Zhaoqing Myopia Study

NCT04219228 | Unknown DMC

• 1 other identifier: 2019KYPJ171
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief 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 abnormalities in school-aged children in both urban and rural settings in Southern China.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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).

  3 years

Secondary Outcomes (10)

• Prevalence of myopia

  baseline

• Change in axial length

  1 year, 2 years, 3 years

• Prevalence of amblyopia, strabismus and other ocular abnormalities

  baseline

• Area under the receiver operating characteristic curve of the deep learning algorithm for the prediction of incident myopia

  1 year

• Sensitivity and specificity of the deep learning algorithm for the prediction of incident myopia

  1 year

Study Arms (2)

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.

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.

Diagnostic Test: Ophthalmic examinations; Device: Wearable devices

Interventions

Ophthalmic examinations 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.

Students in rural counties; Students in urban counties

Wearable devices DEVICE

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

Students in rural counties; Students in urban counties

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• No.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Schools

Zhaoqing, Guangdong, China

RECRUITING

Related Publications (7)

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

  PMID: 22559900 RESULT

• 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.

  PMID: 30907935 RESULT

• 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.

  PMID: 15848921 RESULT

• 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.

  PMID: 24160405 RESULT

• 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.

  PMID: 19104465 RESULT

• 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.

  PMID: 10764848 RESULT

• 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.

  PMID: 34740929 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Yingfeng Zheng, M.D. Ph.D.

CONTACT

+8613922286455; zhyfeng@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 6, 2020
• Study Start: December 14, 2019
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)