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

NCT06607640 — Not applicable, Unknown, 210 participants, Fangbiao Tao

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

Registry	NCT06607640
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	210 (Estimated)
Sponsor	Fangbiao Tao (Other)
Conditions	Axial Length, Myopia
Interventions	Increase outdoor activity time during specific time periods (Behavioral)
Dates	start 2024-09-21 (estimated), primary completion 2025-09-21 (estimated), completion 2025-12-21 (estimated), first posted 2024-09-23, last updated 2024-09-23

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention: Increase outdoor activity time during specific time periods.	Experimental	Behavioral: 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.
continued their regular indoor or outdoor routine	No intervention		The control group continued their regular indoor or outdoor routine.

Increase outdoor activity time during specific time periods (Behavioral), also known as Intervention with a specific outdoor activity model: 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.

+Outcome measures

Primary outcomes

The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention [at baseline, at the 6th month of the intervention, and at the 12th month.]: 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.

Secondary outcomes

The incidence of myopia. [at baseline, at the 6th month of the intervention, and at the 12th month.]: The incidence of myopia is defined as the occurrence of myopia in children who were not myopic at baseline.

+Eligibility

Sex: All, ages: 4 Years to 5 Years, accepts healthy volunteers

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.

+Investigators

Yang Feng, Principal investigator, Anhui Medical University