NCT03244670

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

August 7, 2017

Last Update Submit

September 19, 2019

Conditions

Myopia

Keywords

Myopia

Outcome Measures

Primary Outcomes (1)

  • refraction

    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

Interventions

Observation study only, no specific interventionOTHER

Observation study only, no specific intervention

Eligibility Criteria

Age17 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

First-year medical college student from Zhongshan University

You may qualify if:

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

You may not qualify if:

  • 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…),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Chen xiang

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 9, 2017

Study Start

August 15, 2017

Primary Completion

July 19, 2019

Study Completion

September 19, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)