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Shanghai High Myopia Study for Adults (SHMSA)

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ClinicalTrials.gov Identifier: NCT03446300
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

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
High Myopia

Study Type : Observational
Estimated 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 : January 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
college student population
working population
aged more than 50 years old population



Primary Outcome Measures :
  1. Retina Vessel Density (RVD) [ Time Frame: December 31, 2016 ]
    RVD is calculated both the macular and peripapillary area.

  2. tilted optic disc [ Time Frame: December 31, 2016 ]
    A tilted optic disc was defined as the tilt ratios ≤0.80.

  3. β-zone PPA [ Time Frame: 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 [ Time Frame: December 31, 2020 ]
    This test measures the average blood sugar control for the previous three months or so.


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
college student population; working population; aged more than 50 years old population.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446300


Contacts
Contact: Xun Xu, MD 8613386259538 drxuxun@tom.com

Locations
China, Shanghai
Shanghai Eye Disease Prevention & Treatment Center Recruiting
Shanghai, Shanghai, China, 200040
Contact: Xun Xu, MD    86-13386259538    drxuxun@tom.com   
Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Investigators
Study Director: Jianfeng Zhu, PhD, MD Shanghai Eye Disease Prevention & Treatment Center

Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03446300     History of Changes
Other Study ID Numbers: YFZX2018002
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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:
High Myopia, fundus structure, early visual impairment

Additional relevant MeSH terms:
Myopia
Vision Disorders
Refractive Errors
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms