Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Prophylaxy of Post Traumatic Endophthalmitis; Endophthalmitis; Bacterial Endophthalmitis

Treatments: Drug: gentamycin and clindamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00398658

8019

Details and patient eligibility

About

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.

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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