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Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398658
First Posted: November 14, 2006
Last Update Posted: October 20, 2008
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:
Shahid Beheshti University of Medical Sciences
  Purpose

Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following penetrating eye injuries.

Design: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred forty six eyes of 346 patients with penetrating eye injury.

Method: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received standard prophylactic antibiotic therapy (systemic, subconjunctival and topical).

Main outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.


Condition Intervention Phase
Endophthalmitis Prophylaxy of Post Traumatic Endophthalmitis Bacterial Endophthalmitis Drug: gentamycin and clindamycin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Study Start Date: March 2002
Estimated Study Completion Date: December 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with penetrating eye injuries referred to collaborating institutes for primary repair

Exclusion Criteria:

  • Absence of light perception
  • presence of endophthalmitis at the time of initial evaluation
  • total corneal opacity
  • age under 3 years
  • severe intracameral hemorrhage
  • history of intraocular surgery and presence of a corneal ulcer
  • Monocular patients
  • the better eye in simultaneous bilateral injuries
  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): NCT00398658


Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Masoud Soheilian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00398658     History of Changes
Other Study ID Numbers: 8019
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: October 20, 2008
Last Verified: November 2006

Keywords provided by Shahid Beheshti University of Medical Sciences:
Endophthalmitis
Post-traumatic Endophthalmitis
Bacterial Endophthalmitis
Prophylaxis of Endophthalmitis
Intra Ocular Injection of antibiotics

Additional relevant MeSH terms:
Endophthalmitis
Eye Infections
Infection
Eye Diseases
Clindamycin
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action