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NOT YET RECRUITING
NCT07838597
NA

The Emmetropization Via Accommodation (EVA) - II Study

Sponsor: Ohio State University

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

13 Weeks - 19 Weeks

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2027-04-01

Completion Date

2032-06-30

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Ohio State University College of Optometry

Columbus, Ohio, United States