Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retinal Metabolic Imaging in a Diverse Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442816
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Polytechnique Montreal
Information provided by (Responsible Party):
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.

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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 : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.




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 .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: David Lapointe 438-828-1675 dlapointe@optinadx.com
Contact: Anne-Marie Bédard 514-394-0797 ambedard@optinadx.com

Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Charlene Muller    416-480-5091    Charlene.Muller@sunnybrook.ca   
Principal Investigator: Peter Kertes, MD         
Sponsors and Collaborators
Optina Diagnostics Inc.
Sunnybrook Health Sciences Centre
Polytechnique Montreal
Investigators
Layout table for investigator information
Principal Investigator: Peter Kertes, MD Sunnybrook Health Sciences Centre

Layout table for additonal information
Responsible Party: Optina Diagnostics Inc.
ClinicalTrials.gov Identifier: NCT03442816     History of Changes
Other Study ID Numbers: 050317
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No