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Imaging Device

Retinal Imaging using the OSNAT800 IO device for Diabetic Retinopathy

N/A
Waitlist Available
Research Sponsored by PulseMedica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Diabetic Retinopathy
  • Retinal Imaging

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful performance of the real-time eye tracking function by post-image processing
Secondary outcome measures
Device usability as assessed by a survey
Image Quality as assessed by user assessment of image quality parameters

Trial Design

1Treatment groups
Experimental Treatment
Group I: Retinal Imaging using the OSNAT800 IO deviceExperimental Treatment1 Intervention
Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OSNAT 800 IO
2022
N/A
~60

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Who is running the clinical trial?

PulseMedicaLead Sponsor
2 Previous Clinical Trials
275 Total Patients Enrolled
~22 spots leftby Jun 2025
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