Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study (NCT06119243) | Clinical Trial Compass
RecruitingNot Applicable
Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
United States, Australia230 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range4 Years – 14 Years
SexALL
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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 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 criteria
✕. 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