Clinical trial NCT00472888: Clinical Factors Associated Floppy Iris
Official title: Clinical Factors Associated With Floppy Iris Signs: a Prospective Study From Two Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pupil Constriction
Iris Floppiness
Iris Prolapsus From the Wound
Keywords: Alpha-adrenergic blockers
cataract surgery
pseudoexfoliation syndrome
diabetes mellitus
hypertension
pupil
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2007-05-14
Enrollment: 500
Sex: ALL
Minimum age (years): 28
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University, Faculty of Medicine, Department of Ophthalmology
Study officials:
affiliation: Baskent University, Faculty of Medicine, Department of Ophthalmology
name: Rana Altan-Yaycioglu, MD
role: STUDY_CHAIR
affiliation: Baskent University, Faculty of Medicine, Department of Ophthalmology
name: Yonca A Akova, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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. doi: 10.1016/j.survophthal.2006.06.011.
citation: 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.