ow-dose Atropine for Myopia control in childre
- Conditions
- Myopia in children
- Registration Number
- DRKS00023337
- Lead Sponsor
- niversitätsklinikum Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint:<br>Change of cycloplegic refraction/year [D/year] after 1 year of treatment.<br>
- Secondary Outcome Measures
Name Time Method 1. Axial eye length change/year [mm/year] after 1 year.<br>2. Categorized rate of change in refraction and eye length after 1 year.