NCT06057493

RDP Reliability Study

Analytic Validation of the Optina Retinal Deep Phenotyping.TM (RDP) Platform

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Optina Diagnostics Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Retinal Imaging with Optina4C Camera	The study consists of 2 visits and 8 Imaging sessions: The participant will go through four (8) imaging sessions in two visits with the Optina-4CTM cameras to get pictures of your retina. These imaging sessions will be done by three qualified operators who have been trained on the study device by Optina Diagnostics.

Timeline

• Start date: 2023-09-19
• Primary completion: 2024-02-06
• Completion: 2024-02-06
• First posted: 2023-09-28
• Last updated: 2024-02-29

Locations

1 site across 1 country: Canada