A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) and a Predicate Device.
1 other identifier
observational
49
1 country
1
Brief Summary
A clinical study has been identified as a requirement for the RDSL (Theia). This study involves a clinical comparison of the imaging from the RDSL with that of a predicate device. The clinical evaluation showed that there remains some residual risk in the practitioner's ability to use the imaging from the RDSL to detect pathologies at the same level as when using the imaging function on a predicate device. The aim of this comparative study is to determine the degree, if any, of difference in using images captured from the RDSL for clinical inspection of pathologies, when compared to images captured from a predicate device. Due to the involvement of real patients during the study, ethics approval was sought prior to commencement. This study is limited to the clinical benefits of the device. An additional Human factors study has been conducted to assess the useability of the device Images were taken of healthy eyes and eyes with pathology (with images of several pathologies from each major pathology group to give a full range) on both the predicate device, and the RDSL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedFirst Submitted
Initial submission to the registry
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedApril 7, 2023
April 1, 2023
3 months
January 30, 2023
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Diagnostic Confidence
How confident the practitioner is in respect of their identification of a pathology from image on a scale of 1-5, with 5 being completely confident and 1 being not confident. Images reviewed via online from.
Within 1 week after data collection
Image Clarity
The rating of clarity of image by the practitioner on a scale of 1-5, with 5 being excellent clarity and 1 being low clarity. Images reviewed via online from.
Within 1 week after data collection
Identification of Pathology
% accuracy of identification of pathology shown or healthy eye. Images reviewed via online from.
Within 1 week after data collection
Study Arms (1)
Enrolled participants
Adult human subjects showing either healthy eyes or specific ocular pathologies.
Interventions
Eligibility Criteria
community
You may qualify if:
- Healthy eye or ocular pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyoto Group Ltdlead
Study Sites (1)
National Vision Inc Corporate Office
Atlanta, Georgia, 300096, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Bankowski, DOO
National Vision Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2023
First Posted
March 24, 2023
Study Start
October 1, 2022
Primary Completion
January 5, 2023
Study Completion
January 20, 2023
Last Updated
April 7, 2023
Record last verified: 2023-04