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Not Yet Recruiting NCT07838597

The Emmetropization Via Accommodation (EVA) - II Study

Conditions: Hyperopia, Farsightedness, Hypermetropia

Sex: All
Ages: 13 Weeks – 19 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 52
Sponsor: Ohio State University

Location: The Ohio State University College of Optometry Columbus Ohio

Summary

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).

Eligibility Criteria

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. * Anisometropia \>1.50 D spherical equivalent. * Strabismus. * Previous difficulty with pupil dilation. * Cardiac, liver, asthma, or other respiratory disease. * Ocular disease/abnormality, prior intraocular surgery, retinal detachment, optic nerve hypoplasia, malformation of the eye, cortical visual impairment, or active ocular inflammation. * Hydrocephalus, Down syndrome, cerebral palsy, severe developmental delay, or seizure disorder. * A condition preventing spectacle wear for the study duration (e.g., plagiocephaly).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07838597). StuddyBuddy aggregates publicly available trial information.