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Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations

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ClinicalTrials.gov Identifier: NCT00335088
Recruitment Status : Unknown
Verified March 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : June 8, 2006
Last Update Posted : June 1, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. Patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.

Condition or disease Intervention/treatment Phase
Eye Infections Drug: Moxifloxacin and Povidone Iodine vs Povidone Iodine Phase 3

Detailed Description:
Over all 500 patients admitted for various intraocular surgeries will be included in the study. The study will be prospective, double blind, placebo controlled, and randomized. Patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. For patients treated with povidone iodine alone a placebo will also be given. Lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. All patients will be followed for 6 weeks for symptoms and signs of infection. Bacterial and fungal culture results will be compared between the 2 groups.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : June 2006
Estimated Study Completion Date : May 2007

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Type and amount of bacterial growth
  2. Post surgery infections

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 20 years.
  • Various intraocular surgeries

Exclusion Criteria:

  • Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00335088


Contacts
Contact: Orly Halachmi, MD 972-4-649344
Contact: Dan Miron, MD 972-4-6404316 miron_da@yahoo.om

Locations
Israel
Ophthalmology Department, HaEmek Medical Center, Afula, Israel Recruiting
Afula, Israel, 18101
Contact: Orly Halachmi, MD    972-4-6494344      
Contact: Dan Miron, MD    972-4-6494316    miron_da@yahoo.com   
Sub-Investigator: Yoram Kenes, PhD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: Dan Miron, MD HaEmek Medicak Center, Afula, Israel
Principal Investigator: Orky Halachmi, MD HaEmek Medical Center, Afula, Israel
More Information

ClinicalTrials.gov Identifier: NCT00335088     History of Changes
Other Study ID Numbers: 4780506
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: June 1, 2007
Last Verified: March 2007

Keywords provided by HaEmek Medical Center, Israel:
Prophylaxis,
Intraocular surgery
Lacrimal sac
Eye lid
No conditions

Additional relevant MeSH terms:
Eye Infections
Infection
Eye Diseases
Moxifloxacin
Iodine
Povidone-Iodine
Norgestimate, ethinyl estradiol drug combination
Povidone
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Trace Elements
Micronutrients
Growth Substances
Plasma Substitutes
Blood Substitutes