Zhaoqing Myopia Study

Myopia Clinical Trial

Official title:

A Prospective School-based Study of Myopia in Children in Southern China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04219228
• Other study ID #: 2019KYPJ171
• Status: Recruiting
• Start date: December 14, 2019
• Est. completion date: February 2, 2023

Study information

• Verified date: March 2020
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng, M.D. Ph.D.
• Phone: +8613922286455
• Email: zhyfeng[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Diagnostic Test:
• 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.

Device:
• Wearable devices
Physical activity, light intensity, and visual information will be measured with wearable devices.

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong
China	Schools	Zhaoqing	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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 An — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of myopia	Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).	baseline
Secondary	Change in axial length	Axial length will be measured with a non-contact optical device.	1 year, 2 years, 3 years
Secondary	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.	baseline
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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).	1 year
Secondary	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.	1 year
Secondary	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).	baseline
Secondary	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).	baseline
Secondary	Post-vision screening referral uptake	Any referral uptake will be confirmed by telephone follow-up.	3 months