Ocular PhysiologyNCT00431730
Is There a Difference in Flicker Induced Vasodilatation Between Smokers and Non-Smokers?
A study testing flicker light stimulation in people with Ocular Physiology and Retina, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Physiology, Retina, Blood Flow Velocity
- What is being tested?
- flicker light stimulation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteAustria
- Study dates
- Dec 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ocular Physiology, Retina, Blood Flow Velocity
- Being tested
- flicker light stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flicker light stimulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker response (Retinal vessel analyzer, Laser Doppler Velocimetry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PhysiologyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gabriele Fuchsjaeger-Mayrl, MD, Principal investigator, Department of CLinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431730
- Sponsor's protocol ID
- OPHT-121203
- Status last verified
- Jun 2008
- First submitted
- 5 Feb 2007
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Difference in Flicker Induced Vasodilatation Between Smokers and Non-Smokers?
- ClinicalTrials.gov ID
- NCT00431730
- Acronym / sponsor ID
- OPHT-121203
- Conditions
- Ocular Physiology, Retina, Blood Flow Velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flicker light stimulation | Procedure or surgery | – |
Primary outcome
Flicker response (Retinal vessel analyzer, Laser Doppler Velocimetry)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Fuchsjaeger-Mayrl, MD principal investigator
Department of CLinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flicker light stimulation in people with Ocular Physiology and Retina, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flicker response (Retinal vessel analyzer, Laser Doppler Velocimetry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2008.