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Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

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ClinicalTrials.gov Identifier: NCT00398658
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Endophthalmitis Prophylaxy of Post Traumatic Endophthalmitis Bacterial Endophthalmitis Drug: gentamycin and clindamycin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : March 2002
Study Completion Date : December 2004

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
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
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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
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Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Masoud Soheilian, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00398658    
Other Study ID Numbers: 8019
First Posted: November 14, 2006    Key Record Dates
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:
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Endophthalmitis
Eye Infections
Infection
Eye Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
 Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action