NCT05119543

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36,452

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

4 years

First QC Date

November 1, 2021

Last Update Submit

November 11, 2021

Conditions

Keywords

COVID-19Refractive errorChinaMyopia

Outcome Measures

Primary Outcomes (2)

  • refractive error

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

    change from baseline at 36 months

  • sex disparity

    The changes in refractive error were compared between different sex

    change from baseline at 36 months

Study Arms (1)

Grade

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

Other: outdoor time

Interventions

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

Grade

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This large-scale cohort study was conducted in 36452 schoolchildren on myopia development among schoolchildren in 96 elementary and high schools in 16 districts of Tianjin in China.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, 300020, China

RECRUITING

Related 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.

    PMID: 30707221BACKGROUND
  • 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.

    PMID: 33443542BACKGROUND
  • 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.

    PMID: 33996724BACKGROUND

MeSH Terms

Conditions

MyopiaCOVID-19Refractive Errors

Condition Hierarchy (Ancestors)

Eye DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yan Wang, director

    Tianjin Eye Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 15, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations