NCT01072253

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

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

February 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

February 18, 2010

Last Update Submit

February 19, 2010

Conditions

Eye CancerPainful Blind EyePanophthalmiaTraumas

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

Study Arms (1)

eye amputated

lost an eye

Procedure: eye amputation

Interventions

eye amputationPROCEDURE
eye amputated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Included in this study were patients who came to the clinical investigation, who accepted to receive questionnaires and were alive in 2008.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience and pharmacology, section of eye pathology

Copenhagen, Seland, DK- 2200, Denmark

Location

Related Publications (2)

  • Roed Rasmussen ML, Prause JU, Johnson M, Toft PB. Phantom eye syndrome: types of visual hallucinations and related phenomena. Ophthalmic Plast Reconstr Surg. 2009 Sep-Oct;25(5):390-3. doi: 10.1097/IOP.0b013e3181b54b06.

    PMID: 19966655BACKGROUND

  • Rasmussen ML, Prause JU, Johnson M, Kamper-Jorgensen F, Toft PB. Review of 345 eye amputations carried out in the period 1996-2003, at Rigshospitalet, Denmark. Acta Ophthalmol. 2010 Mar;88(2):218-21. doi: 10.1111/j.1755-3768.2008.01435.x. Epub 2008 Dec 24.

    PMID: 19141150BACKGROUND

MeSH Terms

Conditions

Eye NeoplasmsWounds and Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEye Diseases

Study Officials

  • Marie Louise R Rasmussen, MD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Peter B Toft, MD, DMSc

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 22, 2010

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

DK(1)