Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis
Information source: Shaheed Beheshti Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Shaheed 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 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.
Results: The overall incidence of acute posttraumatic bacterial endophthalmitis was 2. 6% (9
eyes). Endophthalmitis occurred in 8 of 167 eyes in the control group (2. 3%) and only in one
of 179 eyes in the case group (0. 3%) [p<0. 04] . Odds ratio of developing endophthalmitis was
8. 93 times higher in controls (95% CI, 1. 11-71. 43). Retained intraocular foreign body (IOFB)
was present in 52 eyes (including 25 and 27 eyes in controls and cases respectively).
Endophthalmitis developed in 7 of 52 eyes (13%) with retained IOFB and in 2 of 294 eyes
(0. 6%) without an IOFB (p<0. 039). Vitreous culture was positive in 6 of 9 eyes (66. 6%) with
endophthalmitis; the most common isolated microorganism was Staphylococcus epidermis.
Conclusion: Intraocular injection of gentamycin and clindamycin in addition to other methods
of prophylaxis is effective in prevention of acute posttraumatic bacterial endophthalmitis
even in high-risk cases such as those with retained IOFB. These antibiotics have a major role
as adjuncts to primary repair of eyes with penetrating injury without significant side
effects at the dosage used.
Clinical Details
Study design: Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Ending date: December 2004
Last updated: November 13, 2006
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