Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis
|ClinicalTrials.gov Identifier: NCT00398658|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : October 20, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Endophthalmitis Prophylaxy of Post Traumatic Endophthalmitis Bacterial Endophthalmitis||Drug: gentamycin and clindamycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||March 2002|
|Estimated Study Completion Date :||December 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|