NCT02818062

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

7 active sites

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, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

3.7 years

First QC Date

June 22, 2016

Last Update Submit

June 24, 2016

Conditions

Endophthalmitis

Keywords

EndophthalmitisCytokinesChemokinesInflammationRegulation

Outcome Measures

Primary Outcomes (1)

  • 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-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 Outcomes (1)

  • Visual acuity

    Once in the 24 hours following the admission, then 3 months, 6 months and 1 year

Study Arms (2)

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

Cataract (Control)

Controls were patients who underwent cataract surgery.

Biological: Cytokines dosage in Aqueous humor

Interventions

Cytokines dosage in Aqueous humorBIOLOGICAL

Specify details not covered in associated Arm Description.

Cataract (Control)Endophthalmitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Post-operative endophthalmitis
  • Cataract

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Service d'Ophtalmologie, Hôpital Pasteur

Colmar, 68000, France

Location

Service d'Ophtalmologie, Hôpital Général de Dijon

Dijon, 21000, France

Location

Service d'Ophtalmologie, Hôpital Michallon

Grenoble, 38043, France

Location

Service d'Ophtalmologie, Centre Hospitalier de Mulhouse

Mulhouse, 68100, France

Location

Service d'Ophtalmologie, CHU de Nancy

Nancy, 54000, France

Location

Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Service d'Ophtalmologie, Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Aqueous humor obtained by anterior chamber tap.

MeSH Terms

Conditions

EndophthalmitisInflammation

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 29, 2016

Study Start

January 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

FR(7)