Severe Intraocular Infection

Completed

• Conditions: Endophthalmitis
• Interventions: Biological: Cytokines dosage in Aqueous humor

• Registration Number: NCT02818062
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-24
• Last Update Submitted: 2016-06-24
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• Post-operative endophthalmitis
• Cataract

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endophthalmitis	Cytokines dosage in Aqueous humor	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).
Cataract (Control)	Cytokines dosage in Aqueous humor	Controls were patients who underwent cataract surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Visual acuity	Once in the 24 hours following the admission, then 3 months, 6 months and 1 year	E Snellen Conversion in LogMAR unit

Trial Locations

Locations (7)

Service d'Ophtalmologie, Centre Hospitalier de Mulhouse; 🇫🇷 Mulhouse, France

Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

Service d'Ophtalmologie, Hôpital de Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

Service d'Ophtalmologie, Hôpital Pasteur; 🇫🇷 Colmar, France

Service d'Ophtalmologie, CHU de Nancy; 🇫🇷 Nancy, France

Service d'Ophtalmologie, Hôpital Général de Dijon; 🇫🇷 Dijon, France

Service d'Ophtalmologie, Hôpital Michallon; 🇫🇷 Grenoble, France