Low-dose Atropine for Myopia Control in Children (AIM)

March 3, 2025 updated by: University Eye Hospital, Freiburg

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 only to age. Its prevalence is increasing worldwide in pandemic dimensions affecting now > 80% in Asian and > 40% in Caucasian populations. Myopia is one of the five eye diseases identified as immediate priorities by the WHO's global initiative for the elimination of avoidable blindness. It usually develops during primary school and its onset and progression are related to environmental factors such as near work and lack of day light exposure, to a lesser degree to genetic factors. Therefore, retardation of myopia progression is a major therapeutic goal. Clinical trials from Asia have shown that 0.01% atropine eye drops can attenuate progression of myopia while inducing only little side effects such as light sensitivity and reduced accommodation. Subsequent data also from Asia have suggested that a concentration of 0.05% atropine is slightly more effective with a still acceptable level of adverse effects. However, it is unclear whether this therapy is equally and sufficiently efficacious in a Caucasian population. It is also unclear which concentration of atropine represents the best compromise between efficacy and safety. Our own uncontrolled pilot data suggest that 0.01% delays progression by about 50% with negligible side effects, but that 0.05% induces a pupil dilation of > 3 mm, which is considered unacceptable. Due to the increasing prevalence also in Europe and an increasing demand from parents for means to retard myopia progression, the trial is the first European large scale randomized clinical trial investigating the safety and efficacy of 0.01% and 0.02% atropine eye drops in comparison to placebo drops. Such a trial is mandatory to substantiate the increasing off-label prescriptions of low-dose atropine in children and to develop clinical guidelines.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
302

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Ahaus, Germany, 48683
        • Augen-Zentrum-Nordwest, Augenpraxis Ahaus
      • Bonn, Germany, 53127
        • Universitäts-Augenklinik Bonn
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Augenklinik
      • Essen, Germany, 45147
        • Universitätsklinikum Essen, Klinik für Augenheilkunde
      • Freiburg, Germany, 79106
        • Medical Center - University of Freiburg, Eye Hospital
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen, Augenklinik
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg, Augenklinik
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein
      • Köln, Germany, 50937
        • Uniklinik Köln, Zentrum für Augenheilkunde
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig, Klinik und Poliklinik für Augenheilkunde
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
      • München, Germany, 80336
        • Ludwig-Maximilians-Universität München, Augenklinik und Poliklinik
      • Münster, Germany, 48149
        • Klinik für Augenheilkunde des UKM, Gebäude D15
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg, Medizinischer Campus Universität Oldenburg, Universitätsklinik für Augenheilkunde
      • Rosenheim, Germany, 83022
        • AugenCentrum Rosenheim
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm, Klinik für Augenheilkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients aged 8 to 12 years (up to the day before the 13th birthday)
  2. Myopia of -1 D to -6 D with reported or documented annual progression ≥ 0.5 D of myopia
  3. Written informed consent obtained from patient (if applicable) and parents or legal guardians according to international guidelines and local laws
  4. Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion Criteria:

