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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608265
• Other study ID #: OSNATFIHIO001
• Status: Completed
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: January 2024
• Source: PulseMedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Retinal Imaging

Intervention

Device:
• OSNAT 800 IO
Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging

Locations

Country	Name	City	State
Canada	Alberta Retina Consultants	Edmonton

Sponsors (1)

Lead Sponsor	Collaborator
PulseMedica

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful performance of the real-time eye tracking function by post-image processing	Successful acquisition of retinal images	Through study completion, an average of 6 months
Secondary	Device usability as assessed by a survey	Qualitative assessment of user feedback	Through study completion, an average of 6 months
Secondary	Image Quality as assessed by user assessment of image quality parameters	Qualitative assessment of image at time of acquisition	Through study completion, an average of 6 months