Clinical Factors Associated Floppy Iris

Completed

• Conditions: Pupil Constriction; Iris Floppiness; Iris Prolapsus From the Wound

• Registration Number: NCT00472888
• Lead Sponsor: Baskent University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-11
• Study Completion: 2006-11
• Status Verified: 2007-05
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Last Update Submitted: 2007-05-10
• Study First Posted: 2007-05-14
• Last Update Posted: 2007-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Baskent University, Faculty of Medicine, Department of Ophthalmology; 🇹🇷 Ankara, Turkey