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Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335231
Recruitment Status : Withdrawn (Protocol changes underway. Trial never started)
First Posted : June 9, 2006
Last Update Posted : May 2, 2018
Information provided by (Responsible Party):
Queen's University

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.

Condition or disease Intervention/treatment Phase
Endophthalmitis Drug: gatifloxacin ophthalmic (ZYMAR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.
Study Start Date : June 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: gatifloxacin
one group will receive topical application of gatifloxacin prior to surgery,
Drug: gatifloxacin ophthalmic (ZYMAR)
No Intervention: no eye drops
this group will receive no eye drops.

Primary Outcome Measures :
  1. Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group

Secondary Outcome Measures :
  1. Bacterial sensitivity
  2. Patient comfort

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00335231

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Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
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Principal Investigator: Sherif El-Defrawy, MD PhD FRCSC Queen's University, Hotel Dieu Hospital, Kingston General Hospital
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Responsible Party: Queen's University Identifier: NCT00335231    
Other Study ID Numbers: QUEENS-SRE-3
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Keywords provided by Queen's University:
Post-cataract surgery endophthalmitis
Additional relevant MeSH terms:
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Capsule Opacification
Lens Diseases
Eye Diseases
Eye Infections
Anti-Bacterial Agents
Anti-Infective Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents