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Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis

NCT ID: NCT01768078

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-10-31

Brief Summary

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One useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.

Detailed Description

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Conditions

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Post-operative Endophthalmitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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with corticoids

Group Type EXPERIMENTAL

Intravitreal injection of Betamethasone + antibiotics

Intervention Type PROCEDURE

without corticoids

Group Type OTHER

Intravitreal injection of antibiotics

Intervention Type PROCEDURE

Interventions

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Intravitreal injection of Betamethasone + antibiotics

Intervention Type PROCEDURE

Intravitreal injection of antibiotics

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients male or female with no age limit
* Hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery
* Who had given their consent after being informed about intravitreal corticotherapy

Exclusion Criteria

* Patients who refused or were unable to give their consent
* Prior intravitreal corticotherapy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Besançon

Besançon, , France

Site Status

CHU

Dijon, , France

Site Status

CHU de Grenoble

Grenoble, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

CHU de Saint Etienne

Saint-Etienne, , France

Site Status

CHU de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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Creuzot-Garcher PHRC IR 2007

Identifier Type: -

Identifier Source: org_study_id