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

Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05608265

Enrollment

Registered

2022-11-08

Start date

2022-08-31

Completion date

2023-03-21

Last updated

2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Retinal Imaging

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.

Interventions

DEVICEOSNAT 800 IO

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Device usability as assessed by a survey	Through study completion, an average of 6 months	Qualitative assessment of user feedback
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026