Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Part of paid clinical trials in Berkeley, California.

Sponsor
The University of New South Wales
Study ID
NCT06119243
Status
Recruiting

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
4 Years - 14 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 21, 2023
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
230 participants (estimated)

Primary Outcome Measure

Near viewing duration [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
School of Optometry, University of California, BerkeleyBerkeleyCalifornia94720-
New England College of OptometryBostonMassachusetts02115
Fuensanta Vera-Diaz, PhD
State University of New York (SUNY), College of OptometryNew YorkNew York10036
Xiaoying Zhu, PhD

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