Severe Intraocular Infection

June 24, 2016 updated by: University Hospital, Strasbourg, France

The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.

The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colmar, France, 68000
        • Service d'Ophtalmologie, Hôpital Pasteur
      • Dijon, France, 21000
        • Service d'Ophtalmologie, Hôpital Général de Dijon
      • Grenoble, France, 38043
        • Service d'Ophtalmologie, Hôpital Michallon
      • Mulhouse, France, 68100
        • Service d'Ophtalmologie, Centre Hospitalier de Mulhouse
      • Nancy, France, 54000
        • Service d'Ophtalmologie, CHU de Nancy
      • Strasbourg, France, 67091
        • Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
      • Vandoeuvre Les Nancy, France, 54511
        • Service d'Ophtalmologie, Hôpital de Brabois

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from referral centers coming for post-operative endophthalmitis. Multicenter studies (in France: Strasbourg, Dijon, Grenoble, Nancy).

Description

Inclusion Criteria:

  • Post-operative endophthalmitis
  • Cataract

Exclusion Criteria:

  • None

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
Endophthalmitis
The diagnosis of endophthalmitis was made on the basis of clinical features including pain, decreased visual acuity (VA), diffuse bulbar conjunctival hyperaemia, chemosis, inflammation of the anterior segment and posterior segment inflammation (all patients had vitreous infiltration diagnosed by biomicroscopy or ophthalmic ultrasound).
Biological: Cytokines dosage in Aqueous humor
Specify details not covered in associated Arm Description.
Cataract (Control)
Controls were patients who underwent cataract surgery.
Biological: Cytokines dosage in Aqueous humor
Specify details not covered in associated Arm Description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular cytokine network. Intraocular levels of 27 cytokines
Time Frame: Once in the 24 hours following the admission

Cytokines and chemokines levels in Aqueous humor (AqH) are measured with the Bio-Plex® Multiplex System human Cytokine 27-Plex Panel assay (Bio-Rad, Marne-la-Coquette, France).

The immune mediators were classified in five categories: (a) proinflammatory mediators: (IL-6 and monocyte chemoattractant protein (MCP-1), (b) type 1 cytokines: IL-2, IL-12(p70), Interferon (IFN-γ), and tumor necrosis factor-α (TNF-α), (c) type 2 cytokines: IL-4, IL-10 and IL-13, (d) T-regulatory cytokine: IL-10 and (e) Th-17 cytokine: IL-17. The cytokine and chemokine assay plate layout consisted of a standard series in duplicate (1 to 32 000 pg/ml), four blank wells and 20 μl duplicates of pooled AqH samples, diluted to 50 μl with BioPlex mouse serum diluent. The BioPlex® method was performed as recommended by the manufacturer and previously published studies. Data were analyzed with Bio-Plex Manager software® V 1.1 (Bio-Rad).
Once in the 24 hours following the admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: Once in the 24 hours following the admission, then 3 months, 6 months and 1 year
E Snellen Conversion in LogMAR unit
Once in the 24 hours following the admission, then 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

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

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3964

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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