Axial Length, EyeNCT06623760
Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students
A study testing Desk and chair adaptation interventions in people with Axial Length, Eye and Myopia, run by Fangbiao Tao.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Length, Eye, Myopia, Myopia Progression
- What is being tested?
- Desk and chair adaptation interventions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
Translated with DeepL.com (free version)
- Conditions
- Axial Length, Eye, Myopia, Myopia Progression
- Being tested
- Desk and chair adaptation interventions
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desk and chair adaptation interventionsDevice
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。
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, , and at the 12th month of the intervention.
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.
Measured: at baseline, and at the 12th month of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Length, EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623760
- Sponsor's protocol ID
- 20240901
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study：Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students
- ClinicalTrials.gov ID
- NCT06623760
- Acronym / sponsor ID
- 20240901
- Conditions
- Axial Length, Eye, Myopia, Myopia Progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Translated with DeepL.com (free version)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desk and chair adaptation interventions | Experimental | Device: Desk and chair adaptation interventionsAdjustment of the height of desks and chairs according to the height of each student, intervention lasting one year |
| Continued use of original desks and chairs | No intervention | –No change in height of desks and chairs, use as usual |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desk and chair adaptation interventionsAdjustment 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。 | Device | Desk and chair adaptation interventions |
Primary outcome
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention
Time frame: 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.
1 secondary outcome
The incidence of myopia.
Time frame: at baseline, and at the 12th month of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
Related trials for Axial Length, Eye
Not yet recruiting
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia
Myopia, Myopia Progression
Recruiting
Targeted Lens Intervention for Myopic Anisometropia in Children
Anisometropia, Myopia
Not yet recruiting
Effect of a Myopia Control Lens on the Astigmatism in Children
Astigmatism, Myopia
Active, not recruitingPhase 3
MAD Trial: Myopia Atropine Dose
Progressive Myopia
Not yet recruitingObservational study
Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study)
Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Desk and chair adaptation interventions in people with Axial Length, Eye and Myopia, run by Fangbiao Tao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 韶君 许 (18055151289, 601792160@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention (time frame: at baseline, , and at the 12th month of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.