Clincosm LogoSign in Get a demo

The Incidence and Progression of Myopia: Cohort Study

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03244670
Collaborator
Essilor International (Industry)
350
Enrollment
1
Location
25.1
Actual Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Observation study only, no specific intervention

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 Design

Study Type:
Observational
Actual Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Cohort Study on Incidence and Progression of Myopia in a Group of Medical Students
Actual Study Start Date :
Aug 15, 2017
Actual Primary Completion Date :
Jul 19, 2019
Actual Study Completion Date :
Sep 19, 2019

Outcome Measures

Primary Outcome Measures

  1. refraction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 23 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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…),

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University
  • Essilor International

Investigators

  • Principal Investigator: Chen xiang, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Chen, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT03244670
Other Study ID Numbers:
  • TEX2017
First Posted:
Aug 9, 2017
Last Update Posted:
Sep 20, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiang Chen, Associate Professor, Sun Yat-sen University
Myopia
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Sep 20, 2019