Back to resultsReal-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
Primary Purpose
Diabetic Retinopathy, Retinal Imaging
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
OSNAT 800 IO
Sponsored by
About this trial
This is an interventional other trial for Diabetic Retinopathy
Eligibility Criteria
Inclusion Criteria: Between 18 and 70 years of age Male or female Diagnosed diabetic retinopathy Two eyes with clear ocular media Exclusion Criteria: Patients younger than 18 years and over 70 years of age Patients without diabetic retinopathy Opacification of cornea, lens, or vitreous
Sites / Locations
- Alberta Retina Consultants
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Retinal Imaging using the OSNAT800 IO device
Arm Description
Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.
Outcomes
Primary Outcome Measures
Successful performance of the real-time eye tracking function by post-image processing
Successful acquisition of retinal images
Secondary Outcome Measures
Device usability as assessed by a survey
Qualitative assessment of user feedback
Image Quality as assessed by user assessment of image quality parameters
Qualitative assessment of image at time of acquisition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05608265
Brief Title
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
Official Title
Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PulseMedica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Imaging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retinal Imaging using the OSNAT800 IO device
Arm Type
Experimental
Arm Description
Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.
Intervention Type
Device
Intervention Name(s)
OSNAT 800 IO
Intervention Description
Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging
Primary Outcome Measure Information:
Title
Successful performance of the real-time eye tracking function by post-image processing
Description
Successful acquisition of retinal images
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Device usability as assessed by a survey
Description
Qualitative assessment of user feedback
Time Frame
Through study completion, an average of 6 months
Title
Image Quality as assessed by user assessment of image quality parameters
Description
Qualitative assessment of image at time of acquisition
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 18 and 70 years of age
Male or female
Diagnosed diabetic retinopathy
Two eyes with clear ocular media
Exclusion Criteria:
Patients younger than 18 years and over 70 years of age
Patients without diabetic retinopathy
Opacification of cornea, lens, or vitreous
Facility Information:
Facility Name
Alberta Retina Consultants
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
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