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Shanghai High Myopia Study for Adults

The Cohort Study of Early Visual Impairment Mechanism Caused by Change of Fundus Structure in Adults With High Myopia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03446300
Acronym
SHMSA
Enrollment
2000
Registered
2018-02-26
Start date
2016-01-01
Completion date
2020-12-31
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia

Keywords

High Myopia, fundus structure, early visual impairment

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.

Interventions

None listed

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Retina Vessel Density (RVD)December 31, 2016RVD is calculated both the macular and peripapillary area.
tilted optic discDecember 31, 2016A tilted optic disc was defined as the tilt ratios ≤0.80.
β-zone PPADecember 31, 2018The 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.
glycosylated hemoglobinDecember 31, 2020This test measures the average blood sugar control for the previous three months or so.

Countries

China

Contacts

Primary ContactXun Xu, MD
drxuxun@tom.com8613386259538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026