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Clinical Factors Associated Floppy Iris

NCT ID: NCT00472888

Last Updated: 2007-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Pupil Constriction Iris Floppiness Iris Prolapsus From the Wound

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Principal Investigators

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Rana Altan-Yaycioglu, MD

Role: STUDY_CHAIR

Baskent University, Faculty of Medicine, Department of Ophthalmology

Yonca A Akova, MD

Role: STUDY_DIRECTOR

Baskent University, Faculty of Medicine, Department of Ophthalmology

Locations

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Baskent University, Faculty of Medicine, Department of Ophthalmology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005 Apr;31(4):664-73. doi: 10.1016/j.jcrs.2005.02.027.

Reference Type BACKGROUND
PMID: 15899440 (View on PubMed)

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. doi: 10.1016/j.survophthal.2006.06.011.

Reference Type BACKGROUND
PMID: 16950249 (View on PubMed)

Altan-Yaycioglu R, Gedik S, Pelit A, Akova YA, Akman A. Clinical factors associated with floppy iris signs: a prospective study from two centers. Ophthalmic Surg Lasers Imaging. 2009 May-Jun;40(3):232-8. doi: 10.3928/15428877-20090430-02.

Reference Type DERIVED
PMID: 19485285 (View on PubMed)

Other Identifiers

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KA 05/244

Identifier Type: -

Identifier Source: org_study_id