Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bertil Damato

ORCID ID

Contact details

St Paul's Eye Unit
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 (0)151 706 3965
bertil.damato@btinternet.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0207158225

Study information

Scientific title

Porous vs nonporous enucleation implants: a randomised study

Acronym

Study hypothesis

The aim of this study is to compare patient satisfaction and incidence of complications associated with porous and non-porous enucleation implants.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Eye

Intervention

Randomised, prospective study

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Patient comfort, satisfaction and complications according to type of orbital implant after enucleation for ocular melanoma.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2004

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Approximately 400 patients will be invited to participate, and it is likely that 300 patients will accept. The patients will almost all be aged 20 or more, with the peak age being 60 years.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

1. Previous treatment
2. Evidence of systematic malignancy
3. Inability to complete written questionnaires measuring quality of life
4. Overseas residence beyond the British Isles

Recruitment start date

01/07/2004

Recruitment end date

01/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Paul's Eye Unit
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Liverpool and Broadgreen University Hospitals Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding - No External Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator.