A trial to compare Atropine eye drops of 0.05% versus Atropine 0.5% to avoid myopia progression in Dutch Childeren.

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. - Myopia Atropine Dose study (MAD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004015-11-NL

Enrollment

550

Registered

2022-07-07

Start date

2022-11-11

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Trade Name: MINIMS ATROPINESULFAAT oogdruppels Pharmaceutical Form: Eye drops INN or Proposed INN: ATROPINE SULFATE CAS Number: 55-48-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged 6 to =4 years of age Spherical Equivalent Refraction (SER) of at least -1.50 D and no greater than -6.00 D in each eye Intraocular pressure =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy to Atropine or other excipients of the eye drops History of amblyopia or strabismus History of retinal dystrophy or systemic disorder that predisposes to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity). Abnormal ocular biometry aside from axial length (e.g., keratoconus, lenticonus, spherophakia) or previous intraocular or ocular laser/non-laser surgery History of glaucoma; anatomic narrow anterior chamber angles Prior myopia control treatment (Atropine, ortho-keratology, multifocal contact lenses).

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. To create an online BIG DATA registry for myopia treatment in the Netherlands which can be used for evaluation of myopia progression in the long term.;Secondary Objective: Not applicable;Primary end point(s): Progression of AL in mm at Month 36 and Month 60.;Timepoint(s) of evaluation of this end point: Month 36 and Month 60.	—

Measure

Time frame

Main Objective: To compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. To create an online BIG DATA registry for myopia treatment in the Netherlands which can be used for evaluation of myopia progression in the long term.;Secondary Objective: Not applicable;Primary end point(s): Progression of AL in mm at Month 36 and Month 60.;Timepoint(s) of evaluation of this end point: Month 36 and Month 60.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Netherlands

Contacts

Public ContactJan Roelof Polling

Erasmus MC

j.polling@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026