Back to resultsLocal Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
Primary Purpose
Eye Infections
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Moxifloxacin and Povidone Iodine vs Povidone Iodine
Sponsored by
About this trial
This is an interventional prevention trial for Eye Infections focused on measuring Prophylaxis,, Intraocular surgery, Lacrimal sac, Eye lid, No conditions
Eligibility Criteria
Inclusion Criteria: Age > 20 years. Various intraocular surgeries Exclusion Criteria: Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
Sites / Locations
- Ophthalmology Department, HaEmek Medical Center, Afula, IsraelRecruiting
Outcomes
Primary Outcome Measures
Type and amount of bacterial growth
Post surgery infections
Secondary Outcome Measures
Full Information
NCT ID
NCT00335088
First Posted
June 5, 2006
Last Updated
May 31, 2007
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00335088
Brief Title
Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infections
Keywords
Prophylaxis,, Intraocular surgery, Lacrimal sac, Eye lid, No conditions
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin and Povidone Iodine vs Povidone Iodine
Primary Outcome Measure Information:
Title
Type and amount of bacterial growth
Title
Post surgery infections
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 20 years.
Various intraocular surgeries
Exclusion Criteria:
Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orly Halachmi, MD
Phone
972-4-649344
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Miron, MD
Phone
972-4-6404316
Email
miron_da@yahoo.om
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Miron, MD
Organizational Affiliation
HaEmek Medicak Center, Afula, Israel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Orky Halachmi, MD
Organizational Affiliation
HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Department, HaEmek Medical Center, Afula, Israel
City
Afula
ZIP/Postal Code
18101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orly Halachmi, MD
Phone
972-4-6494344
First Name & Middle Initial & Last Name & Degree
Dan Miron, MD
Phone
972-4-6494316
Email
miron_da@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yoram Kenes, PhD
12. IPD Sharing Statement
Learn more about this trial
Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
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