Quality of Life of Eye Amputated Patients in Denmark | NCT01072253

Studies
Quality of Life of Eye Amputated Patients in Denmark

NCT01072253

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Feb 22, 2010Estimated

Enrollment

152Actual

Phase

Not provided

Conditions

Eye Cancer
Painful Blind Eye
Panophthalmia
Traumas

Interventions

eye amputation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2008Actual

Completion Date

Not provided

First Submitted Date

Feb 18, 2010

First Submission Date that Met QC Criteria

Feb 19, 2010

First Posted Date

Feb 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2010

Last Update Posted Date

Feb 22, 2010Estimated

Name	Class
Velux Fonden	OTHER
The Danish Eye Research foundation	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

152Actual

Label	Type	Description	Intervention Names
eye amputated		lost an eye	Procedure: eye amputation

Name	Type	Description	Arm Group Labels	Other Names
eye amputation	Procedure		eye amputated

Measure	Description	Time Frame
Health related quality of life

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie Louise R Rasmussen, MD	University of Copenhagen	Principal Investigator
Peter B Toft, MD, DMSc	University of Copenhagen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neuroscience and pharmacology, section of eye pathology		Copenhagen	Seland	DK- 2200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19966655	Background	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.
19141150	Background	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.

ID	Term
D005134	Eye Neoplasms
D014947	Wounds and Injuries

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D005128	Eye Diseases