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Retinal Metabolic Imaging in a Diverse Population

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ClinicalTrials.gov Identifier: NCT03442816
Recruitment Status : Unknown
Verified September 2019 by Optina Diagnostics Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Polytechnique Montreal
Information provided by (Responsible Party):
Optina Diagnostics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Technical Capabilities of the Device Device: MHRC Camera Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will undergo 1) an ophthalmic evaluation and 2) an evaluation with the device (camera)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of a Metabolic Hyperspectral Retinal Camera (MHRC) in Spectrally Resolved Reflectance and Fluorescence Imaging in a Diverse Population
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : September 26, 2020
Estimated Study Completion Date : September 26, 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Quality images in reflectance and fluorescence [ Time Frame: 1 day visit ]
    Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442816


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Optina Diagnostics Inc.
Sunnybrook Health Sciences Centre
Polytechnique Montreal
Investigators
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Principal Investigator: Peter Kertes, MD Sunnybrook Health Sciences Centre
More Information
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Responsible Party: Optina Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT03442816    
Other Study ID Numbers: 050317
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No