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NCT Number: NCT06162234

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location status: Recruiting

Location contact

CZ Chen, PHD

CONTACT

[email protected]

+86 13072765173

QY Wu, PHD

CONTACT

+86

RH Hu

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

none (observational study)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

QY Wu, MD

CONTACT

[email protected]

+86 18672345926

RH Hu, bachelor

CONTACT

[email protected]

+86 18971669503

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

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

Acronym: LOVE-WH

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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