- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178499
Smoking: Cytokines in Vitreous and Aqueous Humor
November 25, 2019 updated by: Medical University of Graz
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 Overview
Study Type
Observational
Enrollment (Actual)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients scheduled for vitrectomy at the Medical University of Graz/Austria
Description
Inclusion Criteria:
- scheduled vitrectomy and/or cataract surgery
- signed informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
smokers
active smokers
|
analysis of intraocular cytokines
|
non-smokers
never smokers
|
analysis of intraocular cytokines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cotinine
Time Frame: At the time of vitrectomy procedure
|
Concentration of intraocular cotinine
|
At the time of vitrectomy procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
November 18, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 26, 2019
Study Record Updates
Last Update Posted (Actual)
November 26, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 30-107 ex 17/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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