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.
- Diabetic Retinopathy
- Retinal Imaging
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Through study completion, an average of 6 months
Trial Safety
Phase-Based Safety
Awards & Highlights
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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
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
How many individuals are able to participate in this experiment?
"Affirmative. Per the information posted on clinicaltrials.gov, 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
Is this study still seeking potential participants?
"Affirmative. The records on clinicaltrials.gov 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