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

NCT06623760 | Not Yet Recruiting

• 1 other identifier: 20240901
• Study Type: interventional
• Target: 2,100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Axial Length, Eye; Myopia; Myopia Progression

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

Secondary Outcomes (1)

• The incidence of myopia.

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

Study Arms (2)

Desk and chair adaptation interventions

EXPERIMENTAL

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

Continued use of original desks and chairs

NO INTERVENTION

No change in height of desks and chairs, use as usual

Interventions

Desk and chair adaptation interventions DEVICE

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。

Desk and chair adaptation interventions

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• 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

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

韶君 许

CONTACT

18055151289; 601792160@qq.com

亚新 张

CONTACT

18756589920; 824178531@qq.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 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-08