The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin

November 26, 2022 updated by: Tianjin Eye Hospital
There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • TianJin eye hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy children with hyperopia, emmetropia and myopia

Description

Inclusion Criteria:

  • students in grades 1-3
  • Can cooperate with the examination of students

Exclusion Criteria:

  • Obvious strabismus and amblyopia
  • Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
  • History of ocular surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with hyperopia
The refractive error and axial length of eye were observed
Other: No intervention
There was no intervention in each group, and only the natural development was observed
children with emmetropia
The refractive error and axial length of eye were observed
Other: No intervention
There was no intervention in each group, and only the natural development was observed
children with myopia
The refractive error and axial length of eye were observed
Other: No intervention
There was no intervention in each group, and only the natural development was observed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of refractive error
Time Frame: Every 6 months for a period 3 years
The changes of refractive error between visit time in every 6 months
Every 6 months for a period 3 years
The changes of axial length
Time Frame: Every 6 months for a period 3 years
The changes of axial length between visit time in every 6 months.
Every 6 months for a period 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

November 26, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 26, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tianjin children myopia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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