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Low-dose Atropine for Myopia Control in Children
Sponsor: University Eye Hospital, Freiburg
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 detachment. Their risk increases with the degree of myopia. Hence, prevention of myopia and slowing its progression is of high relevance. Almost all clinical studies, including two large randomised clinical trials (RCT) were performed in Asia with Asian study participants. The results indicate that atropine eye drops can attenuate myopic progression in children, even in low concentrations thus minimizing unwanted side effects. However, the cumulative evidence is yet not strong enough to recommend their unrestricted use, especially in a Non-Asian population. We therefore intend to set up an adequately powered RCT comparing atropine 0.02% eye drops with placebo to validate previous findings and to test whether this therapeutic concept holds its promise in a European population.
Official title: Low-dose Atropine for Myopia Control in Children, a Prospective, Double-blind, Placebo-controlled, Multicentric, Randomized Clinical Trial
Key Details
Gender
All
Age Range
8 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
302
Start Date
2021-10-19
Completion Date
2027-11
Last Updated
2025-03-06
Healthy Volunteers
No
Conditions
Interventions
Atropine eye drops, 0.01%
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Atropine eye drops, 0.02%
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Placebo (NaCl 0.9%) eye drops
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Locations (19)
Augen-Zentrum-Nordwest, Augenpraxis Ahaus
Ahaus, Germany
Universitäts-Augenklinik Bonn
Bonn, Germany
Uniklinik Köln, Zentrum für Augenheilkunde
Cologne, Germany
Universitätsklinikum Erlangen, Augenklinik
Erlangen, Germany
Universitätsklinikum Essen, Klinik für Augenheilkunde
Essen, Germany
Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, Germany
Universitätsmedizin Göttingen, Augenklinik
Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde
Hamburg, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, Germany
Universitätsklinikum Heidelberg, Augenklinik
Heidelberg, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Augenheilkunde
Leipzig, Germany
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, Germany
Ludwig-Maximilians-Universität München, Augenklinik und Poliklinik
München, Germany
Klinik für Augenheilkunde des UKM, Gebäude D15
Münster, Germany
Pius-Hospital Oldenburg, Medizinischer Campus Universität Oldenburg, Universitätsklinik für Augenheilkunde
Oldenburg, Germany
AugenCentrum Rosenheim
Rosenheim, Germany
Universitätsklinikum Ulm, Klinik für Augenheilkunde
Ulm, Germany