Smoking: Cytokines in Vitreous and Aqueous Humor | NCT04178499

Studies
Smoking: Cytokines in Vitreous and Aqueous Humor

NCT04178499

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Nov 26, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Smoking

Interventions

cytokine analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Jan 1, 2015Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 25, 2019

First Posted Date

Nov 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2019

Last Update Posted Date

Nov 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
smokers		active smokers	Diagnostic Test: cytokine analysis
non-smokers		never smokers	Diagnostic Test: cytokine analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cytokine analysis	Diagnostic Test	analysis of intraocular cytokines	non-smokers smokers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cotinine	Concentration of intraocular cotinine	At the time of vitrectomy procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients scheduled for vitrectomy at the Medical University of Graz/Austria

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided