NCT07378956

Brief Summary

The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

January 23, 2026

Last Update Submit

April 8, 2026

Conditions

Diabetic Retinopathy (DR)Diabete MellitusFundus Photography

Outcome Measures

Primary Outcomes (1)

  • True Referral Rate

    The true referral rate is defined as the proportion of subjects who were diagnosed with diabetic retinopathy by an ophthalmologist among those referred to ophthalmology with suspected diabetic retinopathy. The true referral rate will be compared between the intervention and control groups.

    within 6 months

Secondary Outcomes (7)

  • Diabetic Retinopathy (DR) Diagnosis Rate

    Within 6 months

  • Odds Ratio

    Within 6 months

  • Referral Rate

    Within 6 months

  • Time to Diabetic Retinopathy Diagnosis

    Within 6 months

  • Performance of the AI System in Detecting Diabetic Retinopathy

    Within 6 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Interim Analysis

    Within 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

For participants assigned to the intervention group, VUNO Med®-Fundus AI™ will be applied to the acquired fundus images, and the AI-generated outputs will be shown to clinicians during routine care.

Device: VUNO Med®-Fundus AI™

Control group

NO INTERVENTION

For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance.

Interventions

VUNO Med®-Fundus AI™DEVICE

VUNO Med®-Fundus AI™ is an artificial intelligence-based fundus image detection and diagnostic support software. The software automatically identifies abnormal retinal findings and provides information on the type and location of detected abnormalities to aid clinical decision-making.

Intervention group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 19 years or older.
  • A documented diagnosis of type 2 diabetes mellitus.
  • Ability to communicate adequately and provide written informed consent for participation in the study.

You may not qualify if:

  • A prior diagnosis of diabetic retinopathy at the time of screening.
  • A history of ophthalmic surgery within 6 months prior to the screening date.
  • A diagnosis of type 1 diabetes mellitus.
  • Pregnancy at the time of screening.
  • Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, Gyeonggi-do, 22332, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Hee Jun Park

CONTACT

82-10-7101-2844heejun.park@vuno.co

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The institutional dataset used in this study, along with de-identified results, is available upon reasonable request for purposes such as systematic review or meta-analysis, only with approval from the corresponding author and the official approval of local IRB.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

KR(1)