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

Not Applicable

• Conditions: Efficacy; Complications
• Interventions: Procedure: cataract surgery with phacoemulsification

• Registration Number: NCT00564356
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-27
• Primary Completion: 2008-08
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-19
• Last Update Posted: 2009-07-21
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• patients who give informed consent to participate in the study

Exclusion Criteria

• single eye complicated cataract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	cataract surgery with phacoemulsification	patients under coumadin and antiaggregants operated by phacoemulsification

Primary Outcome Measures

Name	Time	Method
safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment	3.5 years

Secondary Outcome Measures

Name	Time	Method
other complications	3.5 years

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel