Retinal Metabolic Imaging in a Diverse Population

Not Applicable

Withdrawn

• Conditions: Technical Capabilities of the Device
• Interventions: Device: MHRC Camera

• Registration Number: NCT03442816
• Lead Sponsor: Optina Diagnostics Inc.

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).

Study Timeline

• Study Start: 2017-07-05
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Status Verified: 2019-09
• Primary Completion: 2020-09-26
• Study Completion: 2020-09-26
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MHRC camera	MHRC Camera	Subjects will undergo a retina imaging session with the MHRC camera.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada