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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Sheba Medical Center. Recruitment status was Recruiting

First Received on November 26, 2007. Last Updated on July 19, 2009 History of Changes

Sponsor:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00564356

Purpose

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.

Condition	Intervention
Efficacy Complications	Procedure: cataract surgery with phacoemulsification

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Cataract

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

other complications [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2010
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A patients under coumadin and antiaggregants operated by phacoemulsification	Procedure: cataract surgery with phacoemulsification removal of cataract with phacoemulsification technique

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients who give informed consent to participate in the study

Exclusion Criteria:

single eye complicated cataract

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564356

Contacts

Contact: Ophira Salomon, MD	972-3-5302104	ophiras@sheba.health.gov.il
Contact: Yael Wasserzug, MD	972-3-5302874	yawlwasserzug@gmail.com

Locations

Israel
Sheba Medical Center	Recruiting
Ramat-Gan, Israel
Sub-Investigator: Irina Barequet, md
Sub-Investigator: Joseph Moisseiev, MD

Sponsors and Collaborators

Sheba Medical Center

Investigators

Study Director:

Ophira Salomon

Sheba Medical Center

More Information

Additional Information:

The safety and efficacy of cataract surgery under coumadin treatment This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00564356 History of Changes
Other Study ID Numbers:	SHEBA-07-3017-OS-CTIL
Study First Received:	November 26, 2007
Last Updated:	July 19, 2009
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

cataract, phacoemulsification, coumadin, antiaggregants

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases
Warfarin

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012