Clinical Trials Directory

Trials / Completed

CompletedNCT00398658

Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
Sponsor
Shahid Beheshti University of Medical Sciences · Academic / Other
Sex
All
Age
3 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGgentamycin and clindamycin

Timeline

Start date
2002-03-01
Completion
2004-12-01
First posted
2006-11-14
Last updated
2008-10-20

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT00398658. Inclusion in this directory is not an endorsement.