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Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

NCT00398658 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2008-10-20

No results posted yet for this study

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.

Conditions

  • Endophthalmitis
  • Prophylaxy of Post Traumatic Endophthalmitis
  • Bacterial Endophthalmitis

Interventions

DRUG

gentamycin and clindamycin

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Principal Investigators

  • Masoud Soheilian, MD · Ophthalmic Research Center of Shaheed Beheshti Medical University

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2004-12-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00398658 on ClinicalTrials.gov