Quality of Life of Eye Amputated Patients in Denmark

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01072253
• Collaborator: Velux Fonden (Other), The Danish Eye Research foundation (Other)
• Enrollment: 152
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Cancer; Painful Blind Eye; Panophthalmia; Traumas	Procedure: eye amputation

Study Design

• Study Type: Observational
• Actual Enrollment: 152 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Quality of Life of Eye Amputated Patients in Denmark
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
eye amputated lost an eye	Procedure: eye amputation

Outcome Measures

Primary Outcome Measures

1. Health related quality of life []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT01072253
• Other Study ID Numbers: Velux270479
• First Posted: Feb 22, 2010
• Last Update Posted: Feb 22, 2010
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Eye Neoplasms

Study Results

No Results Posted as of Feb 22, 2010