  1. Asian or African origin
  2. Abnormal binocularity
  3. Strabismus
  4. Astigmatism >1.5 D
  5. Anisometropia >1.5 D
  6. History of amblyopia
  7. Corrected visual acuity in any eye <0.63
  8. Any acquired or developmental organic eye disease
  9. Premature birth
  10. Any known systemic metabolic disease or chromosomal anomaly
  11. Previous use of any kind of contact lenses
  12. Previous use of atropine eye drops
  13. Epilepsy
  14. Known hypersensitivity to the active substances or any of the excipients
  15. Participation in any other interventional clinical trial within the last 30 days before the start of this trial
  16. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registries and diagnostic trials is allowed
  17. Contraindications according to the Summary of Product Characteristics (SmPC): Increased intraocular pressure (primary forms of glaucoma or narrow angle glaucoma), chronic rhinitis sicca
  18. 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
  19. Parents or children with poor understanding of the German language
  20. Person who is in a relationship of dependence/employment with the sponsor or the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
Drug: Placebo (NaCl 0.9%) eye drops
One drop of the above mentioned drug will be installed into each eye daily at bedtime.
Drug: Atropine eye drops, 0.01%
One drop of the above mentioned drug will be installed into each eye daily at bedtime.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demonstration of superiority of low-dose atropine 0.02% eye drops compared to placebo for myopia control
Time Frame: Baseline - 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of axial eye length growth under low-dose atropine 0.02% in comparison to placebo
Time Frame: Baseline - 12 months
Change in axial length [mm/year]. The mean value of both eyes is analysed. Analyses will be performed in a regression model.
Baseline - 12 months
Assessment of the categorized rate of change in refraction of low-dose atropine 0.02% compared to placebo
Time Frame: Baseline - 12 months
The primary endpoint change in cycloplegic refraction after one year will be categorized (patients progressing < 0.25D (dioptre), 0.25D - 0.75D and > 0.75D after one year of treatment) and will be analysed descriptively, giving absolute and relative frequencies of these categories as a supportive analysis.
Baseline - 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of rebound of myopia progression (refraction) after cessation of atropine 0.02% treatment
Time Frame: 24-months - 36-months
Change in refraction [D/year] in year 3, to be determined only in the intervention group.
24-months - 36-months
Assessment of rebound of myopia progression (axial length) after cessation of atropine 0.02% treatment
Time Frame: 24-months - 36-months
Change in axial length [mm/year] in year 3, to be determined only in the intervention group.
24-months - 36-months
Change in refraction [D/year]
Time Frame: intervention group: baseline - 24-months, control group: 12-months - 36-months
Change in refraction [D/year] after two years of treatment with low-dose atropine 0.02% eye drops (after year 2 in the interventional group) compared to low-dose atropine 0.01% eye drops (after year 3 in the control group).
intervention group: baseline - 24-months, control group: 12-months - 36-months
Change in axial length [mm/year]
Time Frame: intervention group: baseline - 24-months, control group: 12-months - 36-months
Change in axial length [mm/year] after two years of treatment with low-dose atropine 0.02% eye drops (after year 2 in the interventional group) compared to low-dose atropine 0.01% eye drops (after year 3 in the control group).
intervention group: baseline - 24-months, control group: 12-months - 36-months
Assessment of safety of topical preservative free atropine in comparison to placebo with regard to pupil size
Time Frame: Baseline - 36-months
Pupil diameter in mm using the IOL Master 500 or 700 or a PlusoptiX device (preferred) at 200 - 300 lux room illumination. Parameter will be listed by site and patient and displayed in summary tables.
Baseline - 36-months
Assessment of safety of topical preservative free atropine in comparison to placebo with regard to near vision
Time Frame: Baseline - 36-months
Visual acuity at near (40 cm distance) using Landolt-C near vision charts (non-crowded version) as decimal acuity. Parameter will be listed by site and patient and displayed in summary tables.
Baseline - 36-months
Assessment of safety of topical preservative free atropine in comparison to placebo with regard to accomodation
Time Frame: Baseline - 36-months
Accommodation in D as the near point by the Royal air force near point rule (RAF) or by the Accommodation Convergence Rule (VISUS GmbH) (mean of three measurements of both eyes). Parameter will be listed by site and patient and displayed in summary tables.
Baseline - 36-months
Assessment of safety of topical preservative free atropine in comparison to placebo with regard to pulse rate
Time Frame: Baseline - 36-months
Pulse rate (per minute): parameter will be listed by site and patient and displayed in summary tables.
Baseline - 36-months
Number of participants with treatment-related adverse events as assessed by the current CTCAE v4.0
Time Frame: Baseline - 36-months
  • A questionnaire about potential side effects will be completed three times during the study course
  • A patient diary of potential side effects will be provided for patients/parents or guardians to complete and bring to each study visit
  • Adverse events will be documented in the eCRF

The adverse events are displayed in summary tables by treatment.
Baseline - 36-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Eye Hospital, Freiburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolf Lagrèze, Prof., Eye Center, Medical Center, University Hospital Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P001307
  • DRKS00023337 (Registry Identifier: German Clinical Trials Register (DRKS))
  • 2020-001575-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings