NCT04178499

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

November 18, 2019

Last Update Submit

November 25, 2019

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

  • cotinine

    Concentration of intraocular cotinine

    At the time of vitrectomy procedure

Study Arms (2)

smokers

active smokers

Diagnostic Test: cytokine analysis

non-smokers

never smokers

Diagnostic Test: cytokine analysis

Interventions

cytokine analysisDIAGNOSTIC_TEST

analysis of intraocular cytokines

non-smokerssmokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • scheduled vitrectomy and/or cataract surgery
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vitreous humor Aqueous humor Serum

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 26, 2019

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

June 1, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share