Determinants of the onset and progression of diabetic retinopathy in south China: Guangzhou Diabetic Eye Study
| ISRCTN | ISRCTN15853192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15853192 |
| Secondary identifying numbers | NOPE-2019-0244.R1 |
- Submission date
- 20/03/2020
- Registration date
- 13/04/2020
- Last edited
- 02/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Diabetic retinopathy is a diabetes complication that affects the eyes. The incidence and risk factors for diabetic retinopathy in southern China remain unclear. This study aims to explore the onset and progression of diabetic retinopathy and its determinants in South China.
Who can participate?
Type 2 diabetic patients registered in community health centres in Yuexiu district in Guangzhou, China
What does the study involve?
Comprehensive eye tests are performed annually for 5 years, as well as blood and urine tests.
What are the possible benefits and risks of participating?
Participants receive an annual comprehensive eye test and one-on-one ophthalmologist consultation based on the exam results. 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 2017 to October 2025
Who is funding the study?
National Natural Science Foundation of China
Who is the main contact?
Prof. Wenyong Huang
hweny@mail.sysu.edu.cn
Contact information
Scientific
No. 54. Xianlie Nan Road
Yuexiu District
Guanghzou
510000
China
| Phone | +86 (0)20 87334687 |
|---|---|
| wangwei@gzzoc.com |
Scientific
No. 54. Xianlie Nan Road
Yuexiu District
Guangzhou
510000
China
| Phone | +86 (0)20 87334687 |
|---|---|
| liyuting@gzzoc.com |
Study information
| Study design | Community-based prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Guangzhou Diabetic Eye Study (GDES): exploring the onset and progression of diabetic retinopathy and the determinants in south China: a prospective cohort study |
| Study acronym | GDES |
| Study objectives | This project aims to explore the onset and progression of diabetic retinopathy (DR) and their determinants through a prospective cohort in South China. |
| Ethics approval(s) | Approved 25/10/2017, Zhongshan Ophthalmic Center Ethics Committee, Sun Yat-sen University (No.7 Jinsui Road, Zhujiang New Town, Guangzhou, China; +86 (0)20 87332529; zocethics@163.com), ref: 2017KYPJ094 |
| Health condition(s) or problem(s) studied | Diabetic retinopathy screening among people with diabetes |
| Intervention | The GDES is an ongoing community-based prospective cohort study that includes type 2 diabetic patients registered in the community health centres in Yuexiu district in Guangzhou. This district is one of the oldest and central areas of Guangzhou, the population is stable. The Zhongshan ophthalmic centre (ZOC), which is affiliated with Sun Yat-sen University in Guangzhou, is located in this district and is the main provider of eye health services for the city. The communities are stable and the community health centres have established long-term collaboration with ZOC and are fully equipped with a well-established registry system for diabetic patients. The participants were originally recruited in November 2017, and the plan was to follow up on them annually for 5 years. All ocular examinations were performed at ZOC. The examinations are as follows: 1. Visual acuity and refraction tests performed by qualified optometrists 2. Ocular biometric measurements 3. Intraocular pressure (IOP) measurement 4. Pupil dilation 5. Refraction 6. Slit lamp and fundus examinations 7. Colour retinal photographs 8. Optical coherence tomography (OCT) 9. Questionnaire interview 10. Biological sample collection |
| Intervention type | Other |
| Primary outcome measure | Prevalence, incidence and progression rates of DR, measured using grading of OCT results annually for 5 years |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/11/2017 |
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 1185 |
| Key inclusion criteria | 1. Aged 35–85 years 2. Diagnosed type 2 diabetes confirmed by medical records from endocrinologists, insulin treatments, oral medicine, fasting blood glucose ≥7.0 mmol/L for at least two consecutive measurements or postprandial blood glucose ≥11.1 mmol/L 3. Ocular-treatment-naïve eyes |
| Key exclusion criteria | 1. Any severe systemic disease, such as ischemic heart disease, stroke, cancer and kidney disease, or a history of systemic surgery, such as cardiac bypass, thrombolysis and kidney transplantation 2. Any cognitive disorder, mental disorder or failure to finish the questionnaire and all the examinations 3. Combined glaucoma, age-related macular degeneration, glaucoma, vitreous macular disease (vitreous haemorrhage, retinal detachment), amblyopia and other eye diseases 4. A history of intraocular surgery, such as retinal laser, intraocular anti-VEGF injection, glaucoma surgery, cataract surgery, laser myopia surgery and vitreoretinal surgery history 5. A failure of mydriasis due to corneal ulcer, severe refractive media turbidity or shallow anterior chamber and angle closure glaucoma |
| Date of first enrolment | 01/11/2017 |
| Date of final enrolment | 31/10/2022 |
Locations
Countries of recruitment
- China
Study participating centre
No. 54 Xianlie Nan Road
Yuexiu District
Guangzhou
510000
China
Sponsor information
University/education
Zhongshan Ophthalmic Center
No. 54. Xianlie Nan Road
Yuexiu District
Guangzhou
510000
China
| Phone | +86 (0)20 87334687 |
|---|---|
| huangwenyong@gzzoc.com | |
| Website | http://www.gzzoc.com/ |
"ROR" |
https://ror.org/0064kty71 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- SYSU
- Location
- China
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| 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 Prof. Wenyong Huang (hweny@mail.sysu.edu.cn). Informed consent will be obtained before the participant join 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 completes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/05/2025 | 27/05/2025 | Yes | No | |
| Results article | 01/07/2025 | 02/07/2025 | Yes | No |
Editorial Notes
02/07/2025: Publication reference added.
27/05/2025: Publication reference added.
12/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/10/2022 to 31/10/2025.
2. The intention to publish date was changed from 31/10/2023 to 31/10/2026.
3. The plain English summary was updated to reflect these changes.
02/04/2020: Trial's existence confirmed by Zhongshan Ophthalmic Center Ethics Committee.
