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NCT Number: NCT07468058

Diabetic Retinopathy Prevalence And Risk Factors

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?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology and Diabetes

Da Nang, 50000, Vietnam

Location status: Recruiting

Location contact

Thao Nguyen Ngoc

CONTACT

[email protected]

84335393897

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thảo Nguyễn, MD

CONTACT

[email protected]

84335393897

Sponsors and collaborators

Lead sponsor

Da Nang Family General Hospital

Other

Registry information

Official study title

Diabetic Retinopathy Prevalence And Risk Factors From A Hospital - Based Cohort In Central Vietnam

Acronym: DR-CENTRAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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