Clinical Factors Associated Floppy Iris

Iris Floppiness Clinical Trial

Official title:

Clinical Factors Associated With Floppy Iris Signs: a Prospective Study From Two Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472888
• Other study ID #: KA 05/244
• Status: Completed
• Phase: N/A
• First received: May 10, 2007
• Last updated: May 10, 2007
• Start date: November 2005
• Est. completion date: November 2006

Study information

• Verified date: May 2007
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This study is planned to investigate the incidence of intraoperative floppy iris and its relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1 adrenergic blocker use.

Description:

Our aim is to investigate the incidence of intraoperative floppy iris syndrome (IFIS) signs and evaluate the relationship of IFIS signs as well as complete IFIS with pseudoexfoliation, diabetes, hypertension, and alpha-1 adrenergic blocker (A1AB) use. Five-hundred patients will be included in this prospective study. Preoperatively, pupil diameter before and after dilation, presence of pseudoexfoliation, history of diabetes, hypertension, and use of any A1AB will be recorded. Intraoperative adverse events such as pupillary constriction, iris billowing, and iris prolapse from the wound will be noted. Multinomial regression analysis will be used to evaluate the relationship of IFIS signs with pseudoexfoliation, diabetes, hypertension, and A1AB usage. According to the results we will determine the incidence of IFIS in our patient population and evaluate its relationship with alpha-1 adrenergic blocker use. We will also investigate the relationship of floppy iris problems with pseudoexfoliation, diabetes, high blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 28 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects with the diagnosis of cataract who were decided to have phacoemulsification

Exclusion Criteria:

• Previous history of trauma or surgery of the eye, congenital ocular disease including cataract, infection, inflammation, angle closure glaucoma, or medication (topical) that might affect the size and shape of the pupil

Only the first operated eye of each patient was included.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Constriction, Pathologic
• Iris Floppiness
• Iris Prolapsus From the Wound
• Miosis
• Pupil Constriction

Locations

Country	Name	City	State
Turkey	Baskent University, Faculty of Medicine, Department of Ophthalmology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005 Apr;31(4):664-73. — View Citation

Schwinn DA, Afshari NA. alpha(1)-Adrenergic receptor antagonists and the iris: new mechanistic insights into floppy iris syndrome. Surv Ophthalmol. 2006 Sep-Oct;51(5):501-12. Review. — View Citation