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Completed

NCT Number: NCT05608265

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

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.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Retinal Imaging Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Retina Consultants

Edmonton, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OSNAT 800 IO

Device

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

Primary outcomes

  1. Successful performance of the real-time eye tracking function by post-image processing

    Time frame: Through study completion, an average of 6 months

    Successful acquisition of retinal images

Secondary outcomes

  1. Device usability as assessed by a survey

    Time frame: 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

    Time frame: Through study completion, an average of 6 months

    Qualitative assessment of image at time of acquisition

Sponsors and collaborators

Lead sponsor

PulseMedica

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2022
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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