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Wuhan High Myopia Study

NCT ID: NCT06162234

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-25

Study Completion Date

2027-09-01

Brief Summary

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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

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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.

Conditions

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High Myopia

Keywords

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ocular biometric parameters Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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entire cohort

entire cohort made up of high myopia patients（observational study）

observational

Intervention Type OTHER

none (observational study)

Interventions

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observational

none (observational study)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Changzheng Chen

Chief of Department of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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QY Wu, MD

Role: CONTACT

Phone: +86 18672345926

Email: [email protected]

RH Hu, bachelor

Role: CONTACT

Phone: +86 18971669503

Email: [email protected]

Facility Contacts

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CZ Chen, PHD

Role: primary

QY Wu, PHD

Role: backup

Other Identifiers

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WWDRY2023-K074

Identifier Type: -

Identifier Source: org_study_id