Retinal Metabolic Imaging in a Diverse Population

NCT03442816 | Withdrawn

• 1 other identifier: 050317
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Technical Capabilities of the Device

Outcome Measures

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 .

  1 day visit

Study Arms (1)

MHRC camera

EXPERIMENTAL

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

Device: MHRC Camera

Interventions

MHRC Camera DEVICE

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

MHRC camera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optina Diagnostics Inc.: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

• Peter Kertes, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will undergo 1) an ophthalmic evaluation and 2) an evaluation with the device (camera)

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 22, 2018
• Study Start: July 5, 2017
• Primary Completion: September 26, 2020
• Study Completion: September 26, 2020
• Last Updated: March 28, 2023

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)