Wuhan High Myopia Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational.
- Who it may be relevant to
- Registry conditions: High Myopia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long Term Observation of Ocular Structure and Visual Function in Eyes With High Myopia：Wuhan High Myopia Study
Overview
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.
Detailed description
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.
Interventions
- Other observational
none (observational study)
Primary outcome measures
- Myopic optic nerve changes [Time frame: Baseline and 6 months and 1，2,3,4years]
- Progression of axial length (AL) [Time frame: Baseline and 6 months and 1，2,3,4years]
- Incidence and progression of visual field (VF) defects [Time frame: Baseline and 6 months and 1，2,3,4years]
- Loss of best corrected visual acuity（BCVA） [Time frame: Baseline and 6 months and 1，2,3,4years]
- Incidence and progression of myopic maculopathy [Time frame: Baseline and 6 months and 1，2,3,4years]
Secondary outcome measures (4)
- Relationship between the changes of visual function and pathological changes among patients with high myopia [Time frame: Baseline and 6 months and 1，2,3,4years]
- Structural parameters of anterior segment [Time frame: Baseline and 6 months and 1，2,3,4years]
- Intraocular pressure(IOP) [Time frame: Baseline and 6 months and 1，2,3,4years]
- Mental state and quality of life [Time frame: Baseline and 6 months and 1，2,3,4years]
Eligibility criteria
Inclusion criteria
- 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；
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renmin Hospital of Wuhan University — Wuhan
Identifiers
NCT: NCT06162234 · WWDRY2023-K074