Retinal Metabolic Imaging in a Diverse Population

NCT ID: NCT03442816

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2020-09-26

Brief Summary

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.

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).

Conditions

Technical Capabilities of the Device

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MHRC camera

Subjects will undergo a retina imaging session with the MHRC camera.

Group Type: EXPERIMENTAL

MHRC Camera

Intervention Type: DEVICE

Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population.

Interventions

MHRC Camera

Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Optina Diagnostics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kertes, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

050317

Identifier Type: -

Identifier Source: org_study_id