Contact information
Type
Scientific
Primary contact
Miss Louisa Wickham
ORCID ID
Contact details
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
+44
Louisa.Wickham@moorfields.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0141156884
Study information
Scientific title
Acronym
Study hypothesis
To compare post-operative pain following vitreoretinal surgery using 2 different surgical systems.
Ethics approval
Obtained in March 2005, ref no 05/Q0602/21
Study design
Single blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Post operative pain
Intervention
20-gauge system vs new 25-gauge transconjunctival system
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Post-operative pain scores using verbal and visual analogue scales
2. Use of post-operative analgesia
Secondary outcome measures
Post operative pain
Added April 2008:
1. Time taken to perform surgical procedure
2. Post operative inflammation
3. Per-operative and post-operative complications
Overall trial start date
01/03/2005
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Added April 2008:
1. Patients with suitable pathology for the 25 gauge system eg macula hole, epiretinal membrane, vitreous opacities
2. Primary vitrectomy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50 vitrectomy patients: 25 intervention and 25 controls
Participant exclusion criteria
Added April 2008:
1. Previous vitrectomy
2. Unwilling to accept randomisation
3. Unable to give informed consent
4. Pre-operative inflammation
Recruitment start date
01/03/2005
Recruitment end date
01/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Moorfields Eye Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19713199
Publication citations
-
Results
Wickham L, Bunce C, Kwan AS, Bainbridge J, Aylward GW, A pilot randomised controlled trial comparing the post-operative pain experience following vitrectomy with a 20-gauge system and the 25-gauge transconjunctival system., Br J Ophthalmol, 2010, 94, 1, 36-40, doi: 10.1136/bjo.2008.153411.