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
Erasmus Medical Center
550 participants
Dec 19, 2022
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
Inclusion Criteria6
- 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
- Intraocular pressure < 21 mm Hg in each eye
- Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye
Exclusion Criteria10
- 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
- History of glaucoma
- Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).
- Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.
- The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks)
- Prior myopia treatments.
- Employees of the study center and their family members.
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Interventions
Atropine 0.05% sulphate ophthalmic solution
Atropine 0.5% sulphate ophthalmic solution
Locations(20)
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NCT05667454