Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 7:58 PM
Study NCT ID:
NCT07404657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Assessment of an Automated Tool for Diabetic Retinopathy Screening
Sponsor:
Centervue SpA
Organization:
Study Overview
Official Title:
Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: