Diabetic Retinopathy Prevalence And Risk Factors (DR-CENTRAL)

March 10, 2026 updated by: Da Nang Family General Hospital

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:

  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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
      • Da Nang, Vietnam, 50000
        • Recruiting
        • Department of Endocrinology and Diabetes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (data collected at the time of retinal examination during the study period, January-September 2025)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Da Nang Family General Hospital

Investigators

  • Principal Investigator: Thao Nguyen Ngoc, Doctor of Medicine, Family Hospital, Da Nang, Vietnam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/BVGĐ -HĐĐĐ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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