Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students

Not Applicable

Not yet recruiting

• Conditions: Axial Length, Eye; Myopia Progression; Myopia
• Interventions: Device: Desk and chair adaptation interventions

• Registration Number: NCT06623760
• Lead Sponsor: Fangbiao Tao

Brief Summary

This study is a randomized controlled trial of a desk and chair adaptation intervention involving primary school students and their parents or primary caregivers. We compared the myopia status of students in the intervention and control groups before and after the intervention to confirm the effect of the desk and chair adaptation intervention on the development of myopia in students.

Detailed Description

In this study, two pilot schools in Anhui Province were selected , and all students were examined by ophthalmologists, and their heights and the heights of their desks and chairs were measured in order to investigate the association between desk and chair adaptations and myopia. One of the elementary school was randomly selected for a one-year desk and chair adaptation intervention to compare the occurrence of myopia and axial growth of the students before and after the intervention in the two schools.

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Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study Start: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desk and chair adaptation interventions	Desk and chair adaptation interventions	Adjustment of the height of desks and chairs according to the height of each student, intervention lasting one year

Primary Outcome Measures

Name	Time	Method
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention	at baseline, , and at the 12th month of the 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.

Secondary Outcome Measures

Name	Time	Method
The incidence of myopia.	at baseline, and at the 12th month of the intervention.	The incidence of myopia is defined as the occurrence of myopia in children who were not myopic at baseline.