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RDP Reliability Study

NCT06057493 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2024-02-29

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Optina Diagnostics Inc.

    lead INDUSTRY

Principal Investigators

  • Ramina Nissan, O.D · LMC Montreal Ville

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-02-06
Completion
2024-02-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057493 on ClinicalTrials.gov