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

• Sponsor: PulseMedica (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05608265
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.1
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy; Retinal Imaging	Device: OSNAT 800 IO	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
• Actual Study Start Date: Aug 31, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: OSNAT 800 IO; Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging

Outcome Measures

Primary Outcome Measures

1. 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

1. Device usability as assessed by a survey [Through study completion, an average of 6 months]

   Qualitative assessment of user feedback

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alberta Retina Consultants	Edmonton	Alberta	Canada

Sponsors and Collaborators

• PulseMedica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PulseMedica
• ClinicalTrials.gov Identifier: NCT05608265
• Other Study ID Numbers: OSNATFIHIO001
• First Posted: Nov 8, 2022
• Last Update Posted: Jan 13, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy

Study Results

No Results Posted as of Jan 13, 2023