Shanghai High Myopia Study for Adults

NCT03446300 | Unknown

• 1 other identifier: YFZX2018002
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia

Keywords

High Myopia, fundus structure, early visual impairment

Outcome Measures

Primary Outcomes (4)

• Retina Vessel Density (RVD)

  RVD is calculated both the macular and peripapillary area.

  December 31, 2016

• tilted optic disc

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

  December 31, 2016

• β-zone PPA

  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.

  December 31, 2018

• glycosylated hemoglobin

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

  December 31, 2020

Study Arms (3)

college student population

working population

aged more than 50 years old population

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

college student population; working population; aged more than 50 years old population.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (1)

• Li M, Xu H, Ye L, Zhou S, Xie J, Liu C, Zhu J, He J, Fan Y, Xu X. Association of macular outward scleral height with axial length, macular choroidal thickness and morphologic characteristics of the optic disc in Chinese adults. Eye (Lond). 2024 Apr;38(5):923-929. doi: 10.1038/s41433-023-02804-5. Epub 2023 Oct 28.

  PMID: 37898715 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianfeng Zhu, PhD, MD

  Shanghai Eye Disease Prevention & Treatment Center

  STUDY DIRECTOR

Central Study Contacts

Xun Xu, MD

CONTACT

8613386259538; drxuxun@tom.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 26, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

CN (1)