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Completed Not applicable Interventional Accepts healthy volunteers Results available

Enhancement of Emmetropization in Highly Hyperopic Infants

ClinicalTrials.gov ID: NCT03669146

Public ClinicalTrials.gov record NCT03669146. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 2:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Enhancement Via Accommodation (EVA) Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Infants do not usually wear glasses because they usually do not need them to see clearly. Most infants are born with a moderate amount of farsightedness. Most infants then undergo a natural process called 'emmetropization' that reduces the amount of farsightedness. However, up to 10% of infants don't emmetropize and end up with very farsighted prescriptions. Farsighted infants must use extra focusing effort to see clearly, which may make their eyes cross and perhaps cause a "lazy eye". If infants avoid this effort and their vision stays blurred into childhood, they may develop two lazy eyes. Farsightedness in school-aged children makes reading and learning more difficult. New studies in animals and in humans show that infant eyes will emmetropize best if they have just a normal, moderate amount of farsightedness. The infant eye must be in this normal target zone in order to emmetropize. If a baby were given glasses with the full prescription to correct all of his farsightedness, the eyes would also be out of the target zone and would not receive any signal to grow. The best strategy might be to give a partial spectacle correction for the farsightedness, just enough to put them in the zone that is most effective for emmetropization. The purpose of this project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction and accommodative (eye focusing) training. The partial correction is an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. As changes in farsightedness occur, the power of the glasses will be reduced to keep the farsightedness within the target zone. If an infant reaches a normal amount of farsightedness, the glasses will be discontinued. The comparison group will be farsighted babies who receive the current standard of care, namely no correction. The main outcome of the study will be whether there is a significant difference in the decrease of farsightedness between the two groups when the infants are 18 months of age. If emmetropization can be enhanced in very farsighted babies, the risk of developing crossed or lazy eye will be reduced. The lifelong need for spectacles, contact lenses, or refractive surgery for high amounts of farsightedness would also be reduced. Positive results might also make infant eye examinations more common and place a new therapeutic option in clinicians' hands.

Study identification

NCT ID
NCT03669146
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Donald O Mutti, OD, PhD
Other
Enrollment
35 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
8 Weeks to 15 Weeks
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 23, 2019
Primary completion
Jan 4, 2023
Completion
Jan 4, 2023
Last update posted
Jul 8, 2024

2019 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
The Ohio State University Columbus Ohio 43210

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03669146, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2024 · Synced Sep 5, 2026

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