Clinical trial NCT06119243: Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
Official title: Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Keywords: Myopia
Myopia control
Progressive myopia
Near vision behavior
Outdoor activity
Environment
Light exposure
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Queensland University of Technology
name: New England College of Optometry
name: State University of New York College of Optometry
name: University of California, Berkeley
First posted: 2023-11-07
Enrollment: 230
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Myopic children will be recruited from the university based myopia control clinic. Some clinical sites have collaborated with community optometry practices so support recruitment.

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

Primary outcomes:
measure: Near viewing duration
timeFrame: 12 months
measure: Near viewing distance
timeFrame: 12 months
measure: Outdoor time
timeFrame: 12 months
Secondary outcomes:
measure: Objective cycloplegic central refraction
timeFrame: 12 months
measure: Axial length
timeFrame: 12 months
measure: Subjective cycloplegic central refraction
timeFrame: 12 months
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: School of Optometry, University of California, Berkeley
state: California
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: New York City
country: United States
facility: State University of New York (SUNY), College of Optometry
state: New York
city: Sydney
country: Australia
facility: School of Optometry and Vision Science, UNSW
state: New South Wales
city: Kelvin Grove
country: Australia
facility: Optometry and Vision Science, Queensland University of Technology
state: Queensland
Study officials:
References: