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Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

Primary Purpose

Endophthalmitis

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
gatifloxacin ophthalmic (ZYMAR)
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endophthalmitis focused on measuring Post-cataract surgery endophthalmitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cataract surgery on first eye (i.e., first cataract surgery. Exclusion Criteria: uveitis, herpetic eye disease, corneal ulceration, severe blepharitis, past trauma to the eye, complicated cataract surgery (e.g., posterior capsule rupture), previous intraocular surgeries.

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

gatifloxacin

no eye drops

Arm Description

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

this group will receive no eye drops.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bacterial sensitivity
Patient comfort

Full Information

First Posted
June 8, 2006
Last Updated
April 30, 2018
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00335231
Brief Title
Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery
Official Title
The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Protocol changes underway. Trial never started
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen's University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis
Keywords
Post-cataract surgery endophthalmitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gatifloxacin
Arm Type
Experimental
Arm Description
one group will receive topical application of gatifloxacin prior to surgery,
Arm Title
no eye drops
Arm Type
No Intervention
Arm Description
this group will receive no eye drops.
Intervention Type
Drug
Intervention Name(s)
gatifloxacin ophthalmic (ZYMAR)
Primary Outcome Measure Information:
Title
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
Secondary Outcome Measure Information:
Title
Bacterial sensitivity
Title
Patient comfort

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cataract surgery on first eye (i.e., first cataract surgery. Exclusion Criteria: uveitis, herpetic eye disease, corneal ulceration, severe blepharitis, past trauma to the eye, complicated cataract surgery (e.g., posterior capsule rupture), previous intraocular surgeries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif El-Defrawy, MD PhD FRCSC
Organizational Affiliation
Queen's University, Hotel Dieu Hospital, Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

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Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

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