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

Eye Infections Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00335088
• Other study ID #: 4780506
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Eye Infections

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