Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Endophthalmitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398658
• Other study ID #: 8019
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2006
• Last updated: October 17, 2008
• Start date: March 2002
• Est. completion date: December 2004

Study information

• Verified date: November 2006
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

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

Intervention

Drug:
• gentamycin and clindamycin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of,