Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endophthalmitis Prophylaxy of Post Traumatic Endophthalmitis Bacterial Endophthalmitis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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gentamycin and clindamycin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Masoud Soheilian, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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Soheilian M, Rafati N, Mohebbi MR, Yazdani S, Habibabadi HF, Feghhi M, Shahriary HA, Eslamipour J, Piri N, Peyman GA; Traumatic Endophthalmitis Trial Research Group. Prophylaxis of acute posttraumatic bacterial endophthalmitis: a multicenter, randomized clinical trial of intraocular antibiotic injection, report 2. Arch Ophthalmol. 2007 Apr;125(4):460-5. doi: 10.1001/archopht.125.4.460.

Reference Type DERIVED

PMID: 17420365 (View on PubMed)

Other Identifiers

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8019

Identifier Type: -

Identifier Source: org_study_id