The Incidence and Progression of Myopia: Cohort Study

September 19, 2019 updated by: Xiang Chen, Sun Yat-sen University

A Cohort Study on Incidence and Progression of Myopia in a Group of Medical Students

A cohort study on incidence and progression of myopia in a group of medical students

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective cohort study to investigate the refractive error development, progression and their risk factors in young adult population comprises a group of medical students in China for two years

Study Type

Observational

Enrollment (Actual)

350

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, 510060
        • Zhongshan Ophthalmic Center

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

17 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

First-year medical college student from Zhongshan University

Description

Inclusion Criteria:

  • Volunteer subject, , willing to follow the protocol and able to read, comprehend and sign the informed consent form,
  • Age between 17 and 23 years

Exclusion Criteria:

  • Vulnerability of the subject,
  • Participation in another study which might have an influence on vision or interfere with study assessments,
  • Aphakic or pseudophakic (intraocular lens)
  • Participants who are wearing ortho-K lenses, or undergone any kind of myopia control treatments or undergone refractive surgery.
  • Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with study assessments (e.g. AMD, glaucoma…),
  • Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…),
  • Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled high blood pressure…),
  • Any medical treatment or medication which might have an influence on vision or interfere with study assessments (e.g. antidepressants, drugs with atropinic effects…),

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
refraction
Time Frame: Change from baseline for two years
The participants will be measured for their refractive error by optometrist, and observe the rate of progression of myopia
Change from baseline for two years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

Essilor International

Investigators

  • Principal Investigator: Chen xiang, Associate Professor

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)

August 15, 2017

Primary Completion (Actual)

July 19, 2019

Study Completion (Actual)

September 19, 2019

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEX2017

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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