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

Sponsor

The University of New South Wales (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06119243

Collaborator

Queensland University of Technology (Other), New England College of Optometry (Other), State University of New York College of Optometry (Other), University of California, Berkeley (Other)

230

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Vivior

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

230 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Outcome Measures

Primary Outcome Measures

Near viewing duration [12 months]
Duration during near tasks
Near viewing distance [12 months]
Distance during near tasks
Outdoor time [12 months]
Ambient illumination to determine time spent outdoors

Secondary Outcome Measures

Objective cycloplegic central refraction [12 months]
Change in objective refraction to measure myopia progression
Axial length [12 months]
Change in axial length to measure myopia progression
Subjective cycloplegic central refraction [12 months]
Change in subjective refraction to measure myopia progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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, amblyopia or significant anisometropia (>1.50 D)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Optometry, University of California, Berkeley	Berkeley	California	United States	94720
2	New England College of Optometry	Boston	Massachusetts	United States	02115
3	State University of New York (SUNY), College of Optometry	New York	New York	United States	10036
4	School of Optometry and Vision Science, UNSW	Sydney	New South Wales	Australia	2052
5	Optometry and Vision Science, Queensland University of Technology	Kelvin Grove	Queensland	Australia	4059