Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivior.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 4 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control
Overview
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.
Interventions
- 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.
Primary outcome measures
- Near viewing duration [Time frame: 12 months]
- Near viewing distance [Time frame: 12 months]
- Outdoor time [Time frame: 12 months]
Secondary outcome measures (3)
- Objective cycloplegic central refraction [Time frame: 12 months]
- Axial length [Time frame: 12 months]
- Subjective cycloplegic central refraction [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 3 centers
- School of Optometry, University of California, Berkeley — Berkeley
- New England College of Optometry — Boston
- State University of New York (SUNY), College of Optometry — New York
Australia · 2 centers
- School of Optometry and Vision Science, UNSW — Sydney
- Optometry and Vision Science, Queensland University of Technology — Kelvin Grove
Identifiers
NCT: NCT06119243 · MENOK