Porous vs nonporous enucleation implants: a randomised study

ISRCTN ISRCTN27193180
DOI https://doi.org/10.1186/ISRCTN27193180
Secondary identifying numbers N0207158225
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
22/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bertil Damato
Scientific

St Paul's Eye Unit
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Phone +44 (0)151 706 3965
Email bertil.damato@btinternet.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titlePorous vs nonporous enucleation implants: a randomised study
Study objectivesThe aim of this study is to compare patient satisfaction and incidence of complications associated with porous and non-porous enucleation implants.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Eye
InterventionRandomised, prospective study
Intervention typeProcedure/Surgery
Primary outcome measurePatient comfort, satisfaction and complications according to type of orbital implant after enucleation for ocular melanoma.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/2004
Completion date01/07/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants300
Key inclusion criteriaApproximately 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.
Key exclusion criteria1. Previous treatment
2. Evidence of systematic malignancy
3. Inability to complete written questionnaires measuring quality of life
4. Overseas residence beyond the British Isles
Date of first enrolment01/07/2004
Date of final enrolment01/07/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Royal Liverpool and Broadgreen University Hospitals Trust

No information available

NHS R&D Support Funding - No External Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2017 22/01/2019 Yes No

Editorial Notes

22/01/2019: Publication reference added
18/11/2016: No publications found in PubMed, verifying study status with principal investigator.