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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01704014
Collaborator
(none)
150
Enrollment
1.9
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2010
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. occurrence of intraoperative floppy iris syndrome [intraoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01704014
    Other Study ID Numbers:
    • 2010-01-034
    First Posted:
    Oct 11, 2012
    Last Update Posted:
    Oct 11, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Samsung Medical Center
    occurrence of
    Additional relevant MeSH terms:
    Syndrome

    Study Results

    No Results Posted as of Oct 11, 2012