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

NCT ID: NCT00335088

Last Updated: 2007-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eye Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Moxifloxacin and Povidone Iodine vs Povidone Iodine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 20 years.
* Various intraocular surgeries

Exclusion Criteria

* Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Principal Investigators

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Dan Miron, MD

Role: STUDY_DIRECTOR

HaEmek Medicak Center, Afula, Israel

Orky Halachmi, MD

Role: PRINCIPAL_INVESTIGATOR

HaEmek Medical Center, Afula, Israel

Locations

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Ophthalmology Department, HaEmek Medical Center, Afula, Israel

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Orly Halachmi, MD

Role: CONTACT

972-4-649344

Dan Miron, MD

Role: CONTACT

[email protected]
972-4-6404316

Facility Contacts

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Orly Halachmi, MD

Role: primary

972-4-6494344

Dan Miron, MD

Role: backup

[email protected]
972-4-6494316

Other Identifiers

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4780506

Identifier Type: -

Identifier Source: org_study_id