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

Primary Purpose

Post-operative Endophthalmitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Intravitreal injection of Betamethasone + antibiotics
Intravitreal injection of antibiotics
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Endophthalmitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Besançon
  • CHU
  • CHU de Grenoble
  • CHU de Nancy
  • CHU de Saint Etienne
  • CHU de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

with corticoids

without corticoids

Arm Description

Outcomes

Primary Outcome Measures

Measure the evolution of visual acuity

Secondary Outcome Measures

Full Information

First Posted
January 8, 2013
Last Updated
December 26, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01768078
Brief Title
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis
Acronym
Endophtalmitis
Official Title
Interest of Intravitreal Corticotherapy as the First-line Treatment for Post-operative Endophthalmitis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Endophthalmitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with corticoids
Arm Type
Experimental
Arm Title
without corticoids
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection of Betamethasone + antibiotics
Intervention Type
Procedure
Intervention Name(s)
Intravitreal injection of antibiotics
Primary Outcome Measure Information:
Title
Measure the evolution of visual acuity
Time Frame
up to12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
CHU de Saint Etienne
City
Saint Etienne
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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