Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Bacterial Endophthalmitis
Endophthalmitis
Prophylaxy of Post Traumatic Endophthalmitis

Clinical Trial Details

NCT number	NCT00398658
Study type	Interventional
Source	hahid Beheshti University of Medical Sciences
Contact
Status	Completed
Phase	Phase 4
Start date	March 2002
Completion date	December 2004

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