ClinicalTrials.gg
CompletedNCT06860555Updated Mar 6, 2025

Hyperspectral Drusen Classification

An observational study in Dry Age Related Macular Degeneration, sponsored by Optina Diagnostics Inc.. Completed at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Optina Diagnostics Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
112
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 94 studies in Macular Degeneration with a site in Canada — 11 open to participants now, 16 under way, 7 of them phase 3. Macular Degeneration · Canada.

Enrollment
10th of 17
112 · median 169
Started
2022
with 2 others
Observational
17 of 94
none open now
Registered
88th of 94
by date

Among the 94 studies in Macular Degeneration with a site in Canada, this one is the 10th largest by enrollment of the 17 observational ones that give a count, is one of 3 that started in 2022, is one of 17 observational ones, and was the 88th registered.

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

Browse Macular Degeneration studies →

Open to participants now

11 of the 94 studies in Macular Degeneration with a site in Canada are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Dry Age Related Macular Degeneration
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects 50 years old and above with dry AMD with the presence of drusenoid deposits in at least one eye.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

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 (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
    • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
112 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Device: Mydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)

Interventions

  • DeviceMydriatic Hyperspectral retinal Camera, (MHRC) and Optical coherence tomography (OCT)

    Imaging with the MHRC and optical coherence tomography (OCT).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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).

    Time frame: 12 months

  4. 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)

    Time frame: 12 months

07

Study locations

1 site
  • Clinique Ophtalmologique 2121
    Montréal, Quebec H3H 1G6, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2022 to primary completion in Aug 2023, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2025
First posted
Mar 6, 2025
StartActual
Nov 8, 2022
Primary completionActual
Aug 15, 2023
CompletionActual
Aug 15, 2023
Last update
Mar 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06860555
Lead sponsor
Optina Diagnostics Inc.
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Nov 8, 2022
Primary completion
Aug 15, 2023
Completion
Aug 15, 2023
Last update
Mar 6, 2025

Study contacts

Dr. Jean Daniel Arbour, MD, FRCSC
principal investigator · Clinique Ophtalmologique 2121, 2121 rue Sherbrooke Ouest, Montréal, Québec, H3H 1G6

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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