Study of the Intervention Effect of Outdoor Activity Period Patterns in Promoting Myopia Among Preschool Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-5
SponsorFangbiao Tao
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Increase outdoor activity time during specific time periods
BehavioralThe 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.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Intervention: Increase outdoor activity time during specific time periods.Experimental treatment 1 intervention
Group B: continued their regular indoor or outdoor routineNo intervention 0 interventions
Trial outcomes
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.
Time frame
at baseline, at the 6th month of the intervention, and at the 12th month.Secondary outcomes
1
The incidence of myopia.
The incidence of myopia is defined as the occurrence of myopia in children who were not myopic at baseline.
Time frame
at baseline, at the 6th month of the intervention, and at the 12th month.Locations
Sponsors and contacts
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Fangbiao Tao
Lead sponsor
Anhui Medical University
Sponsor institution
Source ClinicalTrials.gov
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