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
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00564356
First received: November 26, 2007
Last updated: July 19, 2009
Last verified: July 2009

November 26, 2007
July 19, 2009
July 2007
August 2008   (final data collection date for primary outcome measure)
safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment [ Time Frame: 3.5 years ]
Complete list of historical versions of study NCT00564356 on ClinicalTrials.gov Archive Site
other complications [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
other complications [ Time Frame: 3.5 years ]
Not Provided
Not Provided
 
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Efficacy
  • Complications
Procedure: cataract surgery with phacoemulsification
removal of cataract with phacoemulsification technique
A
patients under coumadin and antiaggregants operated by phacoemulsification
Intervention: Procedure: cataract surgery with phacoemulsification
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
December 2010
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients who give informed consent to participate in the study

Exclusion Criteria:

  • single eye complicated cataract
Both
Not Provided
No
Contact: Ophira Salomon, MD 972-3-5302104 ophiras@sheba.health.gov.il
Contact: Yael Wasserzug, MD 972-3-5302874 yawlwasserzug@gmail.com
Israel
 
NCT00564356
SHEBA-07-3017-OS-CTIL
No
Sheba Medical Center
Sheba Medical Center
Not Provided
Study Director: Ophira Salomon Sheba Medical Center
Sheba Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP