Status:
ACTIVE_NOT_RECRUITING
Low-dose Atropine for Myopia Control in Children
Lead Sponsor:
University Eye Hospital, Freiburg
Conditions:
Myopia, Progressive
Eligibility:
All Genders
8-12 years
Phase:
PHASE2
PHASE3
Brief Summary
Myopia (nearsightedness) is the most common eye disorder. Only second to age, it is the main risk factor for major degenerative eye diseases such as glaucoma, macular degeneration or retinal detachmen...
Detailed Description
Myopia (nearsightedness) is the most common developmental eye disorder in the first decades of life. It is the biggest risk factor for sight threatening degenerative eye diseases later in life, second...
Eligibility Criteria
Inclusion
- Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
- Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
- Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
Exclusion
- Asian or African origin
- Abnormal binocularity
- Strabismus
- Astigmatism \>1.5 D
- Anisometropia \>1.5 D
- History of amblyopia
- Corrected visual acuity in any eye \<0.63
- Any acquired or developmental organic eye disease
- Premature birth
- Any known systemic metabolic disease or chromosomal anomaly
- Previous use of any kind of contact lenses
- Previous use of atropine eye drops
- Epilepsy
- Known hypersensitivity to the active substances or any of the excipients
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
- Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
- 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
- Parents or children with poor understanding of the German language
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2027
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT03865160
Start Date
October 19 2021
End Date
November 1 2027
Last Update
March 6 2025
Active Locations (19)
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1
Augen-Zentrum-Nordwest, Augenpraxis Ahaus
Ahaus, Germany, 48683
2
Universitäts-Augenklinik Bonn
Bonn, Germany, 53127
3
Uniklinik Köln, Zentrum für Augenheilkunde
Cologne, Germany, 50937
4
Universitätsklinikum Erlangen, Augenklinik
Erlangen, Germany, 91054