NCT06119243

Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: The University of New South Wales · Academic / Other
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-21
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2023-11-07
• Last updated: 2024-12-12

Locations

5 sites across 2 countries: United States, Australia