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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014