Quality of Life of Eye Amputated Patients in Denmark

Eye Cancer Clinical Trial

Official title:

Quality of Life of Eye Amputated Patients in Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072253
• Other study ID #: Velux270479
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: February 19, 2010
• Start date: February 2008

Study information

• Verified date: February 2010
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Eye Cancer
• Painful Blind Eye
• Panophthalmia
• Traumas

Intervention

Procedure:
• eye amputation

Locations

Country	Name	City	State
Denmark	Department of Neuroscience and pharmacology, section of eye pathology	Copenhagen	Seland

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	The Danish Eye Research foundation, Velux Fonden

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Rasmussen ML, Prause JU, Johnson M, Kamper-Jørgensen 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life			No