Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study (MENOK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Vivior

• Study Type: Observational
• Enrollment (Estimated): 230

Contacts and Locations

• Study Contact: Name: Pauline Kang, PhD; Phone Number: 612 9065 6112; Email: p.kang@unsw.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2052
      • Recruiting
      • School of Optometry and Vision Science, UNSW
      • Contact: Pauline Kang, PhD
      • Contact: Pauline Kang, PhD; Email: p.kang@unsw.edu.au
  • Queensland
    • Kelvin Grove, Queensland, Australia, 4059
      • Recruiting
      • Optometry and Vision Science, Queensland University of Technology
      • Contact: Emily Pieterse, PhD
• United States
  • California
    • Berkeley, California, United States, 94720
      • Active, not recruiting
      • School of Optometry, University of California, Berkeley
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • New England College of Optometry
      • Contact: Fuensanta Vera-Diaz, PhD
  • New York
    • New York City, New York, United States, 10036
      • Not yet recruiting
      • State University of New York (SUNY), College of Optometry
      • Contact: Xiaoying Zhu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near viewing duration	Duration during near tasks	12 months
Near viewing distance	Distance during near tasks	12 months
Outdoor time	Ambient illumination to determine time spent outdoors	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective cycloplegic central refraction	Change in objective refraction to measure myopia progression	12 months
Axial length	Change in axial length to measure myopia progression	12 months
Subjective cycloplegic central refraction	Change in subjective refraction to measure myopia progression	12 months

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: University of California, Berkeley; State University of New York College of Optometry; Queensland University of Technology; New England College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Environment; Myopia; Myopia control; Outdoor activity; Light exposure; Progressive myopia; Near vision behavior
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: MENOK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No