Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study

Myopia Clinical Trial

Official title:

A Longitudinal Study on Ocular Development and Refractive Error Changes Among children-and Adolescent

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03589937
• Other study ID #: SYSU-OPH-004
• Status: Active, not recruiting
• Start date: July 20, 2018
• Est. completion date: July 20, 2024

Study information

• Verified date: March 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to observe the ocular development and refractive error changes among school children and adolescents

Description:

This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7050
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).

• No allergy to tropicamide or topical anesthetics

• written informed consent is obtained from guardian

• Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

• No history of eye diseases

• Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses

• A history of allergy to topic amide or topical anesthetics

• Have severe systemic disease

• Missing ability to give informed consent

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Locations

Country	Name	City	State
China	Zengcheng	Guangzhou	Guangdong
China	Zengcheng	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spherical equivalent change	SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years	examine every 12 months, follow up for 3 years
Secondary	Axial length	Axial length is measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Secondary	Anterior chamber depth	Anterior chamber depth is measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Secondary	lens thickness	lens thickness is measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Secondary	Vitreous length	Vitreous length was measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Secondary	Environmental factor	Time of outdoor activities & short range reading,measured by questionnaire	examine every 12 months, follow up for 3 years