Wuhan High Myopia Study

High Myopia Clinical Trial

— LOVE-WH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162234
• Other study ID #: WWDRY2023-K074
• Status: Recruiting
• Start date: December 25, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: December 2023
• Source: Renmin Hospital of Wuhan University
• Contact: QY Wu, MD
• Phone: +86 18672345926
• Email: wuqyan[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• High Myopia
• Myopia

Intervention

Other:
• observational
none (observational study)

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myopic optic nerve changes	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	Baseline and 6 months and 1,2,3,4years
Primary	Progression of axial length (AL)	Subjects' axial length and its progression collected by IOL master 700	Baseline and 6 months and 1,2,3,4years
Primary	Incidence and progression of visual field (VF) defects	Variety and progression of visual field defects collected by Humphrey 860 perimetry	Baseline and 6 months and 1,2,3,4years
Primary	Loss of best corrected visual acuity(BCVA)	Incidence of BCVA loss collected by subjective optometry	Baseline and 6 months and 1,2,3,4years
Primary	Incidence and progression of myopic maculopathy	Collected by color fundus photography and ultra-wide fundus photography	Baseline and 6 months and 1,2,3,4years
Secondary	Relationship between the changes of visual function and pathological changes among patients with high myopia	Relationship between the changes of visual function including best corrected visual acuity and visual field and pathological changes among patients with high myopia	Baseline and 6 months and 1,2,3,4years
Secondary	Structural parameters of anterior segment	Structural parameters of anterior segment including corneal curvature,lens thickness(LT),etc	Baseline and 6 months and 1,2,3,4years
Secondary	Intraocular pressure(IOP)	Incidence of elevated intraocular pressure collected by a non-contact tonometer	Baseline and 6 months and 1,2,3,4years
Secondary	Mental state and quality of life	Mental state and quality of life collected by a questionnaire	Baseline and 6 months and 1,2,3,4years