Clincosm LogoSign in Get a demo

Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Sponsor
Shanghai Eye Disease Prevention and Treatment Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760911
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
1,200
Enrollment
2
Arms
18.6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Outdoor activities motivation with smartwatches
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.
No Intervention: Outdoor activities monitoring group

Outdoor activities are monitored with smartwatches.

Outcome Measures

Primary Outcome Measures

  1. The change of spherical equivalent [Two years]

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

Secondary Outcome Measures

  1. The change of axial length [Two years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 9 Years
Sexes Eligible for Study:
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:

  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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier:
NCT05760911
Other Study ID Numbers:
  • kjb-wb-v1.1-20220507
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia
Myopia, Degenerative

Study Results

No Results Posted as of Mar 9, 2023