To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects Clinical Trial
Official title:
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
| Verified date | April 2022 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 48 |
| Est. completion date | December 2023 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 35 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Department of Clinical Pharmacology, Medical University of Vienna, Austria | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in FLIO induced by hyperoxia | 15 minutes | ||
| Secondary | Changes in FLIO induced by hypoxia | 15 minutes | ||
| Secondary | Changes in FLIO induced by flicker stimulation | 15 minutes | ||
| Secondary | Changes in OCT-A induced by hyperoxia | 15 minutes | ||
| Secondary | Changes in OCT-A induced by hypoxia | 15 minutes | ||
| Secondary | Changes in OCT-A induced by flicker stimulation | 15 minutes | ||
| Secondary | Retinal oxygen saturation | 15 minutes | ||
| Secondary | Retinal vessel diameter | 15 minutes | ||
| Secondary | Changes in peripheral oxygen saturation | 15 minutes | ||
| Secondary | Changes in blood gas parameters (pH, pCO2, PO2 and SaO2) | 15 minutes |