Status:
TERMINATED
Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina
Lead Sponsor:
Zilia Inc.
Collaborating Sponsors:
CHU de Quebec-Universite Laval
Conditions:
Retinal Vascular
Retina
Eligibility:
All Genders
18+ years
Phase:
NA
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 vesse...
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...
Eligibility Criteria
Inclusion
- Adult patients above 18 years old, able to consent and willing to undergo mydriasis.
- Caucasian descent.
- Intraocular pressure ≤ 21 mmHg.
- Normal ophthalmological exam.
Exclusion
- 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.
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04408677
Start Date
June 2 2021
End Date
September 22 2021
Last Update
February 27 2023
Active Locations (1)
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1
Hôpital du Saint-Sacrement
Québec, Canada, G1S 4L8