Eye CancerNCT01072253
Quality of Life of Eye Amputated Patients in Denmark
An observational study of Eye Cancer and Painful Blind Eye, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Cancer, Painful Blind Eye, Panophthalmia
- What is being tested?
- eye amputation
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- Dead
- Below 18 years
- Left the country
- Living at Greenland or the Faeroe Islands
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neuroscience and pharmacology, section of eye pathology
Copenhagen, Seland, DK- 2200
About this study
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.
- Conditions
- Eye Cancer, Painful Blind Eye, Panophthalmia, Traumas
- Being tested
- eye amputation
- Medical subject headings
- Eye Neoplasms, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye amputationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| eye amputated | lost an eye Receives: Procedure: eye amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eye CancerStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden, The Danish Eye Research foundation
- Investigators
- Marie Louise R Rasmussen, MD, Principal investigator, University of CopenhagenPeter B Toft, MD, DMSc, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072253
- Sponsor's protocol ID
- Velux270479
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2010
- Last updated
- 22 Feb 2010
- Results posted
- No
Publications
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.
PubMed 19966655Rasmussen 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.
PubMed 19141150
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Eye Amputated Patients in Denmark
- ClinicalTrials.gov ID
- NCT01072253
- Acronym / sponsor ID
- Velux270479
- Conditions
- Eye Cancer, Painful Blind Eye, Panophthalmia, Traumas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Velux Fonden, The Danish Eye Research foundation
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eye amputated | – | Procedure: eye amputationlost an eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Dead
- Below 18 years
- Left the country
- Living at Greenland or the Faeroe Islands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye amputation | Procedure or surgery | eye amputated |
Primary outcome
Health related quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2010.
- Background: PubMed 19966655Roed 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.
- Background: PubMed 19141150Rasmussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Louise R Rasmussen, MD principal investigator
University of Copenhagen
Peter B Toft, MD, DMSc study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Cancer and Painful Blind Eye, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2010.