Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT06057493
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RDP Reliability Study
Sponsor:
Optina Diagnostics Inc.
Organization:
Study Overview
Official Title:
Analytic Validation of the Optina Retinal Deep Phenotyping.TM (RDP) Platform
Status:
COMPLETED
Status Verified Date:
2024-02
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 is an observational study designed to assess the reliability and consistency of the Optina awAIrTM CAS Test for detecting phenotypic changes in the retina that are associated with beta-amyloid status (positive or negative). The purpose of this study is to ensure that the retinal image capture process is consistent and under control, regardless of the operator or the time of measurement. The study will include enough repeated measurements on different systems, by three operators, and at different times to demonstrate.
Detailed Description:
The purpose of this study is to assess the reliability of the Optina Retinal Deep Phenotyping.TM(RDP) platform. The RDP Platform is comprised of the Optina-4CTM retinal camera and its Optina-4C ConnectTM software, as well as the Optina awAIrTM-CAS Test (also called CAS Test) for detecting phenotypic changes in the retina that are associated with cerebral beta-amyloid status (positive or negative). This study will quantify points of variability in the data input for the CAS Test, including:
* Left eye vs. right eye (retinal scan)
* Eye algorithm selection (eye assessment obtained from different eye specialists either an Ophthalmologist or an Optometrist)
* Hardware variability (Inter-instrument Variability retinal scans obtained from different Optina-4CTM cameras)
* Inter-operator variability (retinal scans obtained from different Users of the Optina-4CTM camera)
* Intra-operator variability (retinal scans obtained by the same user on the same Optina-4CTM camera
* Left eye vs. right eye (retinal scan)
* Eye algorithm selection (eye assessment obtained from different eye specialists either an Ophthalmologist or an Optometrist)
* Hardware variability (Inter-instrument Variability retinal scans obtained from different Optina-4CTM cameras)
* Inter-operator variability (retinal scans obtained from different Users of the Optina-4CTM camera)
* Intra-operator variability (retinal scans obtained by the same user on the same Optina-4CTM camera
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: