Zhaoqing Myopia Study

NCT ID: NCT04219228

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-14

Study Completion Date

2023-02-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Ophthalmic examinations

Intervention Type DIAGNOSTIC_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 devices

Intervention Type DEVICE

Physical activity, light intensity, and visual information will be measured with 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.

Ophthalmic examinations

Intervention Type DIAGNOSTIC_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 devices

Intervention Type DEVICE

Physical activity, light intensity, and visual information will be measured with wearable devices.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ophthalmic examinations

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.

Intervention Type DIAGNOSTIC_TEST

Wearable devices

Physical activity, light intensity, and visual information will be measured with wearable devices.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.

Exclusion Criteria

* No.
Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yingfeng Zheng

Clinical investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Schools

Zhaoqing, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yingfeng Zheng, M.D. Ph.D.

Role: CONTACT

+8613922286455

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yingfeng Zheng, M.D, Ph.D

Role: primary

+8613922286455

Yingfeng Zheng

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.

Reference Type RESULT
PMID: 22559900 (View on PubMed)

Zadnik 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.

Reference Type RESULT
PMID: 30907935 (View on PubMed)

Ojaimi 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.

Reference Type RESULT
PMID: 15848921 (View on PubMed)

Li 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.

Reference Type RESULT
PMID: 24160405 (View on PubMed)

He 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.

Reference Type RESULT
PMID: 19104465 (View on PubMed)

Negrel 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.

Reference Type RESULT
PMID: 10764848 (View on PubMed)

Chen 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.

Reference Type DERIVED
PMID: 34740929 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019KYPJ171

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Wuhan High Myopia Study
NCT06162234 RECRUITING
The Beijing Childhood Eye Study
NCT06931444 ENROLLING_BY_INVITATION