High MyopiaSHMSANCT03446300
Shanghai High Myopia Study for Adults
An observational study of High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
High myopia retinopathy has become the first cause of irreversible blindness and severe visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused by high myopia retinopathy, it is very necessary to research the mechanism of early visual impairment to prevent and control damages. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: college student population; working population; aged more than 50 years old population.
Who may be able to join
- ≥18 years old; spherical equivalent refraction ≤-6.00D;
Who cannot join
- a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Xun Xu, MD, 86-13386259538, drxuxun@tom.com
About this study
Official title: The Cohort Study of Early Visual Impairment Mechanism Caused by Change of Fundus Structure in Adults With High Myopia
High myopia retinopathy has become the first cause of irreversible blindness and severe visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused by high myopia retinopathy, it is very necessary to research the mechanism of early visual impairment to prevent and control damages. Our recent research found that the decreasing of macular retina vascular density and subfoveal choroidal thickness, the increasing of Beta Zone area in optic atrophy and the rising of glycosylated hemoglobin in high myopia patients were significantly related to visual impairment, which suggested that the source of visual impairment was the abnormal structure changes surrounding optic and fovea, but so far there is no related study. We will conduct a 5 years prospective cohort study in the population of 2420 high myopia and controls which have established in college student population, working population and aged more than 50 years old population, using the latest OCT-A and SS-OCT to measure macular retina vascular density, subfoveal choroidal thickness, Beta Zone area in optic atrophy, combined with the semiparametric mixed effects model, we will analysis the prediction index between fundus structure parameters, blood biochemical index and individual characteristics prediction to explore the public health management mode of early prevention and treatment during high myopia population.
- Conditions
- High Myopia
- Keywords
- High Myopia, fundus structure, early visual impairment
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| college student population | Not described | |
| working population | Not described | |
| aged more than 50 years old population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retina Vessel Density (RVD)
RVD is calculated both the macular and peripapillary area.
Measured: December 31, 2016
tilted optic disc
A tilted optic disc was defined as the tilt ratios ≤0.80.
Measured: December 31, 2016
β-zone PPA
The β-zone PPA area (an inner crescent of chorioretinal atrophy with good visibility of the large choroidal vessels and the sclera) was determined as the total number of pixels using the ImageJ software in a circumferential pattern.
Measured: December 31, 2018
glycosylated hemoglobin
This test measures the average blood sugar control for the previous three months or so.
Measured: December 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianfeng Zhu, PhD, MD, Study director, Shanghai Eye Disease Prevention & Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446300
- Sponsor's protocol ID
- YFZX2018002
- Acronym
- SHMSA
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li M, Xu H, Ye L, Zhou S, Xie J, Liu C, Zhu J, He J, Fan Y, Xu X. Association of macular outward scleral height with axial length, macular choroidal thickness and morphologic characteristics of the optic disc in Chinese adults. Eye (Lond). 2024 Apr;38(5):923-929. doi: 10.1038/s41433-023-02804-5. Epub 2023 Oct 28.
PubMed 37898715
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cohort Study of Early Visual Impairment Mechanism Caused by Change of Fundus Structure in Adults With High Myopia
- ClinicalTrials.gov ID
- NCT03446300
- Acronym / sponsor ID
- SHMSA / YFZX2018002
- Conditions
- High Myopia
- Keywords
- High Myopia, fundus structure, early visual impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Feb 2018 (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.
High myopia retinopathy has become the first cause of irreversible blindness and severe visual impairment in Chinese adults, in order to avoid the blind and visual impairment caused by high myopia retinopathy, it is very necessary to research the mechanism of early visual impairment to prevent and control damages. Our recent research found that the decreasing of macular retina vascular density and subfoveal choroidal thickness, the increasing of Beta Zone area in optic atrophy and the rising of glycosylated hemoglobin in high myopia patients were significantly related to visual impairment, which suggested that the source of visual impairment was the abnormal structure changes surrounding optic and fovea, but so far there is no related study. We will conduct a 5 years prospective cohort study in the population of 2420 high myopia and controls which have established in college student population, working population and aged more than 50 years old population, using the latest OCT-A and SS-OCT to measure macular retina vascular density, subfoveal choroidal thickness, Beta Zone area in optic atrophy, combined with the semiparametric mixed effects model, we will analysis the prediction index between fundus structure parameters, blood biochemical index and individual characteristics prediction to explore the public health management mode of early prevention and treatment during high myopia population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| college student population | – | – |
| working population | – | – |
| aged more than 50 years old population | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- college student population; working population; aged more than 50 years old population.
Key inclusion criteria (1 listed)
- ≥18 years old; spherical equivalent refraction ≤-6.00D;
Key exclusion criteria (1 listed)
- a history of ocular or systemic diseases including congenital cataract and glaucoma; previous intraocular or refractive surgery;other evidence of retinal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retina Vessel Density (RVD)
Time frame: December 31, 2016
RVD is calculated both the macular and peripapillary area.
tilted optic disc
Time frame: December 31, 2016
A tilted optic disc was defined as the tilt ratios ≤0.80.
β-zone PPA
Time frame: December 31, 2018
The β-zone PPA area (an inner crescent of chorioretinal atrophy with good visibility of the large choroidal vessels and the sclera) was determined as the total number of pixels using the ImageJ software in a circumferential pattern.
glycosylated hemoglobin
Time frame: December 31, 2020
This test measures the average blood sugar control for the previous three months or so.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Derived from this study: PubMed 37898715Li M, Xu H, Ye L, Zhou S, Xie J, Liu C, Zhu J, He J, Fan Y, Xu X. Association of macular outward scleral height with axial length, macular choroidal thickness and morphologic characteristics of the optic disc in Chinese adults. Eye (Lond). 2024 Apr;38(5):923-929. doi: 10.1038/s41433-023-02804-5. Epub 2023 Oct 28.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jianfeng Zhu, PhD, MD study director
Shanghai Eye Disease Prevention & Treatment Center
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 Shanghai Eye Disease Prevention and Treatment Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xun Xu, MD (8613386259538, drxuxun@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retina Vessel Density (RVD) (time frame: December 31, 2016). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446300, which also lists 1 linked publication.
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 26 Feb 2018; AzTrials last refreshed its copy on 27 Oct 2026.