MAD Trial: Myopia Atropine Dose (MAD)

September 10, 2026 updated by: Caroline C.W. Klaver, MD, Erasmus Medical Center

Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.

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

With the current worldwide myopia boom the frequency of high myopia will also increase, and potentially blinding complications such as myopic macular degeneration, retinal detachment, and glaucoma will occur more often. In the Netherlands high myopia will become the most important cause of low vision and blindness by 2050. As treatment options are limited once the eye is fully grown, prevention of a long axial length at childhood is the only way to counteract this prospect. Pharmacological interventions have shown a high efficacy in stopping eye growth, in particular eye drops with high dose Atropine (0.5%, 1%). Nevertheless, the high frequency of side effects (photophobia, reading problems) of these Atropine concentrations has favoured the use of low dose Atropine. Atropine 0.01% is the most commonly used and lowest dosage; it has shown stability of refractive error, but not of axial length. Recent studies have shown that Atropine 0.05% has low risk of side effects, but a higher efficacy than 0.01%. Many ongoing trials are now comparing various low dose Atropine to placebo, but none are comparing the highest low dose to the lowest high dose Atropine.

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 (Estimated)

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.
550

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 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

  • Netherlands
      • Almere Stad, Netherlands
        • Flevoziekenhuis
      • Amsterdam, Netherlands
        • OLVG, locatie Oost
      • Delft, Netherlands
        • Reinier de Graaf Gasthuis
      • Delft, Netherlands
        • Ophthalmologistenpraktijk Delfland
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Dordrecht, Netherlands
        • Albert Schweitzer ziekenhuis
      • Ede, Netherlands
        • Bergman Clinics - Ede
      • Goes, Netherlands
        • Admiraal de Ruyter Ziekenhuis
      • Heerenveen, Netherlands
        • Frisius MC
      • Heerhugowaard, Netherlands
        • Oogcentrum Noordholland
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Lelystad, Netherlands
        • Bergman Clinics - Lelystad
      • Maastricht, Netherlands
        • Maastricht UMC+
      • Nieuwegein, Netherlands
        • St. Antonius
      • Nijmegen, Netherlands
        • Radboudumc
      • Rotterdam, Netherlands
        • Erasmus Medical Center
      • The Hague, Netherlands
        • Haga Ziekenhuis
      • The Hague, Netherlands
        • Oogkliniek Den Haag
      • Tiel, Netherlands
        • Ziekenhuis Rivierenland Tiel
      • Tilburg, Netherlands
        • Elisabeth-TweeSteden Ziekenhuis

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

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 6 to ≤ 11 years with bilateral myopia
  • Onset of myopia ≥ 4 years of age
  • History of progression
  • SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
  • Intraocular pressure < 21 mm Hg in each eye
  • Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye

Exclusion Criteria:

  • Allergy to atropine or other excipients of the eye drops
  • History of amblyopia or strabismus
  • History of retinal dystrophy or systemic disorder
  • Abnormal ocular biometry aside from axial length
  • History of glaucoma
  • Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).
  • Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.
  • The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks)
  • Prior myopia treatments.
  • Employees of the study center and their family members.

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: Quadruple

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.
Active Comparator: Low dose atropine
Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Drug: Atropine Ophthalmic 0.05%
Atropine 0.05% sulphate ophthalmic solution
Active Comparator: High dose atropine
Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Drug: Atropine Ophthalmic 0.5%
Atropine 0.5% sulphate ophthalmic solution

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
Time Frame
Progression of axial length in mm from baseline to t = 36 months.
Time Frame: 3 years
3 years

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
Time Frame
Progression of axial length in mm from baseline to t = 60 months.
Time Frame: 5 years
5 years
Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.
Time Frame: 3 years
3 years
Progression of spherical equivalent of refraction in dioptres from baseline to t = 60
Time Frame: 5 years
5 years
Proportion of subjects who show ≤ 0.20 mm (good response); 0.2 - 0.3 mm (acceptable response), and > 3 mm (nonresponse)
Time Frame: 3 years
3 years
Proportion of subjects who progressed to high myopia (AL 26+ mm)
Time Frame: 3 years
3 years
Change in visual function (BCVA, contrast sensitivity, and glare)
Time Frame: 3 years
3 years
Frequency and type of treatment-related (serious) adverse events as assessed by CTCAE v5.0 (=safety)
Time Frame: 3 years
3 years
Proportion of non-adherence
Time Frame: 3 years
3 years
Difference in health related quality of life
Time Frame: 5 years
5 years

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.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development

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: C.C.W. Klaver, Prof. Dr., EMC

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.
December 19, 2022

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.
April 24, 2029

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.
April 24, 2029

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).
November 21, 2022

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.
December 19, 2022

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.
December 28, 2022

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.
September 14, 2026

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.
September 10, 2026

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.
September 1, 2026

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.
  • NL78526.078.21
  • MEC-2021-0814 (Other Identifier: METC Erasmus MC)
  • 2021-004015-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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