Status:
RECRUITING
Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
Queensland University of Technology
New England College of Optometry
Conditions:
Myopia
Eligibility:
All Genders
4-14 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06119243
Start Date
March 21 2023
End Date
December 31 2026
Last Update
December 12 2024
Active Locations (5)
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1
School of Optometry, University of California, Berkeley
Berkeley, California, United States, 94720
2
New England College of Optometry
Boston, Massachusetts, United States, 02115
3
State University of New York (SUNY), College of Optometry
New York, New York, United States, 10036
4
School of Optometry and Vision Science, UNSW
Sydney, New South Wales, Australia, 2052