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WithdrawnNCT03442816Updated Mar 28, 2023

Retinal Metabolic Imaging in a Diverse Population

An interventional study of MHRC Camera in Technical Capabilities of the Device, sponsored by Optina Diagnostics Inc.. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Optina Diagnostics Inc. · Not applicable, Interventional, and Other

Why this study was withdrawn
Sponsor no longer supported this study
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Technical Capabilities of the Device
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    MHRC camera

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

    Device: MHRC Camera

Interventions

  • DeviceMHRC Camera

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

05

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 1 day visit

06

Study locations

1 site
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03442816
Lead sponsor
Optina Diagnostics Inc.
Collaborators
Sunnybrook Health Sciences Centre
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Jul 5, 2017
Primary completion
Sep 26, 2020
Completion
Sep 26, 2020
Last update
Mar 28, 2023

Study contacts

Peter Kertes, MD
principal investigator · Sunnybrook Health Sciences Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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