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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00335088
Enrollment
500
Registered
2006-06-08
Start date
2006-06-30
Completion date
2007-05-31
Last updated
2007-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Infections

Keywords

Prophylaxis,, Intraocular surgery, Lacrimal sac, Eye lid, No conditions

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.

Interventions

DRUGMoxifloxacin and Povidone Iodine vs Povidone Iodine

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 20 years. * Various intraocular surgeries

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Type and amount of bacterial growth
Post surgery infections

Countries

Israel

Contacts

Primary ContactOrly Halachmi, MD
972-4-649344
Backup ContactDan Miron, MD
miron_da@yahoo.om972-4-6404316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026