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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 7050

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zengcheng
    • Guangzhou, Guangdong, China
      • Zengcheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Axial length is measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
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
lens thickness	lens thickness is measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Vitreous length	Vitreous length was measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Environmental factor	Time of outdoor activities & short range reading,measured by questionnaire	examine every 12 months, follow up for 3 years

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Principal Investigator: Yizhi LIU, PhD, Zhongshan Ophthalmic Center, Sun Yat-san University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Anticipated): July 20, 2024
• Study Completion (Anticipated): July 20, 2024

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: refractive error; ocular structural parameters
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: SYSU-OPH-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No