An interventional study of Experimental treatment arm in Hyperopia, Farsightedness and Hypermetropia, sponsored by Ohio State University. Not yet recruiting at 1 site in United States. Open to participants aged 13 Weeks to 19 Weeks. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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 literacy and scholastic issues. Infants who are at the greatest risk of not undergoing the normal emmetropization process are those with significantly higher levels of hyperopia early in infancy and those with poor ocular accommodation. The emmetropization process is not perfectly understood in human infants but may allow a window of opportunity for early intervention to help reduce the risk of debilitating vision conditions, while the visual system is still plastic. This study seeks to determine if early intervention, specifically partial refractive correction and visual engagement exercises (meant to stimulate ocular accommodation), can help improve the accommodative response and therefore reduce hyperopia in infants at high risk of not undergoing emmetropization. By treating 4-month-old infants with poor accommodation, the study aims to facilitate emmetropization and potentially reduce the risk of long-term visual problems. The study will also explore whether hyperopic defocus or accommodative effort is the primary signal guiding emmetropization, the two major theories of human emmetropization. Positive outcomes from this research could lead to new standards of care for hyperopic infants, potentially preventing a lifetime of vision-related issues and improving early literacy and academic performance.
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's planned enrollment of 52 is below the median of 60 across 125 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
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Exclusion Criteria:
No treatment is administered in this arm.
Participants will receive experimental treatment.
Combination Product: Experimental treatment arm
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.
Ocular Accommodation measured with MEM
Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM).
Time frame: 14 months
Correlation between refractive error and ocular accommodation measured with MEM
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with MEM retinoscopy, in Diopters (D)
Time frame: 14 months
Correlation between refractive error and ocular accommodation measured with PowerRefractor
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with the PlusOptix PowerRefractor, in Diopters (D)
Time frame: 14 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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