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

December 26, 2018 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU de Besançon
      • Dijon, France, 21000
        • CHU
      • Grenoble, France
        • CHU de Grenoble
      • Nancy, France, 54000
        • CHU de Nancy
      • Saint Etienne, France
        • CHU de Saint Étienne
      • Strasbourg, France, 67091
        • CHU de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with corticoids
Procedure: Intravitreal injection of Betamethasone + antibiotics
Other: without corticoids
Procedure: Intravitreal injection of antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure the evolution of visual acuity
Time Frame: up to12 months
up to12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2008

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Creuzot-Garcher PHRC IR 2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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