MAD Trial: Myopia Atropine Dose
ConditionProgressive Myopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorErasmus Medical Center
About this trial
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 criteria
Qualifiers
Children aged 6 to ≤ 11 years with bilateral myopia
Onset of myopia ≥ 4 years of age
History of progression
SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
Disqualifiers
Allergy to atropine or other excipients of the eye drops
History of amblyopia or strabismus
History of retinal dystrophy or systemic disorder
Abnormal ocular biometry aside from axial length
Trial design
Treatments tested in this trial
- Atropine Ophthalmic 0.05%
- Atropine Ophthalmic 0.5%
Treatment groups
550 Participants
are divided into 2 treatment groupsSponsors and collaborators
Erasmus Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov