CClinicalTrials.gg
Status unknownNCT03446300SHMSAUpdated Feb 26, 2018

Shanghai High Myopia Study for Adults

An observational study in High Myopia, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • High Myopia

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Keywords

  • High Myopia, fundus structure, early visual impairment
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • college student population
  • working population
  • aged more than 50 years old population
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What researchers measure

Primary outcomes

  1. Retina Vessel Density (RVD)

    RVD is calculated both the macular and peripapillary area.

    Time frame: December 31, 2016

  2. tilted optic disc

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

    Time frame: December 31, 2016

  3. 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.

    Time frame: December 31, 2018

  4. glycosylated hemoglobin

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

    Time frame: December 31, 2020

06

Study locations

1 of 1 sites recruiting
  • Shanghai Eye Disease Prevention & Treatment Center
    Shanghai, Shanghai 200040, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03446300
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Jan 1, 2016
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Feb 26, 2018

Study contacts

Xun Xu, MD
Contact
drxuxun@tom.com
8613386259538
Jianfeng Zhu, PhD, MD
study director · Shanghai Eye Disease Prevention & Treatment Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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