A pilot randomised controlled trial comparing the post-operative pain experience following vitrectomy with a 20-gauge system and the new 25-gauge transconjunctival system

ISRCTN ISRCTN66846344
DOI https://doi.org/10.1186/ISRCTN66846344
Secondary identifying numbers N0141156884
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
02/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Louisa Wickham
Scientific

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Phone +44
Email Louisa.Wickham@moorfields.nhs.uk

Study information

Study designSingle blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo compare post-operative pain following vitreoretinal surgery using 2 different surgical systems.
Ethics approval(s)Obtained in March 2005, ref no 05/Q0602/21
Health condition(s) or problem(s) studiedSigns and Symptoms: Post operative pain
Intervention20-gauge system vs new 25-gauge transconjunctival system
Intervention typeOther
Primary outcome measure1. Post-operative pain scores using verbal and visual analogue scales
2. Use of post-operative analgesia
Secondary outcome measuresPost operative pain
Added April 2008:
1. Time taken to perform surgical procedure
2. Post operative inflammation
3. Per-operative and post-operative complications
Overall study start date01/03/2005
Completion date01/03/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants50 vitrectomy patients: 25 intervention and 25 controls
Key inclusion criteriaAdded April 2008:
1. Patients with suitable pathology for the 25 gauge system eg macula hole, epiretinal membrane, vitreous opacities
2. Primary vitrectomy
Key exclusion criteriaAdded April 2008:
1. Previous vitrectomy
2. Unwilling to accept randomisation
3. Unable to give informed consent
4. Pre-operative inflammation
Date of first enrolment01/03/2005
Date of final enrolment01/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Moorfields Eye Hospital
London
EC1V 2PD
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

Moorfields Eye Hospital NHS Foundation Trust (UK)

No information available

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2010 Yes No