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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03446300
Other study ID # YFZX2018002
Secondary ID
Status Recruiting
Phase N/A
First received February 10, 2018
Last updated February 20, 2018
Start date January 1, 2016
Est. completion date December 31, 2020

Study information

Verified date February 2018
Source Shanghai Eye Disease Prevention and Treatment Center
Contact Xun Xu, MD
Phone 8613386259538
Email drxuxun@tom.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shanghai Eye Disease Prevention & Treatment Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retina Vessel Density (RVD) RVD is calculated both the macular and peripapillary area. December 31, 2016
Primary tilted optic disc A tilted optic disc was defined as the tilt ratios =0.80. December 31, 2016
Primary ß-zone PPA The ß-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. December 31, 2018
Primary glycosylated hemoglobin This test measures the average blood sugar control for the previous three months or so. December 31, 2020
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