MAD Trial: Myopia Atropine Dose (MAD)
Progressive Myopia
About this trial
This is an interventional treatment trial for Progressive Myopia focused on measuring Myopia, Atropine, Axial length, Child
Eligibility Criteria
Inclusion Criteria: Children aged 6 to ≤ 11 years with bilateral myopia Onset of myopia ≥ 4 years of age History of progression ≥ -0.5D/yr. SER of at least -1.50D 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 Criteria: 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.
Sites / Locations
- Noordwest Ziekenhuisgroep
- Flevoziekenhuis
- OLVG, locatie Oost
- Ophthalmologistenpraktijk Delfland
- Reinier de Graaf Gasthuis
- Bergman Clinics - Den Bosch
- Haaglanden Medisch Centrum
- Deventer Ziekenhuis
- Albert Schweitzer ziekenhuis
- Bergman Clinics - Ede
- Medisch Spectrum Twente
- Admiraal de Ruyter Ziekenhuis
- Tjongerschans Heerenveen
- Oogcentrum Noordholland
- Isala - Kampen
- Leiden University Medical Center
- Bergman Clinics - Lelystad
- Isala - Meppel
- St. Antonius
- Radboudumc
- Erasmus Medical CenterRecruiting
- Ziekenhuis Rivierenland Tiel
- Elisabeth-TweeSteden Ziekenhuis
- Isala - Zwolle
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Low dose atropine
High dose atropine
Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.