NCT03589937

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

June 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

6 years

First QC Date

June 20, 2018

Last Update Submit

March 14, 2022

Conditions

Myopia

Keywords

refractive errorocular structural parameters

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Axial length

    examine every 12 months, follow up for 3 years

  • Anterior chamber depth

    examine every 12 months, follow up for 3 years

  • lens thickness

    examine every 12 months, follow up for 3 years

  • Vitreous length

    examine every 12 months, follow up for 3 years

  • Environmental factor

    examine every 12 months, follow up for 3 years

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zengcheng

Guangzhou, Guangdong, 510000, China

Location

Zengcheng

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Yizhi LIU, PhD

    Zhongshan Ophthalmic Center, Sun Yat-san University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 18, 2018

Study Start

July 20, 2018

Primary Completion

July 20, 2024

Study Completion

July 20, 2024

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

CN(2)