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

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00564356
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Duration (Months): 41
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Efficacy; Complications	Procedure: cataract surgery with phacoemulsification	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: N/A
• 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
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: A patients under coumadin and antiaggregants operated by phacoemulsification	Procedure: cataract surgery with phacoemulsification; removal of cataract with phacoemulsification technique

Outcome Measures

Primary Outcome Measures

1. safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment [3.5 years]

Secondary Outcome Measures

1. other complications [3.5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients who give informed consent to participate in the study

Exclusion Criteria:

• single eye complicated cataract

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center	Ramat-Gan		Israel

Sponsors and Collaborators

• Sheba Medical Center

Investigators

• Study Director: Ophira Salomon, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00564356
• Other Study ID Numbers: SHEBA-07-3017-OS-CTIL
• First Posted: Nov 27, 2007
• Last Update Posted: Jul 21, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: cataract, phacoemulsification, coumadin, antiaggregants
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jul 21, 2009