Back to resultsThe Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment
Primary Purpose
Efficacy, Complications
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
cataract surgery with phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Efficacy focused on measuring cataract, phacoemulsification, coumadin, antiaggregants
Eligibility Criteria
Inclusion Criteria:
- patients who give informed consent to participate in the study
Exclusion Criteria:
- single eye complicated cataract
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
patients under coumadin and antiaggregants operated by phacoemulsification
Outcomes
Primary Outcome Measures
safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment
Secondary Outcome Measures
other complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00564356
Brief Title
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment
Official Title
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Complications
Keywords
cataract, phacoemulsification, coumadin, antiaggregants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
patients under coumadin and antiaggregants operated by phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
cataract surgery with phacoemulsification
Intervention Description
removal of cataract with phacoemulsification technique
Primary Outcome Measure Information:
Title
safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
other complications
Time Frame
3.5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who give informed consent to participate in the study
Exclusion Criteria:
single eye complicated cataract
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ophira Salomon, MD
Phone
972-3-5302104
Email
ophiras@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Wasserzug, MD
Phone
972-3-5302874
Email
yawlwasserzug@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ophira Salomon
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Barequet, md
First Name & Middle Initial & Last Name & Degree
Joseph Moisseiev, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17870045
Citation
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. doi: 10.1016/j.ajo.2007.07.029. Epub 2007 Sep 17.
Results Reference
result
Learn more about this trial
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment
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