Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists
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StatusCompleted
Sponsors
Samsung Medical Center
CLINICAL TRIAL: NCT01704014
BioSeek: nct01704014
Keywords
Abstract
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.
Dates
Last Verified: | 09/30/2012 |
First Submitted: | 10/07/2012 |
Estimated Enrollment Submitted: | 10/09/2012 |
First Posted: | 10/10/2012 |
Last Update Submitted: | 10/09/2012 |
Last Update Posted: | 10/10/2012 |
Actual Study Start Date: | 12/31/2009 |
Estimated Primary Completion Date: | 02/28/2010 |
Estimated Study Completion Date: | 02/28/2010 |
Condition or disease
Intraoperative Floppy Iris Syndrome
Phase
-
Arm Groups
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 |
Eligibility Criteria
Sexes Eligible for Study | All |
Sampling method | Probability Sample |
Accepts Healthy Volunteers | Yes |
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) |
Outcome
Primary Outcome Measures
1. occurrence of intraoperative floppy iris syndrome [intraoperative]