Eye DiseasesNCT04302220
Myopic Optic Neuropathy in Chinese High Myopia Population
An observational study of Eye Diseases, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- How many people
- 813 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2019to 30 Jun 2026
- How long will I take part?
- 3 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have high myopia aged from 18 to above.
Who may be able to join
- Age ≥18 years
- Equivalent spherical ≤-6D or axial length ≥26.5mm
- Best corrected visual acuity ≥ 6/12
Who cannot join
- Unwilling or unable to give consent, or unable to return for scheduled protocol visits.
- Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease.
- Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia.
- Need for ocular surgery/laser or anticipated need for cataract surgery during the study period.
- Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases);
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural History of Myopic Optic Neuropathy for High Myopia in Chinese Adult Population: a Registry Cohort Study
This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.
Read the detailed description
Global prevalence of high myopia brings about markedly increasing of blinding complications as myopic optic neuropathy (MON) and glaucoma. It was estimated that there were 163 million people who have high myopia in 2000, and the population with high myopia would increase to almost one billion (9.8% of the world population) worldwide by 2050.
Glaucoma is the leading cause of irreversible blindness worldwide while it is difficult to distinguish glaucoma among MON in high myopia eyes. However, there lack longitudinal study to illustrate the natural course interpreting the distribution and natural history of MON.
In view of the above problems, this is a longitudinal registry cohort study to observe the long-term changes of structural and functional parameters of MON in high myopia, and to investigate the natural course and associted risk factors that influence the progression in a Chinese adult population.
- Conditions
- Eye Diseases
- Keywords
- myopic optic neuropathy, high myopia, glaucoma
- Medical subject headings
- Eye Diseases, Glaucoma
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 |
|---|---|---|
| high myopia | Population who have high myopia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of glaucoma within 36 months
Structural and functional changes of glaucoma using visual field, stereoscopic fundus photography.
Measured: 3 years
Secondary outcomes (1)
Progression of myopia and other structural changes of retina and choroid.
Structural and functional changes of myopia based on axial length and refractive error.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start6 Jun 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 813 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiulan Zhang, Sun Yat-sen University
- Investigators
- Xiulan Zhang, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302220
- Sponsor's protocol ID
- 2019KYPJ079
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Publications
Lin F, Chen S, Song Y, Li F, Wang W, Zhao Z, Gao X, Wang P, Jin L, Liu Y, Chen M, Liang X, Yang B, Ning G, Cheng CY, Healey PR, Park KH, Zangwill LM, Aung T, Ohno-Matsui K, Jonas JB, Weinreb RN, Zhang X; Glaucoma Suspects with High Myopia Study Group. Classification of Visual Field Abnormalities in Highly Myopic Eyes without Pathologic Change. Ophthalmology. 2022 Jul;129(7):803-812. doi: 10.1016/j.ophtha.2022.03.001. Epub 2022 Mar 12.
PubMed 35288144Song Y, Wang W, Lin F, Chen S, Jin L, Li F, Gao K, Cheng W, Xiong J, Zhou R, Chen M, Liang J, Zhang J, Jonas JB, Zhang X. Natural history of glaucomatous optic neuropathy in highly myopic Chinese: study protocol for a registry cohort study. BMJ Open. 2020 Dec 30;10(12):e039183. doi: 10.1136/bmjopen-2020-039183.
PubMed 33380478
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Myopic Optic Neuropathy for High Myopia in Chinese Adult Population: a Registry Cohort Study
- ClinicalTrials.gov ID
- NCT04302220
- Acronym / sponsor ID
- 2019KYPJ079
- Conditions
- Eye Diseases
- Keywords
- myopic optic neuropathy, high myopia, glaucoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 813 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Mar 2020 (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.
This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.
Detailed description
Global prevalence of high myopia brings about markedly increasing of blinding complications as myopic optic neuropathy (MON) and glaucoma. It was estimated that there were 163 million people who have high myopia in 2000, and the population with high myopia would increase to almost one billion (9.8% of the world population) worldwide by 2050.
Glaucoma is the leading cause of irreversible blindness worldwide while it is difficult to distinguish glaucoma among MON in high myopia eyes. However, there lack longitudinal study to illustrate the natural course interpreting the distribution and natural history of MON.
In view of the above problems, this is a longitudinal registry cohort study to observe the long-term changes of structural and functional parameters of MON in high myopia, and to investigate the natural course and associted risk factors that influence the progression in a Chinese adult population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high myopia | – | –Population who have high myopia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have high myopia aged from 18 to above.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Equivalent spherical ≤-6D or axial length ≥26.5mm
- Best corrected visual acuity ≥ 6/12
Key exclusion criteria (6 listed)
- Unwilling or unable to give consent, or unable to return for scheduled protocol visits.
- Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease.
- Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia.
- Need for ocular surgery/laser or anticipated need for cataract surgery during the study period.
- Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases);
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
Progression of glaucoma within 36 months
Time frame: 3 years
Structural and functional changes of glaucoma using visual field, stereoscopic fundus photography.
1 secondary outcome
Progression of myopia and other structural changes of retina and choroid.
Time frame: 3 years
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 9 Dec 2024.
- Derived from this study: PubMed 35288144Lin F, Chen S, Song Y, Li F, Wang W, Zhao Z, Gao X, Wang P, Jin L, Liu Y, Chen M, Liang X, Yang B, Ning G, Cheng CY, Healey PR, Park KH, Zangwill LM, Aung T, Ohno-Matsui K, Jonas JB, Weinreb RN, Zhang X; Glaucoma Suspects with High Myopia Study Group. Classification of Visual Field Abnormalities in Highly Myopic Eyes without Pathologic Change. Ophthalmology. 2022 Jul;129(7):803-812. doi: 10.1016/j.ophtha.2022.03.001. Epub 2022 Mar 12.
- Derived from this study: PubMed 33380478Song Y, Wang W, Lin F, Chen S, Jin L, Li F, Gao K, Cheng W, Xiong J, Zhou R, Chen M, Liang J, Zhang J, Jonas JB, Zhang X. Natural history of glaucomatous optic neuropathy in highly myopic Chinese: study protocol for a registry cohort study. BMJ Open. 2020 Dec 30;10(12):e039183. doi: 10.1136/bmjopen-2020-039183.
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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.
Xiulan Zhang, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Eye Diseases, run by Sun Yat-sen 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of glaucoma within 36 months (time frame: 3 years). 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 NCT04302220, which also lists 2 linked publications.
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 9 Dec 2024.