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.

Study Type: Interventional

Study Design: Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: gentamycin and clindamycin

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shaheed Beheshti Medical University

Overall Clinical Trial Officials and Contacts

Masoud Soheilian, MD Principal Investigator Ophthalmic Research Center of Shaheed Beheshti Medical University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00398658

Study ID Number: 8019

ClinicalTrials.gov Identifier: NCT00398658

Health Authority: Iran: Ethics Committee