To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy SubjectsPhase 2NCT04094285
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
A Phase 2 study testing SAUERSTOFF and STICKSTOFF in people with To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects
- What is being tested?
- SAUERSTOFF and STICKSTOFF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 24 Oct 2019to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, 1090
About this study
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.
- Being tested
- SAUERSTOFF, STICKSTOFF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAUERSTOFFDrug
SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
min. 95.5%, breathing for 30 minutes
STICKSTOFFDrug
STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
88% with 12% oxygen, breathing for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SAUERSTOFF; Drug: STICKSTOFF |
| 2 | Experimental | Not described Receives: Drug: SAUERSTOFF; Drug: STICKSTOFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in FLIO induced by hyperoxia
Measured: 15 minutes
Secondary outcomes (9)
Changes in FLIO induced by hypoxia
Measured: 15 minutes
Changes in FLIO induced by flicker stimulation
Measured: 15 minutes
Changes in OCT-A induced by hyperoxia
Measured: 15 minutes
Changes in OCT-A induced by hypoxia
Measured: 15 minutes
Changes in OCT-A induced by flicker stimulation
Measured: 15 minutes
Retinal oxygen saturation
Measured: 15 minutes
Retinal vessel diameter
Measured: 15 minutes
Changes in peripheral oxygen saturation
Measured: 15 minutes
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start24 Oct 2019
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094285
- Sponsor's protocol ID
- OPHT-070119
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pai V, Janku P, Lindner T, Graf U, Schmetterer L, Garhofer G, Schmidl D. A New Approach to Retinal Oxygen Extraction Measurement Based on Laser Speckle Flowgraphy and Retinal Oximetry. Transl Vis Sci Technol. 2024 Dec 2;13(12):12. doi: 10.1167/tvst.13.12.12.
PubMed 39661379
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study
- ClinicalTrials.gov ID
- NCT04094285
- Acronym / sponsor ID
- OPHT-070119
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SAUERSTOFF, Drug: STICKSTOFF |
| 2 | Experimental | Drug: SAUERSTOFF, Drug: STICKSTOFF |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 35 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAUERSTOFFSAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for 30 minutes | Drug | 1, 2 |
| STICKSTOFFSTICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: 88% with 12% oxygen, breathing for 30 minutes | Drug | 1, 2 |
Primary outcome
Changes in FLIO induced by hyperoxia
Time frame: 15 minutes
9 secondary outcomes
Changes in FLIO induced by hypoxia
Time frame: 15 minutes
Changes in FLIO induced by flicker stimulation
Time frame: 15 minutes
Changes in OCT-A induced by hyperoxia
Time frame: 15 minutes
Changes in OCT-A induced by hypoxia
Time frame: 15 minutes
Changes in OCT-A induced by flicker stimulation
Time frame: 15 minutes
Retinal oxygen saturation
Time frame: 15 minutes
Retinal vessel diameter
Time frame: 15 minutes
Changes in peripheral oxygen saturation
Time frame: 15 minutes
Changes in blood gas parameters (pH, pCO2, PO2 and SaO2)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39661379Pai V, Janku P, Lindner T, Graf U, Schmetterer L, Garhofer G, Schmidl D. A New Approach to Retinal Oxygen Extraction Measurement Based on Laser Speckle Flowgraphy and Retinal Oximetry. Transl Vis Sci Technol. 2024 Dec 2;13(12):12. doi: 10.1167/tvst.13.12.12.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAUERSTOFF and STICKSTOFF in people with To Investigate the Effect of 100% Oxygen Breathing on Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO) in Healthy Subjects, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in FLIO induced by hyperoxia (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.