Preliminary Assessment of an Automated Tool for Diabetic... | NCT07404657

Studies
Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening

NCT07404657

Sponsor

Centervue SpA

Status

Not yet recruiting

Last Update Posted

Feb 11, 2026Actual

Enrollment

198Estimated

Phase

Not provided

Conditions

Diabetic Retinopathy (DR)

Interventions

automatic analysis of fundus images performed by the software tool based on artificial intelligence

Countries

Not provided

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2026Estimated

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Feb 5, 2026

First Submission Date that Met QC Criteria

Feb 5, 2026

First Posted Date

Feb 11, 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

Feb 5, 2026

Last Update Posted Date

Feb 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

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

This study is being done to evaluate the performance of a software that uses artificial intelligence to analyze photographs of the retina to help detect diabetic retinopathy. The study will also assess the safety of the software in combination with a fundus camera already available on the market. This software analyzes retinal photographs to detect more than mild diabetic retinopathy in adults with diabetes. The results will be compared to expert human evaluations.

Detailed Description

Not provided

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

198Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
automatic analysis of fundus images performed by the software tool based on artificial intelligence	Device	the duration of the intervention is the analysis performed by the software tool based on fundus images acquired

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects whose results provided by the automatic AI-based tool match the reading center grading for the identification of referable diabetic eye disease (more than mild DR).		1-day visit

Secondary Outcomes

Measure	Description	Time Frame
percentage of eyes for which the AI-based automatic tool produced a result		1-day visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

22 years old or older
diabetes or diabetic retinopathy
understand the study information and able to sign a consent form

Exclusion Criteria:

cannot tolerate eye imaging tests
laser treatment or injections
eye surgery, except for simple cataract surgery
currently involved in another study
pregnant
cannot or do not want to have your eyes dilated
photodynamic therapy within the last 90 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

population attending a primary-care facility with diagnosis of diabetes mellitus and/or past diagnosis of diabetic retinopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rui	Contact	00393357442593		chiara.rui@icare-world.com
Rumiato	Contact			ra.imaging@icare-world.com

Overall Officials

Not provided

Locations

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