MAD Trial: Myopia Atropine Dose
MAD
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
3 other identifiers
interventional
550
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedStudy Start
First participant enrolled
December 19, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 27, 2025
April 1, 2025
6.2 years
November 21, 2022
April 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of axial length in mm from baseline to t = 36 months.
3 years
Secondary Outcomes (9)
Progression of axial length in mm from baseline to t = 60 months.
5 years
Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.
3 years
Progression of spherical equivalent of refraction in dioptres from baseline to t = 60
5 years
Proportion of subjects who show ≤ 0.20 mm (good response); 0.2 - 0.3 mm (acceptable response), and > 3 mm (nonresponse)
3 years
Proportion of subjects who progressed to high myopia (AL 26+ mm)
3 years
- +4 more secondary outcomes
Study Arms (2)
Low dose atropine
ACTIVE COMPARATORAtropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
High dose atropine
ACTIVE COMPARATORAtropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Flevoziekenhuis
Almere Stad, Netherlands
OLVG, locatie Oost
Amsterdam, Netherlands
Ophthalmologistenpraktijk Delfland
Delft, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands
Bergman Clinics - Ede
Ede, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Frisius MC
Heerenveen, Netherlands
Oogcentrum Noordholland
Heerhugowaard, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Bergman Clinics - Lelystad
Lelystad, Netherlands
Maastricht UMC+
Maastricht, Netherlands
St. Antonius
Nieuwegein, Netherlands
Radboudumc
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Oogkliniek Den Haag
The Hague, Netherlands
Ziekenhuis Rivierenland Tiel
Tiel, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C.C.W. Klaver, Prof. Dr.
EMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. C.C.W. Klaver
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 28, 2022
Study Start
December 19, 2022
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
April 27, 2025
Record last verified: 2025-04