Low-dose Atropine for Myopia Control in Children
AIM
3 other identifiers
interventional
302
1 country
19
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedStudy Start
First participant enrolled
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedMarch 6, 2025
March 1, 2025
4 years
March 3, 2019
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstration of superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control
Change in cycloplegic refraction \[dioptre (D)/year\] after one year will be performed using an analysis of covariance (ANCOVA) model with the annual change in refraction as the dependent variable. The mean value of both eyes is analysed.
Baseline - 12 months
Secondary Outcomes (2)
Assessment of axial eye length growth under low-dose atropine 0.02% in comparison to placebo
Baseline - 12 months
Assessment of the categorized rate of change in refraction of low-dose atropine 0.02% compared to placebo
Baseline - 12 months
Other Outcomes (9)
Assessment of rebound of myopia progression (refraction) after cessation of atropine 0.02% treatment
24-months - 36-months
Assessment of rebound of myopia progression (axial length) after cessation of atropine 0.02% treatment
24-months - 36-months
Change in refraction [D/year]
intervention group: baseline - 24-months, control group: 12-months - 36-months
- +6 more other outcomes
Study Arms (2)
Arm A, Interventional group
EXPERIMENTALTreatment 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
Arm B, Control group
EXPERIMENTALTreatment 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
Interventions
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Augen-Zentrum-Nordwest, Augenpraxis Ahaus
Ahaus, 48683, Germany
Universitäts-Augenklinik Bonn
Bonn, 53127, Germany
Uniklinik Köln, Zentrum für Augenheilkunde
Cologne, 50937, Germany
Universitätsklinikum Erlangen, Augenklinik
Erlangen, 91054, Germany
Universitätsklinikum Essen, Klinik für Augenheilkunde
Essen, 45147, Germany
Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, 79106, Germany
Universitätsmedizin Göttingen, Augenklinik
Göttingen, 37075, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde
Hamburg, 20246, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, 30625, Germany
Universitätsklinikum Heidelberg, Augenklinik
Heidelberg, 69120, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Augenheilkunde
Leipzig, 04103, Germany
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, 39120, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
Mainz, 55131, Germany
Ludwig-Maximilians-Universität München, Augenklinik und Poliklinik
München, 80336, Germany
Klinik für Augenheilkunde des UKM, Gebäude D15
Münster, 48149, Germany
Pius-Hospital Oldenburg, Medizinischer Campus Universität Oldenburg, Universitätsklinik für Augenheilkunde
Oldenburg, 26121, Germany
AugenCentrum Rosenheim
Rosenheim, 83022, Germany
Universitätsklinikum Ulm, Klinik für Augenheilkunde
Ulm, 89075, Germany
Related Publications (1)
Farassat N, Bohringer D, Kuchlin S, Molnar FE, Schwietering A, Seger D, Hug MJ, Knobel AB, Schneider-Fuchs S, Ihorst G, Wabbels B, Beisse C, Ziemssen F, Schuettauf F, Hedergott A, Ring-Mangold T, Schuart C, Wolf A, Schmickler S, Biermann J, Eberwein P, Hufendiek K, Eckstein A, Gusek-Schneider G, Schittkowski M, Lischka T, Lagreze WA. Low-dose AtropIne for Myopia Control in Children (AIM): protocol for a randomised, controlled, double-blind, multicentre, clinical trial with two parallel arms. BMJ Open. 2023 Apr 20;13(4):e068822. doi: 10.1136/bmjopen-2022-068822.
PMID: 37080623BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolf Lagrèze, Prof.
Eye Center, Medical Center, University Hospital Freiburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Code labelled eye drop containers Blinded investigators
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2019
First Posted
March 6, 2019
Study Start
October 19, 2021
Primary Completion
November 1, 2025
Study Completion (Estimated)
November 1, 2027
Last Updated
March 6, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share