MyopiaNCT04219228
Zhaoqing Myopia Study
An observational study of Myopia, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Myopia is a common cause of vision loss, being particularly prevalent in children in East and Southeast Asia. The investigators will assess prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of myopia and other ocular… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Ophthalmic examinations and Wearable devices
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 2 sitesChina
- Study dates
- 14 Dec 2019to 2 Feb 2023
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.
Who may be able to join
- All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.
Who cannot join
- No.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yingfeng Zheng, M.D, Ph.D, +8613922286455, zhyfeng@mail.sysu.edu.cn
- Recruiting
Schools
Zhaoqing, Guangdong
Yingfeng Zheng, zhyfeng@mail.sysu.edu.cn
About this study
Official title: A Prospective School-based Study of Myopia in Children in Southern China
Myopia is a common cause of vision loss, being particularly prevalent in children in East and Southeast Asia. The investigators will assess prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of myopia and other ocular abnormalities in school-aged children in both urban and rural settings in Southern China.
Read the detailed description
Myopia is a common cause of vision loss, being particularly prevalent in East and Southeast Asia. It is still not entirely clear whether and how visual experience in an urban environment with less outdoor exposure could have an impact on the development and progression of myopia. Zhaoqing has a relatively stable population of 4,084,600, which are representative of the Chinese population in term of demographic and socioeconomic characteristics.
Therefore, the investigators will conduct a longitudinal cohort study in both urban and rural settings to examine prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of incidence and progression of myopia and other ocular abnormalities in school-aged children in Zhaoqing.
- Conditions
- Myopia
- Being tested
- Ophthalmic examinations, Wearable devices
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmic examinationsDiagnostic test
Ophthalmic examinations include visual acuity, cover test and ocular dominance, noncycloplegic autorefraction, cycloplegia, ocular biometric measurements, cycloplegic auto-refraction, subjective refraction, and anterior and posterior segment examination.
Wearable devicesDevice
Physical activity, light intensity, and visual information will be measured with wearable devices.
| Study group | Role | What they receive |
|---|---|---|
| Students in urban counties | All first-grade students in urban counties will undergo anthropometry and ophthalmic examination, and be required to complete questionnaires and wear wearable devices to collect environmental information and daily activities. Receives: Diagnostic Test: Ophthalmic examinations; Device: Wearable devices | |
| Students in rural counties | All first-grade students in rural counties will undergo anthropometry and ophthalmic examination, and be required to complete questionnaires and wear wearable devices to collect environmental information and daily activities. Receives: Diagnostic Test: Ophthalmic examinations; Device: Wearable devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident myopia
Incident myopia is defined as myopia detected during follow up among those without myopia at baseline. Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
Measured: 3 years
Secondary outcomes (10)
Prevalence of myopia
Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
Measured: baseline
Change in axial length
Axial length will be measured with a non-contact optical device.
Measured: 1 year, 2 years, 3 years
Prevalence of amblyopia, strabismus and other ocular abnormalities
Cover-uncover tests will be performed to detect strabismus. Any ocular abnormalities, including corneal opacities, lens opacities, and retinal diseases will be recorded based on slit lamp, direct ophthalmoscopic and/or mobile phone video examination. Participants with an uncorrected visual acuity 6/7.5 or worse with undergo subjective refraction to identify amblyopia.
Measured: baseline
Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia
The investigators will estimate the area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia.
Measured: 1 year
Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia
The investigators will estimate sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia.
Measured: 1 year
Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope
The investigators will estimate the area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope (a change in SER of 0.75D or more per year).
Measured: 1 year
Sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope
The investigators will estimate the sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope (a change in SER of 0.75D or more per year). Cycloplegic spherical refraction changes measured by an auto-refractometer will be used as the indicator of myopia progression.
Measured: 1 year
Area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result
The investigators will estimate the area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result (e.g., abnormal eye lid, abnormal cornea, and strabismus detected with mobile devices).
