The Variations of Macular Thickness in Juvenile Subjects

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT02653794
Collaborator
Ministry of Health, China (Other)
364
1
5
73.4

Study Details

Study Description

Brief Summary

It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. However, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. Similarly macular retinal structure may develop with age. It is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. However, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. Similarly macular retinal structure may develop with age. It is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases.

    Optical Coherence Tomography (OCT) is an imaging technique widely used in clinic in last twenty years. According to the base theory of dim coherent light interference machine, OCT detect the back-reflection or scattering signal of biological tissue to the incident dim coherent light, and acquire the two-dimension or three- dimension image of biological tissue by scan. It enables the characteristic of tissue's microstructure in vivo and makes it possible to observe dynamically developing process of diseases so that it has become an essential test for macular and optic nerve diseases with unmatched measurement reproducibility. It also enables high-resolution and noninvasive imaging of the retinal lamina, the organizational structure of macular. It is most often used clinically to demonstrate the macular morphology, treatment response and disease progression clinically. However, who researchers studyed in through OCT were mostly patients with retinal disease and adults. There was few study focused on OCT's application to children.

    In this study, the investigators aims to measure macular thickness (MT) using spectral-domain optical coherence tomography (SD-OCT) and to investigate MT variations with sex, age, laterality, refraction error (RE) and axial length (AL).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    364 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Variations of Macular Thickness in Juvenile Subjects With Mild-to-Moderate Refractive Error
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2015
    Actual Study Completion Date :
    Jun 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. change of Macular thickness [4 to 17 years after birth]

      MT measurement using SD-OCT(an imaging technique widely used in clinic in last twenty years)

    2. change of axis length measurement using an IOLMaster [4 to 17 years after birth]

      axis length measurement using an IOLMaster

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age from 4 to 17 years

    • children with the mild-to-moderate refraction error(from 0 to -6.00D)

    Exclusion Criteria:
    • children with visual complaints

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University
    • Ministry of Health, China

    Investigators

    • Principal Investigator: Erping Long, M.D.,Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Study Chair: Yizhi Liu, M.D.;Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Study Director: Haotian Lin, M.D.;Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Erping Long, Medical doctor,Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02653794
    Other Study ID Numbers:
    • CCPMOH2016-China1
    First Posted:
    Jan 12, 2016
    Last Update Posted:
    Apr 14, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Erping Long, Medical doctor,Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2016