Retinal Metabolic Imaging in a Diverse Population

Evaluation of a Metabolic Hyperspectral Retinal Camera (MHRC) in Spectrally Resolved Reflectance and Fluorescence Imaging in a Diverse Population

This research project aims to evaluate use in a clinical context of a novel imaging instrument, the Metabolic Hyperspectral retina Camera (MHRC) from Optina Diagnostics. This camera enables the acquisition of retinal images at multiple colors (up to 100 specific colors) and therefore extract way more information that can be captured with a conventional retinal camera (up to 3 colors). This additional color information available for each pixel of the image could be useful to identify signs of pathologies having manifestations in the retina. The performances of this new prototype camera will be evaluated and the acquisition procedures optimized in a diverse population of subjects.

Study Overview

• Status: Withdrawn
• Conditions: Technical Capabilities of the Device
• Intervention / Treatment: Device: MHRC Camera

Detailed Description

Hyperspectral retinal imaging results from several consecutive images taken while the filter scans a wide spectral range to obtain one spectrum for each image pixel. The combination of imaging and spectroscopy offered by hyperspectral imaging makes it possible to identify and quantify several specific biomolecules in the retina and the optic nerve, thus paving the way for metabolic imaging of the fundus. Subsequent analysis of the light signal with algorithms and image analysis software tools permits extracting molecular information modulated according to the underlying pathology. This technique thus permits direct, non-invasive and inexpensive diagnosis of pathologies of the retina and systemic pathologies presenting manifestations in the eye.

In this research project, Optina Diagnostics aims to evaluate in a clinical context a novel Metabolic Hyperspectral Retinal Camera (MHRC) based on a mydriatic camera customized for observation of the fundus in combination with a tunable filter, i.e., one permitting selection of a specific wavelength, in order to provide monochromatic light in the visible and near infrared spectrum (energy spectrum between 450 and 900 nm).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years old and up with vision in at least one eye.

Exclusion Criteria:

• Inadequate pupil dilation (< 6mm diameter) or contraindicated
• Deficient visual fixation
• Refractive error outside the -9 to +9 range
• Media opacities or intraocular bleeding preventing retinal imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MHRC camera; Subjects will undergo a retina imaging session with the MHRC camera.	Device: MHRC Camera; Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality images in reflectance and fluorescence	Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population .	1 day visit

Collaborators and Investigators

• Sponsor: Optina Diagnostics Inc.
• Collaborators: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Peter Kertes, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): September 26, 2020
• Study Completion (Actual): September 26, 2020

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 050317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No