Measured: baseline
Sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result
The investigators will estimate the sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result (e.g., abnormal eye lid, abnormal cornea, and strabismus detected with mobile devices).
Measured: baseline
Post-vision screening referral uptake
Any referral uptake will be confirmed by telephone follow-up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start14 Dec 2019
- Primary completion2 Feb 2023 (estimated)
- Study completion2 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219228
- Sponsor's protocol ID
- 2019KYPJ171
- Status last verified
- Mar 2020
- First submitted
- 28 Dec 2019
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.
PubMed 22559900Zadnik K, Mutti DO. Outdoor Activity Protects Against Childhood Myopia-Let the Sun Shine In. JAMA Pediatr. 2019 May 1;173(5):415-416. doi: 10.1001/jamapediatrics.2019.0278. No abstract available.
PubMed 30907935Ojaimi E, Rose KA, Smith W, Morgan IG, Martin FJ, Mitchell P. Methods for a population-based study of myopia and other eye conditions in school children: the Sydney Myopia Study. Ophthalmic Epidemiol. 2005 Feb;12(1):59-69. doi: 10.1080/09286580490921296.
PubMed 15848921Li SM, Liu LR, Li SY, Ji YZ, Fu J, Wang Y, Li H, Zhu BD, Yang Z, Li L, Chen W, Kang MT, Zhang FJ, Zhan SY, Wang NL, Mitchell P; Anyang Childhood Eye Study Group. Design, methodology and baseline data of a school-based cohort study in Central China: the Anyang Childhood Eye Study. Ophthalmic Epidemiol. 2013 Dec;20(6):348-59. doi: 10.3109/09286586.2013.842596. Epub 2013 Oct 25.
PubMed 24160405He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.
PubMed 19104465Negrel AD, Maul E, Pokharel GP, Zhao J, Ellwein LB. Refractive Error Study in Children: sampling and measurement methods for a multi-country survey. Am J Ophthalmol. 2000 Apr;129(4):421-6. doi: 10.1016/s0002-9394(99)00455-9.
PubMed 10764848Chen X, Ye G, Zhong Y, Jin L, Liang X, Zeng Y, Zheng Y, Lan M, Liu Y. Prevalence, incidence, and risk factors for myopia among urban and rural children in southern China: protocol for a school-based cohort study. BMJ Open. 2021 Nov 5;11(11):e049846. doi: 10.1136/bmjopen-2021-049846.
PubMed 34740929
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective School-based Study of Myopia in Children in Southern China
- ClinicalTrials.gov ID
- NCT04219228
- Acronym / sponsor ID
- 2019KYPJ171
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 2 Feb 2023 (estimated)
- Study completion
- 2 Feb 2023 (estimated)
- First posted
- 6 Jan 2020 (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.
Myopia is a common cause of vision loss, being particularly prevalent in children in East and Southeast Asia. The investigators will assess prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of myopia and other ocular abnormalities in school-aged children in both urban and rural settings in Southern China.
Detailed description
Myopia is a common cause of vision loss, being particularly prevalent in East and Southeast Asia. It is still not entirely clear whether and how visual experience in an urban environment with less outdoor exposure could have an impact on the development and progression of myopia. Zhaoqing has a relatively stable population of 4,084,600, which are representative of the Chinese population in term of demographic and socioeconomic characteristics.
Therefore, the investigators will conduct a longitudinal cohort study in both urban and rural settings to examine prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of incidence and progression of myopia and other ocular abnormalities in school-aged children in Zhaoqing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Students in urban counties | – | Diagnostic Test: Ophthalmic examinations, Device: Wearable devicesAll first-grade students in urban counties will undergo anthropometry and ophthalmic examination, and be required to complete questionnaires and wear wearable devices to collect environmental information and daily activities. |
| Students in rural counties | – | Diagnostic Test: Ophthalmic examinations, Device: Wearable devicesAll first-grade students in rural counties will undergo anthropometry and ophthalmic examination, and be required to complete questionnaires and wear wearable devices to collect environmental information and daily activities. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.
