Shanghai High Myopia Study for Adults

• Conditions: High Myopia

• Registration Number: NCT03446300
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-20
• Last Update Submitted: 2018-02-20
• Study First Posted: 2018-02-26
• Last Update Posted: 2018-02-26
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• ≥18 years old; spherical equivalent refraction ≤-6.00D;

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Exclusion Criteria

• a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tilted optic disc	December 31, 2016	A tilted optic disc was defined as the tilt ratios ≤0.80.
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.
Retina Vessel Density (RVD)	December 31, 2016	RVD is calculated both the macular and peripapillary area.
glycosylated hemoglobin	December 31, 2020	This test measures the average blood sugar control for the previous three months or so.

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Shanghai, China