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

This study is currently recruiting participants.

Verified by HaEmek Medical Center, Israel, March 2007

First Received: June 5, 2006 Last Updated: May 31, 2007 History of Changes

Sponsor:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00335088

Purpose

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	Intervention	Phase
Eye Infections	Drug: Moxifloxacin and Povidone Iodine vs Povidone Iodine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Eye Infections Surgery

Drug Information available for: Povidone-iodine Cadexomer iodine Moxifloxacin Moxifloxacin hydrochloride Iodine Povidone

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

Type and amount of bacterial growth
Post surgery infections

Estimated Enrollment:	500
Study Start Date:	June 2006
Estimated Study Completion Date:	May 2007

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	4780506
Study First Received:	June 5, 2006
Last Updated:	May 31, 2007
ClinicalTrials.gov Identifier:	NCT00335088 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:

Prophylaxis,
Intraocular surgery
Lacrimal sac
Eye lid
No conditions

Additional relevant MeSH terms:

Anti-Infective Agents
Growth Substances
Eye Diseases
Physiological Effects of Drugs
Eye Infections
Hematologic Agents
Trace Elements
Povidone-Iodine
Infection

Pharmacologic Actions
Anti-Infective Agents, Local
Moxifloxacin
Therapeutic Uses
Blood Substitutes
Povidone
Iodine
Micronutrients
Plasma Substitutes

ClinicalTrials.gov processed this record on February 08, 2010