NCT00472888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
Last Updated

May 14, 2007

Status Verified

May 1, 2007

First QC Date

May 10, 2007

Last Update Submit

May 10, 2007

Conditions

Pupil ConstrictionIris FloppinessIris Prolapsus From the Wound

Keywords

Alpha-adrenergic blockerscataract surgerypseudoexfoliation syndromediabetes mellitushypertensionpupil

Eligibility Criteria

Age28 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with the diagnosis of cataract who were decided to have phacoemulsification

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University, Faculty of Medicine, Department of Ophthalmology

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 15899440BACKGROUND

  • 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.

    PMID: 16950249BACKGROUND

  • 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.

    PMID: 19485285DERIVED

MeSH Terms

Conditions

MiosisExfoliation SyndromeDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Pupil DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsIris DiseasesUveal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Rana Altan-Yaycioglu, MD

    Baskent University, Faculty of Medicine, Department of Ophthalmology

    STUDY CHAIR

  • Yonca A Akova, MD

    Baskent University, Faculty of Medicine, Department of Ophthalmology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 14, 2007

Study Start

November 1, 2005

Study Completion

November 1, 2006

Last Updated

May 14, 2007

Record last verified: 2007-05

Locations

TU(1)