Low-Dose Atropine for Treatment of Myopia (Myopia Treatment Study)
Study Objectives The objectives for this randomized trial are: To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
• Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.
• Refractive error meeting the following by cycloplegic autorefraction:
• Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
• Astigmatism <=1.50D in both eyes
• Anisometropia <1.00D SE
• Gestational age ≥ 32 weeks.
• Birth weight >1500g.
• Parent understands the protocol and is willing to accept randomization to atropine or placebo.
• Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
• Able to return in 2 to 4 weeks for possible randomization.
• Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
• Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.