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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00335088
Other study ID # 4780506
Secondary ID
Status Unknown status
Phase Phase 3
First received June 5, 2006
Last updated May 31, 2007
Start date June 2006
Est. completion date May 2007

Study information

Verified date March 2007
Source HaEmek Medical Center, Israel
Contact Orly Halachmi, MD
Phone 972-4-649344
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 500
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Age > 20 years.

- Various intraocular surgeries

Exclusion Criteria:

- Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Moxifloxacin and Povidone Iodine vs Povidone Iodine


Locations

Country Name City State
Israel Ophthalmology Department, HaEmek Medical Center, Afula, Israel Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type and amount of bacterial growth
Primary Post surgery infections
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