The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study

Medical University of Vienna

Status and phase

Completed

Phase 2

Conditions

To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects

Treatments

Drug: STICKSTOFF

Drug: SAUERSTOFF

Study type

Interventional

Funder types

Other

Identifiers

NCT04094285

OPHT-070119

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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