Myopia
Conditions
Interventions
Product Name: Atropin 0.01%
Pharmaceutical Form: Eye drops
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Primary end point(s): Amplitude of accommodation;Timepoint(s) of evaluation of this end point: After end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Accommodation velocity Local tolerability Systemic tolerability Pupil diameter and reaction Contrast sensitivity Light/dark adaptation Glare sensitivity OCT angiography and EDI-OCT Anterior segment OCT Volume of the ciliary muscle;Timepoint(s) of evaluation of this end point: After end of study | — |
Countries
Germany
Contacts
Public ContactFocke Ziemssen
Universitätsklinikum Tübingen
Outcome results
None listed