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CompletedNCT04094285Updated Sep 19, 2024

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

A Phase 2 interventional study of SAUERSTOFF and STICKSTOFF in To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Medical University of Vienna · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    1

    Drug: SAUERSTOFF · Drug: STICKSTOFF

  • Experimental
    2

    Drug: SAUERSTOFF · Drug: STICKSTOFF

Interventions

  • DrugSAUERSTOFF

    SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for 30 minutes

  • DrugSTICKSTOFF

    STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: 88% with 12% oxygen, breathing for 30 minutes

05

What researchers measure

Primary outcomes

  1. Changes in FLIO induced by hyperoxia

    Time frame: 15 minutes

Secondary outcomes

  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

06

Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna, Austria
    Vienna, 1090, Austria
07

Registry details

Key details

Study ID
NCT04094285
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Assoc. Prof. PD. Dr. med. univ., Medical University of Vienna) — Principal investigator
First posted
Sep 18, 2019
Start date
Oct 24, 2019
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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