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RECRUITING
NCT05667454
PHASE3

MAD Trial: Myopia Atropine Dose

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2022-12-19

Completion Date

2029-04-01

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

DRUG

Atropine Ophthalmic 0.05%

Atropine 0.05% sulphate ophthalmic solution

DRUG

Atropine Ophthalmic 0.5%

Atropine 0.5% sulphate ophthalmic solution

Locations (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