Ohio State University
To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).
Uncorrected hyperopia (farsightedness) in children can lead to significant learning and visual problems, affecting their overall well-being and academic potential. Normally, infants are born with a moderate degree of hyperopia which should decrease as undergo a normal, developmental process called emmetropization, which mostly occurs during the first 18 months of life. Sometimes, this process fails, leaving children with higher-than-normal levels of hyperopia, which significantly increases their risk of developing conditions like strabismus (crossed eyes), amblyopia (lazy eye), and early liter…
Inclusion Criteria: * Signed parental permission and HIPAA authorization and willingness to comply with study procedures. * Infant 13-19 weeks of age at baseline. * Either sex and any race or ethnicity. * Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight \>2500 g. * Mean MEM accommodative lag \>+1.25 D based on three measurements throughout the baseline examination. * Cycloplegic spherical-equivalent hyperopia ≥+3.50 D in one or both eyes. Exclusion Criteria: * Astigmatism \>2.00 D in either eye. * Anisometropi…
Infants will receive spectacles that have a prescription relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D from the study protocol. An experimental non-invasive treatment will be prescribed as well. Treatment will continue until study completion at 18 months of age or until the infant reaches a spherical equivalent refractive error of +2.00D or less hyperopia. Participants will also receive a non-invasive treatment to be used at home.
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