Flomax Study for Floppy Iris Syndrome

This study has been completed.
Information provided by (Responsible Party):
Roni Shtein, University of Michigan
ClinicalTrials.gov Identifier:
First received: December 2, 2010
Last updated: April 24, 2015
Last verified: April 2015
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.

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:

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Intraoperative Floppy Iris Syndrome [ Time Frame: during cataract surgery ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Male patients scheduled for cataract surgery with current or past use of Flomax
Male adult patients scheduled for cataract surgery with no history of Flomax use

  Show Detailed Description


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252472

United States, Michigan
Kellogg Eye Center, 1000 Wall Street
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
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 
Study First Received: December 2, 2010
Last Updated: April 24, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Floppy iris Syndrome

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on April 27, 2016