SHMSA: Shanghai High Myopia Study for Adults

Sponsor
Shanghai Eye Disease Prevention and Treatment Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03446300
Collaborator
(none)
2,000
1
60
33.3

Study Details

Study Description

Brief Summary

High myopia retinopathy has become the first cause of irreversible blindness and severe visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused by high myopia retinopathy, it is very necessary to research the mechanism of early visual impairment to prevent and control damages. Our recent research found that the decreasing of macular retina vascular density and subfoveal choroidal thickness, the increasing of Beta Zone area in optic atrophy and the rising of glycosylated hemoglobin in high myopia patients were significantly related to visual impairment, which suggested that the source of visual impairment was the abnormal structure changes surrounding optic and fovea, but so far there is no related study. We will conduct a 5 years prospective cohort study in the population of 2420 high myopia and controls which have established in college student population, working population and aged more than 50 years old population, using the latest OCT-A and SS-OCT to measure macular retina vascular density, subfoveal choroidal thickness, Beta Zone area in optic atrophy, combined with the semiparametric mixed effects model, we will analysis the prediction index between fundus structure parameters, blood biochemical index and individual characteristics prediction to explore the public health management mode of early prevention and treatment during high myopia population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Cohort Study of Early Visual Impairment Mechanism Caused by Change of Fundus Structure in Adults With High Myopia
    Actual Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2019
    Anticipated Study Completion Date :
    Dec 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    college student population

    working population

    aged more than 50 years old population

    Outcome Measures

    Primary Outcome Measures

    1. Retina Vessel Density (RVD) [December 31, 2016]

      RVD is calculated both the macular and peripapillary area.

    2. tilted optic disc [December 31, 2016]

      A tilted optic disc was defined as the tilt ratios ≤0.80.

    3. β-zone PPA [December 31, 2018]

      The β-zone PPA area (an inner crescent of chorioretinal atrophy with good visibility of the large choroidal vessels and the sclera) was determined as the total number of pixels using the ImageJ software in a circumferential pattern.

    4. glycosylated hemoglobin [December 31, 2020]

      This test measures the average blood sugar control for the previous three months or so.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ≥18 years old; spherical equivalent refraction ≤-6.00D;
    Exclusion Criteria:
    • a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Eye Disease Prevention & Treatment Center Shanghai Shanghai China 200040

    Sponsors and Collaborators

    • Shanghai Eye Disease Prevention and Treatment Center

    Investigators

    • Study Director: Jianfeng Zhu, PhD, MD, Shanghai Eye Disease Prevention & Treatment Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Eye Disease Prevention and Treatment Center
    ClinicalTrials.gov Identifier:
    NCT03446300
    Other Study ID Numbers:
    • YFZX2018002
    First Posted:
    Feb 26, 2018
    Last Update Posted:
    Feb 26, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shanghai Eye Disease Prevention and Treatment Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 26, 2018