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

Phase 2

• Conditions: To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
• Interventions: Drug: SAUERSTOFF; Drug: STICKSTOFF

• Registration Number: NCT04094285
• Lead Sponsor: Medical University of Vienna

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Study Start: 2019-10-24
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	SAUERSTOFF	-
1	STICKSTOFF	-
2	STICKSTOFF	-
2	SAUERSTOFF	-

Primary Outcome Measures

Name	Time	Method
Changes in FLIO induced by hyperoxia	15 minutes

Secondary Outcome Measures

Name	Time	Method
Changes in FLIO induced by flicker stimulation	15 minutes
Changes in OCT-A induced by hyperoxia	15 minutes
Changes in OCT-A induced by hypoxia	15 minutes
Changes in OCT-A induced by flicker stimulation	15 minutes
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)	15 minutes
Changes in FLIO induced by hypoxia	15 minutes
Retinal oxygen saturation	15 minutes
Retinal vessel diameter	15 minutes
Changes in peripheral oxygen saturation	15 minutes

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria; 🇦🇹 Vienna, Austria