Suspended

Bifocals Impact on Myopia Progression in Children with Near-Point Esophoria

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What is being tested

Data Collection

Who is being recruted

Cranial Nerve Diseases+5

+ Esotropia

+ Eye Diseases

From 6 to 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 1996
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1996

Actual date on which the first participant was enrolled.

Roughly a quarter of people in the United States have myopia, or nearsightedness, which commonly begins in childhood and progresses rapidly until around age 16. This condition can increase the risk of retinal detachment due to excessive eye growth. Previous studies have shown mixed results about the effectiveness of bifocals in slowing myopia progression. However, there is some evidence to suggest that bifocals may be beneficial for children with near-point esophoria, a condition where the eyes tend to turn inward when focusing on close objects. This study aims to further investigate the potential benefits of bifocals for myopic children with near-point esophoria. Over 80 children with this condition will be randomly assigned to wear either single-vision glasses or bifocals with a +1.50 D add. Participants will visit one of two sites every 6 months for 30 months, for a total of six visits. During these visits, measurements will be taken to assess changes in myopia and eye growth. Questionnaires will also be administered to gather information about the amount of close work, such as reading or using electronic devices, that the participants engage in.

Official TitleA Trial of Bifocals in Myopic Children With Esophoria
Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 12 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Cranial Nerve DiseasesEsotropiaEye DiseasesMyopiaNervous System DiseasesRefractive ErrorsStrabismusOcular Motility Disorders

Criteria

Boys must have been between 6 and 12 years of age; girls between 6 and 11 years of age. All children must have had at least 0.5 diopters of myopia in both eyes, near-point esophoria, at least 20/25 acuity in each eye, and 40 seconds of stereopsis and must have been free of ocular disease or systemic disease that may have altered refraction. All subjects were willing to wear bifocal spectacle lenses for 30 months.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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