A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) and a Predicate Device.

April 5, 2023 updated by: Eyoto Group Ltd

A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) Remote Digital Slit Lamp and a the Topcon SL-D2 With DC-4 Digital Attachment (Predicate Device).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methodology

Overview Images were taken of 14 healthy eyes and 35 unhealthy eyes containing a range of pathologies on both the predicate device and the THEIA. The pathologies to be imaged have been carefully selected using data from the clinical evaluation, and further investigation, to ensure that all aspects of the imaging systems and ocular structures are included.

The images were taken on compliant patients in a real-world setting.

Device Selection Device Type:AC-powered remote enabled slit-lamp Manufacturer:Eyoto Product Number:THEIA (3-008-0001-03)

Intended Use:

The THEIA is intended for non-invasive examination, illumination, magnification, visualization and recording of digital photographs and video of the anterior and posterior eye segments of the human eye and its surrounding area.

Magnification:6 (base Magnification), 10X, 16X, 25X (digital steps) Filters:Blue filter,Red-free filter (digital filter),yellow Filter (fluorescein enhancement filter) Lighting:White LED,12 V, 0.7 - 1.5 A, 8.4 W Image Sensor,CMOS, 1.1", 12 Megapixel The latest pre-production version of the THEIA was used. This is representative of and has all the same functionality as, the production model.

Three individual THEIA devices of the same version were used to collect the images.

Predicate Device Device Type:AC-powered slit lamp biomicroscope Manufacturer:Topcon Product Number:Topcon SL-2G or equivalent (SL-2D with imaging attachment) Intended Use:The Slit Lamp SL-2G is an AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Magnification:10X, 16X, 25X Filters:Blue filter, Red-free filter, Yellow Filter (fluorescein enhancement filter) available as an accessory Lighting:White LED Image Sensor (DC-4):CMOS, 5 Megapixel

The predicate device used for this study was equivalent to the Topcon SL-2G used in the substantial equivalence investigation, used with the recommended Topcon Digital Imaging Adaptor (DC-4) in order to take the images required.

Three individual predicate devices will be used to collect the images.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 300096
        • National Vision Inc Corporate Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community

Description

Inclusion Criteria:

  • Healthy eye or ocular pathology

Exclusion Criteria:

  • No exclusion other than age as above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enrolled participants
Adult human subjects showing either healthy eyes or specific ocular pathologies.
Device: Remote Digital Slit Lamp
Slit Lamp Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Confidence
Time Frame: Within 1 week after data collection
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
Time Frame: Within 1 week after data collection
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
Time Frame: Within 1 week after data collection
% accuracy of identification of pathology shown or healthy eye. Images reviewed via online from.
Within 1 week after data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyoto Group Ltd

Investigators

  • Principal Investigator: John Bankowski, DOO, National Vision Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

January 5, 2023

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYO-CS-001.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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