Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00335088
First received: June 5, 2006
Last updated: May 31, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Eye Infections
Drug: Moxifloxacin and Povidone Iodine vs Povidone Iodine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Type and amount of bacterial growth
  • Post surgery infections

Estimated Enrollment: 500
Study Start Date: June 2006
Estimated Study Completion Date: May 2007
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 20 years.
  • Various intraocular surgeries

Exclusion Criteria:

  • Need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335088

Contacts
Contact: Orly Halachmi, MD 972-4-649344
Contact: Dan Miron, MD 972-4-6404316 miron_da@yahoo.om

Locations
Israel
Ophthalmology Department, HaEmek Medical Center, Afula, Israel Recruiting
Afula, Israel, 18101
Contact: Orly Halachmi, MD    972-4-6494344      
Contact: Dan Miron, MD    972-4-6494316    miron_da@yahoo.com   
Sub-Investigator: Yoram Kenes, PhD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: Dan Miron, MD HaEmek Medicak Center, Afula, Israel
Principal Investigator: Orky Halachmi, MD HaEmek Medical Center, Afula, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00335088     History of Changes
Other Study ID Numbers: 4780506
Study First Received: June 5, 2006
Last Updated: May 31, 2007
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Prophylaxis,
Intraocular surgery
Lacrimal sac
Eye lid
No conditions

Additional relevant MeSH terms:
Eye Infections
Eye Diseases
Infection
Iodine
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Povidone
Povidone-Iodine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents
Blood Substitutes
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Growth Substances
Hematologic Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Trace Elements

ClinicalTrials.gov processed this record on November 27, 2014