The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
Primary Purpose
To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
Status
Recruiting
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
SAUERSTOFF
STICKSTOFF
Sponsored by
About this trial
This is an interventional basic science trial for To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
Eligibility Criteria
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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna, AustriaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Changes in FLIO induced by hyperoxia
Secondary Outcome Measures
Changes in FLIO induced by hypoxia
Changes in FLIO induced by flicker stimulation
Changes in OCT-A induced by hyperoxia
Changes in OCT-A induced by hypoxia
Changes in OCT-A induced by flicker stimulation
Retinal oxygen saturation
Retinal vessel diameter
Changes in peripheral oxygen saturation
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)
Full Information
NCT ID
NCT04094285
First Posted
September 16, 2019
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04094285
Brief Title
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
Official Title
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SAUERSTOFF
Intervention Description
SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
min. 95.5%, breathing for 30 minutes
Intervention Type
Drug
Intervention Name(s)
STICKSTOFF
Intervention Description
STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
88% with 12% oxygen, breathing for 30 minutes
Primary Outcome Measure Information:
Title
Changes in FLIO induced by hyperoxia
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Changes in FLIO induced by hypoxia
Time Frame
15 minutes
Title
Changes in FLIO induced by flicker stimulation
Time Frame
15 minutes
Title
Changes in OCT-A induced by hyperoxia
Time Frame
15 minutes
Title
Changes in OCT-A induced by hypoxia
Time Frame
15 minutes
Title
Changes in OCT-A induced by flicker stimulation
Time Frame
15 minutes
Title
Retinal oxygen saturation
Time Frame
15 minutes
Title
Retinal vessel diameter
Time Frame
15 minutes
Title
Changes in peripheral oxygen saturation
Time Frame
15 minutes
Title
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna, Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhofer, MD
Phone
+43 1 40400
Ext
29810
Email
gerhard.garhoefer@meduniwien.ac.at
12. IPD Sharing Statement
Learn more about this trial
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
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