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Flomax Study for Floppy Iris Syndrome

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ClinicalTrials.gov Identifier: NCT01252472
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Floppy Iris Syndrome

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Diagnostic Imaging for Intraoperative Floppy Iris Syndrome
Study Start Date : June 2010
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Intraoperative Floppy Iris Syndrome [ Time Frame: during cataract surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252472


Locations
United States, Michigan
Kellogg Eye Center, 1000 Wall Street
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Roni Shtein, MD University of Michigan Kellogg Eye Center
More Information

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
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents