Diabetic Retinopathy Prevalence And Risk Factors | NCT07468058

Studies
Diabetic Retinopathy Prevalence And Risk Factors

NCT07468058

Sponsor

Da Nang Family General Hospital

Status

Recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Diabetic Retinopathy (DR)

Interventions

fundus examination and optical coherence tomography (OCT)

Countries

Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 25, 2025Actual

Primary Completion Date

Mar 15, 2026Estimated

Completion Date

Mar 30, 2026Estimated

First Submitted Date

Feb 25, 2026

First Submission Date that Met QC Criteria

Mar 10, 2026

First Posted Date

Mar 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thảo Nguyễn, MD	Contact	84335393897		ngocthao090897@gmail.com

Overall Officials

Name	Affiliation	Role
Thao Nguyen Ngoc, Doctor of Medicine	Family Hospital, Da Nang, Vietnam	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology and Diabetes	Recruiting	Da Nang		50000	Vietnam

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided