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Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Multicenter Study of Near Vision Behavior and Outdoor Time in Children Undergoing Myopia Control

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06119243
Acronym
MENOK
Enrollment
230
Registered
2023-11-07
Start date
2023-03-21
Completion date
2026-12-31
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Myopia, Myopia control, Progressive myopia, Near vision behavior, Outdoor activity, Environment, Light exposure

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.

Interventions

DEVICEVivior

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.

Sponsors

Queensland University of Technology
CollaboratorOTHER
New England College of Optometry
CollaboratorOTHER
State University of New York College of Optometry
CollaboratorOTHER
University of California, Berkeley
CollaboratorOTHER
The University of New South Wales
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Near viewing duration12 monthsDuration during near tasks
Near viewing distance12 monthsDistance during near tasks
Outdoor time12 monthsAmbient illumination to determine time spent outdoors

Secondary

MeasureTime frameDescription
Objective cycloplegic central refraction12 monthsChange in objective refraction to measure myopia progression
Axial length12 monthsChange in axial length to measure myopia progression
Subjective cycloplegic central refraction12 monthsChange in subjective refraction to measure myopia progression

Countries

Australia, United States

Contacts

Primary ContactPauline Kang, PhD
p.kang@unsw.edu.au612 9065 6112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026