Dry Age Related Macular DegenerationNCT06860555
Hyperspectral Drusen Classification
An observational study of Dry Age Related Macular Degeneration, run by Optina Diagnostics Inc. at 1 site in Canada.
Trial summary
This observational, cross-sectional study is designed to explore the feasibility to extract spatial-spectral features from hyperspectral retinal images captured with Optina Diagnostics' MHRC that are characteristic to the different types of drusenoid deposits associated with dry age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age Related Macular Degeneration
- What is being tested?
- Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2022to 15 Aug 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 50 years old and above with dry AMD with the presence of drusenoid deposits in at least one eye.
Who may be able to join
- To be eligible for participation, volunteers must conform to all of the following inclusion criteria:
- Male and female adults aged 50 years and older (inclusive).
- Dry AMD in at least one eye, with at least one type of the following retinal drusenoid deposits: reticular pseudodrusen, soft drusen, hard drusen.
- ○ The presence of multiple small drusen (< 63µm) or intermediate drusen (≥63µm and ≥125µm) is sufficient to qualify for this study (Coleman, 2008).
- Ability and willingness to give informed consent.
Who cannot join
- Individuals that meet any of the following exclusionary criteria cannot be enrolled:
- Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC images and OCT images, including:
- Pupil dilation contraindicated (due to a pathology or with 3 quadrants with Van Herick of 0 or 1 without iridotomy)
- Inadequate pupil dilatation (< 6mm diameter) preventing uniform illumination of the retina with the MHRC
- Dry AMD presenting only with pigmentary changes or geographic atrophy (no drusenoid deposits)
- Presence of geographic atrophy in a cumulative area of >0.5 disc area
Show all 17Show fewer
- Presence of neovascular AMD, defined as the presence of at least 1 of the following 4 characteristics: serous sensory retinal detachment, RPE detachment, subretinal hemorrhage, or subretinal fibrous tissue; or history of photocoagulation for choroidal new vessels (AREDS, 2005)
- 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 (i.e. the area of interest for the MHRC imaging)
- Macular dystrophy
- 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 MHRC 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 (i.e. the area of interest for the MHRC imaging).
- Papilledema
- Inability to obtain an OCT image centered on the macular region of satisfactory quality for analysis of the drusenoid deposits (as indicated by the OCT's software quality indicator)
- Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Retinal Deep PhenotypingTM (RDP) Platform for the Identification of Spatial-spectral Features in Different Types of Drusenoid Deposits in Dry Age-related Macular Degeneration (AMD)
This observational, cross-sectional study is designed to explore the feasibility to extract spatial-spectral features from hyperspectral retinal images captured with Optina Diagnostics' MHRC that are characteristic to the different types of drusenoid deposits associated with dry age-related macular degeneration.
Read the detailed description
In this observational, cross-sectional, prospective study, participants with dry AMD in at least one eye will undergo a hyperspectral retinal imaging session with the Optina Diagnostics' MHRC in addition to retinal imaging with OCT, used as the gold standard method to identify and classify the drusenoid deposits.
Eligible participants visiting the eye clinic for AMD with dry AMD in at least one eye will be invited to participate in the study. Subjects who sign an informed consent to participate in the study will have their eyes evaluated to confirm that at least one eye is meeting all of the inclusion criteria, and none of the exclusion criteria. The dry AMD status and stage as well as information about eye diseases and conditions will be documented for both eyes. If eligible (no ocular exclusion criteria present in at least one eye), subjects will undergo OCT imaging of the macular region. If the OCT imaging session is successful (as described in the OCT imaging procedure below), the participants will then undergo hyperspectral retinal imaging with the Optina Diagnostics MHRC.
- Conditions
- Dry Age Related Macular Degeneration
- Being tested
- Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)Device
Imaging with the MHRC and optical coherence tomography (OCT).
| Study group | Role | What they receive |
|---|---|---|
| Participants with dry AMD | Participants with dry AMD in at least one eye will undergo a hyperspectral retinal imaging session with Optina Diagnostics' MHRC in addition to retinal imaging with OCT, used as the gold standard method to identify and classify the drusenoid deposits. Receives: Device: Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a bank of hyperspectral retinal images
Creation of a bank of hyperspectral retinal images that are normalized, registered, segmented and annotated by visual inspection for drusenoid deposit types (soft, hard or reticular pseudodrusen) identified in OCT images re-examined in these re
Measured: 12 months
Evaluation of the segmented drusenoid deposit
Evaluation of the segmented drusenoid deposit to identify characteristic spatial-spectral features extracted with the use of a method such as, but not limited, to spatial-spectral texture analysis, local spectral normalization, spectral angle mapper (SAM) or Dimension Reduction by Orthogonal Projection for Discrimination (DROP-D) for each type and a creation of classifier.
Measured: 12 months
Explore if spatial-spectral features identified for different drusenoid deposit
Explore if spatial-spectral features identified for different drusenoid deposit types, and in particular for soft drusen, may be present in locations outside the segmented regions visible to the observer on the hyperspectral images and OCT images. Indeed, these regions could be related to basal linear and basal laminar deposits regions and the OCT scans could be re-examined in these regions to evaluate if there is a visible "split" between the RPE and Bruch's membrane previously associated with basal laminar deposits (Sura et al., 2020).
