Quality of Life of Eye Amputated Patients in Denmark

This study has been completed.

Sponsor:

Collaborators:

Velux Fonden

The Danish Eye Research foundation

Information provided by:

University of Copenhagen

ClinicalTrials.gov Identifier:

NCT01072253

First received: February 18, 2010

Last updated: February 19, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2010

Last Updated Date

February 19, 2010

Start Date ^ICMJE

February 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Health related quality of life [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01072253 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Quality of Life of Eye Amputated Patients in Denmark

Official Title ^ICMJE

Quality of Life of Eye Amputated Patients in Denmark

Brief Summary

The purpose of this study is to evaluate eye amputated patients health related quality of life, perceived stress, self-rated health, labour marked participation and socio-economic position.

The investigators hypothesis is that quality of life, perceived stress and self- rated health of many eye amputated patients are drastically changed. Eye amputation has a marked negative influence on labour marked participation and socio-economic position of the patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

eye clinic Rigshospitalet, Denmark. Rigshospitalet is a public, regionalized and national specialized hospital with a recruitment area of Eastern Denmark (approximately 2 million people). Nearly all cases of eye amputation and cancer in the eye region in Eastern Denmark are performed at Rigshospitalet

Condition ^ICMJE

Eye Cancer
Painful Blind Eye
Panophthalmia
Traumas

Intervention ^ICMJE

Procedure: eye amputation

Study Group/Cohort (s)

eye amputated

lost an eye

Intervention: Procedure: eye amputation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

152

Completion Date

Not Provided

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Inclusion criteria were operation for evisceration, enucleation, orbital exenteration or secondary implantation of an orbital implant during the period 1996-2003. 267 patients were in 2005 invited to a clinical investigation and of those 173 accepted.
Included in this study were patients who came to the clinical investigation, who accepted to receive questionnaires and were alive in 2008.

Exclusion Criteria:

Dead
Below 18 years
Left the country
Living at Greenland or the Faeroe Islands

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01072253

Other Study ID Numbers ^ICMJE

Velux270479

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Copenhagen

Collaborators ^ICMJE

Velux Fonden
The Danish Eye Research foundation

Investigators ^ICMJE

Principal Investigator:	Marie Louise R Rasmussen, MD	University of Copenhagen
Study Director:	Peter B Toft, MD, DMSc	University of Copenhagen

Information Provided By

University of Copenhagen

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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