Retinal Imaging using the OSNAT800 IO device for Diabetic Retinopathy

Alberta Retina Consultants, Edmonton, Canada
Diabetic Retinopathy+1 More ConditionsOSNAT 800 IO - Device
18 - 70
All Sexes

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Through study completion, an average of 6 months

Month 6
Device usability as assessed by a survey
Image Quality as assessed by user assessment of image quality parameters
Successful performance of the real-time eye tracking function by post-image processing

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Retinal Imaging using the OSNAT800 IO device
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Retinal Imaging using the OSNAT800 IO device · No Placebo Group · N/A

Retinal Imaging using the OSNAT800 IO device
Experimental Group · 1 Intervention: OSNAT 800 IO · Intervention Types: Device
First Studied
Drug Approval Stage
How many patients have taken this drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 6 months

Who is running the clinical trial?

PulseMedicaLead Sponsor

Eligibility Criteria

Age 18 - 70 · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

Who is the optimal demographic for participating in this research?

"In order to partake in this trial, participants should be aged 18-70 and have been diagnosed with diabetic retinopathy. Currently, the research team is searching for a total of 60 individuals." - Anonymous Online Contributor

Unverified Answer

Is the age restriction for this study above or below sixty years?

"This study is seeking patients aged 18 to 70. 26 studies are available for minors and 98 trials are appropriate for elderly individuals above the age of 65." - Anonymous Online Contributor

Unverified Answer

How many individuals are able to participate in this experiment?

"Affirmative. Per the information posted on, this medical experiment is currently recruiting patients and has been since August 31st 2022; it was last updated October 31st of that same year. For now, 60 participants are being accepted from one specified site." - Anonymous Online Contributor

Unverified Answer

Is this study still seeking potential participants?

"Affirmative. The records on show that this medical investigation, which was posted on August 31st 2022, is actively recruiting. Sixty participants must be enlisted from a solitary research site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.