Status:
COMPLETED
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
Lead Sponsor:
Medical University of Vienna
Conditions:
To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04094285
Start Date
October 24 2019
End Date
July 30 2024
Last Update
September 19 2024
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, Austria, 1090