NCT00564356

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

November 26, 2007

Last Update Submit

July 19, 2009

Conditions

EfficacyComplications

Keywords

cataract, phacoemulsification, coumadin, antiaggregants

Outcome Measures

Primary Outcomes (1)

  • safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment

    3.5 years

Secondary Outcomes (1)

  • other complications

    3.5 years

Study Arms (1)

A

OTHER

patients under coumadin and antiaggregants operated by phacoemulsification

Procedure: cataract surgery with phacoemulsification

Interventions

cataract surgery with phacoemulsificationPROCEDURE

removal of cataract with phacoemulsification technique

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who give informed consent to participate in the study

You may not qualify if:

  • single eye complicated cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 17870045RESULT

MeSH Terms

Conditions

Cataract

Interventions

Cataract ExtractionPhacoemulsification

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Ophira Salomon

    Sheba Medical Center

    STUDY DIRECTOR

Central Study Contacts

Ophira Salomon, MD

CONTACT

972-3-5302104ophiras@sheba.health.gov.il

Yael Wasserzug, MD

CONTACT

972-3-5302874yawlwasserzug@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 27, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2008

Study Completion

December 1, 2010

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

IL(1)