Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

This study has been completed.
Information provided by:
Frederiksberg University Hospital Identifier:
First received: February 25, 2010
Last updated: July 19, 2011
Last verified: January 2010
The purpose of this study is to determine whether corneal endothelium cell loss during cataract surgery is higher in patients taking Tamsulosin.


Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • corneal endothelium cell loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Patients taking tamsulosin
Patients not taking tamsulosin.

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.


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for catarct surgery.

Inclusion Criteria:

  • cataract needing surgery

Exclusion Criteria:

  • glaucoma
  • corneal scarring
  • diabetes
  • uveitis
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Please refer to this study by its identifier: NCT01076309

Frederiksberg University Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
  More Information

No publications provided

Responsible Party: Allan Storr-Paulsen, Frederiksberg University Hospital Identifier: NCT01076309     History of Changes
Other Study ID Numbers: FH4
Study First Received: February 25, 2010
Last Updated: July 19, 2011
Health Authority: Denmark: National Board of Health

Keywords provided by Frederiksberg University Hospital:
cataract surgery
endothelium cell

Additional relevant MeSH terms:
Capsule Opacification
Eye Diseases
Lens Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents processed this record on November 27, 2015