Overview

Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Treatments:
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Gentamicins