Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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