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Wuhan High Myopia Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06162234
Acronym
LOVE-WH
Enrollment
1000
Registered
2023-12-08
Start date
2023-12-25
Completion date
2027-09-01
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia

Keywords

ocular biometric parameters, Refractive Errors

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.

Interventions

OTHERobservational

none (observational study)

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence and progression of myopic maculopathyBaseline and 6 months and 1,2,3,4yearsCollected by color fundus photography and ultra-wide fundus photography
Myopic optic nerve changesBaseline and 6 months and 1,2,3,4yearsChanges 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)Baseline and 6 months and 1,2,3,4yearsSubjects' axial length and its progression collected by IOL master 700
Incidence and progression of visual field (VF) defectsBaseline and 6 months and 1,2,3,4yearsVariety and progression of visual field defects collected by Humphrey 860 perimetry
Loss of best corrected visual acuity(BCVA)Baseline and 6 months and 1,2,3,4yearsIncidence of BCVA loss collected by subjective optometry

Secondary

MeasureTime frameDescription
Structural parameters of anterior segmentBaseline and 6 months and 1,2,3,4yearsStructural parameters of anterior segment including corneal curvature,lens thickness(LT),etc
Intraocular pressure(IOP)Baseline and 6 months and 1,2,3,4yearsIncidence of elevated intraocular pressure collected by a non-contact tonometer
Mental state and quality of lifeBaseline and 6 months and 1,2,3,4yearsMental state and quality of life collected by a questionnaire
Relationship between the changes of visual function and pathological changes among patients with high myopiaBaseline and 6 months and 1,2,3,4yearsRelationship between the changes of visual function including best corrected visual acuity and visual field and pathological changes among patients with high myopia

Countries

China

Contacts

Primary ContactQY Wu, MD
wuqyan@163.com+86 18672345926
Backup ContactRH Hu, bachelor
2019305232102@whu.edu.cn+86 18971669503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026