- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06162234
Wuhan High Myopia Study (LOVE-WH)
Long Term Observation of Ocular Structure and Visual Function in Eyes With High Myopia:Wuhan High Myopia Study
Study Overview
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: QY Wu, MD
- Phone Number: +86 18672345926
- Email: wuqyan@163.com
Study Contact Backup
- Name: RH Hu, bachelor
- Phone Number: +86 18971669503
- Email: 2019305232102@whu.edu.cn
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430060
- Recruiting
- Renmin Hospital Of Wuhan University
-
Contact:
- CZ Chen, PHD
- Phone Number: +86 13072765173
- Email: whuchenchzh@163.com
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Contact:
- QY Wu, PHD
- Phone Number: +86
-
Sub-Investigator:
- RH Hu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
entire cohort
entire cohort made up of high myopia patients(observational study)
|
none (observational study)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myopic optic nerve changes
Time Frame: Baseline and 6 months and 1,2,3,4years
|
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
|
Progression of axial length (AL)
Time Frame: Baseline and 6 months and 1,2,3,4years
|
Subjects' axial length and its progression collected by IOL master 700
|
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
|
Variety and progression of visual field defects collected by Humphrey 860 perimetry
|
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 of BCVA loss collected by subjective optometry
|
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
|
Collected by color fundus photography and ultra-wide fundus photography
|
Baseline and 6 months and 1,2,3,4years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Structural parameters of anterior segment
Time Frame: Baseline and 6 months and 1,2,3,4years
|
Structural parameters of anterior segment including corneal curvature,lens thickness(LT),etc
|
Baseline and 6 months and 1,2,3,4years
|
Intraocular pressure(IOP)
Time Frame: Baseline and 6 months and 1,2,3,4years
|
Incidence of elevated intraocular pressure collected by a non-contact tonometer
|
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
|
Mental state and quality of life collected by a questionnaire
|
Baseline and 6 months and 1,2,3,4years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WWDRY2023-K074
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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