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RecruitingNCT07468058DR-CENTRALUpdated Mar 12, 2026

Diabetic Retinopathy Prevalence And Risk Factors

An observational study in Diabetic Retinopathy (DR), sponsored by Da Nang Family General Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Da Nang Family General Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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. What is the prevalence and distribution of different stages of diabetic retinopathy among diabetic patients at this hospital?
  2. 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.

02

Conditions studied

  • Diabetic Retinopathy (DR)

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03

In context

Diabetic Retinopathy

773 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.

This study's planned enrollment of 300 is above the median of 154 across 264 observational studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

Da Nang Family General Hospital is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • Otherfundus 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

06

What researchers measure

Primary outcomes

  1. Prevalence of diabetic retinopathy (any stage)

    To determine the prevalence of diabetic retinopathy among patients with diabetes mellitus.

    Time frame: At baseline (data collected at the time of retinal examination during the study period, January-September 2025)

07

Study locations

1 of 1 sites recruiting
  • Department of Endocrinology and Diabetes
    Da Nang, 50000, Vietnam
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07468058
Lead sponsor
Da Nang Family General Hospital
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Nov 25, 2025
Primary completion
Mar 15, 2026 (estimated)
Completion
Mar 30, 2026 (estimated)
Last update
Mar 12, 2026

Study contacts

Thảo Nguyễn, MD
Contact
ngocthao090897@gmail.com
84335393897
Thao Nguyen Ngoc, Doctor of Medicine
principal investigator · Family Hospital, Da Nang, Vietnam

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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