CataractNCT05783583
A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) and a Predicate Device.
An observational study of Cataract, run by Eyoto Group Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Remote Digital Slit Lamp
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community
Who may be able to join
- Healthy eye or ocular pathology
Who cannot join
- No exclusion other than age as above
Trial locations and contacts
1 site in 1 country.
United States1 site
National Vision Inc Corporate Office
Atlanta, Georgia, 300096
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- Remote Digital Slit Lamp
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Digital Slit LampDevice
Slit Lamp Examination
| Study group | Role | What they receive |
|---|---|---|
| Enrolled participants | Adult human subjects showing either healthy eyes or specific ocular pathologies. Receives: Device: Remote Digital Slit Lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 1 week after data collection
Identification of Pathology
% accuracy of identification of pathology shown or healthy eye. Images reviewed via online from.
Measured: Within 1 week after data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Oct 2022
- Primary completion5 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyoto Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Bankowski, DOO, Principal investigator, National Vision Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783583
- Sponsor's protocol ID
- EYO-CS-001.1
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT05783583
- Acronym / sponsor ID
- EYO-CS-001.1
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Eyoto Group LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled participants | – | Device: Remote Digital Slit LampAdult human subjects showing either healthy eyes or specific ocular pathologies. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community
Key inclusion criteria (1 listed)
- Healthy eye or ocular pathology
Key exclusion criteria (1 listed)
- No exclusion other than age as above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Digital Slit LampSlit Lamp Examination | Device | Enrolled participants |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Bankowski, DOO principal investigator
National Vision Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Eyoto Group Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Confidence (time frame: Within 1 week after data collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.