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

Not Applicable

Completed

• Conditions: Diabetic Retinopathy; Retinal Imaging
• Interventions: Device: OSNAT 800 IO

• Registration Number: NCT05608265
• Lead Sponsor: PulseMedica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-31
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-08
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Between 18 and 70 years of age
• Male or female
• Diagnosed diabetic retinopathy
• Two eyes with clear ocular media

Exclusion Criteria

• Patients younger than 18 years and over 70 years of age
• Patients without diabetic retinopathy
• Opacification of cornea, lens, or vitreous

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retinal Imaging using the OSNAT800 IO device	OSNAT 800 IO	Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.

Primary Outcome Measures

Name	Time	Method
Successful performance of the real-time eye tracking function by post-image processing	Through study completion, an average of 6 months	Successful acquisition of retinal images

Secondary Outcome Measures

Name	Time	Method
Image Quality as assessed by user assessment of image quality parameters	Through study completion, an average of 6 months	Qualitative assessment of image at time of acquisition
Device usability as assessed by a survey	Through study completion, an average of 6 months	Qualitative assessment of user feedback

Trial Locations

Locations (1)

Alberta Retina Consultants; 🇨🇦 Edmonton, Canada