Wuhan High Myopia Study (LOVE-WH)

December 19, 2023 updated by: Changzheng Chen, Renmin Hospital of Wuhan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital Of Wuhan University
        • Contact:
        • Contact:
          • QY Wu, PHD
          • Phone Number: +86
        • Sub-Investigator:
          • RH Hu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

First-year college student from Wuhan University

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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