Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Myopia Clinical Trial

— MENOK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119243
• Other study ID #: MENOK
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: The University of New South Wales
• Contact: Pauline Kang, PhD
• Phone: 612 9065 6112
• Email: p.kang[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

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, amblyopia or significant anisometropia (>1.50 D)

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

Related Conditions & MeSH terms

• Myopia

Intervention

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.

Locations

Country	Name	City	State
Australia	Optometry and Vision Science, Queensland University of Technology	Kelvin Grove	Queensland
Australia	School of Optometry and Vision Science, UNSW	Sydney	New South Wales
United States	School of Optometry, University of California, Berkeley	Berkeley	California
United States	New England College of Optometry	Boston	Massachusetts
United States	State University of New York (SUNY), College of Optometry	New York	New York

Sponsors (5)

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

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near viewing duration	Duration during near tasks	12 months
Primary	Near viewing distance	Distance during near tasks	12 months
Primary	Outdoor time	Ambient illumination to determine time spent outdoors	12 months
Secondary	Objective cycloplegic central refraction	Change in objective refraction to measure myopia progression	12 months
Secondary	Axial length	Change in axial length to measure myopia progression	12 months
Secondary	Subjective cycloplegic central refraction	Change in subjective refraction to measure myopia progression	12 months