MyopiaNCT05967702
A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study
An observational study of Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 126,810 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Dec 2021
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All 6-18-year students with no significant systemic or eye diseases are eligible for vision screening
Who may be able to join
- All 6-18 years students
Who cannot join
- No eye diseases such as cataracts, glaucoma, keratoconus, etc.
- No psychiatric disorders
- Astigmatism ≤ -6.00D
Trial locations and contacts
1 site in 1 country.
About this study
This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.
Read the detailed description
Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia.
This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.
- Conditions
- Myopia
- Medical subject headings
- Myopia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myopia
Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye
Measured: One day measurement
Prevalence of high myopia
High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye
Measured: One day measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 MyopiaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 126,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study director, Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967702
- Sponsor's protocol ID
- KY-2023040
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 1 Aug 2023
- 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 26875007Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30.
PubMed 33388160Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563.
PubMed 34529002
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study
- ClinicalTrials.gov ID
- NCT05967702
- Acronym / sponsor ID
- KY-2023040
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126,810 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Aug 2023 (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 is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.
Detailed description
Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia.
This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All 6-18-year students with no significant systemic or eye diseases are eligible for vision screening
Key inclusion criteria (1 listed)
- All 6-18 years students
Key exclusion criteria (3 listed)
- No eye diseases such as cataracts, glaucoma, keratoconus, etc.
- No psychiatric disorders
- Astigmatism ≤ -6.00D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of myopia
Time frame: One day measurement
Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye
Prevalence of high myopia
Time frame: One day measurement
High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- 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 33388160Modjtahedi BS, Abbott RL, Fong DS, Lum F, Tan D; Task Force on Myopia. Reducing the Global Burden of Myopia by Delaying the Onset of Myopia and Reducing Myopic Progression in Children: The Academy's Task Force on Myopia. Ophthalmology. 2021 Jun;128(6):816-826. doi: 10.1016/j.ophtha.2020.10.040. Epub 2020 Dec 30.
- Results publication: PubMed 34529002Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563.
- 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.
Yan Wang, director study director
Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital
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, 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 1 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: finished, as of the sponsor's last update on 1 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of myopia (time frame: One day measurement). 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 NCT05967702, 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 1 Aug 2023.