Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00398658
First received: November 13, 2006
Last updated: October 17, 2008
Last verified: November 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
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: NCT00398658

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

No publications provided by Shahid Beheshti Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00398658     History of Changes
Other Study ID Numbers: 8019
Study First Received: November 13, 2006
Last Updated: October 17, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
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
Clindamycin-2-phosphate
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014