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Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina

NCT04408677 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-02-27

No results posted yet for this study

Summary

Mainstream oximetry devices use two-wavelength systems to photograph the retina and estimate the oxygen saturation levels in the retinal vessels by comparing light absorption in the blood of the vessels at the selected wavelengths. This method limits the measurements to large retinal vessels, depends heavily on calibration and is non-reproducible across machines. The few numbers of wavelengths used (two) also makes it very susceptible to noise (such as cataract). These shortcomings have largely limited the use of retinal oximetry in clinical practice.

A new technology for retinal oximetry has recently been developed to address issues of dual-wavelength oximeters. Zilia Ocular's oximetry machine uses multi-wavelengths of light to take continuous oxygenation measurements of any targeted regions of the retina. It can measure any area of the retina, including the blood vessels, retinal tissues and the optic nerve head. Its multi-wavelength design also allows it to be less susceptible to noise, more precise and reproducible. This technology has the potential to extend our understanding of retinal pathologies, serve as a new marker for retinal health and even be used as a diagnostic tool to detect retinal injuries before they become visible.

Zilia's novel technology is one of its kind, allowing continuous and accurate measurements of the retina's oxygen saturation. In order to apply this technology to study and investigate retinal diseases, we need to first examine its performance in normal eyes and build a normative database as a reference. Thus, the purpose of the current study is to build a database of baseline oximetry values in healthy Caucasian subjects. The reproducibility of the measurements will also be studied in a subset of patients.

Conditions

  • Retinal Vascular
  • Retina

Interventions

DEVICE

Zilia Ocular

Measurement of the oxygen saturation in the eye fundus

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Zilia Inc.

    lead INDUSTRY

Principal Investigators

  • Béatrice Des Marchais, MD · CHU de Québec

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2021-09-22
Completion
2021-09-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408677 on ClinicalTrials.gov