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 |
| Protocol serial number | N0141156884 |
| Sponsor | Department of Health |
| Funders | Moorfields Eye Hospital NHS Foundation Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 |
|---|---|
| Louisa.Wickham@moorfields.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To 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) studied | Signs and Symptoms: Post operative pain |
| Intervention | 20-gauge system vs new 25-gauge transconjunctival system |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Post-operative pain scores using verbal and visual analogue scales |
| Key secondary outcome measure(s) |
Post operative pain |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key 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 |
| Key exclusion criteria | Added April 2008: 1. Previous vitrectomy 2. Unwilling to accept randomisation 3. Unable to give informed consent 4. Pre-operative inflammation |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
