NCT07468058

Brief 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. 1.What is the prevalence and distribution of different stages of diabetic retinopathy among diabetic patients at this hospital?
  2. 2.Which clinical and laboratory factors are associated with the presence of diabetic retinopathy?

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

March 12, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

February 25, 2026

Last Update Submit

March 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of diabetic retinopathy (any stage)

    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)

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Diabetes

Da Nang, 50000, Vietnam

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Thao Nguyen Ngoc, Doctor of Medicine

    Family Hospital, Da Nang, Vietnam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thảo Nguyễn, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 12, 2026

Study Start

November 25, 2025

Primary Completion

March 15, 2026

Study Completion

March 30, 2026

Last Updated

March 12, 2026

Record last verified: 2025-11

Locations