Measured: 12 months
Effect of the location each type of drusenoid deposit
Explore the effect of the location each type of drusenoid deposit on the characteristic spatial-spectral features. In this optional sub-study, the drusenoid deposit annotations will include the location based, for example, on circles centered on the fovea within a diameter of 1 mm, 3 mm, 6 mm and beyond 6 mm (if available in the OCT images). (Optional)
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 posted6 Mar 2025
- Study start8 Nov 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age Related Macular DegenerationStudies 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optina Diagnostics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Jean Daniel Arbour, MD, FRCSC, Principal investigator, Clinique Ophtalmologique 2121, 2121 rue Sherbrooke Ouest, Montréal, Québec, H3H 1G6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860555
- Sponsor's protocol ID
- 22-003
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Retinal Deep PhenotypingTM (RDP) Platform for the Identification of Spatial-spectral Features in Different Types of Drusenoid Deposits in Dry Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT06860555
- Acronym / sponsor ID
- 22-003
- Conditions
- Dry Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Optina Diagnostics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 6 Mar 2025 (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 observational, cross-sectional study is designed to explore the feasibility to extract spatial-spectral features from hyperspectral retinal images captured with Optina Diagnostics' MHRC that are characteristic to the different types of drusenoid deposits associated with dry age-related macular degeneration.
Detailed description
In this observational, cross-sectional, prospective study, participants with dry AMD in at least one eye will undergo a hyperspectral retinal imaging session with the Optina Diagnostics' MHRC in addition to retinal imaging with OCT, used as the gold standard method to identify and classify the drusenoid deposits.
Eligible participants visiting the eye clinic for AMD with dry AMD in at least one eye will be invited to participate in the study. Subjects who sign an informed consent to participate in the study will have their eyes evaluated to confirm that at least one eye is meeting all of the inclusion criteria, and none of the exclusion criteria. The dry AMD status and stage as well as information about eye diseases and conditions will be documented for both eyes. If eligible (no ocular exclusion criteria present in at least one eye), subjects will undergo OCT imaging of the macular region. If the OCT imaging session is successful (as described in the OCT imaging procedure below), the participants will then undergo hyperspectral retinal imaging with the Optina Diagnostics MHRC.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with dry AMD | – | Device: Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)Participants with dry AMD in at least one eye will undergo a hyperspectral retinal imaging session with Optina Diagnostics' MHRC in addition to retinal imaging with OCT, used as the gold standard method to identify and classify the drusenoid deposits. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 50 years old and above with dry AMD with the presence of drusenoid deposits in at least one eye.
Key inclusion criteria (5 listed)
- To be eligible for participation, volunteers must conform to all of the following inclusion criteria:
- ○ The presence of multiple small drusen (< 63µm) or intermediate drusen (≥63µm and ≥125µm) is sufficient to qualify for this study (Coleman, 2008).
Key exclusion criteria (17 listed)
- Any ophthalmologic condition that would prevent obtaining retinal imaging and/or could interfere with the analysis of the MHRC images and OCT images, including:
- Inability to obtain an OCT image centered on the macular region of satisfactory quality for analysis of the drusenoid deposits (as indicated by the OCT's software quality indicator)
- Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software.
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 |
|---|---|---|
| Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)Imaging with the MHRC and optical coherence tomography (OCT). | Device | Participants with dry AMD |
Primary outcome
Creation of a bank of hyperspectral retinal images
Time frame: 12 months
Creation of a bank of hyperspectral retinal images that are normalized, registered, segmented and annotated by visual inspection for drusenoid deposit types (soft, hard or reticular pseudodrusen) identified in OCT images re-examined in these re
Evaluation of the segmented drusenoid deposit
Time frame: 12 months
Evaluation of the segmented drusenoid deposit to identify characteristic spatial-spectral features extracted with the use of a method such as, but not limited, to spatial-spectral texture analysis, local spectral normalization, spectral angle mapper (SAM) or Dimension Reduction by Orthogonal Projection for Discrimination (DROP-D) for each type and a creation of classifier.
Explore if spatial-spectral features identified for different drusenoid deposit
Time frame: 12 months
Explore if spatial-spectral features identified for different drusenoid deposit types, and in particular for soft drusen, may be present in locations outside the segmented regions visible to the observer on the hyperspectral images and OCT images. Indeed, these regions could be related to basal linear and basal laminar deposits regions and the OCT scans could be re-examined in these regions to evaluate if there is a visible "split" between the RPE and Bruch's membrane previously associated with basal laminar deposits (Sura et al., 2020).
Effect of the location each type of drusenoid deposit
Time frame: 12 months
Explore the effect of the location each type of drusenoid deposit on the characteristic spatial-spectral features. In this optional sub-study, the drusenoid deposit annotations will include the location based, for example, on circles centered on the fovea within a diameter of 1 mm, 3 mm, 6 mm and beyond 6 mm (if available in the OCT images). (Optional)
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 6 Mar 2025.
- 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.
Dr. Jean Daniel Arbour, MD, FRCSC principal investigator
Clinique Ophtalmologique 2121, 2121 rue Sherbrooke Ouest, Montréal, Québec, H3H 1G6
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 Dry Age Related Macular Degeneration, 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 5 inclusion and 17 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 6 Mar 2025. 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?
Creation of a bank of hyperspectral retinal images (time frame: 12 months). The study lists 4 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 6 Mar 2025.