Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
September 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2023
CompletedJanuary 25, 2024
January 1, 2024
7 months
September 26, 2022
January 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Successful performance of the real-time eye tracking function by post-image processing
Successful acquisition of retinal images
Through study completion, an average of 6 months
Secondary Outcomes (2)
Device usability as assessed by a survey
Through study completion, an average of 6 months
Image Quality as assessed by user assessment of image quality parameters
Through study completion, an average of 6 months
Study Arms (1)
Retinal Imaging using the OSNAT800 IO device
EXPERIMENTALPatients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.
Interventions
Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging
Eligibility Criteria
You may qualify if:
- Between 18 and 70 years of age
- Male or female
- Diagnosed diabetic retinopathy
- Two eyes with clear ocular media
You may not qualify if:
- Patients younger than 18 years and over 70 years of age
- Patients without diabetic retinopathy
- Opacification of cornea, lens, or vitreous
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PulseMedicalead
Study Sites (1)
Alberta Retina Consultants
Edmonton, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2022
First Posted
November 8, 2022
Study Start
August 31, 2022
Primary Completion
March 21, 2023
Study Completion
March 21, 2023
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share