Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
02/09/2009
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

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 (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

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

  1. 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.

Additional files

Editorial Notes