Key inclusion criteria (1 listed)
- All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.
Key exclusion criteria (1 listed)
- No.
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 |
|---|---|---|
| Ophthalmic examinationsOphthalmic examinations include visual acuity, cover test and ocular dominance, noncycloplegic autorefraction, cycloplegia, ocular biometric measurements, cycloplegic auto-refraction, subjective refraction, and anterior and posterior segment examination. | Diagnostic test | Students in rural counties, Students in urban counties |
| Wearable devicesPhysical activity, light intensity, and visual information will be measured with wearable devices. | Device | Students in rural counties, Students in urban counties |
Primary outcome
Incident myopia
Time frame: 3 years
Incident myopia is defined as myopia detected during follow up among those without myopia at baseline. Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).
10 secondary outcomes
Prevalence of myopia
Time frame: baseline
Change in axial length
Time frame: 1 year, 2 years, 3 years
Prevalence of amblyopia, strabismus and other ocular abnormalities
Time frame: baseline
Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia
Time frame: 1 year
Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia
Time frame: 1 year
Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of fast progressing myope
Time frame: 1 year
Sensitivity and specificity of the deep learning algorithm for the prediction of fast progressing myope
Time frame: 1 year
Area under the receiver operating characteristic curve of the diagnostic algorithm in identifying abnormal vision screening result
Time frame: baseline
Sensitivity and specificity of the diagnostic algorithm in identifying abnormal vision screening result
Time frame: baseline
Post-vision screening referral uptake
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Results publication: PubMed 22559900Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.
- Results publication: PubMed 30907935Zadnik K, Mutti DO. Outdoor Activity Protects Against Childhood Myopia-Let the Sun Shine In. JAMA Pediatr. 2019 May 1;173(5):415-416. doi: 10.1001/jamapediatrics.2019.0278. No abstract available.
- Results publication: PubMed 15848921Ojaimi E, Rose KA, Smith W, Morgan IG, Martin FJ, Mitchell P. Methods for a population-based study of myopia and other eye conditions in school children: the Sydney Myopia Study. Ophthalmic Epidemiol. 2005 Feb;12(1):59-69. doi: 10.1080/09286580490921296.
- Results publication: PubMed 24160405Li SM, Liu LR, Li SY, Ji YZ, Fu J, Wang Y, Li H, Zhu BD, Yang Z, Li L, Chen W, Kang MT, Zhang FJ, Zhan SY, Wang NL, Mitchell P; Anyang Childhood Eye Study Group. Design, methodology and baseline data of a school-based cohort study in Central China: the Anyang Childhood Eye Study. Ophthalmic Epidemiol. 2013 Dec;20(6):348-59. doi: 10.3109/09286586.2013.842596. Epub 2013 Oct 25.
- Results publication: PubMed 19104465He M, Zheng Y, Xiang F. Prevalence of myopia in urban and rural children in mainland China. Optom Vis Sci. 2009 Jan;86(1):40-4. doi: 10.1097/OPX.0b013e3181940719.
- Results publication: PubMed 10764848Negrel AD, Maul E, Pokharel GP, Zhao J, Ellwein LB. Refractive Error Study in Children: sampling and measurement methods for a multi-country survey. Am J Ophthalmol. 2000 Apr;129(4):421-6. doi: 10.1016/s0002-9394(99)00455-9.
- Derived from this study: PubMed 34740929Chen X, Ye G, Zhong Y, Jin L, Liang X, Zeng Y, Zheng Y, Lan M, Liu Y. Prevalence, incidence, and risk factors for myopia among urban and rural children in southern China: protocol for a school-based cohort study. BMJ Open. 2021 Nov 5;11(11):e049846. doi: 10.1136/bmjopen-2021-049846.
- 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.
2 sites 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 Sun Yat-sen University at 2 sites 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 1 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yingfeng Zheng, M.D. Ph.D. (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident myopia (time frame: 3 years). 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 NCT04219228, which also lists 7 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 17 Mar 2020.