High MyopiaLOVE-WHNCT06162234
Wuhan High Myopia Study
An observational study of High Myopia, run by Renmin Hospital of Wuhan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia
- What is being tested?
- observational
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 1 Sep 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: First-year college student from Wuhan University
Who may be able to join
- 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；
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
CZ Chen, PHD, +86 13072765173, whuchenchzh@163.com
QY Wu, PHD, +86
About this study
Official title: 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.
Read the 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.
- Conditions
- High Myopia
- Being tested
- observational
- Keywords
- ocular biometric parameters, Refractive Errors
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
none (observational study)
| Study group | Role | What they receive |
|---|---|---|
| entire cohort | entire cohort made up of high myopia patients（observational study） Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 months and 1，2,3,4years
Progression of axial length (AL)
Subjects' axial length and its progression collected by IOL master 700
Measured: Baseline and 6 months and 1，2,3,4years
Incidence and progression of visual field (VF) defects
Variety and progression of visual field defects collected by Humphrey 860 perimetry
Measured: Baseline and 6 months and 1，2,3,4years
Loss of best corrected visual acuity（BCVA）
Incidence of BCVA loss collected by subjective optometry
Measured: Baseline and 6 months and 1，2,3,4years
Incidence and progression of myopic maculopathy
Collected by color fundus photography and ultra-wide fundus photography
Measured: Baseline and 6 months and 1，2,3,4years
Secondary outcomes (4)
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
Measured: Baseline and 6 months and 1，2,3,4years
Structural parameters of anterior segment
Structural parameters of anterior segment including corneal curvature，lens thickness(LT)，etc
Measured: Baseline and 6 months and 1，2,3,4years
Intraocular pressure(IOP)
Incidence of elevated intraocular pressure collected by a non-contact tonometer
Measured: Baseline and 6 months and 1，2,3,4years
Mental state and quality of life
Mental state and quality of life collected by a questionnaire
Measured: Baseline and 6 months and 1，2,3,4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start25 Dec 2023 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changzheng Chen, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162234
- Sponsor's protocol ID
- WWDRY2023-K074
- Acronym
- LOVE-WH
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Observation of Ocular Structure and Visual Function in Eyes With High Myopia：Wuhan High Myopia Study
- ClinicalTrials.gov ID
- NCT06162234
- Acronym / sponsor ID
- LOVE-WH / WWDRY2023-K074
- Conditions
- High Myopia
- Keywords
- ocular biometric parameters, Refractive Errors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| entire cohort | – | Other: observationalentire cohort made up of high myopia patients（observational study） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First-year college student from Wuhan University
Key inclusion criteria (5 listed)
- 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；
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalnone (observational study) | Other | entire cohort |
Primary outcome
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
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
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
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
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
4 secondary outcomes
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
Structural parameters of anterior segment
Time frame: Baseline and 6 months and 1，2,3,4years
Intraocular pressure(IOP)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Myopia, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QY Wu, MD (+86 18672345926, wuqyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopic optic nerve changes (time frame: Baseline and 6 months and 1，2,3,4years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.