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

NCT ID: NCT00564356

Last Updated: 2009-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Efficacy Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

patients under coumadin and antiaggregants operated by phacoemulsification

Group Type OTHER

cataract surgery with phacoemulsification

Intervention Type PROCEDURE

removal of cataract with phacoemulsification technique

Interventions

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cataract surgery with phacoemulsification

removal of cataract with phacoemulsification technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who give informed consent to participate in the study

Exclusion Criteria

* single eye complicated cataract
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Ophira Salomon

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ophira Salomon, MD

Role: CONTACT

972-3-5302104

Yael Wasserzug, MD

Role: CONTACT

972-3-5302874

References

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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.

Reference Type RESULT
PMID: 17870045 (View on PubMed)

Other Identifiers

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SHEBA-07-3017-OS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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