Refractive Error in Chinese Students

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05119543
Collaborator
(none)
36,452
1
48
759.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: outdoor time

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
36452 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Grade

The changes in myopia rate in 3 years were compared by generalized estimation equation in different grades

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

Outcome Measures

Primary Outcome Measures

  1. refractive error [change from baseline at 36 months]

    The changes in refractive error were compared by generalized estimation equation.

  2. sex disparity [change from baseline at 36 months]

    The changes in refractive error were compared between different sex

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Eye Hospital Tianjin China 300020

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

  • Study Chair: Yan Wang, director, Tianjin Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT05119543
Other Study ID Numbers:
  • 2021022
First Posted:
Nov 15, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tianjin Eye Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2021