NCT06119243 Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
| NCT ID | NCT06119243 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of New South Wales |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-03-21 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2023-03-21 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06119243 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 14 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06119243 currently recruiting?
Yes, NCT06119243 is actively recruiting participants. Contact the research team at p.kang@unsw.edu.au for enrollment information.
Where is the NCT06119243 trial being conducted?
This trial is being conducted at Berkeley, United States, Boston, United States, New York, United States, Sydney, Australia and 1 additional location.
Who is sponsoring the NCT06119243 clinical trial?
NCT06119243 is sponsored by The University of New South Wales. The trial plans to enroll 230 participants.