Low-dose Atropine for Myopia Control in Children, a Prospective, Double-blind, Placebo-controlled, Multicentric, Randomized Clinical Trial

Who is this study for? Children with myopia
What treatments are being studied? Atropine
Status: Active_not_recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Augen-Zentrum-Nordwest, Augenpraxis Ahaus
Ahaus
Universitäts-Augenklinik Bonn
Bonn
Uniklinik Köln, Zentrum für Augenheilkunde
Cologne
Universitätsklinikum Erlangen, Augenklinik
Erlangen
Universitätsklinikum Essen, Klinik für Augenheilkunde
Essen
Medical Center - University of Freiburg, Eye Hospital
Freiburg Im Breisgau
Universitätsmedizin Göttingen, Augenklinik
Göttingen
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde
Hamburg
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover
Universitätsklinikum Heidelberg, Augenklinik
Heidelberg
Universitätsklinikum Schleswig-Holstein
Kiel
Universitätsklinikum Leipzig, Klinik und Poliklinik für Augenheilkunde
Leipzig
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz
Ludwig-Maximilians-Universität München, Augenklinik und Poliklinik
München
Klinik für Augenheilkunde des UKM, Gebäude D15
Münster
Pius-Hospital Oldenburg, Medizinischer Campus Universität Oldenburg, Universitätsklinik für Augenheilkunde
Oldenburg
AugenCentrum Rosenheim
Rosenheim
Universitätsklinikum Ulm, Klinik für Augenheilkunde
Ulm
Time Frame
Start Date: 2021-10-19
Completion Date: 2027-11
Participants
Target number of participants: 302
Treatments
Experimental: Arm A, Interventional group
Treatment period 1: Atropine eye drops, 0.02%, 1 drop/eye, daily for 12 months Treatment period 2: Atropine eye drops, 0.02%, 1 drop/eye, daily for 12 months Treatment period 3: Placebo (NaCl 0.9%) eye drops, 1 drop/eye, daily for 12 months
Experimental: Arm B, Control group
Treatment period 1: Placebo (NaCl 0.9%) eye drops, 1 drop/eye, daily for 12 months Treatment period 2: Atropine eye drops, 0.01%, 1 drop/eye, daily for 12 months Treatment period 3: Atropine eye drops, 0.01%, 1 drop/eye, daily for 12 months
Sponsors
Leads: University Eye Hospital, Freiburg

This content was sourced from clinicaltrials.gov