Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

NCT ID: NCT05760911

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2024-09-30

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. 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.

Conditions

Myopia, Progressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Outdoor activities motivating group

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.

Group Type: EXPERIMENTAL

Outdoor activities motivation with smartwatches

Intervention Type: 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 monitoring group

Outdoor activities are monitored with smartwatches.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Outdoor activities motivation with smartwatches

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Haidong Zou, MD

Role: CONTACT

zouhaidong@sjtu.edu.cn

02153555032

Jun Chen, PhD

Role: CONTACT

chenjun_0809@163.com

Other Identifiers

kjb-wb-v1.1-20220507

Identifier Type: -

Identifier Source: org_study_id