We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564356
First Posted: November 27, 2007
Last Update Posted: July 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • other complications [ Time Frame: 3.5 years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00564356     History of Changes
Other Study ID Numbers: SHEBA-07-3017-OS-CTIL
First Submitted: November 26, 2007
First Posted: November 27, 2007
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by Sheba Medical Center:
cataract, phacoemulsification, coumadin, antiaggregants

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Warfarin
Anticoagulants


To Top