<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04408677</url>
  </required_header>
  <id_info>
    <org_study_id>ZCI01</org_study_id>
    <nct_id>NCT04408677</nct_id>
  </id_info>
  <brief_title>Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina</brief_title>
  <official_title>Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zilia Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zilia Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mainstream oximetry devices use two-wavelength systems to photograph the retina and estimate&#xD;
      the oxygen saturation levels in the retinal vessels by comparing light absorption in the&#xD;
      blood of the vessels at the selected wavelengths. This method limits the measurements to&#xD;
      large retinal vessels, depends heavily on calibration and is non-reproducible across&#xD;
      machines. The few numbers of wavelengths used (two) also makes it very susceptible to noise&#xD;
      (such as cataract). These shortcomings have largely limited the use of retinal oximetry in&#xD;
      clinical practice.&#xD;
&#xD;
      A new technology for retinal oximetry has recently been developed to address issues of&#xD;
      dual-wavelength oximeters. Zilia Ocular's oximetry machine uses multi-wavelengths of light to&#xD;
      take continuous oxygenation measurements of any targeted regions of the retina. It can&#xD;
      measure any area of the retina, including the blood vessels, retinal tissues and the optic&#xD;
      nerve head. Its multi-wavelength design also allows it to be less susceptible to noise, more&#xD;
      precise and reproducible. This technology has the potential to extend our understanding of&#xD;
      retinal pathologies, serve as a new marker for retinal health and even be used as a&#xD;
      diagnostic tool to detect retinal injuries before they become visible.&#xD;
&#xD;
      Zilia's novel technology is one of its kind, allowing continuous and accurate measurements of&#xD;
      the retina's oxygen saturation. In order to apply this technology to study and investigate&#xD;
      retinal diseases, we need to first examine its performance in normal eyes and build a&#xD;
      normative database as a reference. Thus, the purpose of the current study is to build a&#xD;
      database of baseline oximetry values in healthy Caucasian subjects. The reproducibility of&#xD;
      the measurements will also be studied in a subset of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY OBJECTIVES&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      1. To measure the oxygen saturation at different locations on the retina (macula, optic nerve&#xD;
      head, nasal retina) in order to provide the range of these values in normal eyes.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. To assess the repeatability of the device's measurements (on a subset of patients).&#xD;
&#xD;
        2. To assess the variability of measurements between the two eyes (on a subset of&#xD;
           patients).&#xD;
&#xD;
      Outcomes&#xD;
&#xD;
      Primary Outcome:&#xD;
&#xD;
      1. Normative values of the retinal oxygen saturation at different locations on the retina.&#xD;
&#xD;
      Secondary Outcomes:&#xD;
&#xD;
        1. Intraclass correlation coefficient of the measurements on the same patient at the same&#xD;
           visit.&#xD;
&#xD;
        2. Percent difference between the measurements of the two eyes.&#xD;
&#xD;
      STUDY HYPOTHESES&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      1. Oxygen saturation should have a consistent range among healthy subjects.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. Intraclass classification (ICC) between two measurements on the same eye of the same&#xD;
           participant should be at least 90%.&#xD;
&#xD;
        2. Measurements between the two eyes should have a percent difference less than 5%.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      Type of study: single-center.&#xD;
&#xD;
      Expected number of subjects:&#xD;
&#xD;
      For primary objective: N=120 subjects For secondary objective #1: n= 62 For secondary&#xD;
      objective #2: n= 12&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator and Sponsor expectations for the study not aligned, along with time conflicts for&#xD;
    study completion. Discontinuation of the study is not related to the safety and/or&#xD;
    effectiveness of the device.&#xD;
  </why_stopped>
  <start_date type="Actual">June 2, 2021</start_date>
  <completion_date type="Actual">September 22, 2021</completion_date>
  <primary_completion_date type="Actual">September 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Normative values of the retinal oxygen saturation at different locations on the retina</measure>
    <time_frame>12-15 months</time_frame>
    <description>Oxygen saturation measurement in the eye fundus of healthy subjects from different age groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraclass correlation coefficient of the measurements on the same patient at the same visit</measure>
    <time_frame>12-15 months</time_frame>
    <description>Repeatability of the eye fundus oxygen saturation measurements (same subject, same visit, same eye, same eye fundus location)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent difference between the measurements of the two eyes.</measure>
    <time_frame>12-15 months</time_frame>
    <description>Variability of the eye fundus oxygen saturation measurements between the right and left eyes (same subject, same visit, different eye, same eye fundus location)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Retinal Vascular</condition>
  <condition>Retina</condition>
  <arm_group>
    <arm_group_label>Normative data</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Repeatability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inter-eye variability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zilia Ocular</intervention_name>
    <description>Measurement of the oxygen saturation in the eye fundus</description>
    <arm_group_label>Inter-eye variability</arm_group_label>
    <arm_group_label>Normative data</arm_group_label>
    <arm_group_label>Repeatability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients above 18 years old, able to consent and willing to undergo mydriasis.&#xD;
&#xD;
          -  Caucasian descent.&#xD;
&#xD;
          -  Intraocular pressure ≤ 21 mmHg.&#xD;
&#xD;
          -  Normal ophthalmological exam.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of systemic disease, which could affect the eye or oxygen levels (eg:&#xD;
             diabetes, severe cardiovascular or respiratory disease).&#xD;
&#xD;
          -  History of epilepsy.&#xD;
&#xD;
          -  Prior intraocular surgery (except cataract surgery).&#xD;
&#xD;
          -  Any history or signs of retinal or optic nerve diseases.&#xD;
&#xD;
          -  Pregnancy, or breastfeeding.&#xD;
&#xD;
          -  Familial history of glaucoma.&#xD;
&#xD;
          -  Ametropia &gt; 6 Diopters.&#xD;
&#xD;
          -  Pupil dilation &lt; 3.6 mm.&#xD;
&#xD;
          -  Current smoker.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Béatrice Des Marchais, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Québec</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital du Saint-Sacrement</name>
      <address>
        <city>Québec</city>
        <zip>G1S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04408677
org study id: ZCI01
nct id: NCT04408677
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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 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
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Normative values of the retinal oxygen saturation at different locations on the retina
time frame: 12-15 months
description: Oxygen saturation measurement in the eye fundus of healthy subjects from different age groups
measure: Intraclass correlation coefficient of the measurements on the same patient at the same visit
time frame: 12-15 months
description: Repeatability of the eye fundus oxygen saturation measurements (same subject, same visit, same eye, same eye fundus location)
measure: Percent difference between the measurements of the two eyes.
time frame: 12-15 months
description: Variability of the eye fundus oxygen saturation measurements between the right and left eyes (same subject, same visit, different eye, same eye fundus location)
arm group label: Normative data
arm group type: Experimental
description: Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye
arm group label: Repeatability
arm group type: Experimental
description: 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.
arm group label: Inter-eye variability
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Zilia Ocular
description: Measurement of the oxygen saturation in the eye fundus
arm group label: Inter-eye variability
arm group label: Normative data
arm group label: Repeatability
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Béatrice Des Marchais, MD
role: Principal Investigator
affiliation: CHU de Québec
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No