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Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

Sponsor
Frederiksberg University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01076309
Collaborator
(none)
60
Enrollment
1
Location
15
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether corneal endothelium cell loss during cataract surgery is higher in patients taking Tamsulosin.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cataract surgery in patients taking Tamsulosin is regarded as more challenging for the surgeon because Intraoperative Floppy Iris Syndrome (IFIS) might occur. However, the question is whether this has any practical implication for the outcomes of surgery. In this study we investigate whether cornea is damage during surgery on Tamsulosin patient. In an observational study 30 cataract patients taking Tamsulosin is compared to 30 patients not taking Tamsulosin, but otherwise similar. Number of patients is based on power calculation.

    Cornea is examined by specular microscopy.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Systemic Sympathetic Alfa-1-a-antagonist Medication (Tamsulosin)
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2010
    Actual Study Completion Date :
    Sep 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Tamsulosin

    Patients taking tamsulosin
    Non-tamsulosin

    Patients not taking tamsulosin.

    Outcome Measures

    Primary Outcome Measures

    1. corneal endothelium cell loss [3 months]

      Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • cataract needing surgery
    Exclusion Criteria:

    • glaucoma

    • corneal scarring

    • diabetes

    • uveitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Frederiksberg University Hospital Frederiksberg Denmark 2000

    Sponsors and Collaborators

    • Frederiksberg University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01076309
    Other Study ID Numbers:
    • FH4
    First Posted:
    Feb 26, 2010
    Last Update Posted:
    Jul 21, 2011
    Last Verified:
    Jan 1, 2010
    Keywords provided by , ,
    cataract surgery
    tamsulosin
    endothelium cell
    Additional relevant MeSH terms:
    Cataract
    Capsule Opacification

    Study Results

    No Results Posted as of Jul 21, 2011