Clinical Factors Associated Floppy Iris

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00472888

Enrollment

500

Registered

2007-05-14

Start date

2005-11-30

Completion date

2006-11-30

Last updated

2007-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iris Floppiness, Iris Prolapsus From the Wound, Pupil Constriction

Keywords

Alpha-adrenergic blockers, cataract surgery, pseudoexfoliation syndrome, diabetes mellitus, hypertension, pupil

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.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

28 Years to 90 Years

Healthy volunteers

Yes

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.

Countries

Turkey (Türkiye)

Outcome results