Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gentamicins

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