Low-Dose Atropine for Treatment of Myopia

Exclusion Criteria

• •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.
• •Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
• •Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
• •Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
• •Known atropine allergy.
• •Abnormality of the cornea, lens, central retina, iris or ciliary body.
• •Current or prior history of manifest strabismus, amblyopia, or nystagmus.
• •Prior eyelid, strabismus, intraocular, or refractive surgery.
• •Down syndrome or cerebral palsy.
• •Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.
• •* A negative urine pregnancy test will be required for all females who have experienced menarche.