Effect of Breathing a Mixture of 92% Oxygen (O2) + 8% Carbon Dioxide (CO2) on Flicker Induced Blood Flow Changes in Ocular Perfusion

NCT ID: NCT00719342

Last Updated: 2014-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-12-31

Brief Summary

It has been shown that diffuse luminance flicker increases retinal and optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural activity and blood flow exists in the retina as described previously for the brain. Although a lot of mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a matter of controversy. However, it has been shown in an animal experiment, that an increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by decrease in pO2 in the tissue. In a recently performed study we could show that breathing of 100% O2 did not influence flicker induced changes in the retina and optic nerve head. However, breathing of 100% oxygen also leads to a pronounced vasoconstriction of the retinal vessels and in turn to a increased tension of the vessel wall. Recent evidence indicates that a combination of 92% O2 and 8% CO2 can, at least partially, counteract the vasoconstrictory effect of O2 and increases tissue pO2. Thus, in this study the investigators set out to investigate the flicker light induced increase in blood flow under a mixture of O2/CO2 .

Conditions

Flicker-induced Vasodilatation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Interventions

Oxygen + Carbondioxide

Mixture of 92 % oxygen and 8 % carbon dioxide for inhalation

Intervention Type: DRUG

full field flickering light at 12.5 Hz

1 minute stimulation with full field flickering light at 12.5 Hz during measurement of vessel diameters and measurement of blood flow.

Intervention Type: OTHER

Other Intervention Names

O² + CO²; Oxymix

Eligibility Criteria

Inclusion Criteria

• Men and Women aged between 18 and 35 years, nonsmokers
• Body mass index between 15th and 85th percentile
• 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
• Treatment in the previous 3 weeks with any drug
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Blood donation during the previous 3 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Wolzt, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

OPHT-030606

Identifier Type: -

Identifier Source: org_study_id