Severe Intraocular Infection

Endophthalmitis Clinical Trial

Official title:

Severe Intraocular Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818062
• Other study ID #: 3964
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: June 24, 2016
• Start date: January 2008
• Est. completion date: September 2011

Study information

• Verified date: June 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: FRANCE: Ministère de la Recherche
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Post-operative endophthalmitis

• Cataract

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endophthalmitis

Intervention

Biological:
• Cytokines dosage in Aqueous humor
Specify details not covered in associated Arm Description.

Locations

Country	Name	City	State
France	Service d'Ophtalmologie, Hôpital Pasteur	Colmar
France	Service d'Ophtalmologie, Hôpital Général de Dijon	Dijon
France	Service d'Ophtalmologie, Hôpital Michallon	Grenoble
France	Service d'Ophtalmologie, Centre Hospitalier de Mulhouse	Mulhouse
France	Service d'Ophtalmologie, CHU de Nancy	Nancy
France	Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Service d'Ophtalmologie, Hôpital de Brabois	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular cytokine network. Intraocular levels of 27 cytokines	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-?), and tumor necrosis factor-a (TNF-a), (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	Yes
Secondary	Visual acuity	E Snellen Conversion in LogMAR unit	Once in the 24 hours following the admission, then 3 months, 6 months and 1 year	Yes