Diabetic Retinopathy Prevalence And Risk Factors

NCT07468058 — Recruiting, 300 participants, Da Nang Family General Hospital

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

Registry	NCT07468058, acronym DR-CENTRAL
Status	Recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	Da Nang Family General Hospital (Other)
Conditions	Diabetic Retinopathy (DR)
Interventions	fundus examination and optical coherence tomography (OCT) (Other)
Dates	start 2025-11-25, primary completion 2026-03-15 (estimated), completion 2026-03-30 (estimated), first posted 2026-03-12, last updated 2026-03-12
Locations	1 site in Vietnam

-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?

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

Prevalence of diabetic retinopathy (any stage) [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Endocrinology and Diabetes	Da Nang	Vietnam	Recruiting

+Investigators

Thao Nguyen Ngoc, Doctor of Medicine, Principal investigator, Family Hospital, Da Nang, Vietnam