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NCT06119243Recruiting

Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

The University of New South Wales

Start Date

3/21/2023

Completion Date

12/31/2026

Summary

Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.

Eligibility Criteria

Age Range: 4 years to 14 years

Inclusion Criteria: 1. Aged 6 to below 14 years old 2. Spherical equivalent myopic refractive error greater than -0.50 D 3. Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations) 4. Good ocular and general health that would not preclude them from myopia control 5. Competent enough in English to fully understand the participant information and consent form 6. Willing to undergo treatment to slow myopia progression for one year Exclusion Criteria: 1. Strabismus at distance or near, or amblyopia 2. Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis) 3. Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision 4. Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development 5. Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration

Interventions

DEVICE

Vivior

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Conditions

Myopia

Locations

School of Optometry, University of California, Berkeley

Berkeley, California 94720

United States

New England College of Optometry

Boston, Massachusetts 02115

United States

State University of New York (SUNY), College of Optometry

New York, New York 10036

United States

School of Optometry and Vision Science, UNSW

Sydney, New South Wales 2052

Australia

Optometry and Vision Science, Queensland University of Technology

Kelvin Grove, Queensland 4059

Australia