The effect of hyperoxia and hypoxia on retinal metabolism in healthy subjects

The effect of hyperoxia and hypoxia on fluorescence lifetime imaging ophthalmoscopy in healthy subjects - Hyperoxia and Hypoxia on FLIO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000804-14-AT

Enrollment

Registered

2019-03-22

Start date

2019-05-10

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Trade Name: SAUERSTOFF medizinisch MESSER Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: OXYGEN CAS Number: 7782-44-7 Concentration unit: % percent Concentration type: not less th

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of 100% oxygen breathing on fluorescence lifetime imaging ophthalmoscopy (FLIO) in healthy subjects;Secondary Objective: • Changes in FLIO induced by hypoxia • Changes in FLIO induced by flicker stimulation • Changes in OCT-A induced by hyperoxia • Changes in OCT-A induced by hypoxia • Changes in OCT-A induced by flicker stimulation • Retinal oxygen saturation • Retinal vessel diameter • Changes in peripheral oxygen saturation • Changes in blood gas parameters (pH, pCO2, PO2 and SaO2);Primary end point(s): • Changes in FLIO induced by hyperoxia;Timepoint(s) of evaluation of this end point: study day	—

Measure

Time frame

Main Objective: To investigate the effect of 100% oxygen breathing on fluorescence lifetime imaging ophthalmoscopy (FLIO) in healthy subjects;Secondary Objective: • Changes in FLIO induced by hypoxia • Changes in FLIO induced by flicker stimulation • Changes in OCT-A induced by hyperoxia • Changes in OCT-A induced by hypoxia • Changes in OCT-A induced by flicker stimulation • Retinal oxygen saturation • Retinal vessel diameter • Changes in peripheral oxygen saturation • Changes in blood gas parameters (pH, pCO2, PO2 and SaO2);Primary end point(s): • Changes in FLIO induced by hyperoxia;Timepoint(s) of evaluation of this end point: study day

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Secondary

Measure	Time frame
Secondary end point(s): • Changes in FLIO induced by hypoxia • Changes in FLIO induced by flicker stimulation • Changes in OCT-A induced by hyperoxia • Changes in OCT-A induced by hypoxia • Changes in OCT-A induced by flicker stimulation • Retinal oxygen saturation • Retinal vessel diameter • Changes in peripheral oxygen saturation • Changes in blood gas parameters (pH, pCO2, PO2 and SaO2) ;Timepoint(s) of evaluation of this end point: study day	—

Measure

Time frame

Secondary end point(s): • Changes in FLIO induced by hypoxia • Changes in FLIO induced by flicker stimulation • Changes in OCT-A induced by hyperoxia • Changes in OCT-A induced by hypoxia • Changes in OCT-A induced by flicker stimulation • Retinal oxygen saturation • Retinal vessel diameter • Changes in peripheral oxygen saturation • Changes in blood gas parameters (pH, pCO2, PO2 and SaO2) ;Timepoint(s) of evaluation of this end point: study day

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Countries

Austria

Contacts

Public ContactDepartment of Clinical Pharmacology

Medical University of Vienna

klin-pharmakologie@meduniwien.ac.at+4314040029810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026