HealthyNCT05903664
Retinal Deep Phenotyping.TM
An observational study of Healthy, run by Optina Diagnostics Inc. at 1 site in United States.
Trial summary
This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 31 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults ages 18 years and older who have undergone pupil dilation and are not contraindicated for mydriatic imaging with a fundus camera. Ideally, the study population will be reflective of the adult population with the following estimates for demographics. TABLE 5.1: US population demographics Gender* 49.5% Male 50.5% Female Age* 55% 18-64 years old 17% 45+ years old Ocular Health in adults 40+ yrsǂ 44% Normal ocular health 56% Eye symptoms * based on US census data (accessed on 30-April-2023) ǂ based on CDC Fast Facts about Vision Loss Of note, these are only guidelines to aid with recruiting a study population that is representative of the adult population in the United States.
Who may be able to join
- Adults 18 years and older who will undergo mydriasis (pupil dilation) as part of their eye clinic visit.
Who cannot join
- Contraindications for mydriatic fundus imaging.
- Pupil dilation contraindicated (due to a 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 MHRC.
- Refractive error outside the range of -15 D to +15 D.
- Deficient visual fixation (inability to fixate for at least 2 s)
- Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software and /or per the eye specialists' evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wagner Macular & Retinal Center
Norfolk, Virginia, 23502
About this study
Official title: Retinal Deep PhenotypingTM by A Novel Mydriatic Hyperspectral Retinal Camera (MHRC) And Analysis by Deep Learning
This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications.
As an exploratory study, there are no endpoints per se, however, the following sub-objective will be evaluated for determining the success of this study:
- Collection and characterization of MHRC retinal images from at least 250 participants that score at least 80 on the real-time Quality Index (included in the MHRC software).
- Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting.
Read the detailed description
This is an exploratory, observational, cross-sectional, multi-site study designed to collect a baseline dataset of MHRC retinal image scans for use in Deep Learning models. Subjects will be recruited from eye clinics where patients will undergo mydriasis (pupil dilation) as part of their clinical visit. Eligible participants will be provided information about the study and delegated site personnel will assist with the Informed Consent process. If a participant provides their Informed Consent, they will be enrolled in the study and undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single group assignment | The participant will undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least one (1) Deep Learning (DL) model that characterizes the retina.
Measured: 12 months
Review of any safety events (AE, SAE, UADEs) that occur throughout the study.
As an exploratory study, there are no acceptance criteria for these study outcomes, rather the study results will be summarized in a Final Clinical Study report that will document the study outcomes and any learnings/models that may be applied to new development project using the MHRC H5 images
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 posted15 Jun 2023
- Study start30 Nov 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Why it stopped: Activation pending due to sponsor decision.
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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optina Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903664
- Sponsor's protocol ID
- 22-002A
- Status last verified
- Jan 2024
- First submitted
- 5 Jun 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Deep PhenotypingTM by A Novel Mydriatic Hyperspectral Retinal Camera (MHRC) And Analysis by Deep Learning
- ClinicalTrials.gov ID
- NCT05903664
- Acronym / sponsor ID
- 22-002A
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Activation pending due to sponsor decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Optina Diagnostics Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 15 Jun 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 study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications.
As an exploratory study, there are no endpoints per se, however, the following sub-objective will be evaluated for determining the success of this study:
- Collection and characterization of MHRC retinal images from at least 250 participants that score at least 80 on the real-time Quality Index (included in the MHRC software).
- Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting.
Detailed description
This is an exploratory, observational, cross-sectional, multi-site study designed to collect a baseline dataset of MHRC retinal image scans for use in Deep Learning models. Subjects will be recruited from eye clinics where patients will undergo mydriasis (pupil dilation) as part of their clinical visit. Eligible participants will be provided information about the study and delegated site personnel will assist with the Informed Consent process. If a participant provides their Informed Consent, they will be enrolled in the study and undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group assignment | – | –The participant will undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18 years and older who have undergone pupil dilation and are not contraindicated for mydriatic imaging with a fundus camera. Ideally, the study population will be reflective of the adult population with the following estimates for demographics. TABLE 5.1: US population demographics Gender* 49.5% Male 50.5% Female Age* 55% 18-64 years old 17% 45+ years old Ocular Health in adults 40+ yrsǂ 44% Normal ocular health 56% Eye symptoms * based on US census data (accessed on 30-April-2023) ǂ based on CDC Fast Facts about Vision Loss Of note, these are only guidelines to aid with recruiting a study population that is representative of the adult population in the United States.
Key inclusion criteria (1 listed)
- Adults 18 years and older who will undergo mydriasis (pupil dilation) as part of their eye clinic visit.
Key exclusion criteria (6 listed)
- Contraindications for mydriatic fundus imaging.
- Pupil dilation contraindicated (due to a 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 MHRC.
- Refractive error outside the range of -15 D to +15 D.
- Deficient visual fixation (inability to fixate for at least 2 s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
At least one (1) Deep Learning (DL) model that characterizes the retina.
Time frame: 12 months
Review of any safety events (AE, SAE, UADEs) that occur throughout the study.
Time frame: 12 months
As an exploratory study, there are no acceptance criteria for these study outcomes, rather the study results will be summarized in a Final Clinical Study report that will document the study outcomes and any learnings/models that may be applied to new development project using the MHRC H5 images
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 6 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: withdrawn, as of the sponsor's last update on 25 Jan 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 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 was withdrawn before enrolling participants, so there are no results.
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?
At least one (1) Deep Learning (DL) model that characterizes the retina. (time frame: 12 months). The study lists 2 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 25 Jan 2024.