SmokingNCT04178499
Smoking: Cytokines in Vitreous and Aqueous Humor
An observational study of Smoking, run by Medical University of Graz.
Trial summary
Smoking is a risk factor for ophthalmologic diseases. Inflammation might play a role in their pathogenesis. This study elucidates intraocular cytokine profiles in smokers and non smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- cytokine analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jun 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for vitrectomy at the Medical University of Graz/Austria
Who may be able to join
- scheduled vitrectomy and/or cataract surgery
- signed informed consent
Who cannot join
- diabetes
- uveitis
- rheumatologic disease
- anti-inflammatory/immunomodulatory medications
- st.p. intravitreal injections
- st.p. glaucoma surgery
- cataract surgery on the eye to be examined within the past 6 months
About this study
Smoking is a risk factor for ophthalmologic diseases. Inflammation might play a role in their pathogenesis.
This study elucidates intraocular cytokine profiles in smokers and non smokers.
- Conditions
- Smoking
- Being tested
- cytokine analysis
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine analysisDiagnostic test
analysis of intraocular cytokines
| Study group | Role | What they receive |
|---|---|---|
| smokers | active smokers Receives: Diagnostic Test: cytokine analysis | |
| non-smokers | never smokers Receives: Diagnostic Test: cytokine analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
cotinine
Concentration of intraocular cotinine
Measured: At the time of vitrectomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jan 2012
- Primary completion1 Jan 2015
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178499
- Sponsor's protocol ID
- 30-107 ex 17/18
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking: Cytokines in Vitreous and Aqueous Humor
- ClinicalTrials.gov ID
- NCT04178499
- Acronym / sponsor ID
- 30-107 ex 17/18
- Conditions
- Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
Smoking is a risk factor for ophthalmologic diseases. Inflammation might play a role in their pathogenesis.
This study elucidates intraocular cytokine profiles in smokers and non smokers.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers | – | Diagnostic Test: cytokine analysisactive smokers |
| non-smokers | – | Diagnostic Test: cytokine analysisnever smokers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for vitrectomy at the Medical University of Graz/Austria
Key inclusion criteria (2 listed)
- scheduled vitrectomy and/or cataract surgery
- signed informed consent
Key exclusion criteria (7 listed)
- diabetes
- uveitis
- rheumatologic disease
- anti-inflammatory/immunomodulatory medications
- st.p. intravitreal injections
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 |
|---|---|---|
| cytokine analysisanalysis of intraocular cytokines | Diagnostic test | non-smokers, smokers |
Primary outcome
cotinine
Time frame: At the time of vitrectomy procedure
Concentration of intraocular cotinine
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 26 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by Medical University of Graz.
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 2 inclusion and 7 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 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
cotinine (time frame: At the time of vitrectomy procedure). 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 26 Nov 2019.