Local Moxifloxacin and Povidone Iodine Versus Povidone Iodine Alone as a Prophylaxis Before Eye Operations
Information source: HaEmek Medical Center, Israel
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Eye Infections
Intervention: Moxifloxacin and Povidone Iodine vs Povidone Iodine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s):
Dan Miron, MD, Study Director, Affiliation: HaEmek Medicak Center, Afula, Israel
Orky Halachmi, MD, Principal Investigator, Affiliation: HaEmek Medical Center, Afula, Israel
Overall contact:
Orly Halachmi, MD, Phone: 972-4-649344
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.
Clinical Details
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Type and amount of bacterial growthPost surgery infections
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age > 20 years.
- Various intraocular surgeries
Exclusion Criteria:
- Need for emergency therapy, immunosuppression, any malignancy, psychomotor
retardation, drug and alcohol abuse.
Locations and Contacts
Orly Halachmi, MD, Phone: 972-4-649344
Ophthalmology Department, HaEmek Medical Center, Afula, Israel, Afula 18101, Israel; Recruiting
Orly Halachmi, MD, Phone: 972-4-6494344
Dan Miron, MD, Phone: 972-4-6494316, Email: miron_da@yahoo.com
Yoram Kenes, PhD, Sub-Investigator
Additional Information
Starting date: June 2006
Ending date: May 2007
Last updated: May 31, 2007
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