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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00719342
Other study ID # OPHT-030606
Secondary ID
Status Completed
Phase N/A
First received July 1, 2008
Last updated November 13, 2014
Start date July 2008
Est. completion date December 2009

Study information

Verified date November 2014
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Oxygen + Carbondioxide
Mixture of 92 % oxygen and 8 % carbon dioxide for inhalation
Other:
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.

Locations

Country Name City State
Austria Department of Clinical Pharmacology, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Optic nerve head blood flow 1 hour No
Primary Retinal vessel diameters 1 hour No
Secondary blood pressure 1 hour Yes
Secondary pulse rate 1 hour Yes