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Clinical Trials |

Prophylaxis of Acute Posttraumatic Bacterial Endophthalmitis A Multicenter, Randomized Clinical Trial of Intraocular Antibiotic Injection, Report 2

Masoud Soheilian, MD; Nasrin Rafati, MD; Mohammad-Reza Mohebbi, PhD; Shahin Yazdani, MD; Houshang Faghihi Habibabadi, MD; Mostafa Feghhi, MD; Hossein A. Shahriary, MD; Jamil Eslamipour, MD; Niloofar Piri, MD; Gholam A. Peyman, MD ; Traumatic Endophthalmitis Trial (TET) Research Group
Arch Ophthalmol. 2007;125(4):460-465. doi:10.1001/archopht.125.4.460.
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Objective  To evaluate the efficacy of intraocular gentamicin sulfate and clindamycin in the prevention of acute posttraumatic bacterial endophthalmitis following penetrating eye injuries.

Method  We conducted a multicenter, randomized, double-masked controlled trial of 346 eyes with penetrating eye injury. Following primary repair, eyes were randomized to intracameral or intravitreal injection of 40 μg of gentamicin sulfate and 45 μg of clindamycin (cases) vs balanced salt solution (controls).

Main Outcome Measure  Occurrence of endophthalmitis within 2 weeks.

Results  Endophthalmitis occurred in 8 (2.3%) of 167 eyes in the control group and only in 1 (0.3%) of 179 eyes in the case group (P = .04; odds ratio, 8.93 [95% confidence interval, 1.11-71.43]). In eyes with an intraocular foreign body, endophthalmitis developed in 7 of 25 control eyes and in none of 27 eyes receiving antibiotics. However, in eyes without an intraocular foreign body, endophthalmitis developed in 1 of 142 eyes and 1 of 152 eyes in the 2 groups, respectively (P value for interaction = .04). Intravitreal injection was superior to intracameral injection in preventing endophthalmitis (P value for interaction = .01). Vitreous culture results were positive in 6 (67%) of 9 eyes with endophthalmitis.

Conclusion  Intraocular gentamicin and clindamycin are effective in the prevention of acute posttraumatic bacterial endophthalmitis in eyes with retained intraocular foreign body.

Application to Clinical Practice  Prophylaxis of traumatic endophthalmitis.

Trial Registration  clinicaltrials.gov Identifier: "http://clinicaltrials.gov/ct/show/NCT00398658"

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Flow of participants through each stage of randomization. BSS indicates balanced salt solution.

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