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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27861329 (added 22/01/2019)