NCT01076309

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 21, 2011

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

February 25, 2010

Last Update Submit

July 19, 2011

Conditions

Cataract

Keywords

cataract surgerytamsulosinendothelium cell

Outcome Measures

Primary Outcomes (1)

  • corneal endothelium cell loss

    Corneal endothelium cells was evaluated by specular microskopy before and 3 month post-operatively.

    3 months

Study Arms (2)

Tamsulosin

Patients taking tamsulosin

Non-tamsulosin

Patients not taking tamsulosin.

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for catarct surgery.

You may qualify if:

  • cataract needing surgery

You may not qualify if:

  • glaucoma
  • corneal scarring
  • diabetes
  • uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederiksberg University Hospital

Frederiksberg, Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 21, 2011

Record last verified: 2010-01

Locations

DK(1)