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

NCT ID: NCT05608265

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-03-21

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.

Conditions

Diabetic Retinopathy; Retinal Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Retinal Imaging using the OSNAT800 IO device

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

Group Type: EXPERIMENTAL

OSNAT 800 IO

Intervention Type: DEVICE

Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging

Interventions

OSNAT 800 IO

Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PulseMedica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alberta Retina Consultants

Edmonton, , Canada

Countries

Canada

Other Identifiers

OSNATFIHIO001

Identifier Type: -

Identifier Source: org_study_id