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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768078
First Posted: January 15, 2013
Last Update Posted: January 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  Purpose
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.

Condition Intervention Phase
Post-operative Endophthalmitis Procedure: Intravitreal injection of Betamethasone + antibiotics Procedure: Intravitreal injection of antibiotics Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.

Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Measure the evolution of visual acuity [ Time Frame: up to12 months ]

Estimated Enrollment: 130
Study Start Date: September 2008
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: with corticoids Procedure: Intravitreal injection of Betamethasone + antibiotics
without corticoids Procedure: Intravitreal injection of antibiotics

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768078


Contacts
Contact: Catherine CREUZOT-GARCHER 3 80 29 51 73 ext +33 catherine.creuzot-garcher@chu-dijon.fr

Locations
France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Bernard DELBOSC       ophtalmologie@chu-besancon.fr   
Principal Investigator: Bernard DELBOSC         
Sub-Investigator: Romain FEBVRE         
CHU Recruiting
Dijon, France, 21000
Contact: Catherine CREUZOT-GARCHER    3 80 29 51 73 ext +33    catherine.creuzot-garcher@chu-dijon.fr   
Principal Investigator: Catherine CREUZOT-GARCHER         
Sub-Investigator: Alain BRON         
Sub-Investigator: Alexandre GUILLAUBEY         
Sub-Investigator: Stéphane ARNAVIELLE         
CHU de Grenoble Recruiting
Grenoble, France
Contact: Christophe CHIQUET       cchiquet@chu-grenoble.fr   
Sub-Investigator: Karine PALOMBI         
Sub-Investigator: Viviane VINH         
Principal Investigator: Christophe CHIQUET         
CHU de Nancy Recruiting
Nancy, France, 54000
Contact: Jean-Paul BERROD       jp.berrod@chu-nancy.fr   
Principal Investigator: Jean-Paul BERROD         
Principal Investigator: Jean Toufic MAALOUF         
Sub-Investigator: Pierre LESURE         
Sub-Investigator: Rym OULED-MOUSSA         
Sub-Investigator: Angélique POIRSON         
Sub-Investigator: Grégoire MINOYAN         
Sub-Investigator: Marie-Christine BAZARD         
CHU de Saint Etienne Recruiting
Saint Etienne, France
Contact: Philippe GAIN       philippe.gain@univ-st-etienne.fr   
Principal Investigator: Philippe GAIN         
Sub-Investigator: Gilles THURET         
Sub-Investigator: Nelly CAMPOLMI         
CHU de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Claude SPEEG-SCHATZ       claude.speeg@chru-strasbourg.fr   
Principal Investigator: Claude SPEEG-SCHATZ         
Sub-Investigator: Tristan BOURCIER         
Sub-Investigator: David GAUCHER         
Sub-Investigator: Laurent BALLONZOLI         
Sub-Investigator: Arnaud SAUER         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01768078     History of Changes
Other Study ID Numbers: Creuzot-Garcher PHRC IR 2007
First Submitted: January 8, 2013
First Posted: January 15, 2013
Last Update Posted: January 15, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Endophthalmitis
Eye Infections
Infection
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Betamethasone
Anti-Infective Agents
Antitubercular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents