NCT01704014

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

2 months

First QC Date

October 8, 2012

Last Update Submit

October 10, 2012

Conditions

Intraoperative Floppy Iris Syndrome

Keywords

occurrence of

Outcome Measures

Primary Outcomes (1)

  • occurrence of intraoperative floppy iris syndrome

    intraoperative

Study Arms (2)

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All korean patients who underwent cataract surgeries in Samsung Medical Center

You may qualify if:

  • clinical diagnosis of cataract
  • korean patients

You may not qualify if:

  • history of iridocyclitis, iris neovascularization, or prior iris surgery
  • traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease (e.g., uveitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 11, 2012

Record last verified: 2012-10