Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

NCT00335231 | Withdrawn

• 1 other identifier: QUEENS-SRE-3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. However, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. This study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. If the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis. Patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. The participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e., colony forming units (CFUs), will be used as an indicator of the bacterial contamination of the fluid.

Conditions

Endophthalmitis

Keywords

Post-cataract surgery endophthalmitis

Outcome Measures

Primary Outcomes (1)

• Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group

Secondary Outcomes (2)

• Bacterial sensitivity

• Patient comfort

Study Arms (2)

gatifloxacin

EXPERIMENTAL

one group will receive topical application of gatifloxacin prior to surgery,

Drug: gatifloxacin ophthalmic (ZYMAR)

no eye drops

NO INTERVENTION

this group will receive no eye drops.

Interventions

gatifloxacin ophthalmic (ZYMAR) DRUG

gatifloxacin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract surgery on first eye (i.e., first cataract surgery.

You may not qualify if:

• uveitis,
• herpetic eye disease,
• corneal ulceration,
• severe blepharitis,
• past trauma to the eye,
• complicated cataract surgery (e.g., posterior capsule rupture),
• previous intraocular surgeries.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Endophthalmitis

Interventions

Gatifloxacin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sherif El-Defrawy, MD PhD FRCSC

  Queen's University, Hotel Dieu Hospital, Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2006
• First Posted: June 9, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

CA (1)