Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Last updated: December 8, 2024
Sponsor: The University of New South Wales
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

Vivior

Clinical Study ID

NCT06119243
MENOK
  • Ages 4-14
  • All Genders

Study 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

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-oldchildren (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 andconsent form

  6. Willing to undergo treatment to slow myopia progression for one year

Exclusion

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 affecttheir vision

  4. Ocular or systemic medication use which may interfere or interact with myopiatreatment or ocular development

  5. Child, parents or guardians not willing to comply with treatment and/or follow-upschedule and planning to migrate or move during the one-year study duration

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: Vivior
Phase:
Study Start date:
March 21, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • School of Optometry and Vision Science, UNSW

    Sydney, New South Wales 2052
    Australia

    Active - Recruiting

  • Optometry and Vision Science, Queensland University of Technology

    Kelvin Grove, Queensland 4059
    Australia

    Active - Recruiting

  • School of Optometry, University of California, Berkeley

    Berkeley, California 94720
    United States

    Site Not Available

  • New England College of Optometry

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • State University of New York (SUNY), College of Optometry

    New York, New York 10036
    United States

    Site Not Available

  • State University of New York (SUNY), College of Optometry

    New York City, New York 10036
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.