Diabetic Retinopathy (DR)DR-CENTRALNCT07468058
Diabetic Retinopathy Prevalence And Risk Factors
An observational study of Diabetic Retinopathy (DR), run by Da Nang Family General Hospital at 1 site in Vietnam.
Trial summary
The goal of this retrospective observational study is to evaluate the prevalence and severity of diabetic retinopathy (DR) and to identify associated risk factors among patients with diabetes mellitus at Gia Dinh Family Hospital in Da Nang, Vietnam. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy (DR)
- What is being tested?
- fundus examination and optical coherence tomography (OCT)
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Nov 2025to 30 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This hospital-based retrospective cohort study included adult patients with diabetes mellitus who attended the Endocrinology-Diabetes Center and underwent ophthalmologic evaluation at the Eye Clinic of Family General Hospital, Da Nang, Vietnam, between January 2025 and September 2025.
Who may be able to join
- Diagnosed diabetes mellitus (type 1 or type 2) according to ADA criteria
- Underwent ophthalmic examination including dilated fundus examination and OCT
- Available electronic medical records with key clinical and laboratory data
Who cannot join
- Gestational diabetes mellitus
- Media opacity precluding fundus examination (advanced cataract, corneal opacity, dense vitreous hemorrhage)
- Other retinal diseases (e.g., hypertensive retinopathy, retinal vein occlusion)
- History of ocular trauma or intraocular surgery within 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Diabetes
Da Nang, 50000
Thao Nguyen Ngoc, 84335393897, ngocthao090897@gmail.com
About this study
Official title: Diabetic Retinopathy Prevalence And Risk Factors From A Hospital - Based Cohort In Central Vietnam
The goal of this retrospective observational study is to evaluate the prevalence and severity of diabetic retinopathy (DR) and to identify associated risk factors among patients with diabetes mellitus at Gia Dinh Family Hospital in Da Nang, Vietnam.
The main questions it aims to answer are:
- What is the prevalence and distribution of different stages of diabetic retinopathy among diabetic patients at this hospital?
- Which clinical and laboratory factors are associated with the presence of diabetic retinopathy?
Read the detailed description
Diabetic retinopathy (DR) is a leading cause of preventable visual impairment worldwide. Global estimates suggest that approximately 22-26% of people with diabetes have some degree of DR, with about 6% experiencing vision-threatening disease. The burden is expected to increase substantially, particularly in low- and middle-income countries.
Vietnam is experiencing a rapid rise in diabetes prevalence, however, data from Central Vietnam, particularly from multidisciplinary general hospitals, remain limited.
This study aims to evalutate the local prevalence, severity distribution, and associated risk factors of DR in a general hospital in Da Nang which is essential to inform screening strategies, optimize management, and reduce preventable vision loss.
- Conditions
- Diabetic Retinopathy (DR)
- Being tested
- fundus examination and optical coherence tomography (OCT)
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fundus examination and optical coherence tomography (OCT)Other
Patients will be identified through the Ehealth program at the Family Hospital, Da Nang.
All diabetic patients who visited the Center of Endocrinology and Diabetes and had ophthalmologic examination, including fundus examination and optical coherence tomography (OCT), during the study period will be screened for eligibility
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diabetic retinopathy (any stage)
To determine the prevalence of diabetic retinopathy among patients with diabetes mellitus.
Measured: At baseline (data collected at the time of retinal examination during the study period, January-September 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start25 Nov 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Da Nang Family General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thao Nguyen Ngoc, Doctor of Medicine, Principal investigator, Family Hospital, Da Nang, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468058
- Sponsor's protocol ID
- 2025/BVGĐ -HĐĐĐ
- Acronym
- DR-CENTRAL
- Status last verified
- Nov 2025
- First submitted
- 25 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy Prevalence And Risk Factors From A Hospital - Based Cohort In Central Vietnam
- ClinicalTrials.gov ID
- NCT07468058
- Acronym / sponsor ID
- DR-CENTRAL / 2025/BVGĐ -HĐĐĐ
- Conditions
- Diabetic Retinopathy (DR)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Da Nang Family General HospitalUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Mar 2026 (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.
The goal of this retrospective observational study is to evaluate the prevalence and severity of diabetic retinopathy (DR) and to identify associated risk factors among patients with diabetes mellitus at Gia Dinh Family Hospital in Da Nang, Vietnam.
The main questions it aims to answer are:
- What is the prevalence and distribution of different stages of diabetic retinopathy among diabetic patients at this hospital?
- Which clinical and laboratory factors are associated with the presence of diabetic retinopathy?
Detailed description
Diabetic retinopathy (DR) is a leading cause of preventable visual impairment worldwide. Global estimates suggest that approximately 22-26% of people with diabetes have some degree of DR, with about 6% experiencing vision-threatening disease. The burden is expected to increase substantially, particularly in low- and middle-income countries.
Vietnam is experiencing a rapid rise in diabetes prevalence, however, data from Central Vietnam, particularly from multidisciplinary general hospitals, remain limited.
This study aims to evalutate the local prevalence, severity distribution, and associated risk factors of DR in a general hospital in Da Nang which is essential to inform screening strategies, optimize management, and reduce preventable vision loss.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This hospital-based retrospective cohort study included adult patients with diabetes mellitus who attended the Endocrinology-Diabetes Center and underwent ophthalmologic evaluation at the Eye Clinic of Family General Hospital, Da Nang, Vietnam, between January 2025 and September 2025.
Key inclusion criteria (3 listed)
- Diagnosed diabetes mellitus (type 1 or type 2) according to ADA criteria
- Underwent ophthalmic examination including dilated fundus examination and OCT
- Available electronic medical records with key clinical and laboratory data
Key exclusion criteria (4 listed)
- Gestational diabetes mellitus
- Media opacity precluding fundus examination (advanced cataract, corneal opacity, dense vitreous hemorrhage)
- Other retinal diseases (e.g., hypertensive retinopathy, retinal vein occlusion)
- History of ocular trauma or intraocular surgery within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fundus examination and optical coherence tomography (OCT)Patients will be identified through the Ehealth program at the Family Hospital, Da Nang. All diabetic patients who visited the Center of Endocrinology and Diabetes and had ophthalmologic examination, including fundus examination and optical coherence tomography (OCT), during the study period will be screened for eligibility | Other | – |
Primary outcome
Prevalence of diabetic retinopathy (any stage)
Time frame: At baseline (data collected at the time of retinal examination during the study period, January-September 2025)
To determine the prevalence of diabetic retinopathy among patients with diabetes mellitus.
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 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Thao Nguyen Ngoc, Doctor of Medicine principal investigator
Family Hospital, Da Nang, Vietnam
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 Diabetic Retinopathy (DR), run by Da Nang Family General Hospital at 1 site in Vietnam.
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 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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 Vietnam. 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?
Contact Thảo Nguyễn, MD (84335393897, ngocthao090897@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of diabetic retinopathy (any stage) (time frame: At baseline (data collected at the time of retinal examination during the study period, January-September 2025)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.