Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

This study has been completed.
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01076309
First received: February 25, 2010
Last updated: July 19, 2011
Last verified: January 2010
  Purpose

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


Condition
Cataract

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)
Groups/Cohorts
Tamsulosin
Patients taking tamsulosin
Non-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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076309

Locations
Denmark
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
ClinicalTrials.gov 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
tamsulosin
endothelium cell

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014