Study of the Intervention Effect of Outdoor Activity Period Patterns in Promoting Myopia Among Preschool Children

Study on the Association of Time Pattern of Outdoor Activity With Axial Length and Myopia of Preschool Children and Its Intervention

This study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to determine the effect of outdoor activities at specific time periods on the prevention of myopia in preschool children. Additionally, the study investigated the association between outdoor activities at specific time periods and axial length and myopia in preschool children.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Axial Length
• Intervention / Treatment: Behavioral: Increase outdoor activity time during specific time periods

Detailed Description

Preschool children with insufficient outdoor activity during specific time periods from one kindergarten were assigned to the intervention group, while those from another kindergarten with insufficient outdoor activity during specific time periods were assigned to the control group. The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, while the control group did not receive any intervention and continued their regular routine. The intervention lasted for one year.

Participants underwent multiple assessments after joining the study. These assessments took place at baseline, at the 6th month of the intervention, and at the 12th month.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Fang biao, professor; Phone Number: 13856986775; Email: taofangbiao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
• Able to cooperate with eye examinations and questionnaires.

Exclusion Criteria:

• Communication barriers, unable to cooperate.
• Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
• Children currently using orthokeratology lenses or rigid contact lenses.
• Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Increase outdoor activity time during specific time periods.; The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, with the intervention lasting for one year.	Behavioral: Increase outdoor activity time during specific time periods; The specific time periods of outdoor activity found to be beneficial for myopia prevention will be used as the intervention "target," and a one-year intervention will be initiated.; Other Names: Intervention with a specific outdoor activity model
No Intervention: continued their regular indoor or outdoor routine; The control group continued their regular indoor or outdoor routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention	The ocular physiological parameters, including axial length (AL), horizontal and vertical corneal curvature (K1 and K2), were measured using an optical biometer (model IOL Master 700). Each eye was measured three times, and if the difference between any two measurements exceeded 0.05 mm, the process was repeated until the difference was less than this value.An objective examination method was used under non-cycloplegic conditions (i.e., without pupil dilation), utilizing a tabletop automatic refractometer (ISO 10342-2010 Ophthalmic Instruments - Refractometers). The spherical equivalent (SE) was calculated as follows: SE = sphere power + 1/2 cylinder power.	at baseline, at the 6th month of the intervention, and at the 12th month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of myopia.	The incidence of myopia is defined as the occurrence of myopia in children who were not myopic at baseline.	at baseline, at the 6th month of the intervention, and at the 12th month.

Collaborators and Investigators

• Sponsor: Fangbiao Tao
• Investigators: Principal Investigator: Yang Feng, Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): September 21, 2024
• Primary Completion (Estimated): September 21, 2025
• Study Completion (Estimated): December 21, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 20240666

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No