← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 6 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PulseMedicaLead Sponsor

2 Previous Clinical Trials

275 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients

2022. "Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05608265.