Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

Cataract Clinical Trial

Official title:

Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Systemic Sympathetic Alfa-1-a-antagonist Medication (Tamsulosin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076309
• Other study ID #: FH4
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: July 19, 2011
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: January 2010
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cataract needing surgery

Exclusion Criteria:

• glaucoma

• corneal scarring

• diabetes

• uveitis

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Locations

Country	Name	City	State
Denmark	Frederiksberg University Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corneal endothelium cell loss	Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.	3 months	No