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| Sponsor: | HaEmek Medical Center, Israel |
|---|---|
| Information provided by: | HaEmek Medical Center, Israel |
| ClinicalTrials.gov Identifier: | NCT00335088 |
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 III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | May 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Orly Halachmi, MD | 972-4-649344 | |
| Contact: Dan Miron, MD | 972-4-6404316 | miron_da@yahoo.om |
| 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 | |
| Study Director: | Dan Miron, MD | HaEmek Medicak Center, Afula, Israel |
| Principal Investigator: | Orky Halachmi, MD | HaEmek Medical Center, Afula, Israel |
More Information
| 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 |
|
Prophylaxis, Intraocular surgery Lacrimal sac Eye lid No conditions |
|
Eye Infections Infection Eye Diseases Povidone Iodine Cadexomer iodine Povidone-Iodine Moxifloxacin Norgestimate, ethinyl estradiol drug combination Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
