Retinal VascularNCT04408677
Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina
A study testing Zilia Ocular in people with Retinal Vascular and Retina, run by Zilia Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Vascular, Retina
- What is being tested?
- Zilia Ocular
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2021to 22 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients above 18 years old, able to consent and willing to undergo mydriasis.
- Caucasian descent.
- Intraocular pressure ≤ 21 mmHg.
- Normal ophthalmological exam.
Who cannot join
- 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.
Show all 9Show fewer
- Ametropia > 6 Diopters.
- Pupil dilation < 3.6 mm.
- Current smoker.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
STUDY OBJECTIVES
Objectives
Primary:
- 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:
- To assess the repeatability of the device's measurements (on a subset of patients).
- To assess the variability of measurements between the two eyes (on a subset of patients).
Outcomes
Primary Outcome:
- Normative values of the retinal oxygen saturation at different locations on the retina.
Secondary Outcomes:
- Intraclass correlation coefficient of the measurements on the same patient at the same visit.
- Percent difference between the measurements of the two eyes.
STUDY HYPOTHESES
Primary:
- Oxygen saturation should have a consistent range among healthy subjects.
Secondary:
- Intraclass classification (ICC) between two measurements on the same eye of the same participant should be at least 90%.
- 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
- Conditions
- Retinal Vascular, Retina
- Being tested
- Zilia Ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilia OcularDevice
Measurement of the oxygen saturation in the eye fundus
| Study group | Role | What they receive |
|---|---|---|
| Normative data | Experimental | Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye Receives: Device: Zilia Ocular |
| Repeatability | Experimental | 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. Receives: Device: Zilia Ocular |
| Inter-eye variability | Experimental | 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. Receives: Device: Zilia Ocular |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-15 months
Secondary outcomes (2)
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)
Measured: 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)
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start2 Jun 2021
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Why it stopped: Investigator and Sponsor expectations for the study not aligned, along with time conflicts for study completion. Discontinuation of the study is not related to the safety and/or effectiveness of the device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal VascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zilia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CHU de Quebec-Universite Laval
- Responsible party
- Sponsor
- Investigators
- Béatrice Des Marchais, MD, Principal investigator, CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408677
- Sponsor's protocol ID
- ZCI01
- Status last verified
- Feb 2023
- First submitted
- 15 May 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina
- ClinicalTrials.gov ID
- NCT04408677
- Acronym / sponsor ID
- ZCI01
- Conditions
- Retinal Vascular, Retina
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator and Sponsor expectations for the study not aligned, along with time conflicts for study completion. Discontinuation of the study is not related to the safety and/or effectiveness of the device.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Zilia Inc.Industry (pharma, biotech, devices)
- Collaborators
- CHU de Quebec-Universite Laval
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
STUDY OBJECTIVES
Objectives
Primary:
- 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:
- To assess the repeatability of the device's measurements (on a subset of patients).
- To assess the variability of measurements between the two eyes (on a subset of patients).
Outcomes
Primary Outcome:
- Normative values of the retinal oxygen saturation at different locations on the retina.
Secondary Outcomes:
- Intraclass correlation coefficient of the measurements on the same patient at the same visit.
- Percent difference between the measurements of the two eyes.
STUDY HYPOTHESES
Primary:
- Oxygen saturation should have a consistent range among healthy subjects.
Secondary:
- Intraclass classification (ICC) between two measurements on the same eye of the same participant should be at least 90%.
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normative data | Experimental | Device: Zilia OcularOcular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye |
| Repeatability | Experimental | Device: Zilia OcularOcular 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. |
| Inter-eye variability | Experimental | Device: Zilia OcularOcular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients above 18 years old, able to consent and willing to undergo mydriasis.
- Caucasian descent.
- Intraocular pressure ≤ 21 mmHg.
- Normal ophthalmological exam.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zilia OcularMeasurement of the oxygen saturation in the eye fundus | Device | Inter-eye variability, Normative data, Repeatability |
Primary outcome
Normative values of the retinal oxygen saturation at different locations on the retina
Time frame: 12-15 months
Oxygen saturation measurement in the eye fundus of healthy subjects from different age groups
2 secondary outcomes
Intraclass correlation coefficient of the measurements on the same patient at the same visit
Time frame: 12-15 months
Percent difference between the measurements of the two eyes.
Time frame: 12-15 months
Results and safety
The study was stopped early (reason given: Investigator and Sponsor expectations for the study not aligned, along with time conflicts for study completion. Discontinuation of the study is not related to the safety and/or effectiveness of the device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice Des Marchais, MD principal investigator
CHU de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zilia Ocular in people with Retinal Vascular and Retina, run by Zilia Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator and Sponsor expectations for the study not aligned, along with time conflicts for study completion. Discontinuation of the study is not related to the safety and/or effectiveness of the device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative values of the retinal oxygen saturation at different locations on the retina (time frame: 12-15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.