Exploring eye and phenotype characteristics in adults: high-definition oculo-phenomic evaluation study
| ISRCTN | ISRCTN47133398 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47133398 |
| Secondary identifying numbers | HOPE-2022-v6 |
- Submission date
- 27/02/2024
- Registration date
- 29/02/2024
- Last edited
- 28/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
With the growth and aging of the global population, vision impairment caused by age-related eye diseases has become a significant public health challenge worldwide. Understanding the natural progression and related factors of eye structure and function, and comparing the differences in eye structure and function between high myopia (short-sighted) and non-high myopia populations, is particularly important. This study aims to explore eye and phenotypic traits in adults.
Who can participate?
Adults who permanently live in Guangzhou without serious eye or systemic diseases
What does the study involve?
Comprehensive eye and general tests are performed every 2 years for 6 years.
What are the possible benefits and risks of participating?
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.
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?
November 2022 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
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 |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | High-Definition Oculo-Phenomic Evaluation (HOPE) Study: profiling the ocular and phenotypic traits in adults |
| Study acronym | HOPE |
| Study objectives | The project aims to explore the ocular and phenotypic traits in adults through a retrospective and prospective ambispective cohort. |
| Ethics approval(s) |
Approved 11/12/2022, Zhongshan Ophthalmic Center Ethics Committee, Sun Yat-sen University (No.7 Jinsui Road, Zhujiang New Town, Guangzhou, 510060, China; +86 (0)20 87332529; zocethics@163.com), ref: 2022KYPJ247 |
| Health condition(s) or problem(s) studied | Adults with high myopia and non-high myopia control |
| Intervention | The HOPE study is a retrospective and prospective ambispective cohort study that includes adults from Guangzhou, China. By conducting follow-ups every 2 years over a continuous period of 6 years, an adult eye health profile is constructed. All ocular examinations will be performed at the Zhongshan Ophthalmic Center (ZOC). The examinations include: questionnaire surveys (covering basic demographic information, general medical history, ocular disease history, lifestyle habits, cognitive function, dry eye scoring), general physical examinations (height, weight, waist circumference, hip circumference, blood pressure, lung capacity, grip strength, simple physical fitness tests), and ocular examinations (visual acuity, intraocular pressure, refraction, slit lamp examination, anterior segment photography, dry eye testing, comprehensive ocular surface analyzer, ocular biometry parameters, optical coherence tomography (OCT), OCT angiography (OCTA), fundus photography, and ultra-widefield fundus imaging. |
| Intervention type | Other |
| Primary outcome measure | Retinal and choroidal structures and blood flow measured by optical coherence tomography angiography at baseline and each follow-up visit (2, 4 and 6 years) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/11/2022 |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2000 |
| Key inclusion criteria | 1. Adults 2. Permanent residents of Guangzhou (residing for more than 6 months) 3. Volunteers for this study and have signed an informed consent form |
| Key exclusion criteria | 1. Presence of severe ocular diseases, such as advanced cataract, glaucoma, retinal diseases, etc 2. History of corneal or intraocular surgery, radiotherapy, laser treatment 3. Presence of severe systemic diseases, such as coronary heart disease, myocardial infarction, stroke, multiple sclerosis, dementia, depression, mania, etc 4. History of life-threatening major disease treatments, such as cardiac stent placement, major surgery under general anesthesia, surgery for malignant tumors 5. Pregnant women, disabled individuals, those with communication barriers, or those unable to complete the examination |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Yuexiu District
Guangzhou
510060
China
Sponsor information
University/education
Zhongshan Ophthalmic Center
No. 54. Xianlie Nan Road
Yuexiu District
Guangzhou
510060
China
| Phone | +86 (0)20 66607666 |
|---|---|
| wangw289@mail.sysu.edu.cn | |
| Website | http://www.gzzoc.com/ |
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 | 31/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the study will be presented as scientific article. |
| 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
28/02/2024: Study's existence confirmed by the Zhongshan Ophthalmic Center Ethics Committee, Sun Yat-sen University.
