Is There a Difference in Flicker Induced Vasodilatation Between Smokers and Non-Smokers?

NCT ID: NCT00431730

Last Updated: 2008-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Habitual smoking is associated with an increased risk of coronary artery disease, cerebral and peripheral vascular disease, including ocular diseases like age-related macular degeneration or diabetic retinopathy. Data of a recent study performed in the investigators lab revealed abnormal choroidal blood flow regulation in chronic smokers as compared to age-matched non-smoking subjects during isometric exercise. However, no information is yet available about the regulation of retinal vascular tone in habitual smokers.

Thus, in the current study, the investigators set out to investigate whether the regulation of retinal vessels diameters is affected in habitual smokers. It has been shown in several reports that stimulation with diffuse luminance flicker, increases retinal arterial and venous diameters, indicating for the ability of the retina to adapt to changing metabolic demands. In the current study we use this effect as a tool to investigate whether the flicker induced vasodilatation is affected in habitual smokers. This would indicate for an impaired vascular regulation process in smokers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Physiology Retina Blood Flow Velocity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

flicker light stimulation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 24 subjects aged between 18 and 35 years, nonsmokers (since at least 2 years)
* 24 subjects aged between 18 and 35 years, smokers (at least 10 cigarettes/day since 2 years)
* 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
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropy \>= 3 dpt
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Clinical Pharmacology, Medical University of Vienna

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gabriele Fuchsjaeger-Mayrl, MD

Role: PRINCIPAL_INVESTIGATOR

Department of CLinical Pharmacology, Medical University of Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Clinical Pharmacology

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OPHT-121203

Identifier Type: -

Identifier Source: org_study_id