Condition category
Eye Diseases
Date applied
20/03/2020
Date assigned
13/04/2020
Last edited
03/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 2023

Who is funding the study?
National Natural Science Foundation of China

Who is the main contact?
Prof. Wenyong Huang
hweny@mail.sysu.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wei Wang

ORCID ID

Contact details

No. 54. Xianlie Nan Road
Yuexiu District
Guanghzou
510000
China
+86 (0)20 87334687
wangwei@gzzoc.com

Type

Scientific

Additional contact

Ms Yuting Li

ORCID ID

Contact details

No. 54. Xianlie Nan Road
Yuexiu District
Guangzhou
510000
China
+86 (0)20 87334687
liyuting@gzzoc.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NOPE-2019-0244.R1

Study information

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

Acronym

GDES

Study hypothesis

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

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

Study design

Community-based prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/11/2017

Overall trial end date

31/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1185

Participant 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

Recruitment start date

01/11/2017

Recruitment end date

31/10/2022

Locations

Countries of recruitment

China

Trial participating centre

Zhongshan Ophthalmic Center
Sun Yat-sen University No. 54 Xianlie Nan Road Yuexiu District
Guangzhou
510000
China

Sponsor information

Organisation

Sun Yat-sen University

Sponsor details

Zhongshan Ophthalmic Center
No. 54. Xianlie Nan Road
Yuexiu District
Guangzhou
510000
China
+86 (0)20 87334687
huangwenyong@gzzoc.com

Sponsor type

University/education

Website

http://www.gzzoc.com/

Funders

Funder type

University/education

Funder name

Sun Yat-sen University

Alternative name(s)

SYSU

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

China

Results and Publications

Publication and dissemination plan

The results of the study will be presented as scientific article.

IPD sharing statement
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.

Intention to publish date

31/10/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/04/2020: Trial's existence confirmed by Zhongshan Ophthalmic Center Ethics Committee.