The Incidence and Progression of Myopia: Cohort Study

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244670
• Other study ID #: TEX2017
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: September 19, 2019

Study information

• Verified date: September 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: September 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 23 Years

Eligibility

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…),

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Observation study only, no specific intervention
Observation study only, no specific intervention

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Essilor International

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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