Actively Recruiting

Phase 3
Age: 6Years - 11Years
All Genders
NCT05667454

MAD Trial: Myopia Atropine Dose

Led by Erasmus Medical Center · Updated on 2025-04-27

550

Participants Needed

20

Research Sites

327 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MAD Trial: Myopia Atropine Dose

Who Can Participate

Age: 6Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 6#8804; 11 years with myopia in both eyes
  • Myopia started at age 4 or older
  • History of myopia progression
  • Spherical equivalent refraction between -1.00D and -6.00D in each eye measured with cycloplegic auto refraction
  • Intraocular pressure less than 21 mm Hg in each eye
  • Distance vision correctable to at least 0.1 Log MAR in each eye
Not Eligible

You will not qualify if you...

  • Allergy to atropine or any ingredients in the eye drops
  • History of amblyopia or strabismus
  • History of retinal dystrophy or systemic disorders
  • Abnormal eye measurements other than axial length
  • History of glaucoma
  • Chronic use of antimuscarinic or anticholinergic medications within 21 days before screening or expected chronic use during the study
  • Frequent use (more than 3 days a week) of other eye medications besides study drops
  • Expected need for chronic corticosteroid use during the study
  • Previous myopia treatments
  • Employees of the study center and their family members

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 20 locations

1

Flevoziekenhuis

Almere Stad, Netherlands

Actively Recruiting

2

OLVG, locatie Oost

Amsterdam, Netherlands

Actively Recruiting

3

Ophthalmologistenpraktijk Delfland

Delft, Netherlands

Actively Recruiting

4

Reinier de Graaf Gasthuis

Delft, Netherlands

Actively Recruiting

5

Deventer Ziekenhuis

Deventer, Netherlands

Actively Recruiting

6

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Actively Recruiting

7

Bergman Clinics - Ede

Ede, Netherlands

Actively Recruiting

8

Admiraal de Ruyter Ziekenhuis

Goes, Netherlands

Actively Recruiting

9

Frisius MC

Heerenveen, Netherlands

Actively Recruiting

10

Oogcentrum Noordholland

Heerhugowaard, Netherlands

Actively Recruiting

11

Leiden University Medical Center

Leiden, Netherlands

Actively Recruiting

12

Bergman Clinics - Lelystad

Lelystad, Netherlands

Actively Recruiting

13

Maastricht UMC+

Maastricht, Netherlands

Actively Recruiting

14

St. Antonius

Nieuwegein, Netherlands

Actively Recruiting

15

Radboudumc

Nijmegen, Netherlands

Actively Recruiting

16

Erasmus Medical Center

Rotterdam, Netherlands

Actively Recruiting

17

Haga Ziekenhuis

The Hague, Netherlands

Actively Recruiting

18

Oogkliniek Den Haag

The Hague, Netherlands

Actively Recruiting

19

Ziekenhuis Rivierenland Tiel

Tiel, Netherlands

Actively Recruiting

20

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Actively Recruiting

Loading map...

Research Team

J

Jan Roelof Polling, Dr.

CONTACT

T

Trialbureau Oogheelkunde

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here