Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin

Completed

• Conditions: Cataract

• Registration Number: NCT01076309
• Lead Sponsor: Frederiksberg University Hospital

Brief Summary

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

Study Timeline

• Study Start: 2009-06
• Status Verified: 2010-01
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• cataract needing surgery

Exclusion Criteria

• glaucoma
• corneal scarring
• diabetes
• uveitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
corneal endothelium cell loss	3 months	Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.

Trial Locations

Locations (1)

Frederiksberg University Hospital; 🇩🇰 Frederiksberg, Denmark