Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

NCT05760911 | Unknown

• 1 other identifier: kjb-wb-v1.1-20220507
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To evaluate the two-year change of spherical equivalent progression.
2. 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.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• The change of spherical equivalent

  The mean change of spherical equivalent after cycloplegia was calculated during the study.

  Two years

Secondary Outcomes (1)

• The change of axial length

  Two years

Study Arms (2)

Outdoor activities motivating group

EXPERIMENTAL

Wear a smartwatch and receive Mini Program reminders and encouragement for outdoor activities. The required outdoor time is at least 2 hours from Monday to Friday and more than 2 hours on weekends.

Behavioral: Outdoor activities motivation with smartwatches

Outdoor activities monitoring group

NO INTERVENTION

Outdoor activities are monitored with smartwatches.

Interventions

Outdoor activities motivation with smartwatches BEHAVIORAL

Wearing a smartwatch and receiving outdoor activity reminders and encouragement through a mini-program. The required outdoor time is at least 2 hours from Monday to Friday, and more than 2 hours on weekends.

Outdoor activities motivating group

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Central Study Contacts

Haidong Zou, MD

CONTACT

02153555032; zouhaidong@sjtu.edu.cn

Jun Chen, PhD

CONTACT

chenjun_0809@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 9, 2023
• Study Start: March 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share