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
  Purpose

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.


Condition Intervention
Eye Cancer
Painful Blind Eye
Panophthalmia
Traumas
Procedure: eye amputation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life of Eye Amputated Patients in Denmark

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Health related quality of life [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: February 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
eye amputated
lost an eye
Procedure: eye amputation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072253

Locations
Denmark
Department of Neuroscience and pharmacology, section of eye pathology
Copenhagen, Seland, Denmark, DK- 2200
Sponsors and Collaborators
University of Copenhagen
Velux Fonden
The Danish Eye Research foundation
Investigators
Principal Investigator: Marie Louise R Rasmussen, MD University of Copenhagen
Study Director: Peter B Toft, MD, DMSc University of Copenhagen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01072253     History of Changes
Other Study ID Numbers: Velux270479
Study First Received: February 18, 2010
Last Updated: February 19, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Eye Neoplasms
Neoplasms by Site
Neoplasms
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014