Clinical trial NCT06162234: Wuhan High Myopia Study
Official title: Long Term Observation of Ocular Structure and Visual Function in Eyes With High Myopia：Wuhan High Myopia Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Myopia
Keywords: ocular biometric parameters
Refractive Errors
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First-year college student from Wuhan University

Brief summary: 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.

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

Primary outcomes:
measure: Myopic optic nerve changes
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Progression of axial length (AL)
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Incidence and progression of visual field (VF) defects
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Loss of best corrected visual acuity（BCVA）
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Incidence and progression of myopic maculopathy
timeFrame: Baseline and 6 months and 1，2,3,4years
Secondary outcomes:
measure: Relationship between the changes of visual function and pathological changes among patients with high myopia
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Structural parameters of anterior segment
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Intraocular pressure(IOP)
timeFrame: Baseline and 6 months and 1，2,3,4years
measure: Mental state and quality of life
timeFrame: Baseline and 6 months and 1，2,3,4years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: