Refractive Error in Chinese Students

Myopia Clinical Trial

Official title:

Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119543
• Other study ID #: 2021022
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2021
• Source: Tianjin Eye Hospital
• Contact: Yan Wang, director
• Phone: +8615022756478
• Email: fanqian2002_yahoo[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This cohort study aimed to assess the change of refractive status in Chinese school children.

Description:

A cohort study was conducted in 96 primary and secondary schools in 16 districts of Tianjin from 2018 to 2020, including about 36452 people totally. The changes in myopia rate in 3 years were compared by a generalized estimation equation. The distribution of average equivalent spherical mirror and different regions and grades was evaluated by linear regression analysis, and the correlation between the equivalent spherical mirror and different gender, nationality, and age was evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36452
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• no concurrent eye disease
• age from 6 to 18 years old

Exclusion Criteria:

• significant systemic illnesses
• ocular conditions
• congenital corneal diseases
• pterygium, keratoconus
• corneal degeneration or dystrophy
• media opacity, uveitis, glaucoma
• history of ocular surgery
• neurologic diseases
• retinal disease.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Other:
• outdoor time
This cohort study aimed to assess the change of refractive status in Chinese school children under different outdoor time

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Saw SM, Matsumura S, Hoang QV. Prevention and Management of Myopia and Myopic Pathology. Invest Ophthalmol Vis Sci. 2019 Feb 1;60(2):488-499. doi: 10.1167/iovs.18-25221. — View Citation

Wang J, Li Y, Musch DC, Wei N, Qi X, Ding G, Li X, Li J, Song L, Zhang Y, Ning Y, Zeng X, Hua N, Li S, Qian X. Progression of Myopia in School-Aged Children After COVID-19 Home Confinement. JAMA Ophthalmol. 2021 Mar 1;139(3):293-300. doi: 10.1001/jamaophthalmol.2020.6239. — View Citation

Wang W, Zhu L, Zheng S, Ji Y, Xiang Y, Lv B, Xiong L, Li Z, Yi S, Huang H, Zhang L, Liu F, Wan W, Hu K. Survey on the Progression of Myopia in Children and Adolescents in Chongqing During COVID-19 Pandemic. Front Public Health. 2021 Apr 28;9:646770. doi: 10.3389/fpubh.2021.646770. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	refractive error	The changes in refractive error were compared by generalized estimation equation.	change from baseline at 36 months
Primary	sex disparity	The changes in refractive error were compared between different sex	change from baseline at 36 months