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.

Completed

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Key information

Conditions

Endophthalmitis Bacterial Endophthalmitis Eye Diseases Eye Infections Infections Prophylaxy of Post Traumatic Endophthalmitis

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gentamycin and clindamycin

Drug

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start: 2002
Study completion: 2004
First posted: Nov 14, 2006
Registry last updated: Oct 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed