NCT06643403

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

October 14, 2024

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Retinal oxygen extraction in different age groups

    15 minutes

Study Arms (1)

Arm 1

EXPERIMENTAL

SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for max. 45 minutes

Drug: Oxygen 100% Gas for Inhalation

Interventions

SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria Dose: min. 95.5%, breathing for max. 45 minutes

Arm 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

OxygenGasesInhalation

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsRespiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Doreen Schmidl-Schordje, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv.-Doz. Dr.med.univ. PhD

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 16, 2024

Study Start

September 30, 2024

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations