The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

May 5, 2024 updated by: Tianjin Eye Hospital
The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Tiajin Eye Hospital

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 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All students in grades 1 to 4
  • 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-school training group
There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.
Behavioral: Home training
Letter Chart Accomodative Rock Training for 2 minutes each time
Behavioral: School training
Letter Chart Accomodative Rock Training for 2 minutes each time
Experimental: School training group
There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.
Behavioral: School training
Letter Chart Accomodative Rock Training for 2 minutes each time
No Intervention: No training group
There was no such treatment for students.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of new-onset myopia
Time Frame: Through study completion, an average of 1 year
The number of new children with myopia was counted
Through study completion, an average of 1 year
The changes of refractive error
Time Frame: Every 6 months, up to 3 years
The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
Every 6 months, up to 3 years
The changes of axial length
Time Frame: Every 6 months, up to 3 years
The axial length was measured by a biological measuring instrument.
Every 6 months, up to 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)

May 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tianjin myopia Intervention

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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