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

PulseMedica

Status: Completed

Conditions: Retinal Imaging; Diabetic Retinopathy

Treatments: Device: OSNAT 800 IO

Study type: Interventional

Funder types: Industry

Identifiers

NCT05608265

OSNATFIHIO001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Retinal Imaging using the OSNAT800 IO device

Experimental group

Description:

Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.

Treatment:

Device: OSNAT 800 IO