Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Recruiting

• Conditions: Myopia

• Registration Number: NCT06119243
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-21
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

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 City, New York, United States

School of Optometry and Vision Science, UNSW; 🇦🇺 Sydney, New South Wales, Australia

Optometry and Vision Science, Queensland University of Technology; 🇦🇺 Kelvin Grove, Queensland, Australia