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

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.

Study Overview

• Status: Terminated
• Conditions: Retinal Vascular; Retina
• Intervention / Treatment: Device: Zilia Ocular

Detailed Description

STUDY OBJECTIVES

Objectives

Primary:

1. To measure the oxygen saturation at different locations on the retina (macula, optic nerve head, nasal retina) in order to provide the range of these values in normal eyes.

Secondary:

1. To assess the repeatability of the device's measurements (on a subset of patients).
2. To assess the variability of measurements between the two eyes (on a subset of patients).

Outcomes

Primary Outcome:

1. Normative values of the retinal oxygen saturation at different locations on the retina.

Secondary Outcomes:

1. Intraclass correlation coefficient of the measurements on the same patient at the same visit.
2. Percent difference between the measurements of the two eyes.

STUDY HYPOTHESES

Primary:

1. Oxygen saturation should have a consistent range among healthy subjects.

Secondary:

1. Intraclass classification (ICC) between two measurements on the same eye of the same participant should be at least 90%.
2. Measurements between the two eyes should have a percent difference less than 5%.

STUDY DESIGN

Type of study: single-center.

Expected number of subjects:

For primary objective: N=120 subjects For secondary objective #1: n= 62 For secondary objective #2: n= 12

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1S 4L8
    • Hopital Du Saint-Sacrement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients above 18 years old, able to consent and willing to undergo mydriasis.
• Caucasian descent.
• Intraocular pressure ≤ 21 mmHg.
• Normal ophthalmological exam.

Exclusion Criteria:

• Any history of systemic disease, which could affect the eye or oxygen levels (eg: diabetes, severe cardiovascular or respiratory disease).
• History of epilepsy.
• Prior intraocular surgery (except cataract surgery).
• Any history or signs of retinal or optic nerve diseases.
• Pregnancy, or breastfeeding.
• Familial history of glaucoma.
• Ametropia > 6 Diopters.
• Pupil dilation < 3.6 mm.
• Current smoker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normative data; Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye	Device: Zilia Ocular; Measurement of the oxygen saturation in the eye fundus
Experimental: Repeatability; Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye. After a 15 to 30 minutes break, same measurements repeated.	Device: Zilia Ocular; Measurement of the oxygen saturation in the eye fundus
Experimental: Inter-eye variability; Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye. After a 15 to 30 minutes break, same measurements repeated in the left eye.	Device: Zilia Ocular; Measurement of the oxygen saturation in the eye fundus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normative values of the retinal oxygen saturation at different locations on the retina	Oxygen saturation measurement in the eye fundus of healthy subjects from different age groups	12-15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass correlation coefficient of the measurements on the same patient at the same visit	Repeatability of the eye fundus oxygen saturation measurements (same subject, same visit, same eye, same eye fundus location)	12-15 months
Percent difference between the measurements of the two eyes.	Variability of the eye fundus oxygen saturation measurements between the right and left eyes (same subject, same visit, different eye, same eye fundus location)	12-15 months

Collaborators and Investigators

• Sponsor: Zilia Inc.
• Collaborators: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Béatrice Des Marchais, MD, CHU de Québec

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ZCI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No