Hyperspectral Drusen Classification

NCT06860555 | Completed FDA Device

• 1 other identifier: 22-003
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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).

  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)

  12 months

Study Arms (1)

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

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

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

Participants with dry AMD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead

Study Sites (1)

Clinique Ophtalmologique 2121

Montreal, Quebec, H3H 1G6, Canada

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Dr. Jean Daniel Arbour, MD, FRCSC

  Clinique Ophtalmologique 2121, 2121 rue Sherbrooke Ouest, Montréal, Québec, H3H 1G6

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: November 8, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)