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
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 |
|---|---|
| Louisa.Wickham@moorfields.nhs.uk |
Study information
| Study design | Single blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/2005 |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 50 vitrectomy patients: 25 intervention and 25 controls |
| 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
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
