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

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ClinicalTrials.gov Identifier: NCT01704014
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
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

Group/Cohort
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 ]


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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
Criteria

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
ClinicalTrials.gov Identifier: NCT01704014     History of Changes
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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Syndrome
Disease
Pathologic Processes
Adrenergic Agents
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs