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NCT00564356 Clinical Trial

The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment

Complications Clinical Trial

Official title:
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00564356
Other study ID # SHEBA-07-3017-OS-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received November 26, 2007
Last updated July 19, 2009
Start date July 2007
Est. completion date December 2010

Study information
Verified date July 2009
Source Sheba Medical Center
Contact Ophira Salomon, MD
Phone 972-3-5302104
Email ophiras@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

To assess the risks of intra- and postoperative bleeding tendency associated with cataract surgery by phacoemulsification in patients on coumadin and antiaggregant treatments.

Design: Consecutive prospective study.

Description:

To assess the risks of intra- and postoperative bleeding tendency associated with cataract surgery by phacoemulsification technique in patients on coumadin and antiaggregant treatment Design: Consecutive prospective study.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date December 2010
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients who give informed consent to participate in the study

Exclusion Criteria:

- single eye complicated cataract

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• cataract surgery with phacoemulsification
removal of cataract with phacoemulsification technique

Locations
Country Name City State
Israel Sheba Medical Center Ramat-Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Barequet IS, Sachs D, Priel A, Wasserzug Y, Martinowitz U, Moisseiev J, Salomon O. Phacoemulsification of cataract in patients receiving Coumadin therapy: ocular and hematologic risk assessment. Am J Ophthalmol. 2007 Nov;144(5):719-723. Epub 2007 Sep 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment 3.5 years Yes
Secondary other complications 3.5 years Yes
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