Lateral tarsal strip and everting sutures vs lateral tarsal strip and Jones procedure for involutional entropion: 2 year prospective randomized controlled trial
| ISRCTN | ISRCTN29030032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29030032 |
| Secondary identifying numbers | N0436186550 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 29/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr David F Gilmour
Scientific
Scientific
Ophthalmology Department
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | This trial will compare two methods of surgically correcting age-related in-turning of the eyelid (involutional entropion) and address the following: which is the commonest malposition of the eyelid seen in our practice? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Eye Diseases: Involutional entropion |
| Intervention | Questionnaire. Lateral tarsal strip and everting sutures compared to lateral tarsal strip and Jones procedure. |
| Intervention type | Other |
| Primary outcome measure | The functional (absence of symptoms) cosmetic (patient satisfaction with appearance) and anatomical ( as assessed by surgeon) success of the procedure at final follow up visit. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 22/06/2006 |
| Overall study end date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Participant inclusion criteria | 1. Patients older than 60 years of age with primary involutional lower lid entropion 2. Patients suitable for local anaesthetic 3. Patients able to consent for the procedure |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 22/06/2006 |
| Recruitment end date | 01/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ophthalmology Department
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, 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
Leeds Teaching Hospitals NHS Trust
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 |
