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Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704014
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Information provided by (Responsible Party):
Samsung Medical Center

Brief Summary:
Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS. However the prevalence of IFIS in Korean population is not reported. The purpose of this study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris anatomical change in Korean patients taking α1-ARA.

Condition or disease
Intraoperative Floppy Iris Syndrome

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists
Study Start Date : January 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

α1-ARA Group
All patients on α1-ARA(α1-adrenergic receptor antagonists) medication who underwent cataract surgeries.
Control Group
Age and sex-matched control subjects

Primary Outcome Measures :
  1. occurrence of intraoperative floppy iris syndrome [ Time Frame: intraoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All korean patients who underwent cataract surgeries in Samsung Medical Center

Inclusion Criteria:

  • clinical diagnosis of cataract
  • korean patients

Exclusion Criteria:

  • history of iridocyclitis, iris neovascularization, or prior iris surgery
  • traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease (e.g., uveitis)
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Responsible Party: Samsung Medical Center Identifier: NCT01704014    
Other Study ID Numbers: 2010-01-034
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Samsung Medical Center:
occurrence of
Additional relevant MeSH terms:
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Pathologic Processes