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

Intraoperative Floppy Iris Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704014
• Other study ID #: 2010-01-034
• Status: Completed
• Phase: N/A
• First received: October 8, 2012
• Last updated: October 10, 2012
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: October 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intraoperative Floppy Iris Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of intraoperative floppy iris syndrome		intraoperative	No