Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, 1090, Austria
Completed
NCT Number: NCT04094285
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
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.
Completed
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Notify MeKey information
Age range
18 year–35 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
SAUERSTOFF
DrugSAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
min. 95.5%, breathing for 30 minutes
STICKSTOFF
DrugSTICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
88% with 12% oxygen, breathing for 30 minutes
Primary outcomes
-
Changes in FLIO induced by hyperoxia
Time frame: 15 minutes
Secondary outcomes
-
Changes in FLIO induced by hypoxia
Time frame: 15 minutes
-
Changes in FLIO induced by flicker stimulation
Time frame: 15 minutes
-
Changes in OCT-A induced by hyperoxia
Time frame: 15 minutes
-
Changes in OCT-A induced by hypoxia
Time frame: 15 minutes
-
Changes in OCT-A induced by flicker stimulation
Time frame: 15 minutes
-
Retinal oxygen saturation
Time frame: 15 minutes
-
Retinal vessel diameter
Time frame: 15 minutes
-
Changes in peripheral oxygen saturation
Time frame: 15 minutes
-
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)
Time frame: 15 minutes
Sponsors and collaborators
Lead sponsor
Medical University of Vienna
Other
Registry information
Important dates
- Study start
- 2019
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Sep 18, 2019
- Registry last updated
- Sep 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.