The Emmetropization Via Accommodation (EVA) - II Study

NCT07838597 | Not Yet Recruiting FDA Device

• 1 other identifier: 20261737
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hyperopia; Farsightedness; Hypermetropia

Keywords

emmetropization

Outcome Measures

Primary Outcomes (1)

• Ocular Accommodation measured with MEM

  Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM).

  14 months

Secondary Outcomes (2)

• Correlation between refractive error and ocular accommodation measured with MEM

  14 months

• Correlation between refractive error and ocular accommodation measured with PowerRefractor

  14 months

Study Arms (2)

Observation

NO INTERVENTION

No treatment is administered in this arm.

Spectacles and At-Home Therapy

EXPERIMENTAL

Participants will receive experimental treatment.

Combination Product: Experimental treatment arm

Interventions

Experimental treatment arm COMBINATION_PRODUCT

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.

Spectacles and At-Home Therapy

Eligibility Criteria

• Age: 13 Weeks - 19 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43209, United States

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Ann M Morrison, OD, PhD

CONTACT

614-247-0010; morrison.421@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

US (1)