Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
NCT ID:
NCT04612868
Group ID:
EG000
Title:
AEYE Software Device
Description:
An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.
AEYE Software Device: Eligible participants will undergo the following procedures:
* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.
* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.
* All study subjects will have their pupils dilated using dilation drops.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
0
Other Number Affected:
0
Other Number At Risk:
0
Study:
NCT04612868
Results Section:
NCT04612868
Adverse Events Module:
NCT04612868