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MAD Trial: Myopia Atropine Dose
Sponsor: Erasmus Medical Center
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
Conditions
Interventions
Atropine Ophthalmic 0.05%
Atropine 0.05% sulphate ophthalmic solution
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