NCT05305274

Brief Summary

To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

March 29, 2022

Last Update Submit

March 29, 2022

Conditions

Refraction ErrorMyopia

Outcome Measures

Primary Outcomes (4)

  • changes of sphere

    changes of sphere

    change from baseline at 36 months

  • changes of cylinder

    changes of cylinder

    change from baseline at 36 months

  • changes of spherical equivalent

    changes of spherical equivalent

    change from baseline at 36 months

  • changes and distribution of visual acuity

    changes and distribution of visual acuity

    change from baseline at 36 months

Study Arms (3)

2019 screening

34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Other: screening

2020 screening

34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Other: screening

2021 screening

34,400 schoolchildren with a 36-month follow-up from 2019 to 2021.

Other: screening

Interventions

screeningOTHER

This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.

2019 screening2020 screening2021 screening

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

This study includes 34,400 schoolchildren, with a 36-month follow-up from 2019 to 2021. In addition to RE considerations, the inclusion criteria were: no concurrent eye disease; age 6-15 years. The exclusion criteria were: significant systemic illnesses or ocular conditions that could affect the corneal curvature, including congenital corneal diseases, pterygium, keratoconus, other corneal degeneration or dystrophy conditions, media opacity, uveitis, glaucoma or a history of intraocular surgery, refractive surgery, neurologic or retinal diseases, current corneal refractive therapy (ortho-K), or low-dose atropine therapy for myopia control. The ethics board of the Tianjin Eye Hospital, Tianjin, China, approved this school-based cohort study (No: 2022018).

You may qualify if:

  • no concurrent eye disease;
  • age 6-15 years.

You may not qualify if:

  • significant systemic illnesses
  • ocular conditions that could affect the corneal curvature, including congenital corneal diseases,
  • pterygium, keratoconus, other corneal degeneration or dystrophy conditions,
  • media opacity, uveitis, glaucoma
  • a history of intraocular surgery, refractive surgery,
  • neurologic or retinal diseases, current corneal refractive therapy (ortho-K),
  • low-dose atropine therapy for myopia control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, 300020, China

Location

Related Publications (2)

  • Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563.

    PMID: 34529002BACKGROUND

  • Ma D, Wei S, Li SM, Yang X, Cao K, Hu J, Fan S, Zhang L, Wang N. Progression of myopia in a natural cohort of Chinese children during COVID-19 pandemic. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2813-2820. doi: 10.1007/s00417-021-05305-x. Epub 2021 Jul 21.

    PMID: 34287693BACKGROUND

MeSH Terms

Conditions

Refractive ErrorsMyopia

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Yan Wang, director

    Tianjin Eye Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 29, 2022

First Posted

March 31, 2022

Study Start

October 1, 2019

Primary Completion

October 31, 2021

Study Completion

December 1, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

CN(1)