NCT03533647

Brief Summary

The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.

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
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 10, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

May 10, 2018

Last Update Submit

June 18, 2018

Conditions

High Myopia

Keywords

high myopiaocular biometric parametersadolescentchildren

Outcome Measures

Primary Outcomes (1)

  • To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.

    examine the ocular pathological changes

    examine every 12 months, follow up 3 years

Secondary Outcomes (1)

  • To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia

    examine every 12 months, follow up 3 years

Study Arms (1)

entire cohort (observational)

none (observational study)

Other: Observational

Interventions

ObservationalOTHER

none (observational study)

entire cohort (observational)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

6 to 18 years old school students in Guangzhou. Age between 9-18 years old with either eye had myopia equal or greater than 6.0D ,age between 6-8 years old with either eye had myopia equal or greater than 3.0D

You may qualify if:

  • to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
  • Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
  • Written informed consent for study participation
  • Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

You may not qualify if:

  • None school students in Guangzhou
  • Other contraindications
  • A history of allergy to tropicamide or topical anesthetics
  • Missing ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yet-san University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (3)

  • Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

    PMID: 26875007BACKGROUND

  • Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.

    PMID: 15008558BACKGROUND

  • Sun J, Zhou J, Zhao P, Lian J, Zhu H, Zhou Y, Sun Y, Wang Y, Zhao L, Wei Y, Wang L, Cun B, Ge S, Fan X. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7504-9. doi: 10.1167/iovs.11-8343.

    PMID: 23060137BACKGROUND

Related Links

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Yizhi LIU, MD,PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuting LI, master

CONTACT

+86-020-87334687ytdorothy@163.com

Qianyun CHEN, Bachelor

CONTACT

+86-020-87334687torunchen@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor,director of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

May 10, 2018

First Posted

May 23, 2018

Study Start

May 14, 2018

Primary Completion

May 13, 2021

Study Completion

May 31, 2021

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

CN(1)