Severe Intraocular Infection

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT02818062
Collaborator
(none)
263
7
44
37.6
0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Cytokines dosage in Aqueous humor

Study Design

Study Type:
Observational
Actual Enrollment :
263 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Severe Intraocular Infection
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Intraocular cytokine network. Intraocular levels of 27 cytokines [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).

Secondary Outcome Measures

  1. Visual acuity [Once in the 24 hours following the admission, then 3 months, 6 months and 1 year]

    E Snellen Conversion in LogMAR unit

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Post-operative endophthalmitis

  • Cataract

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service d'Ophtalmologie, Hôpital Pasteur Colmar France 68000
2 Service d'Ophtalmologie, Hôpital Général de Dijon Dijon France 21000
3 Service d'Ophtalmologie, Hôpital Michallon Grenoble France 38043
4 Service d'Ophtalmologie, Centre Hospitalier de Mulhouse Mulhouse France 68100
5 Service d'Ophtalmologie, CHU de Nancy Nancy France 54000
6 Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Strasbourg France 67091
7 Service d'Ophtalmologie, Hôpital de Brabois Vandoeuvre Les Nancy France 54511

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02818062
Other Study ID Numbers:
  • 3964
First Posted:
Jun 29, 2016
Last Update Posted:
Jun 29, 2016
Last Verified:
Jun 1, 2016
Keywords provided by University Hospital, Strasbourg, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2016