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

Phase 1

• Conditions: healthy volunteers; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2019-000804-14-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 35

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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