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NCT Number: NCT06119243

Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

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.

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Key information

Conditions

Myopia Eye Diseases Myopia, Degenerative Refractive Errors

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Optometry and Vision Science, UNSW, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vivior

Device

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 outcomes

  1. Near viewing duration

    Time frame: 12 months

    Duration during near tasks

  2. Near viewing distance

    Time frame: 12 months

    Distance during near tasks

  3. Outdoor time

    Time frame: 12 months

    Ambient illumination to determine time spent outdoors

Secondary outcomes

  1. Objective cycloplegic central refraction

    Time frame: 12 months

    Change in objective refraction to measure myopia progression

  2. Axial length

    Time frame: 12 months

    Change in axial length to measure myopia progression

  3. Subjective cycloplegic central refraction

    Time frame: 12 months

    Change in subjective refraction to measure myopia progression

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline Kang, PhD

CONTACT

[email protected]

612 9065 6112

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • New England College of Optometry
  • Queensland University of Technology
  • State University of New York College of Optometry
  • University of California, Berkeley

Registry information

Official study title

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

Acronym: MENOK

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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