Safety and effects on visual function of 0.01% atropine eye drops for myopia Inhibition in children and adolescents
- Conditions
- H52.5Disorders of accommodation
- Registration Number
- DRKS00020585
- Lead Sponsor
- niversitätsklinikum TübingenTübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 28
Children and adolescents in whom the decision to be treated with 0.01% atropine was made based on the individual situation (eye length, observed progression of myopia)
- Age 6-17 years
- Myopia progression at least 0.5 dpt in the past 12 months in at least one eye
- Myopia below 4.0 dpt
- Written consent of all parents and the proband
- Anisometropia > 1.0 dpt.
- Astigmatism > 1.5 dpt.
- Best corrected visual acuity < 0.8
- diseases of the eye other than myopia, in particular changes in the conjunctiva, corneal scars and diseases of the anterior segment of the eye
- Known incompatibility of atropine or other components of the test product
- Primary and secondary open angle glaucoma, narrow angle glaucoma
- Tachycardia, heart failure, coronary stenosis
thyrotoxicosis, hyperthyroidism
- Mechanical closures of the gastrointestinal tract
- Paralytic ileus, megacolon
- Obstructive urinary tract diseases
- myasthenia gravis
- Acute pulmonary oedema
- Spastic paralysis
- rhinitis sicca
- Participation in another clinical trial within the last 30 days
- Breastfeeding, pregnant or childbearing study participants without highly effective contraceptive protection
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method width of accommodation.<br>It is examined at each visit (day 1, week 1, month 6, 12, 13) with the pupillometer.
- Secondary Outcome Measures
Name Time Method Accommodation speed<br>Local compatibility<br>Systemic tolerance in the form of heart rate variability<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 M.ciliaris<br><br>will be examined at each visit (day 1, week 1, month 6, 12, 13) with the pupillometer, EDI-OCT, slit lamp examination, mesoptometer, finometer