The Safety of Cataract Removal by Phacoemulsification Sur... | NCT00564356

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

NCT00564356

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jul 21, 2009Estimated

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Efficacy
Complications

Interventions

cataract surgery with phacoemulsification

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Dec 2010Estimated

First Submitted Date

Nov 26, 2007

First Submission Date that Met QC Criteria

Nov 26, 2007

First Posted Date

Nov 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2009

Last Update Posted Date

Jul 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Other	patients under coumadin and antiaggregants operated by phacoemulsification	Procedure: cataract surgery with phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery with phacoemulsification	Procedure	removal of cataract with phacoemulsification technique	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment		3.5 years

Secondary Outcomes

Measure	Description	Time Frame
other complications		3.5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who give informed consent to participate in the study

Exclusion Criteria:

single eye complicated cataract

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ophira Salomon, MD	Contact	972-3-5302104		ophiras@sheba.health.gov.il
Yael Wasserzug, MD	Contact	972-3-5302874		yawlwasserzug@gmail.com

Overall Officials

Name	Affiliation	Role
Ophira Salomon	Sheba Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17870045	Result	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.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

ID	Term
D002387	Cataract Extraction
D018918	Phacoemulsification

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D059708	Ultrasonic Surgical Procedures