Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis
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.
|Endophthalmitis Prophylaxy of Post Traumatic Endophthalmitis Bacterial Endophthalmitis||Drug: gentamycin and clindamycin||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398658
|Iran, Islamic Republic of|
|Ophthalmic Research Center|
|Tehran, Iran, Islamic Republic of, 16666|
|Principal Investigator:||Masoud Soheilian, MD||Ophthalmic Research Center of Shaheed Beheshti Medical University|