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Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endophthalmitis; Prophylaxy of Post Traumatic Endophthalmitis; Bacterial Endophthalmitis

Intervention: gentamycin and clindamycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shahid Beheshti Medical University

Official(s) and/or principal investigator(s):
Masoud Soheilian, MD, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University

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 40g gentamycin and 45g 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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Eligibility

Minimum age: 3 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ophthalmic Research Center, Tehran 16666, Iran, Islamic Republic of
Additional Information

Starting date: March 2002
Last updated: October 17, 2008

Page last updated: August 23, 2015

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