Healthy ParticipantsNCT06643403
Age-related Changes in Retinal Oxygen Extraction in Healthy Subjects
A study testing Oxygen 100% Gas for Inhalation in people with Healthy Participants and Retinal Oxygen Extraction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
It has been found that several systemic and ocular diseases are associated with impaired retinal oxygen extraction. In the present study, retinal oxygen extraction will be measured in different age groups in order to identify age related changes in otherwise healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Retinal Oxygen Extraction
- What is being tested?
- Oxygen 100% Gas for Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 30 Sep 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 80 years
- Signed informed consent
- Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study
- Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study
- Nonsmokers
Who cannot join
- Abuse of alcoholic beverages or drugs
- Participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, State of Vienna, 1090
Doreen Schmidl-Schordje, MD, +43 1 40400 ext. 29810, doreen.schmidl@meduniwien.ac.at
About this study
It has been found that several systemic and ocular diseases are associated with impaired retinal oxygen extraction. In the present study, retinal oxygen extraction will be measured in different age groups in order to identify age related changes in otherwise healthy subjects. In addition, the study will explore short-term changes in retinal metabolism induced by breathing pure oxygen. Measurements will be performed with dynamic vessel analyzer and laser speckle flowgraphy to evaluate retinal blood flow and retinal oxygen saturation, in order to calculate retinal oxygen extraction.
- Conditions
- Healthy Participants, Retinal Oxygen Extraction
- Being tested
- Oxygen 100% Gas for Inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen 100% Gas for InhalationDrug
SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
Dose:
min. 95.5%, breathing for max. 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for max. 45 minutes Receives: Drug: Oxygen 100% Gas for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal oxygen extraction in different age groups
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 posted16 Oct 2024
- Study start30 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643403
- Sponsor's protocol ID
- OPHT-26052024
- Status last verified
- Nov 2025
- First submitted
- 14 Oct 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Changes in Retinal Oxygen Extraction in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06643403
- Acronym / sponsor ID
- OPHT-26052024
- Conditions
- Healthy Participants, Retinal Oxygen Extraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 16 Oct 2024 (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.
It has been found that several systemic and ocular diseases are associated with impaired retinal oxygen extraction. In the present study, retinal oxygen extraction will be measured in different age groups in order to identify age related changes in otherwise healthy subjects. In addition, the study will explore short-term changes in retinal metabolism induced by breathing pure oxygen. Measurements will be performed with dynamic vessel analyzer and laser speckle flowgraphy to evaluate retinal blood flow and retinal oxygen saturation, in order to calculate retinal oxygen extraction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Oxygen 100% Gas for InhalationSAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for max. 45 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 80 years
- Signed informed consent
- Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study
- Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant for the purpose of the study
- Nonsmokers
Key exclusion criteria (5 listed)
- Abuse of alcoholic beverages or drugs
- Participation in a clinical trial in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Oxygen 100% Gas for InhalationSAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for max. 45 minutes | Drug | Arm 1 |
Primary outcome
Retinal oxygen extraction in different age groups
Time frame: 15 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen 100% Gas for Inhalation in people with Healthy Participants and Retinal Oxygen Extraction, 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 5 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doreen Schmidl-Schordje, MD (+43 1 40400 ext. 29810, doreen.schmidl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal oxygen extraction in different age groups (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.