The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
April 6, 2022 updated by: Gerhard Garhofer, Medical University of Vienna
The present study aims to investigate whether FLIO can also detect shorttime changes in retinal metabolism induced by hyperoxia and hypoxia.
For this purpose, 48 healthy subjects will be included in the present study and changes in FLIO will be assessed during breathing of 100% oxygen to induce hyperoxia as well as during breathing of 12% oxygen in nitrogen to induce hypoxia.
Since stimulation with flickering light also induces a higher metabolic demand in the retina (functional hyperemia), thisprovocation test will also applied during breathing of the different gas mixtures and compared to baseline.
To gain information about retinal blood flow, optical coherence tomography angiography (OCT-A) will be performed.
The results of the present study can help to gain more insight into the physiology of the retinal metabolism and might give grounds to establish new biomarkers in future studies.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Department of Clinical Pharmacology, Medical University of Vienna, Austria
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Men and women aged between 18 and 35 years
- Normal ophthalmic findings
- Ametropia ≤ 6 diopters
- Normal findings in the medical history and physical examination including ECG unless the investigator considers an abnormality to be clinically irrelevant
- Nonsmokers
Exclusion Criteria:
Regular use of medication, abuse of alcoholic beverages or drugs
- Participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug (except contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- History or family history of epilepsy
- Pregnant or breast-feeding women
- Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for 30 minutes STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: 88% with 12% oxygen, breathing for 30 minutes |
|
Experimental: 2
|
SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for 30 minutes STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: 88% with 12% oxygen, breathing for 30 minutes |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in FLIO induced by hyperoxia
Time Frame: 15 minutes
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in FLIO induced by hypoxia
Time Frame: 15 minutes
|
15 minutes
|
|
Changes in FLIO induced by flicker stimulation
Time Frame: 15 minutes
|
15 minutes
|
|
Changes in OCT-A induced by hyperoxia
Time Frame: 15 minutes
|
15 minutes
|
|
Changes in OCT-A induced by hypoxia
Time Frame: 15 minutes
|
15 minutes
|
|
Changes in OCT-A induced by flicker stimulation
Time Frame: 15 minutes
|
15 minutes
|
|
Retinal oxygen saturation
Time Frame: 15 minutes
|
15 minutes
|
|
Retinal vessel diameter
Time Frame: 15 minutes
|
15 minutes
|
|
Changes in peripheral oxygen saturation
Time Frame: 15 minutes
|
15 minutes
|
|
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2019
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
September 16, 2019
First Submitted That Met QC Criteria
September 16, 2019
First Posted (Actual)
September 18, 2019
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
April 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPHT-070119
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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