跳至主要内容
临床试验/NCT06162234
NCT06162234招募中不适用

Long Term Observation of Ocular Structure and Visual Function in Eyes With High Myopia:Wuhan High Myopia Study

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Myopic optic nerve changes

研究概览

简要总结

The study aims to observe the long-term changes of ocular(especially fundus) structure and visual function in patients with high myopia, so as to provide evidence for the prevention, diagnosis and prognosis of high myopia.

详细描述

High myopia is defined as a refractive error of ≤-6.00D or an axial length greater than 26mm. In recent years, the population of highly myopic individuals has been increasing rapidly. Scholars predict that if no effective interventions are taken, the global incidence rate of myopia is expected to increase from 22.9% in 2000 to 49.8% in 2050, and the visual impairment caused by high myopia will be seven times higher than in 2000 on a global scale. In China, a survey conducted by the National Health Commission in 2018 found that highly myopic students accounted for 21.9% of third-year high school students, indicating that high myopia has become a major public health issue due to its prevalence among younger populations.

In recent years, with the development of ocular imaging technologies such as optical coherence tomography (OCT) and corresponding image analysis techniques, high-resolution, non-invasive, fast and in vivo retinal imaging has become more accessible. This has led to the discovery and exploration of various imaging parameters related to optic disc and macula changes in highly myopic patients. We will conduct a 4 years prospective cohort study in the population of 1000 high myopia and controls which have established in mainly college student population, using the latest OCT-A and SS-OCT to observe the long-term changes of fundus structure combined with visual function in patients with high myopia , and explore biomarkers affecting visual function, so as to provide basis for prevention and control of high myopia and prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntarily sign informed consent;
  • Commit to follow the research procedures and cooperate with the whole process of the study;
  • Age ≥18 years old;
  • Best corrected visual acuity ≥0.1;
  • Spherical Equivalent Refraction≤-6.00D or axial length ≥26mm in high myopia group;

排除标准

  • Unable or unwilling to sign informed consent;
  • Unable to cooperate with the examination;
  • Astigmatism ≤-1.5D;
  • Patients with refractive interstitial opacity so that fundus images cannot be collected;
  • Patients with fundus diseases such as diabetic retinopathy, hypertensive retinopathy, age-related macular degeneration, retinal vein obstruction, retinal artery obstruction, etc

结局指标

主要结局

Myopic optic nerve changes

时间窗: Baseline and 6 months and 1,2,3,4years

Changes in the optic nerve head morphology and blood supply which are supposed to be related with high myopia,examined by fundus photography,OCT,OCTA,etc

Progression of axial length (AL)

时间窗: Baseline and 6 months and 1,2,3,4years

Subjects' axial length and its progression collected by IOL master 700

Incidence and progression of myopic maculopathy

时间窗: Baseline and 6 months and 1,2,3,4years

Collected by color fundus photography and ultra-wide fundus photography

Incidence and progression of visual field (VF) defects

时间窗: Baseline and 6 months and 1,2,3,4years

Variety and progression of visual field defects collected by Humphrey 860 perimetry

Loss of best corrected visual acuity(BCVA)

时间窗: Baseline and 6 months and 1,2,3,4years

Incidence of BCVA loss collected by subjective optometry

次要结局

  • Structural parameters of anterior segment(Baseline and 6 months and 1,2,3,4years)
  • Relationship between the changes of visual function and pathological changes among patients with high myopia(Baseline and 6 months and 1,2,3,4years)
  • Intraocular pressure(IOP)(Baseline and 6 months and 1,2,3,4years)
  • Mental state and quality of life(Baseline and 6 months and 1,2,3,4years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Changzheng Chen

Chief of Department of Ophthalmology

Renmin Hospital of Wuhan University

研究点 (1)

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