Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Vivior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Criteria: Strabismus at distance or near, amblyopia or significant anisometropia (>1.50 D) 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vivior|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near viewing duration | Duration during near tasks | 12 months | 
| Near viewing distance | Distance during near tasks | 12 months | 
| Outdoor time | Ambient illumination to determine time spent outdoors | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cycloplegic central refraction | Change in objective refraction to measure myopia progression | 12 months | 
| Axial length | Change in axial length to measure myopia progression | 12 months | 
| Subjective cycloplegic central refraction | Change in subjective refraction to measure myopia progression | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Myopia control, Progressive myopia, Near vision behavior, Outdoor activity, Environment, Light exposure