Safety and effects on visual function of 0.01% Atropin eye drops for inhibition of nearsightedness in children and adolescence
- Conditions
- MyopiaTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-002588-17-DE
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
• Children and adolescents for whom the decision was already made for treatment with 0.01% atropine based on their individual situation (eye length, observed myopia progression) and after thorough information discussion about the special status of the myopia. Determining indications for treatment and general consultation will be based on the recommendations of the scientific medical societies.
• Age 6-17 years
• Myopia progression of at least 0.5 dpt in the last 12 months in at least on eye
• Myopia below 4.0 dpt
• Written consent of at least one legal guardian and assent of the subject
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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
• Anisometropia > 1.0 dpt.
• Astigmatism > 1.5 Dpt.
• Best corrected vision < 0.8
• Eye diseases other than myopia, in particular changes of the conjunctiva, scarring of the cornea and diseases of the anterior segment of the eye
• Known intolerance of atropine eye drops
• Participation in another clinical trial within the last 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Amplitude of accommodation;Timepoint(s) of evaluation of this end point: After end of study;Main Objective: To assess the amplitude of accommodation;Secondary Objective: The investigation of treatment effects as reflected by clinical endpoints of visual functions, accommodation velocity, pupil reaction, choroidal thickness are secondary aims of the trial.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Accommodation velocity<br>Local tolerability<br>Systemic tolerability<br>Pupil diameter and reaction<br>Contrast sensitivity<br>Light/dark adaptation<br>Glare sensitivity<br>OCT angiography and EDI-OCT<br>Anterior segment OCT<br>Volume of the ciliary muscle;Timepoint(s) of evaluation of this end point: After end of study