Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

NCT ID: NCT01076309

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Tamsulosin

Patients taking tamsulosin

No interventions assigned to this group

Non-tamsulosin

Patients not taking tamsulosin.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* cataract needing surgery

Exclusion Criteria

* glaucoma
* corneal scarring
* diabetes
* uveitis
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frederiksberg University Hospital

Locations

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Frederiksberg University Hospital

Frederiksberg, Frederiksberg, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FH4

Identifier Type: -

Identifier Source: org_study_id

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