HealthyNCT06057493
RDP Reliability Study
An observational study of Healthy, run by Optina Diagnostics Inc. at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Retinal Imaging with Optina4C Camera
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2023to 6 Feb 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women 50 years and older who can undergo pupil dilation for both eyes and are not contraindicated for mydriatic imaging with a fundus camera.
Who may be able to join
- Male and female adults aged 50 years and older with vision in both eyes.
- Sufficient fluency in English or French to participate in study visits.
- Ability to give informed consent.
- Individuals with both eyes meet the eligibility criteria for retinal imaging.
Who cannot join
- Pupil dilation contraindicated (due to pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy).
- Inadequate pupil dilatation (< 6mm diameter) preventing uniform illumination of the retina with the Optina 4CTM camera.
- Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7).
- Signs of vascular occlusion or retinopathy (microaneurysm, exudate, hemorrhage, or edema) within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.
- Presence of drusen and/or age-related macular degeneration (AREDS 9-step scale
- ≥4 - cumulative drusen area diameter ≥ 250 µm, pigmentary changes and cumulative drusen area diameter ≥ 63 µm or pigmentary changes and cumulative geographic atrophy area diameter ≥ 354 µm).
Show all 15Show fewer
- Nuclear sclerosis > 2 (LOCS II four-point grading system) or presence of central cortical or central posterior subcapsular cataract.
- Deficient visual fixation (inability to fixate for at least 2 s).
- Refractive error outside the range of -15 D to +15 D.
- Corneal or media opacities (e.g., Weiss ring) affecting retinal imaging on a cumulative area > 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula (i.e., the area of interest for the Optina 4CTM imaging)
- Scar, atrophy, naevus, tumor, epiretinal membrane or retinal pucker with a cumulative area > 1 disc area within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.
- Papilledema and/or optic disc swelling.
- Macular anomaly (e.g., macular hole, dystrophy, degeneration).
- Inability to obtain up to 5 images or a minimum of 3 images of satisfactory quality with the Optina 4CTM per the Optina Diagnostics quality index software and /or per the eye specialists' evaluation. This exclusion criterion also applies if participants are unable to provide the required number of images during the second visit as well.
- Currently taking or has previously taken cerebral amyloid modifying medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analytic Validation of the Optina Retinal Deep Phenotyping.TM (RDP) Platform
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.
Read the 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
- Being tested
- Retinal Imaging with Optina4C Camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal Imaging with Optina4C CameraOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The reliability of the investigational device's imaging process will be analyzed using agreement of CAS Test results within 95% confidence intervals for the following conditions:
- Eye to eye variability
- Eye selection process variability
- Instrument to instrument variability
- Inter-Operator variability
- Intra-Operator variability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Sep 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optina Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramina Nissan, O.D, Principal investigator, LMC Montreal Ville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057493
- Sponsor's protocol ID
- 23-008
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytic Validation of the Optina Retinal Deep Phenotyping.TM (RDP) Platform
- ClinicalTrials.gov ID
- NCT06057493
- Acronym / sponsor ID
- 23-008
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Optina Diagnostics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 28 Sep 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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women 50 years and older who can undergo pupil dilation for both eyes and are not contraindicated for mydriatic imaging with a fundus camera.
Key inclusion criteria (4 listed)
- Male and female adults aged 50 years and older with vision in both eyes.
- Sufficient fluency in English or French to participate in study visits.
- Ability to give informed consent.
- Individuals with both eyes meet the eligibility criteria for retinal imaging.
Key exclusion criteria (15 listed)
- Pupil dilation contraindicated (due to pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy).
- Inadequate pupil dilatation (< 6mm diameter) preventing uniform illumination of the retina with the Optina 4CTM camera.
- Diagnosis of glaucoma or signs of glaucoma (excavation ratio ≥0.7).
- Signs of vascular occlusion or retinopathy (microaneurysm, exudate, hemorrhage, or edema) within a diameter of 10 mm from the mid-point between the optic nerve head and the macula.
- Presence of drusen and/or age-related macular degeneration (AREDS 9-step scale
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 |
|---|---|---|
| Retinal Imaging with Optina4C CameraThe 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. | Other | – |
Primary outcome
The reliability of the investigational device's imaging process will be analyzed using agreement of CAS Test results within 95% confidence intervals for the following conditions:
Time frame: 12 months
* Eye to eye variability * Eye selection process variability * Instrument to instrument variability * Inter-Operator variability * Intra-Operator variability
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 29 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Ramina Nissan, O.D principal investigator
LMC Montreal Ville
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 Healthy, run by Optina Diagnostics Inc. at 1 site in Canada.
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 4 inclusion and 15 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 29 Feb 2024. 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 Canada. 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?
The reliability of the investigational device's imaging process will be analyzed using agreement of CAS Test results within 95% confidence intervals for the following conditions: (time frame: 12 months). 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 29 Feb 2024.