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ACTIVE NOT RECRUITING
NCT03865160
PHASE2/PHASE3

Low-dose Atropine for Myopia Control in Children

Sponsor: University Eye Hospital, Freiburg

View on ClinicalTrials.gov

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

Interventions

DRUG

Atropine eye drops, 0.01%

One drop of the above mentioned drug will be installed into each eye daily at bedtime.

DRUG

Atropine eye drops, 0.02%

One drop of the above mentioned drug will be installed into each eye daily at bedtime.

DRUG

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