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Flomax Study for Floppy Iris Syndrome

This study is currently recruiting participants.
Verified September 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Roni Shtein, University of Michigan
ClinicalTrials.gov Identifier:
NCT01252472
First received: December 2, 2010
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

Some men who have a history of use of Tamsulosin (Flomax) are at risk for a condition called Intraoperative Floppy Iris Syndrome that can develop during otherwise routine cataract surgery. It is not fully understood why this condition develops or who is at risk for developing it. In this study the investigators will take pictures of the iris and iris blood vessels before cataract surgery. The investigators hope that the results of this study will provide a better understanding of how Intraoperative Floppy Iris Syndrome develops and give us a non-surgical way of figuring out who might develop this problem during surgery.


Condition
Floppy Iris Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Diagnostic Imaging for Intraoperative Floppy Iris Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by University of Michigan:

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Flomax
Male patients scheduled for cataract surgery with current or past use of Flomax
Control
Male adult patients scheduled for cataract surgery with no history of Flomax use

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult male patients seen and scheduled for cataract surgery at the Kellogg eye Centers in Ann Arbor, Livonia and Brighton campuses.

Criteria

Inclusion Criteria:

  • Male
  • 18 years or older
  • Scheduled for Cataract Surgery
  • Current or Past use of Tamsulosin (flomax)
  • Blue colored iris

For controls, no history of Flomax

Exclusion Criteria:

  • Females
  • Diabetes
  • Glaucoma
  • Use of medicated eye drops
  • Trauma or prior surgery to the eye
  • Black or brown iris
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252472

Contacts
Contact: Munira Hussain 734-647-8397 hussain@umich.edu

Locations
United States, Michigan
Kellogg Eye Center, 1000 Wall Street Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Munira Hussain, MS     734-647-8397     hussain@umich.edu    
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roni Shtein, MD University of Michigan Kellogg Eye Center
  More Information

No publications provided

Responsible Party: Roni Shtein, Assistant Professor of Ophthalmology and Visual Sciences, University of Michigan
ClinicalTrials.gov Identifier: NCT01252472     History of Changes
Other Study ID Numbers: HUM00039333
Study First Received: December 2, 2010
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Flomax
Floppy iris Syndrome
Tamsulosin

Additional relevant MeSH terms:
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013