Shanghai High Myopia Study for Adults

High Myopia Clinical Trial

— SHMSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03446300
• Other study ID #: YFZX2018002
• 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
• 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

Related Conditions & MeSH terms

• High Myopia
• Myopia
• Vision Disorders

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