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

NCT06607640 | Not Yet Recruiting

• 1 other identifier: 20240666
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Axial Length; Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The incidence of myopia.

  at baseline, at the 6th month of the intervention, and at the 12th month.

Study Arms (2)

Intervention: Increase outdoor activity time during specific time periods.

EXPERIMENTAL

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

continued their regular indoor or outdoor routine

NO INTERVENTION

The control group continued their regular indoor or outdoor routine.

Interventions

Increase outdoor activity time during specific time periods BEHAVIORAL

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.

Also known as: Intervention with a specific outdoor activity model

Intervention: Increase outdoor activity time during specific time periods.

Eligibility Criteria

• Age: 4 Years - 5 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fangbiao Tao: lead

MeSH Terms

Conditions

Myopia

Interventions

Methods

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yang Feng

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Fang biao, professor

CONTACT

13856986775; taofangbiao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: September 21, 2024
• Primary Completion: September 21, 2025
• Study Completion: December 21, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09