Development and Pathological Changes of High Myopia Among Children and Adolescents in China

NCT ID: NCT03533647

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-14

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.

Conditions

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High Myopia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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entire cohort (observational)

none (observational study)

Observational

Intervention Type OTHER

none (observational study)

Interventions

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Observational

none (observational study)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 9 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.

Exclusion Criteria

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

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yizhi Liu

Clinical Professor,director of Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yizhi LIU, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yet-san University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuting LI, master

Role: CONTACT

+86-020-87334687

Qianyun CHEN, Bachelor

Role: CONTACT

+86-020-87334687

Facility Contacts

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Yuting LI, Master

Role: primary

+86-020-87334687

Qianyun Chen, bachelor

Role: backup

+86-020-87334687

References

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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.

Reference Type BACKGROUND
PMID: 26875007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15008558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23060137 (View on PubMed)

Related Links

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Other Identifiers

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SYSU-OPH-003

Identifier Type: -

Identifier Source: org_study_id

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