RecruitingPhase 3NCT05667454

MAD Trial: Myopia Atropine Dose

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


Sponsor

Erasmus Medical Center

Enrollment

550 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atropine Ophthalmic 0.05% and a drug called Atropine Ophthalmic 0.5% for people with progressive myopia. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 6 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtropine Ophthalmic 0.05%

Atropine 0.05% sulphate ophthalmic solution

DRUGAtropine 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

View Full Details on ClinicalTrials.gov

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NCT05667454