A prospective randomised study of the early complication rates of hydroxyapatite versus Medpor orbital implant in the post-enucleation and evisceration socket

ISRCTN ISRCTN55878769
DOI https://doi.org/10.1186/ISRCTN55878769
Secondary identifying numbers N0547145274
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
16/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A Ang
Scientific

Ophthalmology Department
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA prospective randomised study of the early complication rates of hydroxyapatite versus Medpor orbital implant in the post-enucleation and evisceration socket
Study objectivesTo determine in a prospective and randomised manner if hydroxyapatite or Medpor is associated with lower rate of complication in the early post-operative period (ie within 3 months of surgery).
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Orbitant implants
InterventionHydroxyapatite versus Medpor
Intervention typeProcedure/Surgery
Primary outcome measureRate of complication within the first 3 months post surgery.
Secondary outcome measuresNumber of additional unplanned surgical procedures in that period.
Overall study start date01/10/2003
Completion date01/10/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants80
Key inclusion criteriaAll patients having an eyeball removed and having orbital implants inserted at the same operation.
Key exclusion criteriaPatients who are having implants inserted in a secondary procedure.
Date of first enrolment01/10/2003
Date of final enrolment01/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
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

East Norfolk and Waveney Research Consortium - Norfolk and Norwich University, Hospital/Norwich PCT (UK), NHS R&D Support 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