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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

SAUERSTOFF

Intervention Type DRUG

SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria

Dose:

min. 95.5%, breathing for 30 minutes

STICKSTOFF

Intervention Type DRUG

STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria

Dose:

88% with 12% oxygen, breathing for 30 minutes

2

Group Type EXPERIMENTAL

SAUERSTOFF

Intervention Type DRUG

SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria

Dose:

min. 95.5%, breathing for 30 minutes

STICKSTOFF

Intervention Type DRUG

STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria

Dose:

88% with 12% oxygen, breathing for 30 minutes

Interventions

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SAUERSTOFF

SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria

Dose:

min. 95.5%, breathing for 30 minutes

Intervention Type DRUG

STICKSTOFF

STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria

Dose:

88% with 12% oxygen, breathing for 30 minutes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes