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Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches

NCT05760911•Shanghai Eye Disease Prevention and Treatment Center

View on ClinicalTrials.gov

Summary

The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are: 1. To evaluate the two-year change of spherical equivalent progression. 2. To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention. Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.

Eligibility

Age

4 - 9 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Gender is not limited;
•2. Age: 4 \~ 9 years old;
•3. Spherical equivalent: -0.5D \< SE \< 2.5D;
•4. Be able to follow up for at least 2 years;
•5. Be able to wear a smartwatch on a daily basis as required;
•6. Parents or guardians sign an informed consent form;
•7. Children over 6 years old need oral consent to participate.

Exclusion Criteria

•1. Anisometropia \> 1.50D;
•2. Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;
•3. Strabismus and/or amblyopia;
•4. Previous history of eye surgery (including strabismus correction);
•5. Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
•6. Other circumstances that the investigator judges inappropriate to participate in the trial.

Key Dates

Start Date

March 15, 2023

Primary Completion Date

June 30, 2024

Completion Date

September 30, 2024

Last Updated

March 9, 2023

Enrollment

1,200

ESTIMATED participants

Conditions

Myopia, Progressive

Interventions

Outdoor activities motivation with smartwatches

BEHAVIORAL

Contacts

Haidong Zou, MD

CONTACT

02153555032 zouhaidong@sjtu.edu.cn

Jun Chen, PhD

CONTACT

chenjun_0809@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Inclusion Criteria

Exclusion Criteria

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