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