Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/04/2015
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

Dr A Ang

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0547145274

Study information

Scientific title

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

Acronym

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Orbitant implants

Intervention

Hydroxyapatite versus Medpor

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Rate of complication within the first 3 months post surgery.

Secondary outcome measures

Number of additional unplanned surgical procedures in that period.

Overall trial start date

01/10/2003

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients having an eyeball removed and having orbital implants inserted at the same operation.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Patients who are having implants inserted in a secondary procedure.

Recruitment start date

01/10/2003

Recruitment end date

01/10/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
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

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