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Clinical Factors Associated Floppy Iris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472888
First Posted: May 14, 2007
Last Update Posted: May 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baskent University
  Purpose
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.

Condition
Pupil Constriction Iris Floppiness Iris Prolapsus From the Wound

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Clinical Factors Associated With Floppy Iris Signs: a Prospective Study From Two Centers

Further study details as provided by Baskent University:

Enrollment: 500
Study Start Date: November 2005
Study Completion Date: November 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472888


Locations
Turkey
Baskent University, Faculty of Medicine, Department of Ophthalmology
Ankara, Turkey, 06490
Sponsors and Collaborators
Baskent University
Investigators
Study Chair: Rana Altan-Yaycioglu, MD Baskent University, Faculty of Medicine, Department of Ophthalmology
Study Director: Yonca A Akova, MD Baskent University, Faculty of Medicine, Department of Ophthalmology
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00472888     History of Changes
Other Study ID Numbers: KA 05/244
First Submitted: May 10, 2007
First Posted: May 14, 2007
Last Update Posted: May 14, 2007
Last Verified: May 2007

Keywords provided by Baskent University:
Alpha-adrenergic blockers
cataract surgery
pseudoexfoliation syndrome
diabetes mellitus
hypertension
pupil

Additional relevant MeSH terms:
Constriction, Pathologic
Miosis
Pathological Conditions, Anatomical
Pupil Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms