Clinical trial NCT06860555: Hyperspectral Drusen Classification
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Age Related Macular Degeneration
Lead sponsor: Optina Diagnostics Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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 informed consent.

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 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)
* Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software.

Primary outcomes:
measure: Creation of a bank of hyperspectral retinal images
timeFrame: 12 months
measure: Evaluation of the segmented drusenoid deposit
timeFrame: 12 months
measure: Explore if spatial-spectral features identified for different drusenoid deposit
timeFrame: 12 months
measure: Effect of the location each type of drusenoid deposit
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ophtalmologique 2121
state: Quebec
Study officials:
affiliation: Clinique Ophtalmologique 2121, 2121 rue Sherbrooke Ouest, Montréal, Québec, H3H 1G6
name: Dr. Jean Daniel Arbour, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: