NCT01252472

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

3.5 years

First QC Date

December 2, 2010

Last Update Submit

April 24, 2015

Conditions

Floppy Iris Syndrome

Keywords

FlomaxFloppy iris SyndromeTamsulosin

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Floppy Iris Syndrome

    during cataract surgery

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Male
  • years or older
  • Scheduled for Cataract Surgery
  • Current or Past use of Tamsulosin (flomax)
  • Blue colored iris
  • For controls, no history of Flomax

You may not qualify if:

  • Females
  • Diabetes
  • Glaucoma
  • Use of medicated eye drops
  • Trauma or prior surgery to the eye
  • Black or brown iris

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kellogg Eye Center, 1000 Wall Street

Ann Arbor, Michigan, 48105, United States

Location

Study Officials

  • Roni Shtein, MD

    University of Michigan Kellogg Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology and Visual Sciences

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

US(1)