Myopia; Refractive ErrorNCT05637827
The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin
An observational study of Myopia; Refractive Error, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Myopia; Refractive Error
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2024
- Phase
- Observational
- 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 5 to 11 years
- All sexes
- Child
Study population: Healthy children with hyperopia, emmetropia and myopia
Who may be able to join
- students in grades 1-3
- Can cooperate with the examination of students
Who cannot join
- Obvious strabismus and amblyopia
- Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
- History of ocular surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300020
yan wang, director, +86-22-27305083, wangyan7143@vip.sina.com
About this study
There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.
- Conditions
- Myopia; Refractive Error
- Being tested
- No intervention
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There was no intervention in each group, and only the natural development was observed
| Study group | Role | What they receive |
|---|---|---|
| children with hyperopia | The refractive error and axial length of eye were observed Receives: Other: No intervention | |
| children with emmetropia | The refractive error and axial length of eye were observed Receives: Other: No intervention | |
| children with myopia | The refractive error and axial length of eye were observed Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of refractive error
The changes of refractive error between visit time in every 6 months
Measured: Every 6 months for a period 3 years
The changes of axial length
The changes of axial length between visit time in every 6 months.
Measured: Every 6 months for a period 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myopia; Refractive ErrorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637827
- Sponsor's protocol ID
- Tianjin children myopia
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
PubMed 26875007Rose KA, French AN, Morgan IG. Environmental Factors and Myopia: Paradoxes and Prospects for Prevention. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):403-410. doi: 10.1097/APO.0000000000000233.
PubMed 27898443Seidemann A, Schaeffel F. An evaluation of the lag of accommodation using photorefraction. Vision Res. 2003 Feb;43(4):419-30. doi: 10.1016/s0042-6989(02)00571-0.
PubMed 12535999
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin
- ClinicalTrials.gov ID
- NCT05637827
- Acronym / sponsor ID
- Tianjin children myopia
- Conditions
- Myopia; Refractive Error
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Dec 2022 (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.
There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children with hyperopia | – | Other: No interventionThe refractive error and axial length of eye were observed |
| children with emmetropia | – | Other: No interventionThe refractive error and axial length of eye were observed |
| children with myopia | – | Other: No interventionThe refractive error and axial length of eye were observed |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Age groups
- Child
- Study population
- Healthy children with hyperopia, emmetropia and myopia
Key inclusion criteria (2 listed)
- students in grades 1-3
- Can cooperate with the examination of students
Key exclusion criteria (3 listed)
- Obvious strabismus and amblyopia
- Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
- History of ocular surgery
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 |
|---|---|---|
| No interventionThere was no intervention in each group, and only the natural development was observed | Other | children with emmetropia, children with hyperopia, children with myopia |
Primary outcome
The changes of refractive error
Time frame: Every 6 months for a period 3 years
The changes of refractive error between visit time in every 6 months
The changes of axial length
Time frame: Every 6 months for a period 3 years
The changes of axial length between visit time in every 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Results publication: PubMed 26875007Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
- Results publication: PubMed 27898443Rose KA, French AN, Morgan IG. Environmental Factors and Myopia: Paradoxes and Prospects for Prevention. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):403-410. doi: 10.1097/APO.0000000000000233.
- Results publication: PubMed 12535999Seidemann A, Schaeffel F. An evaluation of the lag of accommodation using photorefraction. Vision Res. 2003 Feb;43(4):419-30. doi: 10.1016/s0042-6989(02)00571-0.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia; Refractive Error, run by Tianjin Eye Hospital at 1 site in China.
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 3 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 yan wang (+86-22-27305083, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of refractive error (time frame: Every 6 months for a period 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637827, which also lists 3 linked publications.
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 5 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.