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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Myopia Progression; Axial Length, Eye
• Intervention / Treatment: Device: Desk and chair adaptation interventions

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 Type: Interventional
• Enrollment (Estimated): 2100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: 韶君 许; Phone Number: 18055151289; Email: 601792160@qq.com
• Study Contact Backup: Name: 亚新 张; Phone Number: 18756589920; Email: 824178531@qq.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: Desk and chair adaptation interventions; Adjustment of the height of desks and chairs according to the height of each student, intervention lasting one year	Device: Desk and chair adaptation interventions; Adjustment of the height of tables and chairs to the height of each pupil in accordance with Functional sizes and technical requirements of chairs and tables for educational institutions (GB/T 3976--2014）, with a duration of intervention of one year。
No Intervention: Continued use of original desks and chairs; No change in height of desks and chairs, use as usual

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

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, and at the 12th month of the intervention.

Collaborators and Investigators

• Sponsor: Fangbiao Tao

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 20240901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No