Exploring the natural history of myopic maculopathy and optic neuropathy in high myopia: Zhongshan High Myopia Cohort
| ISRCTN | ISRCTN56368396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56368396 |
| Secondary identifying numbers | ZHMC-2023-v1 |
- Submission date
- 09/03/2024
- Registration date
- 12/03/2024
- Last edited
- 12/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Currently, pathologies including myopic maculopathy and high myopia-associated optic neuropathy are already the most frequent causes of irreversible vision loss and blindness in East Asia. However, the exact pathogenesis of these two disorders in high myopia remains elusive. Thus, it is imperative to conduct a longitudinal study to fully understand the natural history of myopic maculopathy and optic neuropathy in high myopia, determine associated risk factors and develop a precise prediction model, which will aid in improving the monitoring of high myopia and prevent vision loss.
Who can participate?
Individuals aged between 7 and 70 years old with high myopia who permanently live in Guangzhou, China. Our participants include the subjects who completed the 8-year follow-up from Zhongshan Ophthalmic Centre–Brien Holden Vision Institute (ZOC-BHVI) High Myopia Cohort Study and newly recruited subjects with high myopia.
What does the study involve?
Comprehensive eye and general tests are performed every 2 years for 8 years. Participants receive comprehensive eye and general tests and one-on-one ophthalmologist consultations based on the exam results every 2 years. All the exams follow the normal clinical operation.
What are the possible benefits and risks of participating?
Participants benefit from receiving comprehensive eye and general tests and one-on-one ophthalmologist consultations based on the results every 2 years. No additional risks are anticipated as all the exams follow the normal clinical operation.
Where is the study run from?
Zhongshan Ophthalmic Center, Sun Yat-sen University (China)
When is the study starting and how long is it expected to run for?
December 2023 to December 2030
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Dr Wei Wang, wangwei@gzzoc.com (China)
Contact information
Public, Scientific, Principal Investigator
No. 54. Xianlie Nan Road Yuexiu District
Guanghzou
510060
China
| Phone | +86 (0)20 87334687 |
|---|---|
| wangwei@gzzoc.com |
Study information
| Study design | Retrospective and prospective ambispective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | Zhongshan High Myopia Cohort: the natural history of myopic maculopathy and optic neuropathy in individuals with high myopia |
| Study acronym | ZHMC |
| Study objectives | The project aims to explore the natural history of myopic maculopathy and optic neuropathy in highly myopic individuals, construct an intelligent automatic analysis system based on multimodal imaging and build precise prediction models. |
| Ethics approval(s) |
Approved 12/03/2023, Zhongshan Ophthalmic Center Ethics Committee of Sun Yat-sen University (No.7 Jinsui Road, Zhujiang New Town, Guangzhou, 510060, China; +86 (0)20 87332529; zocethics@163.com), ref: 2023KYPJ090 |
| Health condition(s) or problem(s) studied | Individuals with high myopia |
| Intervention | Current interventions as of 12/03/2024: The ZHMC study is a retrospective and prospective ambispective cohort study that includes individuals who completed the 8-year follow-up from Zhongshan Ophthalmic Centre–Brien Holden Vision Institute (ZOC-BHVI) High Myopia Cohort Study and newly recruited subjects with high myopia. All individuals with high myopia in the study will be followed up every 2 years over a continuous period of 8 years. The examinations include: questionnaire surveys (e.g. basic demographic information, general medical history), general physical examinations (e.g. height, weight), and ocular examinations (strabismus and dominant eye, visual acuity, visual field, intraocular pressure, refraction, slit lamp examination, anterior segment photography, ocular biometry , (ultra-widefield) optical coherence tomography (OCT), ultra-widefield OCT angiography (OCTA), (ultra-widefield) fundus photography and autofluorescence, fundus examination, and magnetic resonance imaging (a portion of our participants by random sampling). _____ Previous interventions: The ZHMC study is a retrospective and prospective ambispective cohort study that includes individuals from Guangzhou, China. All individuals with high myopia in the study will be followed up every 2 years over a continuous period of 8 years. The examinations include: questionnaire surveys (e.g. basic demographic information, general medical history), general physical examinations (e.g. height, weight), and ocular examinations (strabismus and dominant eye, visual acuity, visual field, intraocular pressure, refraction, slit lamp examination, anterior segment photography, ocular biometry , (ultra-widefield) optical coherence tomography (OCT), ultra-widefield OCT angiography (OCTA), (ultra-widefield) fundus photography and autofluorescence, fundus examination, and magnetic resonance imaging (a portion of our participants by random sampling). |
| Intervention type | Other |
| Primary outcome measure | The long-term development and progression of myopic maculopathy measured using fundus photography and optic neuropathy measured using optical coherence tomography and visual field in highly myopic populations and associated risk factors at baseline and each follow-up visit (2, 4, 6, and 8 years). |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2022 |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 7 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Sphere ≤ −6.00 diopter (cylinder is not included) in both eyes 2. Aged between 7 and 70 years old |
| Key exclusion criteria | 1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome 2. History of laser treatment for myopia correction or any intraocular surgery affecting refractive status 3. Have autoimmunity disease such as systemic lupus erythematosus, rheumatoid arthritis; 4. Have severe health problems precluding follow-up such as end-stage heart disease, kidney disease, lung disease, or terminal cancer 5. Have significant ocular media opacity preventing fundus examinations (e.g.dense corneal opacity) 6. Unable to give their own informed consent 7. Plan to move from the area within the next 8 years |
| Date of first enrolment | 13/03/2023 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Guangzhou
510060
China
Sponsor information
University/education
Zhongshan Ophthalmic Center, No. 54. Xianlie Nan Road Yuexiu District
Guangzhou
510060
China
| Phone | +86 (0)20 87330487 |
|---|---|
| yyzhc@mail.sysu.edu.cn | |
| Website | https://www.gzzoc.com/ |
"ROR" |
https://ror.org/00mjawt10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 30/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Wei Wang (wangwei@gzzoc.com). Informed consent will be obtained before the participant joins the study. The study will follow the legal restrictions of the Ethics Committee of Zhongshan Ophthalmic Center, Sun Yat-sen University. For access to the data, please contact the principal investigator after the study is completed. |
Editorial Notes
12/03/2024: The following changes were made to the trial record:
1. The interventions were changed.
2. The plain English summary was updated to reflect these changes.
11/03/2024: Study's existence confirmed by the Zhongshan Ophthalmic Center Ethics Committee of Sun Yat-sen University.
