Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01692821

Enrollment

Registered

2012-09-25

Start date

2012-06-30

Completion date

2013-01-31

Last updated

2013-01-30

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

Conditions

Retinal Blood Flow, Retinal Oxygenation

Keywords

retinal oxygen saturation, retinal blood flow, hyperoxia, hypoxia

Brief summary

Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.

Interventions

DRUG100% oxygen breathing

100% oxygen breathing - 30 minutes

DRUG15% oxygen in N2 breathing

15% oxygen in N2 breathing - 30 minutes

DRUG12% oxygen in N2 breathing

12% oxygen in N2 breathing - 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Men and women aged between 18 and 35 years * Nonsmokers * Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings, ametropy \< 3 Dpt.

Exclusion criteria

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive) * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Presence of any form of anemia * Blood donation during the previous 3 weeks * Pregnancy

Design outcomes

Primary

Measure	Time frame
Retinal oxygen saturation	On the study day - during each breathing period (6 times)

Secondary

Measure	Time frame
Retinal blood flow	On the study day - during each breathing period (6 times)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026