Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

NCT06119243 | Recruiting

• 1 other identifier: MENOK
• Study Type: observational
• Target: 230
• Locations: 2 countries
• Sites: 5

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.

Conditions

Myopia

Keywords

Myopia; Myopia control; Progressive myopia; Near vision behavior; Outdoor activity; Environment; Light exposure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Objective cycloplegic central refraction

  12 months

• Axial length

  12 months

• Subjective cycloplegic central refraction

  12 months

Interventions

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.

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of New South Wales: lead
• Queensland University of Technology: collaborator
• New England College of Optometry: collaborator
• State University of New York College of Optometry: collaborator
• University of California, Berkeley: collaborator

Study Sites (5)

School of Optometry, University of California, Berkeley

Berkeley, California, 94720, United States

ACTIVE NOT RECRUITING

New England College of Optometry

Boston, Massachusetts, 02115, United States

RECRUITING

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

New York, New York, 10036, United States

NOT YET RECRUITING

School of Optometry and Vision Science, UNSW

Sydney, New South Wales, 2052, Australia

RECRUITING

Optometry and Vision Science, Queensland University of Technology

Kelvin Grove, Queensland, 4059, Australia

RECRUITING

MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Pauline Kang, PhD

CONTACT

612 9065 6112; p.kang@unsw.edu.au

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: March 21, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (3)