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Status unknownNCT00564356Updated Jul 21, 2009

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

An interventional study of cataract surgery with phacoemulsification in Efficacy and Complications, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Per ClinicalTrials.gov, last updated 2009-07-21.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Efficacy
  • Complications

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Keywords

  • cataract, phacoemulsification, coumadin, antiaggregants
03

In context

Cataract

1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 75 is close to the median of 80 across 1,171 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who give informed consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • single eye complicated cataract
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Other
    A

    patients under coumadin and antiaggregants operated by phacoemulsification

    Procedure: cataract surgery with phacoemulsification

Interventions

  • Procedurecataract surgery with phacoemulsification

    removal of cataract with phacoemulsification technique

06

What researchers measure

Primary outcomes

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

    Time frame: 3.5 years

Secondary outcomes

  1. other complications

    Time frame: 3.5 years

07

Study locations

1 of 1 sites recruiting
  • Sheba Medical Center
    Ramat Gan, Israel
    • Irina Barequet, md · Sub investigator
    • Joseph Moisseiev, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 17870045 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00564356
First posted
Nov 27, 2007
Start date
Jul 2007
Primary completion
Aug 2008
Completion
Dec 2010 (estimated)
Last update
Jul 21, 2009

Study contacts

Ophira Salomon, MD
Contact
ophiras@sheba.health.gov.il
972-3-5302104
Yael Wasserzug, MD
Contact
yawlwasserzug@gmail.com
972-3-5302874
Ophira Salomon
study director · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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