CClinicalTrials.gg
Status unknownNCT05760911Updated Mar 9, 2023

Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

An interventional study of Outdoor activities motivation with smartwatches in Myopia, Progressive, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia, Progressive
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Outdoor activities motivation with smartwatches

  • No intervention
    Outdoor activities monitoring group

    Outdoor activities are monitored with smartwatches.

Interventions

  • BehavioralOutdoor 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.

06

What researchers measure

Primary outcomes

  1. The change of spherical equivalent

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

    Time frame: Two years

Secondary outcomes

  1. The change of axial length

    The mean change of axial length by IOL Master was calculated during the study.

    Time frame: Two years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05760911
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Mar 9, 2023
Start date
Mar 15, 2023 (estimated)
Primary completion
Jun 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Mar 9, 2023

Study contacts

Haidong Zou, MD
Contact
zouhaidong@sjtu.edu.cn
02153555032
Jun Chen, PhD
Contact
chenjun_0809@163.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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