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:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01768078
First received: January 8, 2013
Last updated: January 14, 2013
Last verified: January 2013
  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 Blind (Subject)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768078

Locations
France
CHU de Besançon
Besançon, France, 25000
CHU
Dijon, France, 21000
CHU de Grenoble
Grenoble, France
CHU de Nancy
Nancy, France, 54000
CHU de Saint Etienne
Saint Etienne, France
CHU de Strasbourg
Strasbourg, France, 67091
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 
Study First Received: January 8, 2013
Last Updated: January 14, 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

ClinicalTrials.gov processed this record on January 19, 2017