systemic metabolic disease or chromosomal anomaly
11.Previous use of any kind of contact lenses
12. Previous use of atropine eye drops
13.Epilepsy
14.Known hypersensitivity to the active substances or any of the excipients
15.Participation in any other interventional clinical trial within the last 30 days before the start of this trial
16.Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
17.Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
18.Caution and pediatric counselling shall be assured if any of the following conditions are present according to the Summary of Product Characteristics (SmPC): Cardiac insufficiency, arrhythmia, coronary stenosis, hyperthyroidism, stomach or bowel stenosis, bowel paralysis, megacolon, muscle weakness, lung edema, hypersensitivity to atropine, spastic paralysis
19.Parents or children with poor understanding of the German language
20.Person who is in a relationship of dependence/employment with the sponsor or the investigator