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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094285
Recruitment Status : Not yet recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, 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.

Condition or disease Intervention/treatment Phase
To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects Drug: SAUERSTOFF Drug: STICKSTOFF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: SAUERSTOFF

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

Dose:

min. 95.5%, breathing for 30 minutes


Drug: STICKSTOFF

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

Dose:

88% with 12% oxygen, breathing for 30 minutes


Experimental: 2 Drug: SAUERSTOFF

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

Dose:

min. 95.5%, breathing for 30 minutes


Drug: STICKSTOFF

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

Dose:

88% with 12% oxygen, breathing for 30 minutes





Primary Outcome Measures :
  1. Changes in FLIO induced by hyperoxia [ Time Frame: 15 minutes ]

Secondary Outcome Measures :
  1. Changes in FLIO induced by hypoxia [ Time Frame: 15 minutes ]
  2. Changes in FLIO induced by flicker stimulation [ Time Frame: 15 minutes ]
  3. Changes in OCT-A induced by hyperoxia [ Time Frame: 15 minutes ]
  4. Changes in OCT-A induced by hypoxia [ Time Frame: 15 minutes ]
  5. Changes in OCT-A induced by flicker stimulation [ Time Frame: 15 minutes ]
  6. Retinal oxygen saturation [ Time Frame: 15 minutes ]
  7. Retinal vessel diameter [ Time Frame: 15 minutes ]
  8. Changes in peripheral oxygen saturation [ Time Frame: 15 minutes ]
  9. Changes in blood gas parameters (pH, pCO2, PO2 and SaO2) [ Time Frame: 15 minutes ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094285


Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD. Dr. med. univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04094285    
Other Study ID Numbers: OPHT-070119
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms