NCT00398658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

October 20, 2008

Status Verified

November 1, 2006

First QC Date

November 13, 2006

Last Update Submit

October 17, 2008

Conditions

EndophthalmitisProphylaxy of Post Traumatic EndophthalmitisBacterial Endophthalmitis

Keywords

EndophthalmitisPost-traumatic EndophthalmitisBacterial EndophthalmitisProphylaxis of EndophthalmitisIntra Ocular Injection of antibiotics

Interventions

gentamycin and clindamycinDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with penetrating eye injuries referred to collaborating institutes for primary repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 16666, Iran

Location

Related Publications (1)

  • 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.

    PMID: 17420365DERIVED

MeSH Terms

Conditions

Endophthalmitis

Interventions

GentamicinsClindamycin

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Masoud Soheilian, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

March 1, 2002

Study Completion

December 1, 2004

Last Updated

October 20, 2008

Record last verified: 2006-11

Locations

IR(1)