Development and Pathological Changes of High Myopia Among Children and Adolescents in China

June 18, 2018 updated by: Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University

A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China

The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.

Study Type

Observational

Enrollment (Anticipated)

1400

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yet-san University
        • Contact:
        • 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

2 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

6 to 18 years old school students in Guangzhou. Age between 9-18 years old with either eye had myopia equal or greater than 6.0D ,age between 6-8 years old with either eye had myopia equal or greater than 3.0D

Description

Inclusion Criteria:

  • 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
  • Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
  • Written informed consent for study participation
  • Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

  • None school students in Guangzhou
  • Other contraindications
  • A history of allergy to tropicamide or topical anesthetics
  • Missing ability to give informed consent

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
entire cohort (observational)
none (observational study)
Other: Observational
none (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.
Time Frame: examine every 12 months, follow up 3 years
examine the ocular pathological changes
examine every 12 months, follow up 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia
Time Frame: examine every 12 months, follow up 3 years
axial length, refractive error changes, environmental factors, family history, exercise time, eye care habits, form of exercise
examine every 12 months, follow up 3 years

Collaborators and Investigators

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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhi LIU, MD,PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Helpful Links

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 14, 2018

Primary Completion (Anticipated)

May 13, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-OPH-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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