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

NCT04408677 | Terminated

• 1 other identifier: ZCI01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intraclass correlation coefficient of the measurements on the same patient at the same visit

  12-15 months

• Percent difference between the measurements of the two eyes.

  12-15 months

Study Arms (3)

Normative data

EXPERIMENTAL

Ocular oxygen saturation non-invasively measured at 3 eye fundus locations in the participant's right eye

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.

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.

Device: Zilia Ocular

Interventions

Zilia Ocular DEVICE

Measurement of the oxygen saturation in the eye fundus

Inter-eye variability; Normative data; Repeatability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zilia Inc.: lead
• CHU de Quebec-Universite Laval: collaborator

Study Sites (1)

Hôpital du Saint-Sacrement

Québec, G1S 4L8, Canada

Location

Study Officials

• Béatrice Des Marchais, MD

  CHU de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 29, 2020
• Study Start: June 2, 2021
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)