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Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01076309
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:
Frederiksberg University Hospital

Study Description
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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
Cataract

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
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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 : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort
Tamsulosin
Patients taking tamsulosin
Non-tamsulosin
Patients not taking tamsulosin.


Outcome Measures
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Primary Outcome Measures :
  1. corneal endothelium cell loss [ Time Frame: 3 months ]
    Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for catarct surgery.
Criteria

Inclusion Criteria:

  • cataract needing surgery

Exclusion Criteria:

  • glaucoma
  • corneal scarring
  • diabetes
  • uveitis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076309


Locations
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Denmark
Frederiksberg University Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
More Information
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Responsible Party: Allan Storr-Paulsen, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT01076309    
Other Study ID Numbers: FH4
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: January 2010
Keywords provided by Frederiksberg University Hospital:
cataract surgery
tamsulosin
endothelium cell
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Lens Diseases
Eye Diseases