Porous vs nonporous enucleation implants: a randomised study
| ISRCTN | ISRCTN27193180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27193180 |
| Protocol serial number | N0207158225 |
| Sponsor | Department of Health |
| Funders | Royal Liverpool and Broadgreen University Hospitals Trust, NHS R&D Support Funding - No External Funding |
- 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
Scientific
St Paul's Eye Unit
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
| Phone | +44 (0)151 706 3965 |
|---|---|
| bertil.damato@btinternet.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Porous vs nonporous enucleation implants: a randomised study |
| Study objectives | The 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) studied | Surgery: Eye |
| Intervention | Randomised, prospective study |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Patient comfort, satisfaction and complications according to type of orbital implant after enucleation for ocular melanoma. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 300 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Paul's Eye Unit
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
