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Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00398658
Enrollment
Unknown
Registered
2006-11-14
Start date
2002-03-31
Completion date
2004-12-31
Last updated
2008-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Endophthalmitis, Endophthalmitis, Prophylaxy of Post Traumatic Endophthalmitis

Keywords

Endophthalmitis, Post-traumatic Endophthalmitis, Bacterial Endophthalmitis, Prophylaxis of Endophthalmitis, Intra Ocular Injection of antibiotics

Brief 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.

Interventions

DRUGgentamycin and clindamycin

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026