Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06241664
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-01-21
Brief Title:
Efficacy and Safety of AEYE Diagnostic Screening AEYE-DS Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images
Sponsor:
AEYE Health Inc
Organization:
AEYE Health Inc
Study Overview
Official Title:
Prospective Clinical Trial to Demonstrate the Efficacy and Safety of the AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images Obtained With Multiple Fundoscopy Camera Devices
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy mtmDR in adult participants diagnosed with Diabetic Mellitus DM using fundoscopic images of the eyes The main question it aims to answer is if the software is effective in diagnosing more than mild Diabetic Retinopathy mtmDR in patients with known diabetes using digital funduscopic images acquired from each of the participating fundoscopy devices and based on one macula centered image per eye
Participants
will have an eye exam in which photographic images of each eye will be taken by a novice operator using four different FDA approvedregistered fundoscopy cameras These images will be sent to and analyzed by the AEYE-DS software device
will have additional eye imaging taken using a different FDA approved desktop camera system by a professional ophthalmic photographer These images will be sent to an independent reading center for analysis
will have dilation drops put in their eyes either during or after the imaging with the fundoscopy cameras wait about 30 minutes for the pupils to dilate and continue the eye imaging exams
The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis
Participants
will have an eye exam in which photographic images of each eye will be taken by a novice operator using four different FDA approvedregistered fundoscopy cameras These images will be sent to and analyzed by the AEYE-DS software device
will have additional eye imaging taken using a different FDA approved desktop camera system by a professional ophthalmic photographer These images will be sent to an independent reading center for analysis
will have dilation drops put in their eyes either during or after the imaging with the fundoscopy cameras wait about 30 minutes for the pupils to dilate and continue the eye imaging exams
The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None