Quality of Life of Eye Amputated Patients in Denmark

February 19, 2010 updated by: University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Seland
      • Copenhagen, Seland, Denmark, DK- 2200
        • Department of Neuroscience and pharmacology, section of eye pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
eye amputated
lost an eye
Procedure: eye amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Health related quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (ESTIMATE)

February 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2010

Last Update Submitted That Met QC Criteria

February 19, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Velux270479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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