RecruitingNCT06119243

Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control

Sponsor

The University of New South Wales

Enrollment

230 participants

Start Date

Mar 21, 2023

Study Type

OBSERVATIONAL

Conditions

Myopia

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

Min Age: 4 YearsMax Age: 14 Years

Inclusion Criteria6

Aged 6 to below 14 years old
Spherical equivalent myopic refractive error greater than -0.50 D
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)
Good ocular and general health that would not preclude them from myopia control
Competent enough in English to fully understand the participant information and consent form
Willing to undergo treatment to slow myopia progression for one year

Exclusion Criteria5

Strabismus at distance or near, or amblyopia
Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
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

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Interventions

DEVICEVivior

The Vivior is a wearable clip-on sensor that objectively quantifies near viewing distance and duration, and ambient illumination. The Vivior will be attached to the spectacles frame of children undergoing myopia control treatment.