Retinal Deep PhenotypingTM

NCT05903651 | Completed

• 1 other identifier: 22-002
• Study Type: observational
• Target: 813
• Locations: 1 country
• Sites: 2

Brief 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. A sub-set of the images will also be analyzed by eye specialists to determine if visual inspection of the images could provide useful information in their practice. 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 2000 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.
• At least 5% of participants shall have an MHRC retinal image reviewed by an eye specialist (Optometrist or Ophthalmologist) to assess the image quality and potential clinical usefulness.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• At least one (1) pre-trained DL model from hyperspectral retinal images.

  12 months

• Report describing the clinical utility of visual inspection of the MHRC retinal images.

  12 months

• Review of any safety events (AE, SAE, UADEs) that occur throughout the study.

  12 months

Study Arms (1)

Single Group Assignment

The subjects will undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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. Gender\* 49% Male 51% Female Age\* 45% 18-44 years old 55% 44+ years old Ocular Health ǂ 70% Normal ocular health 30% Eye symptoms \* based on 2021 Canada census data ǂ based on CNIB Fast Facts about Vision Loss

You may qualify if:

• Adults 18 years and older who will undergo mydriasis (pupil dilation) as part of their eye clinic visit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead

Study Sites (2)

Ecole d'Optometrie, University of Montreal

Montreal, Quebec, H3T 1P1, Canada

Location

Clinique d'Opthalmologie desLaurentides, Institue de l'Oeil (IOL)

Montreal, Quebec, QC J7H 0E8, Canada

Location

Study Design

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

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: April 3, 2023
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CA (2)